U.S.

Food and Drug Administration

USER’S GUIDE
to Cosmetics Direct
(FDA Direct)

March 2024
 User’s Guide

Table of Contents
1 FDA DIRECT .....................................................................................................................................3
1.1 Overview.....................................................................................................................................3
1.2 Account Types ............................................................................................................................3
1.2.1 CDER Direct Account .............................................................................................................3
1.2.2 Cosmetics Direct Account .......................................................................................................3
1.2.3 ‘Combined’ Account – CDER Direct & Cosmetics Direct ........................................................ 3
2 ACCOUNTS ......................................................................................................................................4
2.1 FDA Direct URL: https://direct.fda.gov/ ......................................................................................4
2.2 Account Creation ........................................................................................................................4
2.3 Account Main Page ....................................................................................................................7
2.4 Edit Profile ................................................................................................................................10
2.5 Subaccounts .............................................................................................................................12
2.5.1 Creating A Subaccount: ........................................................................................................12
2.5.2 Managing A Subaccount .......................................................................................................14
3 SUBMISSION INFORMATION........................................................................................................15
3.1 Submission Options..................................................................................................................15
3.2 Submission Statuses ................................................................................................................17
3.3 Submission Header Information ...............................................................................................18
3.4 Submission Help.......................................................................................................................18
4 COSMETIC REGISTRATION AND LISTING..................................................................................21
4.1 Cosmetic Registration and Product Listing SPL ....................................................................... 21
4.1.1 Registering a New Cosmetic Product Facility ....................................................................... 23
4.1.1.1 Save and Validate..........................................................................................................31
4.1.1.2 Submit SPL to FDA........................................................................................................32
4.1.1.3 Submission Accepted ....................................................................................................33
4.1.1.4 Submission Failed .........................................................................................................34
4.1.1.5 Validation Failure ...........................................................................................................35
4.1.2 Amending Cosmetic Product Facility Registration ................................................................ 35
4.1.3 Amending Cosmetic Product Facility Cancellation ............................................................... 36
4.1.4 Biennial Cosmetic Product Facility Registration Renewal .................................................... 36
4.1.5 Abbreviated Cosmetic Product Facility Registration ............................................................. 37
4.2 Cosmetics Product Listing ........................................................................................................37
4.2.1 New Cosmetics Product Listing ............................................................................................37
4.2.2 Create a New Cosmetic Product Listing ............................................................................... 39
4.2.3 Product(s), Ingredient(s), and Facility(ies) ............................................................................ 48
4.2.3.1 Save and Validate..........................................................................................................65
4.2.3.2 Submit SPL to FDA........................................................................................................66
4.2.3.3 Submission Accepted ....................................................................................................66
4.2.3.4 Submission Failed .........................................................................................................67
4.2.3.5 Validation Failure ...........................................................................................................68

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1 FDA DIRECT
1.1 Overview
FDA Direct is the U.S. Food and Drug Administration's web-based and free Structured Product Labeling
(SPL) authoring tool. Previously titled ‘CDER Direct,’ the newly upgraded FDA Direct platform now
includes two modules: CDER Direct and Cosmetics Direct. Users can create separate accounts in CDER
Direct or in Cosmetics Direct, or a single ‘Combined’ account that allows access to both CDER Direct
submissions and Cosmetics Direct submissions.
Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce
Investment Act of 1993, requires that all electronic and information technology (EIT) products and
services developed, acquired, maintained, or used under this contract/order must comply with the
“Electronic and Information Technology Accessibility Provisions” set forth by the Architectural and
Transportation Barriers Compliance Board (also referred to as the “Access Board”) in 36 CFR part 1194.
Information about Section 508 is available at http://www.section508.gov/.

1.2 Account Types

1.2.1 CDER Direct Account

CDER Direct can submit the following types of data directly to the FDA/CDER:
(Not to be used for CVM/CDRH registration and listing)
• Establishment Registration & Drug Listing
o Establishment Registration
o NDC Labeler Code Request
o Drug Listing and Certification
o NDC Reservation
• Outsourcing Facility Registration and Product Reporting
o Outsourcing Drug Facility Registration
o Compounded Drug Reporting
• DSCSA Annual Reporting
o Wholesale Drug Distributor and Third-Party Logistics (WDD/3PL) Provider Reports
o WDD/3PL Facilities
o WDD/3PL Licenses
• Generic Drug Self-Identification
o Generic Facility GDUFA Self-Identification

1.2.2 Cosmetics Direct Account

Cosmetics Direct allows users to submit the following types of data directly to the FDA:
• Registration of Cosmetic Product Facility
• Cosmetic Product Listing

1.2.3 ‘Combined’ Account – CDER Direct & Cosmetics Direct

Combined accounts have access to all CDER Direct and Cosmetics Direct submission types listed in
Sections 1.2.1 and 1.2.2 above and should be used by companies that manufacture/distribute both

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drugs and cosmetics. For help with changing your account type, visit the Section 2.4: Edit Profile.

2 ACCOUNTS
2.1 FDA Direct URL: https://direct.fda.gov/

At the bottom of the Login area, there are Quick Links that can provide you with further assistance on
various topics:
• Resources - Links to the FDA’s Structured Product Labeling (SPL) Resources page, which
includes an extensive list of SPL help documents and information.
• Tutorials - List of walkthrough documentation for various areas of FDA Direct (submissions,
registration, etc).
• FAQs - Frequently asked questions, searchable.
• Help Desk - Email contact for the CDER Direct and Cosmetics Direct helpdesks.

2.2 Account Creation

Follow these steps to create a new account:

1. Navigate to the FDA Direct main page and click Create New Account.

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2. Select your desired account type. This can be changed after account creation:

• CDER Direct – Select this option to register human drug or biological products. You will
have access to all drug-related submission forms including Establishment Registration
and Drug Listing, Outsourcing Facility Registration and Product Reporting, DSCSA
Annual Reporting, and Generic Drug Self-Identification. A complete list of all forms will
be shown upon selecting this option.
• Cosmetics Direct – Select this option to register cosmetic products only. You will have
access to Cosmetic Registration and Listing submission forms. A complete list of all
forms will be shown upon selecting this option.
• Combined – Full access to both Cosmetics Direct and CDER Direct submission forms.
Select this option to register both cosmetic and drug products. This account should be
used by companies that manufacture/distribute both drugs and cosmetics. A complete
list of all forms will be shown upon selecting this option.
3. Fill out your details in the fields that appear:

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*The DUNS field is optional in Cosmetics Direct account creation only.

4. A list of available submission forms will be automatically selected for you at the bottom of the
page. If there are any unwanted submission forms in the list, de-select any of the boxes as
desired:

5. Click the ‘I have read and agree to the Terms and Conditions stated above’ checkbox at the end
of the page. Then click ‘Submit’:

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6. An account activation email will be sent from [email protected] to the email address you used
in Step 3. Activation links are valid for 48 hours. If your link has expired, you must re-do Steps 1-
5 above.
*Activation email missing or delayed: Check your spam/junk folder first. There may also be a
slight delay for DUNS verification, if entered.
If you still have not received your activation email after 5-10 minutes, you can contact the Help
Desk at:
• [email protected] (CDER Direct, Combination accounts)
OR
• [email protected] (Cosmetics Direct accounts)
7. Click the link in the activation email and enter an account username, password, and 3 security
questions:

8. Click ‘Submit’ when all fields have been filled.

9. Check your email inbox for an ‘Account Activated’ email as confirmation. This email will contain
your username and a link to FDA Direct. Once you have received this email, you may now log in
to FDA Direct.

2.3 Account Main Page

Once you have completed account activation, return to the FDA Direct main page at direct.fda.gov.

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To log in to FDA Direct and access your account:

1. Enter your username and password.
2. Check the ‘I accept the Terms of Service’ box and a warning banner will display. Then click ‘I
Agree’.

3. Click the ‘Login’ button. If this is your first time logging in for the day, you will be redirected to a
verification page:

4. Check your email for a one-time passcode (OTP). Enter the number into the OTP field and check
the box ‘Remember this device for 8 hours.’ This will prevent the verification step from
appearing within an 8-hour timeframe. If you do not check the box, you must re-do this
verification step every single time you log in to FDA Direct. Please note, if this is the first time
logging in, you are required to verify your email address to use the OTP functionality.
Therefore, you may not see the OTP feature when you sign in for the first time.
IMPORTANT: All accounts are subject to a 30-minute session timeout. If you are inactive for
longer than 30 minutes, you will automatically be logged out of FDA Direct.
5. Click ‘Submit.’ You will then be taken to your account homepage.
6. If you have a Cosmetics account or a Combined account, a Paperwork Reduction Act (PRA) banner
will display. Click ‘OK’ to continue.
7. Your homepage will display all your submissions. If you are a first-time user, this area will be
empty.

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• The left menu displays all available submission forms in FDA Direct. Access to certain
forms is limited based on both your account type (Cosmetic/CDER/Combined) and any
de-selections made in Step 4 of Account Creation. Greyed out areas of the menu
indicate you do not have access to a particular form or group of forms.
• The ‘Self Help’ section links to the FEI Portal (FEI number lookup), Dun & Bradstreet
(DUNS number lookup), FDA Direct tutorials/user guides, and other useful
information.
• The ‘Manage Account’ section allows you to edit your profile (such as changing
account type or account information) and manage your users.

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2.4 Edit Profile

To change your account type (Cosmetics Direct, CDER Direct, or Combined) log in to FDA Direct.
Scroll down to the bottom of the page. Click ‘Edit User Profile’ under the Manage Account section on
the left side:

*The ‘Manage Users’ option only displays for certain account types. See Section 2.5 for more
information.
Select the desired account type:

*If you are converting from a Cosmetics Direct account to a CDER Direct or Combined account, you
must enter a valid DUNS number to successfully switch accounts.
You can modify the following in the next section:
• Contact Information
• Organization Information
• Security Questions – Click ‘Change Password’ at the bottom of this section to change your
password.

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Finally, inspect your form accesses and check/uncheck form boxes as desired:

Click ‘Submit’ to finalize all changes made, or ‘Cancel’ to abandon your changes.

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2.5 Subaccounts

If you are the first person to create an account for your organization, you are considered an ‘Admin’
user by default. Only Admin users can create subaccounts, which are limited-access accounts for
other users within your organization. Subaccounts can be customized in a few ways:
• Form Access: Subaccounts can be limited to one or many submission forms.
• User Roles: Subaccounts can have either ‘User’ or ‘Admin’ roles.
• Status: Subaccounts can be inactivated by Admin users at any time. Inactivated accounts can
also be reactivated.
Log in to FDA Direct. Scroll to the bottom of your account main page and select ‘Manage Users’ under
the Manage Account section:

If you have already created subaccounts, they will display in a list. Otherwise, the page will be empty:

2.5.1 Creating A Subaccount:

1. Click the ‘Create Subaccount’ button

2. Enter all required fields for the subaccount user:

3. Select the ‘User Role’ in the dropdown. This will determine whether the subaccount will have
full access (Admin) or limited access (User).

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4. Select which forms the subaccount will have access to. This view will differ based on your
organizational account type, which is modifiable in the Section 2.4: Edit Profile section. Click the
form checkboxes then click ‘Submit.’

5. Subaccount creation confirmation will display at the top of the page, and the new user will be
listed immediately:

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6. An activation email is sent to the subaccount user’s email. The Username field will remain
empty until the account has been activated.

2.5.2 Managing A Subaccount

To edit a user’s details, including their email and role, click the pencil icon to the far left of the user’s
entry:

You may edit the following information on this page:

• Inactivate/Reactivate Account - Select the ‘Status’ dropdown and choose ‘Inactive.’ To
reactivate an inactive account, choose ‘Active.’ Inactivating an account will prevent the user
from logging in and accessing organizational data. Subaccounts cannot be deleted.
• User Roles – Select the ‘User Role’ dropdown and choose either ‘Admin’ or ‘User.’ Admins have
the ability to create and manage subaccounts, while Users do not.
• Contact Information – All fields are editable.
• Form Access – To limit users to specific forms, check or uncheck the boxes. Unchecked boxes
will show as greyed out text on the subaccount user’s homepage and will not be clickable.

Click ‘Submit’ to confirm changes.

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3 SUBMISSION INFORMATION
Please read this section fully before starting a submission!
This section contains general submission information that applies to all account types (Combined,
CDER Direct, Cosmetics Direct).

3.1 Submission Options

There are three ways in FDA Direct to submit information to the FDA:
1. Create a new submission via the standard SPL submission templates in FDA Direct.
Recommended if you have never submitted an establishment registration, product listing, etc.
FDA Direct has several blank templates available for different types of submissions. See
Sections 4 – 8 for walkthroughs based on specific submission types.
2. ‘Clone’ or copy a previously submitted FDA Direct SPL submission.
Recommended if you have previously submitted using one of the templates in FDA Direct and
your submission was accepted by the FDA. An exact copy of your previous submission will be
generated, and you can make updates as needed.
To clone a submission:
a. Navigate to the main page and click the most recent submission with the ‘Submission
Accepted’ status:

b. Click ‘Create New Version’ at the top of the page:

c. Make any necessary changes, then return to the top and click ‘Submit.’
3. Upload an FDA-accepted SPL submission file using a third-party tool.
Recommended if you already have a completed submission file (SPL) that is ready for
submission to the FDA. The file must be in XML format and compressed into a zip file. Changes
can be made to the file once it has been uploaded to FDA Direct.
To upload a completed file into FDA Direct:

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a. Select your submission category from the menu on the left:

b. Click ‘Create New/Upload File’:

c. Select the ‘Import an existing’ option then click ‘Continue’:

d. Click the upload area to select a submission file (SPL) from your computer, or drag the
file from your computer onto this area:

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e. Once the file has been selected from your computer, click the ‘Upload’ button:

f. Your file will be ready for editing. Make any changes necessary.
g. For more information on editing existing data in your uploaded SPL submission file or
how to add new details, skip to the appropriate walkthrough (Sections 4 – 8) of this
guide.

3.2 Submission Statuses

Your submissions will always be in one of the following statuses:

• Draft – An in-progress submission that has been started but has not been sent to the FDA.
• Awaiting Acceptance - A submission that is sent but is pending approval/rejection by the FDA.
Displays right after an SPL has been submitted. No changes can be made after the SPL is sent,
but the submission is viewable.
• Validation In Progress: A submission that is being screened and pre-validated for potential
errors prior to being sent to the FDA. This status will display after clicking ‘Save And Validate,’
and will typically last only a few minutes before changing to ‘Validation Failure’ or ‘Ready For
Submission.’
• Ready For Submission: A submission that has passed the initial screening and pre-validation
check and is ready to be sent to the FDA. If you receive this status after clicking ‘Save And
Validate,’ you must open your submission and click ‘Submit’ to complete the process.
• Submission Accepted – A submission that has been accepted by the FDA.
o For NDC labeler code requests only: If you did not enter the optional labeler details in
an initial NDC Labeler Code Request submission, you will receive an email from the FDA
to supply the data.
• Submission Failed – A submission that has not been accepted by the FDA’s automated
validations and has been rejected. You must open your submission to review error messages
and update the data to correct them. Submit again and your submission will once again be in
‘Awaiting Acceptance’ Status.
• Submission Override – If you are unable to resolve a failed submission because you are
correcting a previous error, the data may need to be manually loaded. A manual override

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request can be forwarded to the following email addresses:

o [email protected] for non-GDUFA related documents
o [email protected] for GDUFA documents
A manual override is a lengthy process and may need approval from the respective FDA
component before the data is loaded. If your request is granted, the file will be accepted by the
FDA. A successfully overridden submission will change to the ‘Submission Successful’ status.

3.3 Submission Header Information

At the top of every submission is a pre-generated set of information:

1. Set ID: A ‘Globally Unique Identifier’ (GUID) that remains the same for each submission
‘set,’ which is a group of submission versions. When you submit a different version of a
submission, the set ID stays the same through each new version.
2. Root ID: A GUID that is generated uniquely for every single submission that is submitted
to the FDA. When you create a new submission or submit a new version of a previous
submission, the root ID will change every time (unlike the set ID).
3. Version Number: A number greater than zero that provides a sequence to the versions
of the document. Any number can be inputted here, and the next version will
automatically continue upward from that number (ex: 23, 24, 25, etc).
4. Effective Date: The date this form is created.

3.4 Submission Help

There are many ways to find assistance during the submission process:
1. Help Text/Tool Tips: You can click on the underlined title text beside every field in any FDA
Direct submission. An informational box will display to help you understand what to enter into
each field:

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2. Tutorials/User Guide: This User Guide provides complete and detailed information on all
aspects of FDA Direct. It is recommended for first-time users of FDA Direct.
Tutorials will show you how to complete specific actions like creating an account or submitting
a drug product listing. They are less detailed than this User Guide, and in slideshow format.
Recommended for users familiar with FDA Direct who may want a quick refresher.
Both the User Guide and tutorials can be found in two places:
a. In the Quick Links section below the login area on the FDA Direct homepage:

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b. Under the Self Help section on the left menu (after you log in):

3. Resources: Useful links to official submission-related guidance, DUNS & FEI numbers, and so on.
4. FAQs: Answers to the most commonly asked questions about FDA Direct. You can use the
keyword search bar at the top of the page to find a question related to your issue. The user
guide, tutorials, and other helpful information can also be accessed from this page (right side
menu).

5. Help Desk: If none of the above resources can help with a particular error or question, you may
contact the Help Desk at either [email protected] (CDER Direct, Combination accounts),
or [email protected] (Cosmetics Direct accounts).

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4 COSMETIC REGISTRATION AND LISTING

4.1 Cosmetic Registration and Product Listing SPL

On December 29, 2022, the President signed the Consolidated Appropriations Act, 2023 (Pub. L. 117-
328) into law, which included the Modernization of Cosmetics Registration Act of 2022 (MoCRA).
Among other provisions, MoCRA added section 607 to the Federal Food, Drug, and Cosmetic Act
(FD&C Act), establishing requirements for cosmetic product facility registration and cosmetic product
listing.
Section 607(a) of the FD&C Act requires every person that owns or operates a facility that engages in
the manufacturing or processing of a cosmetic product for distribution in the United States to register
each facility with FDA. Section 607(c) of the FD&C Act requires that for each cosmetic product, the
responsible person submit to FDA “a cosmetic product listing.” Certain small businesses, as defined in
section 612 of the FD&C Act, are exempt from the registration and listing requirements. Click here to
learn more about MoCRA.
This free tool allows you to create and submit the following types of data directly to the FDA:
Registration of Cosmetic Product Facility and Cosmetic Product Listing. This system will provide
information to FDA about cosmetic product manufacturers/processors and cosmetic products on the
market.

The Cosmetic Registration and Listing SPL submission template can be used for the following purposes:
Document Types
• Cosmetic Facility Registration (INITIAL): Every person that, on December 29, 2022, owns or
operates a facility that engages in the manufacturing or processing of a cosmetic product for
distribution in the United States must register each facility no later than December 29, 2023
(section 607(a)(1)(A) of the FD&C Act).
Every person that owns or operates a facility that first engages, after December 29, 2022, in
manufacturing or processing of a cosmetic product for distribution in the United States, must
register such facility within 60 days of first engaging in such activity or by February 27, 2024,
whichever is later (section 607(a)(1)(B) of the FD&C Act).
o PLEASE NOTE: Cosmetic Facility Registration (Initial) is preselected when entering the
SPL application.
o Additional note: On November 8, 2023, FDA issued a guidance for industry titled
“Compliance Policy for Cosmetic Product Facility Registration and Cosmetic Product

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Listing.” This guidance explains that FDA does not intend to enforce the requirements
under section 607 of the FD&C Act related to cosmetic product facility registration until
July 1, 2024.
• Cosmetic Facility Registration (ABBREVIATED REGISTRATION RENEWAL): FDA is providing for
an abbreviated renewal of registrations when there have not been any updates to the
registration since the most recent facility registration submission, as required under section
607(a)(4) of the FD&C Act.
• Cosmetic Facility Registration (AMENDMENT): Every person who is required to register must
update their registration within 60 days of any changes to the information required for
registration (section 607(a)(4) of the FD&C Act) (an “amended” registration). This includes any
changes that result in cancellation of the registration.
• Cosmetic Facility Registration (BIENNIAL REGISTRATION RENEWAL): Every person who is
required to register a facility must renew such registration biennially (i.e., every two years)
(section 607(a)(2) of the FD&C Act).
• Cosmetic Facility Registration (CANCELLATION): Every person who is required to register must
update their registration within 60 days of any changes to the information required for
registration (section 607(a)(4) of the FD&C Act). This includes any changes that result in
cancellation of the registration.
Product Listing
• COSMETIC-(INITIAL): The responsible person of a cosmetic product that is marketed on
December 29, 2022, must submit a cosmetic product listing, or ensure such submission is made,
not later than December 29, 2023, or for a cosmetic product that is first marketed after
December 29, 2022, within 120 days of marketing such product in interstate commerce (section
607(c)(2) of the FD&C Act). Consistent with the approach for registration of a facility that starts
manufacturing or processing cosmetic products after December 29, 2022 (section 607(a)(1)(B)
of the FD&C Act), FDA expects the product listing for a cosmetic product to be submitted within
120 days after marketing the product, or within 120 days after December 29, 2023, whichever
is later.
o PLEASE NOTE: On November 8, 2023, FDA issued a guidance for industry titled
“Compliance Policy for Cosmetic Product Facility Registration and Cosmetic Product
Listing.” This guidance explains that FDA does not intend to enforce the requirements
under section 607 of the FD&C Act related to cosmetic product listing until July 1, 2024.
o PLEASE NOTE: Cosmetic (Initial) is preselected when entering the SPL application form.
• COSMETIC-ABBREVIATED RENEWAL: FDA is providing for an abbreviated process for the
renewal of any cosmetic product listing, as required under section 607(c)(3), for which there
has been no change since the responsible person submitted the previous listing.
o PLEASE NOTE: When making this selection an ALERT box will appear, “By selecting this
document type, you are certifying that no changes have been made to your product
listing since the previous listing was submitted”.

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• COSMETIC-UPDATE (CHANGES TO LISTING or DISCONTINUATION OF LISTING) (annual):

The responsible person must provide any updates to such listing annually (CHANGES TO LISTING
or DISCONTINUATION OF LISTING) (section 607(c)(5) of the FD&C Act). This includes an update
that the product was discontinued.

4.1.1 Registering a New Cosmetic Product Facility

1. Log in to FDA Direct
2. Select ‘Registration of Cosmetic Product Facility’ under Cosmetic Registration and Listing
section:

3. Click ‘Create New/Upload File’:

You will be given two options:

4. Select ‘Create a new Cosmetic Product Facility Registration using a blank form’ then click
‘Continue’:

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5. A blank template will display with required fields marked with a red (*) and optional fields:

6. Selecting the ‘Save As Draft’ button on the top right will save your work without submitting it.
The ‘Return’ button will send you back to the main Establishment Registration SPL page
without saving your changes.

7. Cosmetic Facility Registration (INITIAL) is preselected. The Set ID, Root ID, Version Number,
and Effective Date fields will always auto-populate:

Select words are underlined and provide definitions; select them to open the tool tip.
a. Set ID*: This field is auto generated by the system. The Set ID uniquely identifies a
group of versions of an SPL submission. When an SPL submission changes, a new Root
ID is assigned to the new SPL submission, but the Set ID in the original SPL submission
also is used. The Set ID is a Globally Unique Identifier (GUID). A GUID is a string of
numbers and lower- case letters generated using a specifically defined mathematical
algorithm to ensure a very low probability of identical GUID used in the same system.
An example is: 9aa9d2e6-6982-48e5-831d- dbe7c04a14ed.

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b. Root ID*: This field is auto generated by the system. The Root ID uniquely identifies a
specific SPL file. Each new version of an SPL file has a new id root. The id root is a
Globally Unique Identifier (GUID). A GUID is a string of numbers and lower-case letters
generated using a specifically defined mathematical algorithm to ensure a very low
probability of identical GUID used in the same system. An example is: 9aa9d2e6-6982-
48e5-831d-dbe7c04a14ed.
c. Version Number*: The Version Number gives sequential order to the different versions
of an SPL submission. The version number is a whole number greater than zero, such
as 6, 7, or 8. The version number is increased with each change to the SPL submission.
Enter a number greater than zero (0) in the Version Number field.
d. Effective Date*: The date the submission is created, users can modify it. However, the
system will only use the actual registration date submitted to FDA. It also provides a
date reference to the SPL version. Select the date by clicking on the calendar icon.
Once an SPL has been submitted, this date cannot be edited by users.
8. Fill in all the blank fields in the Registrant Details and Facility Contact Details section:

a. Is this a facility for a small business (optional registration) Yes or No: (Optional) Indicate
whether this registration is for a small business (optional registration) by selecting one
of the options provided. Section 612 of the FD&C Act provides exemptions to certain
small businesses from the requirements of section 607 (Registration and Product
Listing). However, such exemptions from the requirements of section 607 of the FD&C
Act do not apply to any responsible person or facility engaged in the manufacturing or
processing of any of the following products listed in section 612(b) of the FD&C Act:
• (1) Cosmetic products that regularly come into contact with mucus
membrane of the eye under conditions of use that are customary or usual
• (2) Cosmetic products that are injected
• (3) Cosmetic products that are intended for internal use
• (4) Cosmetic products that are intended to alter appearance for more than 24
hours under conditions of use that are customary or usual and removal by the
consumer is not part of such conditions of use that are customary or usual.

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b. Facility Name*: Enter the complete name of the existing facility.

c. Facility FEI Number*: Enter the existing 7 to 10-digit facility FEI number. The FEI
number is a unique identifier assigned by the FDA to identify firms associated with
FDA-regulated products. To facilitate the registration process, the owner or operator of
a facility will need to obtain an FEI number before submitting the facility registration.
• To determine if an entity already has an FEI number, please refer to the FEI
Search Portal.
• If your firm does not have an FEI number assigned by FDA, see “How can I
request an FEI?” at FEI Search Portal.
d. Parent Company Name: (optional field) Enter the parent company's name if available.
e. Facility D&B D-U-N-S Number: (optional field) Enter the existing 9-digit facility DUNS
number. Obtain a DUNS number: https://www.dnb.com
f. Name of the Owner and/or Operator of the Facility*: Enter the facility owner's name
and/or the name of the facility operator.
g. Facility Email*: Enter the facility's email address.
h. Facility Phone Number*: Enter the facility's phone number including the area or the
country code. The format for Phone number should be <Country Code>-<Area Code>-
<Subscriber Number>. For example, in the U.S. the phone number would be 1-999-
9999999 or 1-999-999-9999
i. Facility Country*: Select facility's country name where the facility is physically located.
j. Facility Street Address*: Enter the complete information of the street where the facility
is physically located.
k. Facility City*: Enter the complete name of the city where the facility is physically
located.
l. Facility State or Province: Enter the complete name of the state or province where the
facility is physically located.
m. Facility Zip/Postal Code: Enter the postal code or the zip code where the facility is
physically located.
9. Fill in all the blank fields in the U.S. Agent Contact Information section (for foreign facilities):

a. U.S. Agent Name (for foreign facilities) *: For foreign facilities, enter the business name
of the U.S. agent.
b. U.S. Agent Email (if not available, enter “N/A”) *: For foreign facilities, enter the email
address for the US agent contact person. If email address not available, enter N/A.

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c. U.S. Agent Phone Number (Include Country/Area Code) *: For foreign facilities, enter
the U.S. agent telephone number including the country code and the area code. The
format for Phone number should be <Area Code>-<Subscriber Number>. For example,
in the U.S. the phone number would be 1-999-9999999 or 1-999-999-9999.
d. U.S. Agent Phone Extension: (optional Field) For foreign facilities, enter U.S. agent
phone extension, if any.
PLEASE NOTE: With respect to a foreign facility, a United States agent (“U.S. agent”) is
required for registration purposes. The U.S. agent is the person, which includes an individual
or business entity, that resides in the U.S. or maintains a U.S. place of business and is
physically present in the U.S. A U.S. agent should not be a mailbox, answering machine or
service, or other place where an individual acting as the foreign facility’s agent is not physically
present.
10. To add multiple facility brand names to your SPL template, click the ‘Add Brand Name’ button
in Facility Brand Names section:

11. A blank template titled Brand Information will display. Fill in the required fields and select all
that apply.

a. Brand Name of Cosmetic Product*: Enter brand names under which cosmetic products
manufactured or processed in the facility are sold.
b. Responsible Person (As listed on the label) *: Enter the responsible person name as it
appears on the label.
c. Product Category Code(s) (Select all that apply) *: Select the product category or

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categories for this brand name. Each main product category has a sub-product
category. And some sub-product categories have sub-sub product categories, select
the one that applies to this brand name. (i.e., leave-on or rinse-off).
12. Fill in all the blank fields in the Brand Information section.
13. Select the (+) of Product Category Code(s) and select all that apply:
a. (01) - (16) are Main Product Categories

b. (A) - (K) are Sub Product Categories. If that sub product category has a Sub-
Subcategory, (+) can be selected to display the Sub-Subcategories (select if one or both
apply; if none, leave unselected):
• Leave-on
• Rinse-off

14. Click 'SAVE BRAND’, located at the top right of the page:

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15. The platform will return to the SPL Submission page with the verification banner ‘Product
brand saved.’

Under ‘FACILITY BRAND NAMES’ the inputted information will be present.

To edit the information, select the pencil icon under the ‘EDIT’ column.

16. To add more Brand Names, go to ‘FACILITY BRAND NAMES’ and select ‘ADD BRAND NAME.’
17. In the Confirmation Statement section, fill in the following blank fields:
a. Date: (Optional field) Enter today's date, two-digit month, two-digit day, and four-digit
year.
b. Name of Submitter: (optional field) Enter the full name of the submitter.

18. Click ‘AGREE’ after reading and understanding the confirmation statement:

19. If you would like to list additional contact information for an authorized agent, go to the
‘Additional Contact Information For Authorized Agent’ section and fill in the following blanks:

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a. Additional Contact Name: (optional field) Enter an additional contact information for
individuals associated with the registration.
b. Email: (optional field) Provide the additional contact person’s email address
c. Phone Number (Include Country/Area Code): (optional field) Enter the additional
contact person's phone number including the country code and the area code. The
format for Phone number should be <Country Code>-<Area Code>-<Subscriber
Number>. For example, in the U.S. the phone number would be 1- 999-9999999 or 1-
999-999-9999.
d. Phone Extension: (optional field) Enter additional contact person's phone extension, if
any.
20. Return to the top of the SPL Submission page where you can do the following:

a. ‘SUBMIT SPL’
• Submit SPL will send the submission to FDA for additional validation and
processing.
b. ‘SAVE AS DRAFT’
• Save Draft button allows you to save your work, preserving your progress
without submitting it to the FDA.
• PLEASE NOTE: Click ‘SAVE AS DRAFT’ from any screen during the process of
registering the cosmetic product facility. The system saves all the information
you inputted and will bring you back to the homepage. The status column will
be in ‘DRAFT’.

c. ‘SAVE AND VALIDATE’

• You can check your SPL for an initial validation before submitting to FDA. This
option does not automatically submit your SPL to FDA, even if it passes the
initial validation, but scans for certain errors prior to the actual submission.
d. ‘DELETE’
• Delete will remove the submission from your account.
21. Click ‘RETURN’ at any time to return to the Registration of Cosmetic Product Facility main
page.

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4.1.1.1 Save and Validate

1. Click ‘SAVE AND VALIDATE’ if you want to check for errors within your SPL. To submit your SPL
to FDA, skip to section 4.1.1.2 Submit to FDA.
a. PLEASE NOTE: This option is only for an initial validation of your SPL before submitting
to FDA. It does not automatically submit your SPL to FDA, even if it passes the initial
validation, but scans for certain errors prior to the actual submission. To submit your
data to the FDA, select “Submit SPL”.
2. The Registration of Cosmetic Product Facility homepage will have the following details shown
below. The status of your SPL will be in ‘VALIDATION IN PROGRESS’. A yellow message will
appear across your screen stating, “Additional in-depth validation by the FDA is in progress.
Check back on the status after a few minutes by refreshing the page or logging back into the
system.”

3. Once the system has completed validation, the status, ‘VALIDATION IN PROGRESS’, will change
to ‘READY FOR SUBMISSION’.

a. If the system finds any errors, the status field will change to ‘VALIDATION FAILURE’, see
section 4.1.1.5 Validation Failure for additional details.
4. Click ‘READY FOR SUBMISSION’, the homepage will change to reflect the following:

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a. The system will generate a message stating that, ‘This submission has passed the INITIAL
VALIDATION but has NOT been ACTUALLY SUBMITTED TO FDA. Click ON "SUBMIT SPL" to
SUBMIT.’

4.1.1.2 Submit SPL to FDA

1. Click ‘SUBMIT SPL’ if you are ready to submit your SPL to FDA.

a. A green message will appear across your screen stating, “Your submission has been sent
to FDA for additional validation and processing. Check the status of your submission
after a few minutes by refreshing the page or logging back into the system. You will also
receive an email from FDA when the processing is complete.”

b. The status field should read ‘AWAITING ACCEPTANCE’.

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4.1.1.3 Submission Accepted

1. The status column will change to ‘SUBMISSION ACCEPTED’ after the registration process has
been successfully completed. A ‘SUBMISSION ID’ will be generated automatically when an SPL
is submitted to FDA.
Please Note: A ‘SUBMISSION ID’ does not always mean that the submission was in fact
accepted by FDA. The ‘Submission ID’ will also appear with “Awaiting Acceptance’ and
‘Submission Failure

2. Click on ‘SUBMISSION ACCEPTED’ to VIEW SPL and DOWNLOAD SPL.

a. To clone and create a new version of your successfully submitted SPL, click ‘CREATE A
NEW VERSION’

1. PLEASE NOTE: After selecting, your SPL will be successfully cloned and the
ROOT ID, VERSION NUMBER, and EFFECTIVE DATE will change. All other fields
will retain the same information from the initial successfully submitted SPL.

b. To view your SPL, click ‘VIEW SPL’

c. To download your SPL for your records, click ‘DOWNLOAD SPL’

d. When your submission has been validated and accepted by the FDA. You will receive an
email to your account email address when the submission status changes.

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e. A ‘SUBMISSION ACCEPTED’ status will appear in the status column of your SPL
submission if it has been successfully submitted to the FDA. At this point, the process is
finished and there is no further action needed unless you need to make any changes to
your registration.

4.1.1.4 Submission Failed

1. If the status column changes to ‘SUBMISSION FAILED’, your submission has not passed the
FDA’s requirements and has been rejected.

a. You must open your submission at this stage to review error messages and update your
submission to correct them.

b. Submit again and your submission will once again be ‘AWAITING ACCEPTANCE.’
2. If the status column changes to ‘SUBMISSION ACCEPTED’, refer to section 4.1.1.3 Submission
Accepted for additional information.

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4.1.1.5 Validation Failure

1. After clicking ‘SAVE AND VALIDATE’, the registration of cosmetic product facility home page
will have the following details as shown below. The status column will be in VALIDATION IN
PROGRESS. However, if the system finds any errors the status will change to VALIDATION
FAILURE.

2. Click ‘VALIDATION FAILURE’, the system will provide a list of errors that need to be fixed
before submitting the SPL:

a. After reviewing and fixing the errors, you can select ‘SUBMIT SPL’ to resubmit or ‘SAVE
AND VALIDATE’ to check of any additional errors.

4.1.2 Amending Cosmetic Product Facility Registration

This document type should be selected if you are updating your registration within 60 days of any
changes to the information required for registration (section 607(a)(4) of the FD&C Act)
1. Under Document Type, select ‘COSMETIC PRODUCT FACILITY REGISTRATION –
AMENDMENT’.

2. Repeat the steps from Sections 4.1.1 – 4.1.1.1.

3. Refer to the steps from Sections 4.1.1.2 – 4.1.1.5 for Submit to FDA instructions.

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4.1.3 Amending Cosmetic Product Facility Cancellation

This document type should be selected if you are updating your registration within 60 days of any
changes to the information required for registration (section 607(a)(4) of the FD&C Act) that result in
cancellation of the registration.
1. Under Document Type, select ‘COSMETIC PRODUCT FACILITY REGISTRATION –
CANCELLATION'.

2.
a. PLEASE NOTE: The following message will appear, “By selecting this document type, any
changes made to the submission will be lost and the submission details will be reverted
to the previous submission.” Select ‘OK’:

3. After selecting ‘OK’, the fields for Registration Details, Confirmation Statement, and Additional
Contact Information for Authorized Agent will be grayed out and can no longer undergo
changes.
4. Click ‘SUBMIT SPL’ to submit your cancellation request to FDA.

4.1.4 Biennial Cosmetic Product Facility Registration Renewal

This document type should be selected to renew your registration biennially (i.e., every two years).
1. Under Document Type, select ‘COSMETIC PRODUCT FACILITY REGISTRATION – BIENNIAL
REGISTRATION RENEWAL’.

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2. Repeat the steps from Sections 4.1.1 – 4.1.1.1.

3. Refer to the steps from Sections 4.1.1.2 – 4.1.1.5 for Submit to FDA instructions.

4.1.5 Abbreviated Cosmetic Product Facility Registration

This document type should be selected if there have not been any updates to the registration since the
most recent facility registration submission as required under section 607(a)(4) of the FD&C Act.
1. Under Document Type, select ‘COSMETIC PRODUCT FACILITY REGISTRATION – ABBREVIATED
REGISTRATION RENEWAL’.

a. PLEASE NOTE: The following message will appear, “By selecting this document type, you
are certifying that no changes have been made to your registration since the previous
registration was submitted. Any changes made to the submission will be lost and the
submission details will be reverted to the previous submission.” Select, ‘OK’ to proceed.

2. After selecting ‘OK’, the fields for Registration Details, Confirmation Statement, and Additional
Contact Information for Authorized Agent will be grayed out and can no longer undergo
changes.
3. Click ‘SUBMIT SPL’ to submit your request to FDA.

4.2 Cosmetics Product Listing

4.2.1 New Cosmetics Product Listing

1. Log in to FDA Direct.
2. Select ‘Cosmetic Product Listing’ under Cosmetic Registration and Listing section, on the left
side of the FDA Direct menu.

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3. Navigate to the Cosmetic Product Listing Home Page AFTER selecting ‘Cosmetic Product
Listing’ under Cosmetic Registration and Listing section, on the left side of the FDA Direct
menu. This will navigate the user to the Cosmetic Product Listing Home Page. The Cosmetic
Product Listing Home Page will provide the ability to view all the previous product listing
submissions based on the user’s accessibility.

a. Submission status: The status of each submission made to FDA. The status types are
draft, validation in process, validation failure, ready for submission, and submission
accepted.
b. Self-Help box is also available at the bottom of the left side underneath all the
submission boxes.

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• This box contains articles and weblinks for additional information. It is also
available on the FDA Direct home pages as well.
c. Search bar is available on the Cosmetic Product Listing home page.

• A user can search any previous submission or current submission by providing

the Set ID, Root ID, or the submission ID number.
d. A product can be searched by select the SEARCH PRODUCT box next to CREATE
NEW/UPLOAD FILE.

PLEASE NOTE: For assistance with validation errors in Cosmetic Direct contact
[email protected]. For general questions regarding electronic registration and listing of
cosmetic product facilities, contact [email protected].
e. Select ‘CREATE NEW/UPLOAD FILE’ to begin the Cosmetics Product Listing submission
process.

4.2.2 Create a New Cosmetic Product Listing

1. Click ‘Create New/Upload File’:

2. Click on the "CREATE NEW/UPLOAD FILE" button. This will open a new window where you will
be given two options: create a new/initial Cosmetic Product Listing or upload an FDA-
accepted SPL stored on your computer in a valid XML zip file. Importing an existing Cosmetic
Product Listing SPL will be beneficial for bulk submission of multiple product listings under one
submission.
SPL (Structured Product Labeling) is a document markup standard approved by Health Level
Seven (HL7) and adopted by FDA as a mechanism for exchanging product and facility
information.
a. If you are ‘Creating a New Cosmetic Product Listing using a blank form’, enter the
required information. This includes:
• The facility registration number (FEI) of each facility where the cosmetic product
is manufactured or processed:

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o PLEASE NOTE: The responsible person will need to obtain the relevant
facility registration number(s) for each facility where its cosmetic
products are manufactured or processed, because the facility registration
number(s) is required for the product listing submission. If the facility is
exempt from registration, for example because it is a small business, and
has no facility registration number, then facility name/address can be
provided instead.
• The name and contact number of the responsible person and the name for the
cosmetic product, as such name appears on the label.
• The applicable cosmetic category or categories for the cosmetic product
• A list of ingredients in the cosmetic product, including any fragrances, flavors, or
colors, with each ingredient identified by the name, as required under section
701.3 of title 21, Code of Federal Regulations (or any successor regulations), or
by the common or usual name of the ingredient.
• The product listing number, if any previously assigned by the system.
• Type of submission (initial, update to content (annual), abbreviated renewal).
b. Additional information can be provided, such as:
• Parent company name (if applicable)
• Type of business (as listed on the label), i.e., manufacturer, packer, or
distributor.
• Image of the label (currently jpg files are accepted)
• Product webpage link
• Whether the cosmetic product is for professional use only
• Responsible person DUNS Number for address listed on product label.
• Unique Ingredient Identifiers (UNIIs)
o PLEASE NOTE: For more information and to search for UNIIs please refer
to the webpage at: https://precision.fda.gov/uniisearch. For UNII
requests contact: [email protected].
• Additional contact information for individuals associated with the listing.
c. If you are uploading/importing an existing Cosmetic Product Listing SPL file containing
multiple product listings, make sure that the file is in the correct SPL format. This file
may contain both the XML file and image (jpg) files, for bulk submission. Once the file
has been uploaded, a user can SAVE AND VALIDATE to run a system validation check or
SUBMIT SPL.

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3. Select ‘Creating a New Cosmetic Product Listing using a blank form’ then click ‘Continue’:

4. Navigate to the Create a New Cosmetics Product Listing using a blank form page. You can do
this by clicking on the "Create an initial Cosmetic Product Listing using a blank form" option on
the Create a New Product Listing or Upload an Existing File page.
a. This will allow users to create a new product listing for a cosmetic product using a blank
form.
5. A blank template will display with required and optional fields, a red asterisk (*) indicates a
required field throughout the submission process:

6. Enter the required information as indicated by red asterisk (*) throughout the submission
process.
a. PLEASE NOTE: For assistance with validation errors in Cosmetic Direct contact
[email protected]. For general questions regarding electronic registration
and listing of cosmetic product facilities, contact [email protected].

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7. A tour guide is available to walk a user through the submission icon as shown below.

a. SUBMIT SPL: Submit SPL will send the submission to FDA for additional validation and
processing.
b. SAVE AS DRAFT: Save Draft button allows you to save your work, preserving your
progress without submitting it to the FDA.
c. Validate SPL: You can check your SPL for an initial validation before submitting to FDA.
This option does not automatically submit your SPL to FDA, even if it passes the initial
validation, but scans for certain errors prior to the actual submission.
d. DELETE: This will remove the submission from your account.
e. RETURN: will guide the user to Cosmetics Product Listing Submissions home page
8. Select the ‘ +’ to open or ‘-‘ to close the DOCUMENT TYPES section of the COSMETIC
PRODUCT LISTING to focus one section at a time, a red asterisk (*) indicates a required field
throughout the submission process:

a. PLEASE NOTE: The DOCUMENT TYPE of the DOCUMENT TYPE DETAILS section is
preselected to COSMETIC PRODUCT LISTING, which is the (INITIAL) submission. The Set
ID, Root ID, Version Number, and Effective Date fields will always auto- populate for
the INITIAL SUBMISSION:
9. Select “DOCUMENT TYPE DETAILS,” a red asterisk (*) indicates a required field throughout the
submission process:

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a. PLEASE NOTE: By selecting the dotted underlined words throughout the system will pop
up a tooltip with brief explanation/definitions, along with the link to the MoCRA
guidance, as shown as an example below.

10. Select one of the ‘DOCUMENT TYPE’ by selecting the drop-down icon, a red asterisk (*)
indicates a required field throughout the submission process:

a. DOCUMENT TYPES INFORMATION*:

• COSMETIC PRODUCT LISTING -(INITIAL): The responsible person of a cosmetic
product that is marketed on December 29, 2022, must submit a cosmetic
product listing, or ensure such submission is made, not later than December 29,
2023, or for a cosmetic product that is first marketed after December 29, 2022,
within 120 days of marketing such product in interstate commerce (section
607(c)(2) of the FD&C Act). Consistent with the approach for registration of a
facility that starts manufacturing or processing cosmetic products after
December 29, 2022 (section 607(a)(1)(B) of the FD&C Act), FDA expects the
product listing for a cosmetic product to be submitted within 120 days after
marketing the product, or within 120 days after December 29, 2023, whichever
is later.
o PLEASE NOTE: On November 8, 2023, FDA issued a guidance for industry
titled “Compliance Policy for Cosmetic Product Facility Registration and
Cosmetic Product Listing.” This guidance explains that FDA does not

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intend to enforce the requirements under section 607 of the FD&C Act
related to cosmetic product listing until July 1, 2024.
o PLEASE NOTE: Cosmetic Product Listing (Initial) is preselected when
entering the SPL application form.
• COSMETIC-ABBREVIATED RENEWAL: FDA is providing for an abbreviated process
for the renewal of any cosmetic product listing, as required under section
607(c)(3), for which there has been no change since the responsible person
submitted the previous listing.
o PLEASE NOTE: When making this selection an ALERT box will appear, “By
selecting this document type, you are certifying that no changes have
been made to your product listing since the previous listing was
submitted”.

• COSMETIC -UPDATE (CHANGES TO LISTING or DISCONTINUATION OF LISTING)

(annual): The responsible person must provide any updates to such listing
annually (CHANGES TO LISTING or DISCONTINUATION OF LISTING) (section
607(c)(5) of the FD&C Act). This includes an update that the product was
discontinued.
o PLEASE NOTE: For more information visit: Registration and Listing of
Cosmetic Product Facilities and Products: Guidance for Industry (fda.gov)
11. The Set ID, Root ID, Version Number, and Effective Date fields will always auto- populate for
the INITIAL SUBMISSION ONLY. When an SPL submission changes, a new Root ID is assigned
to the new SPL submission along with a NEW VERSION NUMBER.

a. PLEASE NOTE: Select words are underlined and provide definitions. Select each field and
a tool tip will pop up with additional information related to that specific field.
b. The other four elements under section one: Document Type Details
• Set ID
• Root ID
• Version Number
• Effective Date

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c. INFORMATION on the Four Elements:

• SET ID*: The Set ID uniquely identifies a group of versions of an SPL submission.
When an SPL submission changes, a new Root ID is assigned to the new SPL
submission, but the Set ID in the original SPL submission also is used. The Set ID
is a Globally Unique Identifier (GUID). A GUID is a string of numbers and lower-
case letters generated using a specifically defined mathematical algorithm to
ensure a very low probability of identical GUID used in the same system. An
example is: 9aa9d2e6-6982-48e5-831d-dbe7c04a14ed.

• ROOT ID*: The Root ID uniquely identifies a specific SPL file. Each new version of
an SPL file has a new id root. The id root is a Globally Unique Identifier (GUID). A
GUID is a string of numbers and lower-case letters generated using a specifically
defined mathematical algorithm to ensure a very low probability of identical
GUID used in the same system. An example is: 9aa9d2e6-6982-48e5-831d-
dbe7c04a14ed.

• VERSION NUMBER*: The Version Number gives sequential order to the different
versions of an SPL submission. The version number is a whole number greater
than zero, such as 6, 7, or 8. The version number is increased with each change
to the SPL submission. Enter a number greater than zero (0) in the Version
Number field.

• EFFECTIVE DATE*: The date the submission is created, users can modify it.
However, the system will only use the actual registration date submitted to FDA.
It also provides a date reference to the SPL version. Select the date by clicking on
the calendar icon. Once an SPL has been submitted, this date cannot be edited
by users.

12. Fill in all the blank fields in the PRODUCT, INGREDIENT AND FACILITY LISTING OF THE
COSMETIC PRODUCT section, a red asterisk (*) indicates a required field throughout the
submission process:

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a. PLEASE NOTE: By selecting the dotted underlined words throughout the system will pop
up a tooltip with brief explanation/definitions, along with the link to the MoCRA
guidance.
13. Fill in all the blank fields in the RESPONSIBLE PERSON section of the PRODUCT, INGREDIENT
AND FACILITY LISTING OF THE COSMETIC PRODUCT section, a red asterisk (*) indicates a
required field throughout the submission process:

14. The elements toward the LEFT side of the webpage section of the PRODUCT, INGREDIENT
AND FACILITY LISTING OF THE COSMETIC PRODUCT section, a red asterisk (*) indicates a
required field throughout the submission process:
a. Is this product listing for a small business?: (optional) Indicate whether you are listing
the product(s) for a small business by selecting one of the options provided.
• Section 612 of the FD&C Act provides exemptions to certain small businesses
from the requirements of section 607 (Registration and Product Listing).
However, such exemptions from the requirements of section 607 of the FD&C
Act do not apply to any responsible person or facility engaged in the
manufacturing or processing of any of the following products listed in section
612(b) of the FD&C Act:
o Cosmetic products that regularly come into contact with mucus
membrane of the eye under conditions of use that are customary or
usual.
o Cosmetic products that are injected.
o Cosmetic products that are intended for internal use.

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o Cosmetic products that are intended to alter appearance for more than
24 hours under conditions of use that are customary or usual and
removal by the consumer is not part of such conditions of use that are
customary or usual.
• PLEASE NOTE: For more information visit: Registration and Listing of Cosmetic
Product Facilities and Products: Guidance for Industry (fda.gov)

b. Responsible Person (as Listed on the label): (optional) The manufacturer, packer, or
distributor of a cosmetic product whose name appears on the label of such cosmetic
product.
• PLEASE NOTE: ANY of the combination can be selected (one, none, or all).

c. Responsible Person Name (as Listed on the label) *: Enter the responsible person name
AS IT APPEARS ON THE LABEL.

d. Parent Company Name (if applicable): (optional) Enter the name of the parent company
that is associated with this submission.

15. The elements toward the RIGHT side of the webpage section of the PRODUCT, INGREDIENT
AND FACILITY LISTING OF THE COSMETIC PRODUCT section, a red asterisk (*) indicates a
required field throughout the submission process:
a. Responsible Person Phone Number (Include Country /Area Code) *: Enter the
responsible person's phone number including the area or the country code. The format
for Phone number should be <Country Code>-<Area Code>-<Subscriber Number >For
example, in the U.S. the phone number would be 1-999-9999999 or 1-999-999-9999

b. Responsible Person D&B D-U-N-S Number for Address Listed on the Product Label:
(optional) Enter the existing 9-digit DUNS number of the address listed on the product
label. Obtain a DUNS number: https://www.dnb.com

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c. PLEASE NOTE: For more information on any of the fields ABOVE PLEASE visit:
Registration and Listing of Cosmetic Product Facilities and Products: Guidance for
Industry (fda.gov)
16. To add PRODUCT(S), INGREDIENT(S), AND FACILITY(IES) to your SPL template, click the ‘ADD
PRODUCT(S), INGREDIENT(S), AND FACILITY(IES)’ button in the PRODUCT, INGREDIENT AND
FACILITY LISTING OF THE COSMETIC PRODUCT section as shown below, a red asterisk (*)
indicates a required field throughout the submission process:

17. A blank template titled PRODUCT(S), INGREDIENT(S), AND FACILITY(IES) will display. Fill in the
required fields and select all that apply, a red asterisk (*) indicates a required field throughout
the submission process.

4.2.3 Product(s), Ingredient(s), and Facility(ies)

1. Fill in all the blank fields in the COSMETIC PRODUCTS section of the PRODUCT(S), INGREDIENT(S), AND
FACILITY(IES) section, a red asterisk (*) indicates a required field throughout the submission process:

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2. Select the ‘+’ to open or ‘- ‘ to close any sections.

PLEASE NOTE: By selecting the dotted underlined words throughout the system will pop up a
tooltip with brief explanation/definitions, along with the link to the MoCRA guidance.
a. Product Listing Number*: This 14-digit number will be generated by the system for each
cosmetic product submission after acceptance. PLEASE NOTE: THE PRODUCT LISTING
NUMBER WILL BE GENERATED AFTER A SUBMISSION HAS BEEN ACCPETED BY FDA.
b. Product Name (As Listed on Label)*:In the product name field, enter the statement of
identity, as such name appears on the label. If the product names in the listing are not
unique, then also include distinguishing information for identification purposes, for
example brand name or a code that the responsible person uses to distinguish the
product. Such information may also be included in addition to the product name even
when product names in the listing are unique. If you believe certain distinguishing
information is confidential, include that distinguishing information in parenthesis.
c. Product Webpage Link: (optional) Provide the webpage link of the product.
d. Fragrance or Flavor*: Select if the product contains fragrance, flavor, fragrance and
flavor or N/A.
• PLEASE NOTE: An INFORMATION BANNER will pop-up when FRAGRANCE OR
FLAVOR SELECTION is made, as shown below:

e. Professional Use Only: (optional) Indicate whether this product is for professional use by
selecting yes or no.
3. To add multiple PRODUCT CATEGORY CODE(S) section of the PRODUCT(S), INGREDIENT(S),
AND FACILITY(IES) section, click the ‘MANAGE CATEGORIES’ button in Product Category
Code(s) section, as shown below. A red asterisk (*) indicates a required field throughout the
submission process:

4. A selection window titled COSMETIC PRODUCT CATEGORIES will display as shown below. Select all that
apply.

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a. Product Category Code(s) *: Select the product category or categories for this product
name. Each main product category has a sub- product category. And some sub-product
categories have sub-sub product category, select the one that applies to this product
name. (e.g., leave-on or rinse-off). For example:

• (01) is considered a main product category (e.g. any section that begins with (#)
are main product category).
• (A) to (D) are considered sub- product categories (e.g., any section that begins
with (capital letter) are a sub-product category).
• 1. and 2. are considered a sub-sub product (e.g., any section that begins with a
number that ends with a dot (.) are a sub-sub product category).
b. PLEASE NOTE: For more information visit Registration and Listing of Cosmetic Product
Facilities and Products: Guidance for Industry (fda.gov):
https://www.fda.gov/cosmetics/registration-listing-cosmetic- product-facilities-and-
products/cosmetic-product-categories-and-codes
c. PLEASE NOTE: Any combination can be selected, EXCEPT leave-on and rinse-off (one or
the other may be selected). However, if sub- product category has been selected, then a
sub-sub product category must be selected.

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5. Once completed Click 'SAVE CATEGORIES’, located at the top right of the page:

6. After clicking 'SAVE CATEGORIES’ all the selection that was made on the previous page will be
stated under the PRODUCT CATEGORY CODE(S) tab in the PRODUCT(S), INGREDIENT(S), AND
FACILITY(IES) section with a saved banner on the top of the page, as shown below:

a. At this point, the option to ‘DELETE’ this product tab on the upper right hand will appear
along with ‘SAVE PRODUCT’ and ‘RETURN’ as shown below.

7. To add PRODUCT INGREDIENTS section of the PRODUCT(S), INGREDIENT(S), AND

FACILITY(IES) section, click the ‘MANAGE INGREDIENTS’ button in INGREDIENTS section, as
shown below. A red asterisk (*) indicates a required field throughout the submission process.

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8. A blank template titled COSMETIC INGREDIENTS will display. Ingredients can be searched,
added or uploaded, in the INGREDIENTS section., A red asterisk (*) indicates a required field
throughout the submission process:

a. PLEASE NOTE: Selection on Fragrance and/or Flavor made in the previous section, on
the PRODUCT(S), INGREDIENT(S), AND FACILITY(IES) section, will be auto filled in the
INGREDIENTS section. As an example, shown below:

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9. Fill in all the ingredients that are included in this product (as listed on label). Common, usual,
or chemical name will auto-populate as you type along with its UNII. If ingredient does not
auto- populate continue typing and select ADD. As an example, shown below:

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10. An ingredient can be deleted by selecting the X on the left-most column. As an example,
shown below:

a. PLEASE NOTE: Any update on Fragrance and/or Flavor, will have to go to the previous
section, on the PRODUCT(S), INGREDIENT(S), AND FACILITY(IES) section and make the
changes as needed. Any changes made on the PRODUCT(S), INGREDIENT(S), AND
FACILITY(IES) section will regenerate it here on the ingredient list.

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11. Ingredients can be re-ordered using drag and drop feature. Select an ingredient then move it
into the new location. As an example, shown below:

12. To download current ingredient list with its UNII CODE(S) from the INGREDIENTS section, click
the ‘DOWNLOAD CURRENT INGREDIENT LIST’, as shown below:

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a. It will download an EXCEL sheet prefilled with the current ingredient list, as shown
below.

13. Edit the ingredient list, if necessary, then upload the completed template to replace the
previous ingredient list. UNIIs should be entered in the first column and ingredient names in
the second column.
a. PLEASE NOTE: DO NOT enter CAS numbers instead of UNIIs. CAS numbers will not be
recognized by the system.
14. SAVE it on to the computer.
15. Upload the completed template to replace the previous ingredient list, by selecting the
UPLOAD button underneath the DRAG AND DROP in the UPLOAD INGREDIENT FILE section. As
shown below:

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a. PLEASE NOTE: Any update regarding Fragrance and/or Flavor made through the
ingredient upload tool, will automatically update the above “Fragrance or Flavor”
selection field in the previous section.
16. Once all the INGREDIENT(S) are listed, select SAVE INGREDIENTS. If the user chooses to delete
the ingredient’s list, select DELETE INGREDIENT. By selecting RETURN, a warning banner will
appear. As an example, shown below:

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17. After clicking 'SAVE INGREDIENTS’ all the INGREDIENTS that were listed on the previous page
will be listed under the ingredients tab in the PRODUCT(S), INGREDIENT(S), AND FACILITY(IES)
section with a saved banner on the top of the page, as shown below:

18. To add the LIST OF FACILITIES WHERE THE COSMETIC IS MANUFACTURED OR PROCESSED,
section of the PRODUCT(S), INGREDIENT(S), AND FACILITY(IES) section, click the ‘ADD
FACILITY’ button in LIST OF FACILITIES WHERE THE COSMETIC IS MANUFACTURED OR
PROCESSED section, as shown below. A red asterisk (*) indicates a required field throughout
the submission process.

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19. Fill in all the blank fields in the LIST OF FACILITIES WHERE THE COSMETIC IS MANUFACTURED
OR PROCESSED section of the PRODUCT(S), INGREDIENT(S), AND FACILITY(IES) section, as
shown below. A red asterisk (*) indicates a required field throughout the submission process:

a. Is the facility where the product is manufactured or processed exempt from registration
(for example because it is a small business)?*: Indicate by selecting one of the options,
whether the facility where the product is manufactured or processed is exempt from
registration (for example because it is a small business).
b. SMALL BUSINESSES. — Under section 612(b) of the FD&C Act, regardless of their
average gross annual sales, businesses that engage in the manufacturing or processing
of the following are not exempt from the registration and listing requirements:
• Cosmetic products that regularly come into contact with mucus membrane of
the eye under conditions of use that are customary or usual;
• Cosmetic products that are injected;
• Cosmetic products that are intended for internal use; or
• Cosmetic products that are intended to alter appearance for more than 24 hours
under conditions of use that are customary or usual and removal by the
consumer is not part of such conditions of use that are customary or usual.

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c. Facility FEI: Enter the existing 7 to 10-digit facility FEI number. The FEI number is a
unique identifier assigned by the FDA to identify firms associated with FDA-regulated
products. To facilitate the registration process, the owner or operator of a facility will
need to obtain an FEI number before submitting the facility registration.
d. PLEASE NOTE: To determine if an entity already has an FEI number, please refer to the
FEI Search Portal. If your firm does not have an FEI number assigned by FDA, see How
can I request an FEI? at FEI Search Portal
• Facility Name: Enter the complete name of the existing facility.
• Facility country: Select facility's country name where the facility is physically
located.
• Facility Street Address: Enter the complete information of the street where the
facility is physically located.
• Facility City: Enter the complete name of the city where the facility is physically
located.
• Facility State or Province: Enter the complete name of the state or province
where the facility is physically located.
• Facility Zip/Postal Code: Enter the postal code or the zip code where the facility
is physically located.
e. PLEASE NOTE: For more information visit: Registration and Listing of Cosmetic Product
Facilities and Products: Guidance for Industry (fda.gov)
20. If selected YES to the question, “Is the facility where the product is manufactured or
processed exempt from registration (for example because it is a small business)?” all data
fields are optional. As shown below:

21. If selected NO to the question, “Is the facility where the product is manufactured or
processed exempt from registration (for example because it is a small business)?” the FEI is
mandatory, and the name/address is greyed. As shown below:

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22. Once complete, clicking 'SAVE FACILITY’ and the FACILITY will be saved on the previous page
under the LIST OF FACILITIES WHERE THE COSMETIC IS MANUFACTURED OR PROCESSED tab
in the PRODUCT(S), INGREDIENT(S), AND FACILITY(IES) section with a saved banner on the
top of the page, as shown below:

23. If any edit needs to be made in the LIST OF FACILITIES WHERE THE COSMETIC IS
MANUFACTURED OR PROCESSED, after coming back to the PRODUCT(S), INGREDIENT(S),
AND FACILITY(IES), select the icon under the EDIT tab, as shown below:

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a. Multiple FACILITY(IES) can be added by selecting the ADD FACILITY on the top right, as
shown above.
24. The PRODUCT IMAGES section of the PRODUCT(S), INGREDIENT(S), AND FACILITY(IES)
section, a red asterisk (*) indicates a required field throughout the submission process:
a. (optional) Upload an image of the label, any sides of the label whether it front back or
sides by selecting or drag and drop the image, as shown below. The image must be in a
.jpg.

PLEASE NOTE: It is important that the image uploaded is to be in .JPEG format. Additionally, if you are
uploading more than one image, ensure that the naming convention for each image is
different/unique.
b. The image will display under the PRODUCT IMAGES section under PRODUCT(S),
INGREDIENT(S), AND FACILITY(IES), as shown below:

25. Select SAVE PRODUCT after completing all the required sections of the PRODUCT(S),
INGREDIENT(S), AND FACILITY(IES), as shown below:

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26. AFTER selecting SAVE PRODUCT, an overall product detail will be displayed under
PRODUCT(S), INGREDIENT(S), AND FACILITY(IES), as shown below:

a. Multiple PRODUCT can be added by selecting the ADD PRODUCT(S), INGREDIENT(S),

AND FACILITY(IES)on the top right, as shown above.

b. If any edit needs to be made, select the icon under the EDIT tab, as shown below:

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27. ANY similar PRODUCT with common ingredient(S) can be CLONED by selecting the CLONE icon,
as shown below:

28. In the CONFIRMATION STATEMENT section, fill in the following blank fields.

29. Click ‘AGREE’ after reading and understanding the confirmation statement:

30. If you would like to list additional contact information for an authorized agent, go to the
‘Additional Contact Information for Authorized Agent’ section and fill in the following blanks:

a. PLEASE NOTE: ALL the above elements are optional.

• Additional Contact Name: (optional field) Enter an additional contact information
for individuals associated with the listing. For more information visit:
Registration and Listing of Cosmetic Product Facilities and Products: Guidance for
Industry (fda.gov).
• Email: (optional field) Provide the additional contact person’s email address.
• Phone Number (Include Country/Area Code): (optional field) Enter the additional
contact person's phone number including the country code and the area code.
The format for Phone number should be <Country Code>-<Area Code>-
<Subscriber Number>.
• Phone Extension: (optional field) Enter additional contact person's phone

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extension, if any.
31. After filling in all the required information, return to the top of the SPL submission page, select
SAVE AND VALIDATE to identify any errors OR select SUBMIT SPL for the form to be
submitted to FDA.

a. SUBMIT SPL: Submit SPL will send the submission to FDA for additional validation and
processing.
b. SAVE AS DRAFT: Save Draft button allows you to save your work, preserving your
progress without submitting it to the FDA.
• PLEASE NOTE: Click ‘SAVE AS DRAFT’ from any screen during the process of
registering the cosmetic product facility. The system saves all the information
you inputted and will bring you back to the homepage. The status column will be
in ‘DRAFT’.

c. Validate SPL: You can check your SPL for an initial validation before submitting to FDA.
This option does not automatically submit your SPL to FDA, even if it passes the initial
validation, but scans for certain errors prior to the actual submission.
d. DELETE: This will remove the submission from your account.
e. RETURN: will guide the user to Cosmetics Product Listing Submissions home page
32. Click ‘RETURN’ at any time to return to the Cosmetic Product listing home page.

4.2.3.1 Save and Validate

1. Click ‘SAVE AND VALIDATE’ if you want to check for errors with your SPL. To submit your SPL to
FDA,
a. PLEASE NOTE: This option is only for an initial validation of your SPL before submitting
to FDA. It does not automatically submit your SPL to FDA, even if it passes the initial
validation, but scans for certain errors prior to the actual submission. To submit your
data to the FDA, select “Submit SPL”.
2. The status of your SPL will be in ‘VALIDATION IN PROGRESS’. A yellow message will appear
across your screen stating, “Additional in-depth validation by the FDA is in progress. Check back
on the status after a few minutes by refreshing the page or logging back into the system.”

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3. Once the system has completed validation the status, ‘VALIDATION IN PROGRESS’, will change
to ‘READY FOR SUBMISSION’.

4. Click ‘READY FOR SUBMISSION’, the homepage will change to reflect the following:

a. The system will generate a message stating that, ‘This submission has passed the INITIAL
VALIDATION but has NOT been ACTUALLY SUBMITTED TO FDA. Click ON "SUBMIT SPL" to
SUBMIT.’

4.2.3.2 Submit SPL to FDA

1. Click ‘SUBMIT SPL’ if you are ready to submit your SPL to FDA.

a. A green message will appear across your screen stating, “Your submission has been sent
to FDA for additional validation and processing. Check the status of your submission
after a few minutes by refreshing the page or logging back into the system. You will also
receive an email from FDA when the processing is complete.”

b. The status field should read ‘AWAITING ACCEPTANCE’.

4.2.3.3 Submission Accepted

1. The status column will change to ‘SUBMISSION ACCEPTED’ after the submissions has been
successfully completed and ACCEPTED BY FDA. A ‘SUBMISSION ID’ will be generated
automatically when an SPL is submitted to FDA.

Please Note: A ‘SUBMISSION ID’ does not always mean that the submission was in fact
accepted by FDA. The ‘Submission ID’ will also appear with “Awaiting Acceptance’ and
‘Submission Failure’.

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2. Click on ‘SUBMISSION ACCEPTED’ to VIEW SPL and DOWNLOAD SPL.

a. To clone and create a new version of your successfully submitted SPL, click
‘CREATE A NEW VERSION’

• PLEASE NOTE: After selecting, your SPL will be successfully cloned and the
ROOT ID, VERSION NUMBER, and EFFECTIVE DATE will change. All other
fields will retain the same information from the initial successfully submitted
SPL.

b. To view your SPL, click ‘VIEW SPL’

c. To download your SPL for your records, click ‘DOWNLOAD SPL’

d. When your submission has been validated and accepted by the FDA. You will
receive an email to your account email address when the submission status
changes.

4.2.3.4 Submission Failed

1. If the status column changes to ‘SUBMISSION FAILED’, your submission has not passed the
FDA’s requirements and has been rejected.

a. You must open your submission at this stage to review error messages and update
your submission to correct them. click on (GO TO ERROR) and the system will direct
right to the error.

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b. Submit again and your submission will once again be ‘AWAITING ACCEPTANCE.’
2. If the status column changes to ‘SUBMISSION ACCEPTED’, refer to section 4.2.3.3 for additional
information.

4.2.3.5 Validation Failure

1. After clicking ‘SAVE AND VALIDATE’, the product listing of cosmetic product listing home page will
have the following details as shown below. The status column will be in VALIDATION IN PROGRESS.
However, if the system finds any errors the status will change to VALIDATION FAILURE.

2. Click ‘VALIDATION FAILURE’, the system will provide a list of errors that need to be fixed before
submitting the SPL:

c. After reviewing and fixing the errors, you can select ‘SUBMIT SPL’ to resubmit or ‘SAVE AND
VALIDATE’ to check of any additional errors.

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