TGA - Therapeutic Goods Administration

07/28/2021 | News release | Distributed by Public on 07/27/2021 20:01

Australian regulatory guidelines for sunscreens (ARGS)

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.

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