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Australian regulatory guidelines for sunscreens (ARGS)

Version 1.2

30 August 2019

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Version history

This guideline is currently under review.

Version history
Version Description of change Author Effective date
V1.0 Original publication Office of Medicines Authorisation 10/10/2012

Updated to reflect the changes to the Therapeutic Goods Regulations 1990 by removing references to sunscreens with a claimed SPF of <4 that contain certain human or animal derived ingredients.

Updated the relevant sections by including reference to the recently made Therapeutic Goods (Permissible Ingredients) Determination No.1 of 2015.

Updated the table listing the permitted active ingredients by adding the newly approved sunscreen active Tris-biphenyl triazine.

Complementary and Over the counter Medicines Branch
OTC Medicines Evaluation
V1.2 Updated to remove Table 3 - Permitted active ingredients for therapeutic sunscreens and replace with links to the Therapeutic Goods (Permissible Ingredients) Determination Complementary and Over the Counter Medicines Branch 30/08/2019

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