Ongoing Investigation: Australia’s TGA Provides Guidance for Sponsors Who Identify Problems with Their Sunscreens

The Australian Therapeutic Goods Administration (TGA) is actively investigating the CHOICE report on Sunscreen SPF testing, as per the previous statement on August 21, 2025. On September 16, 2025, TGA released a notice outlining the steps that sunscreen sponsors should take if they identify problems with their products.

Background

TGA is actively investigating findings from a report by consumer advocacy group CHOICE, which revealed that 16 out of 20 tested sunscreens failed to meet their claimed SPF ratings. These results raise concerns about the reliability of SPF labeling and the potential risks to consumers relying on these products for sun protection. In response, TGA has taken several actions:

• Product Recall: Ultra Violette Lean Screen SPF50 (a sunscreen shows significant disparity between claimed and tested SPF) has been recalled, and its listing on the Australian Register of Therapeutic Goods (ARTG) has been canceled.

• Data Review: The TGA is conducting a comprehensive review of data provided by sunscreen sponsors to identify the reasons for inconsistent SPF results.

• Market Monitoring: Sunscreens with similar formulations are under review to determine if further regulatory action is necessary.

Sponsor Action Steps

Under Australian regulations, sponsors of listed sunscreen are required to maintain information or evidence to support any claims made about their sunscreen, such as an SPF claim, at all times. Non-compliance could result in product recalls, regulatory penalties, and reputational damage. See more info in Australia Cosmetic Regulation and Australian Sunscreen Regulations at our Cosmepedia

TGA’s investigation of sunscreens includes requiring information from sponsors and providing them with a fair opportunity to respond before taking any regulatory action (if appropriate). The notice released on September 16 outlines the steps that sunscreen sponsors should take if they identify a problem with their product, including a concern about its quality, safety, or efficacy:

• Assess the problem by gathering details of the affected product(s) and conducting a risk analysis.

• 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.

Ongoing Monitoring and Updates

The TGA will publish further updates as its investigation progresses, and additional regulatory actions will be taken when necessary. Industry stakeholders are advised to review their compliance with SPF labeling requirements and monitor TGA announcements for any changes to testing standards or enforcement policies.

ChemLinked will continue to monitor the issue of inaccurate SPF claims in Australian sunscreens. Please stay tuned for further updates.