Sunscreen SPF Testing – Information for Sponsors
16 Sep 2025
This process involves requesting information from sponsors and giving them a fair chance to respond before any regulatory action is considered. Because of the large amount of data involved, these reviews can take time.
We encourage sponsors to stay informed by regularly checking updates on the TGA News and Community page.
Regulatory obligations
If you are the sponsor of a listed sunscreen, you must:
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Hold reliable evidence to support all claims made about your product, including SPF claims.
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Act promptly if you become aware of information that may cast doubt on your claims, for example, by arranging further SPF testing.
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Ensure your product’s ARTG entry is accurate and supported by up-to-date evidence (such as claimed SPF rating).
What to do if you identify a problem
If you discover a problem with your sunscreen (safety, quality, or performance), you should:
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Assess the issue – Gather product details and carry out a risk analysis.
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Notify the TGA – Submit a notification through TGA eBusiness Services (Business Services > Applications > Market actions). Your notification must describe the problem and how you propose to address it.
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Follow the PRAC process – Refer to the Procedure for recalls, product alerts and product corrections (PRAC) for detailed guidance.
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Wait for TGA review – Sponsors must not contact customers about market actions until the TGA has reviewed and agreed to the proposed steps.
Safety reporting requirements
Sponsors are required to report:
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All serious adverse events, and
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Any significant safety issues
within the timeframes outlined in the Pharmacovigilance responsibilities of medicine sponsors.
Choosing a laboratory for SPF testing
The TGA has identified that the reliability of SPF test results may vary between laboratories. We are developing guidance to help sponsors select appropriate laboratories for SPF testing, which will be published soon.
Source: Therapeutic Goods Administration (TGA), Sunscreen SPF Testing – Information for Sponsors
