How the TGA regulates sunscreens

13 November 2012

Sunscreens classified as therapeutic goods are (unless exempt) required to be included in the Australian Register of Therapeutic Goods (ARTG) before they can legally be marketed in Australia.

When a company or individual (called sponsors by the TGA) want to supply a sunscreen product in Australia they must comply with the information in the Australian Regulatory Guidelines for Sunscreens. These guidelines contain information on:

  • listing of therapeutic sunscreens
  • registration of therapeutic sunscreens
  • sunscreens which are exempt from regulation by the TGA
  • responsibility of sponsors to report adverse reactions
  • labelling (including a labelling checklist)
  • advertisements for therapeutic sunscreens
  • reproducibility of SPF test results
  • stability testing
  • manufacture and quality control
  • permitted ingredients
  • new ingredients.

Sunscreens are required to be manufactured in accordance with the principles of Good Manufacturing Practice (GMP).

Sunscreens must comply with the Australian and New Zealand Sunscreen Standard AS/NZS 2604 Sunscreen products - Evaluation and classification in force at the time of listing on the ARTG.

What sponsors need to do

If you are a sponsor who has no previous experience with listing a therapeutic good in Australia, you may wish to seek the services of an Australian regulatory affairs consultant.

Applications to list medicines (including sunscreens) in the ARTG are completed electronically online using the Electronic Listing Facility (ELF), which is part of the TGA Business Services system.  In order to access eBS and ELF, you will need to complete the TGA Business Services access forms.

Fees and charges are associated with listing or registering a product on the ARTG and for obtaining a GMP licence.

Contact information

For more information please contact the TGA information line or email: info@tga.gov.au.