Sunscreen SPF testing - information for sponsors

The TGA is currently investigating the CHOICE report on Sunscreen SPF testing, as per our previous statement on 21 August 2025. This update outlines the steps that sunscreen sponsors should take if they identify a problem with their product.

Our investigation of sunscreens includes requiring information from sponsors and providing them with a fair opportunity to respond before taking any regulatory action (if appropriate). Due to the complexity and scale of the information/data involved, this process takes time.

We encourage sponsors to remain up to date with any developments through the News and Community page of the TGA website.

Regulatory obligations

As a sponsor of a listed sunscreen, you are required to hold information or evidence to support any claims made about your sunscreen, such as an SPF claim, at all times. If you become aware of information that casts doubt on your claims, you should gather additional information (such as further SPF testing) promptly to ensure that you continue to hold evidence to support your claims.

What to do if you identify a problem with your sunscreen

If you identify a problem with your sunscreen, including a concern about its quality, safety, or efficacy, you should take the following steps:

1. Assess the problem by gathering details of the affected product(s) and conducting a risk analysis.
2. Submit a notification to the TGA through the TGA eBusiness Services (Business Services > Applications > Market actions). This notification should explain the problem and the proposed mitigation. Refer to the Procedure for recalls, product alerts and product corrections (PRAC) for more information.

A market action addresses problems with therapeutic goods supplied in the Australian market that have, or may potentially have, deficiencies relating to safety, quality, efficacy (performance), presentation or use.

Sponsors are expected to notify the TGA and wait until the TGA has reviewed and agreed to proposed market actions before contacting customers, consistent with the PRAC, to ensure that market actions are carried out appropriately.

You must ensure that your sunscreen’s ARTG entry meets all regulatory requirements. This may involve updating certain product details (e.g. the claimed SPF rating) to ensure that the ARTG entry remains accurate and supported by information/evidence you hold. Refer to the Guidance on changing information in the ARTG for more details.

Sponsors must report all serious adverse events and significant safety issues to us within the required timeframes detailed in the Pharmacovigilance responsibilities of medicine sponsors.

Guidance on how to select a reputable laboratory to conduct your SPF testing

As part of our investigations into SPF sunscreen testing it has come to our attention that some testing laboratories may be more reliable than others. The TGA is currently developing guidance to assist sponsors in choosing an appropriate laboratory to conduct their sunscreen SPF testing. We will publish this guidance in due course.