Sunscreen is an important component of an effective sun protection regime. They must be safe, effective, and of good quality. For this reason, the TGA regulates sunscreens as therapeutic goods in Australia under the Therapeutic Goods Act 1989. The Australian Regulatory Guidelines for Sunscreens (ARGS) describe the Regulatory requirements and standards for sunscreens and their ingredients. As per the ARGS, sunscreens regulated under the Act are referred to as therapeutic sunscreens.

Sunscreens that fall under therapeutic goods are classified into:

  • Primary Sunscreens - Products primarily used for protection from UV radiation.
  • Some Secondary Sunscreens - Products with a primary purpose other than sun protection but contain sun screening agents, e.g., Moisturizers containing sunscreen with SPF greater than 15.

Manufacturers must include only approved ingredients in sunscreens, and all these approved ingredients are assessed for safety. Therapeutic sunscreens must be listed in the Australian Register of Therapeutic Goods (ARTG) before they can be legally marketed in Australia. To market a sunscreen in Australia, manufacturers must have:

  • an ARTG entry for that therapeutic sunscreen; or
  • retail arrangements with a sponsor who has an ARTG entry for that therapeutic sunscreen

TGA requires the efficacy of each product to be tested to determine the Sun Protection Factor (SPF) printed on the label. Sunscreen labels may carry company logos, symbols, and consumer information as per the current Labeling Order and Advertising Code. The advertising and labeling of therapeutic sunscreens must comply with the following:

  • the current version of the Advertising Code
  • the current version of the Labeling Order
  • the Australian Sunscreen Standard

In a nutshell, manufacturers of therapeutic sunscreens must comply with the TGA ARGS standard for market entry in Australia. Partnering with a Regulatory expert is always a flexible option for hassle-free market entry of sunscreens in Australia. Contact Freyr today!


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