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Australian regulatory guidelines for sunscreens (ARGS)
Version 3.0
Last updated
The Australian Regulatory Guidelines for Sunscreens (ARGS) describe the regulatory requirements and standards for sunscreens (and their ingredients) regulated as therapeutic goods in Australia by the TGA under the Therapeutic Goods Act 1989.
For the purpose of the ARGS, sunscreens that are regulated as therapeutic goods are referred to as 'therapeutic sunscreens'. 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 also contain sunscreening agents and are not excluded from the therapeutic goods legislation.
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
- Email: nonprescriptionmedicines@health.gov.au
- Phone: 1800 020 653 (free call within Australia)
- 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
- Ingredients permitted for use in listed therapeutic sunscreens
- Applying for a new ingredient to be used in listed therapeutic sunscreens
- Manufacture and quality control of listed therapeutic sunscreens
- Changing the ARTG entry of listed therapeutic sunscreens
- 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
Supporting documents
Australian regulatory guidelines for sunscreens
[Word, 650.39 KB]
Australian regulatory guidelines for sunscreens
[PDF, 484.78 KB]
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