In Australia, cosmetics that contain sunscreens (UV filters) are regulated by the Health Authority Therapeutic Goods Administration (TGA). It is important to understand that in Australia almost all cosmetic ingredients are regulated as industrial chemicals, this  includes those described as ‘natural’ or ‘organic’ such as oils and extracts.The cosmetic can only be approved for market if it meets the legal definition of either ‘therapeutic’ or ‘cosmetic’. 

Therapeutic Vs Cosmetic

Products are determined to be either ‘cosmetics’ or ‘therapeutic goods’ based on three factors:

  • the primary use of the product
  • the ingredients in the product
  • the claims made about the product


A cosmetic product is a substance designed to be used on any external part of the body – or inside the mouth – to change its odour or appearance, cleanse it, keep it in good condition or protect it.


A therapeutic product is used to prevent, diagnose or treat a disease or its symptoms, or affect the structure or functions of the human body.

Therapeutic Sunscreens:

Therapeutic sunscreens can include:

  • Primary Sunscreens: products having a Sun Protection Factor (SPF) of 4 or more and are primarily used for the protection from UV radiations
  • Secondary Sunscreens: these products include SPF of 15 or more and are added as a secondary purpose, for example with moisturizers.
  • Some insect repellant having SPF or 4 or sunscreens with specific ingredients included in Schedule 5 of TGA 1990.

Ingredients in Cosmetic Sunscreens:

Ingredients that meet all the relevant requirements of Therapeutic Goods (Excluded Goods) Determination 2018 like:

    • Products containing SPF 4 or more applied to lips, foundations and tinctures
    • Products containing SPF between 4 and 15 and are sunbathing or moisturizing skin-care products having a pack size up to 300ml or 300g.




To register a product containing sunscreen and which meet the definition of cosmetics as per the Therapeutic Goods, manufacturers should:

  • Register the business (not the product) with TGA before importation of the product
  • Register if there already exist a same chemical from another business
  • Not register if the blending ingredients are purchased in Australia

Every chemical to be introduced in Australia should be authorized under 1 of the following:

  • Listed (on Australia’s inventory)
  • Exempted
  • Reported
  • Assessed
  • Commercial Evaluation Authorization

The manufacturer should follow the following obligations for reporting cosmetics with sunscreens that contain ingredients that are:

  • Under exempted category (very low risk), should submit a once-off exempted introduction declaration after importation.
  • Under reported category (low risk), should submit a once-off-pre-introduction report before importation.
  • Assessed category, should apply for an assessment certification before introduction of the chemical
Record KeepingRecords should be maintained for 5 years for the introduced chemicals irrespective of the chemical in the market.
Annual DeclarationThese are submitted at the end of every year to confirm the introduction of chemicals are authorized under TGA’s laws.

Animal Testing:

Since July 1,2020 Australia banned the use of new animal test data for ingredients solely used in cosmetics.  If the chemical ingredients has multiple end uses including its use in a cosmetic the manufacturer must confirm that the ingredient complies with the rules on using animal test data.

About Global Regulatory Partners

Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices and pharmaceutical companies globally. GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and Argentina. GRP helps many life science companies register their products in different countries in compliance with local regulations.  To learn more, please contact us at  info@globalregulatorypartners.com

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