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Australian regulatory guidelines for sunscreens (ARGS)

Version 1.2

30 August 2019

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9. Permitted ingredients

This guideline is currently under review.

9.1 Sunscreening agents permitted as active ingredients

The only sunscreening active ingredients permitted in therapeutic sunscreens are those included in the Therapeutic Goods (Permissible Ingredients) Determination Sponsors should consult the Determination for restrictions applying to each ingredient. The labelling must include the Australian Approved Name (AAN) for each active sunscreening ingredient.

Sponsors wanting to market a therapeutic sunscreen product containing a sunscreening active ingredient which is not on the list of permitted substances in therapeutic sunscreens must submit data to establish the safety and efficacy of the ingredient under its proposed conditions of use (see section 10).

9.2 Excipients

Only those excipients approved by the TGA for use in topical medicines may be used in therapeutic sunscreens. In some cases the TGA has set limits on the amounts of such ingredients and sunscreens must comply with those limits. For more information on the substances that may be used in Listed medicines supplied in Australia and the restrictions applying to their use, please consult the Therapeutic Goods (Permissible Ingredients) Determination.

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