Public Summary: 1 - Ashanti Exotic Ostrich Oil Spf30+ Lip Protection Ointment

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Public Summary

Summary for ARTG Entry: 58434 ASHANTI EXOTIC OSTRICH OIL SPF30+ LIP PROTECTION ointment tube

ARTG entry for Medicine Listed (Export Only)

Sponsor Ashanti Ostrich Oil Pty Ltd


Postal Address 34 Hargrave Drive, THORNLIE, WA, 6108
Australia
ARTG Start Date 20/12/1996
Product Category Medicine
Status Active
Approval Area Export only Medicines

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods Under
Section 28 of the Therapeutic Goods Act 1989" effective 1 February 1992, other than condition No. 8 and condition No. 9.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered or
Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 February 1992, other than condition No. 11.

Except where the sponsor has been contracted by an overseas partry to manufacturer the goods and that party will be responsible for placing the goods on
the market in countries other than Australia, the sponsor must have and shall retain, while the goods remain listed, evidence necessary to substantiate and
support the accuracy of the indications in relation to the listed goods, and upon the request of the Head, Office of Prescription Medicines Authorisation
Branch, Therapeutic Goods Administration, shall produce such evidence to this officer.

Public Summary
Products

1 . ASHANTI EXOTIC OSTRICH OIL SPF30+ LIP PROTECTION ointment


Product Type Single Medicine Product Effective Date 3/07/2002

Permitted Indications
No Permitted Indications included on Record

Indication Requirements

No Indication Requirements included on Record

Standard Indications

No Standard Indications included on Record

Specific Indications

Soothing, moisturising, lip protection assists in the prevention of dryness and cracking associated with moisture loss. Sunscreen protection factor. 30+ SPF
30+.

Warnings

No Warnings included on Record

Additional Product information

Container information

Type Material Life Time Temperature Closure Conditions


Tube Not recorded 2 Years Not recorded Not recorded Not recorded

Pack Size/Poison information

Pack Size Poison Schedule


4.5g Not scheduled. Not considered by committee

Components
1 . ointment

Dosage Form Ointment


Route of Administration Topical
Visual Identification Yellow/orange firm ointment stick.

Active Ingredients

butyl methoxydibenzoylmethane 15 mg/g

Page 1 of 2 Produced at 20.08.2020 at 11:33:15 AEST


This is not an ARTG Certificate document.
The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.
Visit www.tga.gov.au for contact information
octyl methoxycinnamate 80 mg/g
oxybenzone 30 mg/g

Other Ingredients (Excipients)

butylated hydroxytoluene
Carnauba Wax
cetostearyl alcohol
Fragrance (perfume)
hard paraffin
Ostrich oil
white beeswax
white soft paraffin
Wool fat

© Commonwealth of Australia. This work is copyright. You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior
written approval from the Commonwealth. Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 2 of 2 Produced at 20.08.2020 at 11:33:15 AEST


This is not an ARTG Certificate document.
The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.
Visit www.tga.gov.au for contact information

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