Scribd Logo
Upload

Welcome to Scribd!

  • 14 views

    Public Summary: 1 - Cancer - Council Ultra Cooling Sunscreen SPF50+

    Uploaded by

    Rado

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd

    Public Summary: 1 - Cancer - Council Ultra Cooling Sunscreen SPF50+

    Uploaded by

    Rado
    14 views2 pages

    Original Title

    butyle1

    Copyright

    © © All Rights Reserved

    Available Formats

    PDF, TXT or read online from Scribd

    Did you find this document useful?

    Is this content inappropriate?

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    14 views2 pages

    Public Summary: 1 - Cancer - Council Ultra Cooling Sunscreen SPF50+

    Uploaded by

    Rado

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 2

    Public Summary

    Summary for ARTG Entry: 238198 Cancer_Council Ultra Cooling Sunscreen SPF50+

    ARTG entry for Medicine Listed

    Sponsor VitalityBrands Worldwide Pty Ltd


    Postal Address Level 2 / 415 Riversdale Road, HAWTHORN EAST, VIC, 3123
    Australia
    ARTG Start Date 18/05/2015
    Product Category Medicine
    Status Active
    Approval Area Listed Medicines

    Conditions

    The sponsor shall keep records relating to this listed medicine as are necessary to: (a) Expedite recall if necessary of any batch of the listed medicine, (b)
    Identify the manufacturer(s) of each batch of the listed medicine. Where any part of or step in manufacture in Australia of the listed medicine is sub-contracted
    to a third party who is not the sponsor, copies of relevant Good Manufacturing Practice agreements relation to such manufacture shall be kept.

    The sponsor shall retain records of the distribution of the listed medicine for a period of five years and shall provide the records or copies of the records to the
    Complementary Medicines Branch, Therapeutic Goods Administration, upon request.

    The sponsor of the listed medicine must not, by any means, intentionally or recklessly advertise the medicine for an indication other than those accepted in
    relation to the inclusion of the medicine in the Register.

    Public Summary
    All reports of adverse reactions or similar experiences associated with the use or administration of the listed medicine shall be notified to the Head, Office of
    Product Review, Therapeutic Goods Administration, as soon as practicable after the sponsor of the goods becomes aware of those reports. Sponsors of listed
    medicines must retain records of such reports for a period of not less than 18 months from the day the Head, Office of Product Review is notified of the report
    or reports.

    The sponsor shall not supply the listed medicine after the expiry date of the goods.

    Where a listed medicine is distributed overseas as well as in Australia, product recall or any other regulatory action taken in relation to the medicine outside
    Australia which has or may have relevance to the quality, safety or efficacy of the goods distributed in Australia, must be notified to the National Manager
    Therapeutic Goods Administration, immediately the action or information is known to the sponsor.

    Products

    1 . Cancer_Council Ultra Cooling Sunscreen SPF50+


    Product Type Single Medicine Product Effective Date 8/05/2019

    Permitted Indications
    May assist in preventing some skin cancers (sunscreen)
    May reduce the risk of some skin cancers (sunscreen)
    SPF 50 PLUS Broad spectrum very high protection sunscreen
    Can aid in the prevention of premature skin ageing (sunscreen)
    Can aid in the prevention of solar keratosis (sunscreen)
    Can aid in the prevention of sunspots (sunscreen)

    Indication Requirements

    Indication can only be used for sunscreen products with an SPF rating of 30 or higher.
    Indication for use in sunscreen products only.

    Standard Indications

    No Standard Indications included on Record

    Specific Indications

    No Specific Indications included on Record

    Warnings

    (If medicine contains one hydroxybenzoate) Contains [insert name of hydroxybenzoate] OR (If medicine contains two or more hydroxybenzoates) Contains
    hydroxybenzoates [or words to that effect].
    Contains phenoxyethanol (or words to that effect).
    Contains benzyl alcohol (or words to that effect).
    Avoid prolonged exposure in the sun.[or words to that effect]
    Wear protective clothing, hats and eyewear when exposed to the sun.[Or words to this effect]

    Page 1 of 2 Produced at 17.08.2020 at 10:23:43 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
    Additional Product information

    Pack Size/Poison information

    Pack Size Poison Schedule

    Components
    1 . Formulation 1

    Dosage Form Lotion


    Route of Administration Topical
    Visual Identification

    Active Ingredients

    butyl methoxydibenzoylmethane 40 mg/g


    homosalate 100 mg/g
    octocrylene 80 mg/g
    octyl salicylate 50 mg/g

    Other Ingredients (Excipients)

    alkyl (C12-15) benzoate


    Aloe vera

    Public Summary
    benzyl alcohol
    carbomer 941
    citric acid
    dl-alpha-tocopheryl acetate
    ethyl hydroxybenzoate
    Fragrance (perfume)
    hyetellose
    menthyl lactate
    methyl hydroxybenzoate
    PEG-15 cocamine
    PEG-40 stearate
    phenoxyethanol
    propyl hydroxybenzoate
    propylene glycol
    purified water
    silicon dioxide
    trolamine
    white beeswax

    © 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.

    Page 2 of 2 Produced at 17.08.2020 at 10:23:43 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

    You might also like