Australian regulatory guidelines for sunscreens (ARGS)

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The Australian Regulatory Guidelines for Sunscreens (ARGS; the Guidelines) describe the regulatory requirements and standards for sunscreens (and their ingredients) regulated as therapeutic goods in Australia by the Therapeutic Goods Administration (TGA) under the Therapeutic Goods Act 1989 (the Act) as at the date of publication.

For the purpose of these Guidelines, sunscreens that are regulated as therapeutic goods under the Act are referred to as 'therapeutic sunscreens'. Unless excluded, therapeutic sunscreens include:

  • Primary sunscreens: Products that are used primarily for protection from UV radiation.
  • Some secondary sunscreens: Products with a primary purpose other than sun protection, but which also contain sun screening agents.

Many secondary sunscreen products, such as cosmetic sunscreens, are not considered to be therapeutic goods and are 'excluded' from therapeutic goods legislation.

For more information

  • Part A – General information about the regulation of sunscreens
    • Introduction
    • The Australian/New Zealand Sunscreen Standard
    • Regulatory categories of sunscreens
    • Sunscreens not required to be included in the ARTG
    • Sunscreens required to be included in the ARTG
    • Legislative requirements for all therapeutic sunscreens
  • Part B – Information for listed therapeutic sunscreens
    • Legislative requirements for listed therapeutic sunscreens
    • Indications permitted for use in listed therapeutic sunscreens
    • Applying for a new ingredient to be used in listed therapeutic sunscreens
    • Changing the ARTG entry of listed therapeutic sunscreens
    • Record-keeping obligations for Australian sponsors
    • Glossary of terms and abbreviations
    • Appendix 1: Indications permitted for use in listed therapeutic sunscreens
    • Appendix 2: Active ingredients restricted to use in therapeutic sunscreens
Publication Date: 
Wednesday, July 28, 2021 - 11:00am
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