Sunscreens using the same base formulation as Ultra Violette Lean Screen SPF 50+ sunscreen

The purpose of this page is to provide consumers up to date information on issues relating to sunscreens using the same base formulation as Ultra Violette Lean Screen SPF 50+ (formerly AUST L 332788) (Lean Screen) following the recent CHOICE SPF testing of a range of sunscreens on the Australian market.

This page provides an update to:

• The TGA’s statement dated 22 August 2025, outlining the recall of all batches of Ultra Violette Lean Screen SPF 50+ due to inconsistency in the SPF level of the product.
• the TGA’s statement dated 21 August 2025 on the CHOICE SPF sunscreen findings.

Background

The TGA continues to investigate the concerns arising from recent CHOICE SPF testing of a range of sunscreens on the Australian market.

One of those sunscreens, Lean Screen has been voluntarily recalled due to a range of SPF testing results that are well below the claimed SPF of 50+, including test results showing an SPF as low as 4. Ultra Violette have also voluntarily cancelled the listing of Lean Screen from the Australian Register of Therapeutic Goods.

Our concerns about SPF of Lean Screen base formulation

Lean Screen was manufactured using the same base formulation as a number of other sunscreens. The manufacturer of that base formulation, Wild Child Laboratories Pty Ltd, has now received preliminary SPF testing results for that base formulation.

The preliminary testing indicates that this base formulation is unlikely to have an SPF greater than 21. Preliminary testing of specific goods manufactured using the base formulation indicate that the SPF value of the goods may, for at least some of the goods, be as low as SPF 4.

The TGA is aware that each company that is responsible for an affected sunscreen will hold its own test results to substantiate the SPF claim for that sunscreen. However, as a part of the TGA’s investigations into SPF sunscreen testing, it has come to our attention that some testing laboratories may be more reliable than others. Advice for sponsors and manufacturers on SPF testing, and selecting an appropriate lab, can be found at Advice for sunscreen sponsors and manufacturers: Acceptance of additional SPF testing information.

In particular, the TGA has significant concerns about the reliability of SPF testing undertaken by Princeton Consumer Research Corp (PCR Corp), a testing laboratory based in the United Kingdom. The TGA is aware that many companies responsible for sunscreens manufactured using this base formulation relied on testing by PCR Corp to support their SPF claims, and that they obtained that testing before they were informed of the TGA’s concerns.

The TGA has now outlined its concerns with PCR Corp testing to all companies responsible for sunscreens manufactured using this base formulation. The TGA has also written to PCR Corp regarding its concerns and has not received a response.

The TGA is aware that each company adds different types and amounts of excipients (like fragrances and colour tints) to the base formulation. It is possible that the addition of excipients could increase or decrease the SPF of a sunscreen. The TGA is, nonetheless, concerned that the test results relating to Lean Screen and the base formulation suggest that sunscreens made with the base formulation may not provide the claimed SPF.

What we are doing about sunscreens using the same base formulation

The TGA has notified all companies responsible for affected sunscreens of this testing and its concerns about the reliability of testing performed by PCR Corp. Where we are contemplating taking regulatory action for a product, we are required to give the sponsor of each product a fair opportunity to respond before making a final decision.

Sponsors may choose to take their own action in relation to their product, such as voluntarily cancelling their product from the ARTG and voluntarily recalling their product, while an investigation is underway, including after receiving notification of a proposed course of action from us. Where sponsors choose to take such an action, we work with them to implement the appropriate outcome.

In cases where a sponsor does not elect to voluntarily recall their product, the TGA can require that the sponsor recalls the product in accordance with Section 30EA of the Therapeutic Goods Act 1989.

When responding to proposed regulatory action, companies often provide the TGA with any SPF testing results they rely on to support the SPF of the product.

The current SPF testing standard requires a test to be performed on at least 10 different people, with more tests required if any of those tests provide an invalid result. The SPF is the mean (average) of the SPF from each valid test. To claim that your sunscreen is SPF 50+, the average SPF must be at least 60.

The TGA is aware that at least some companies are likely to have obtained preliminary or incomplete test results from an independent laboratory other than PCR Corp that may or may not support the SPF claim of their sunscreen. All affected companies are free to publish their SPF testing.

Where the company responsible for a sunscreen has decided to cancel or recall the affected goods, the TGA is working to support them in doing so.

In the meantime, if you purchased a product in the below list, you may wish to consider using an alternative product until the TGA completes its review.

GMP inspection of Wild Child Laboratories

As part of our investigation, we conducted a Good Manufacturing Practice (GMP) inspection of Wild Child Laboratories Pty Ltd, the manufacturer of the same base formulation, in September 2025. You can find more about what a GMP inspection is at Manufacturer inspections: an overview.

This inspection was focussed on the end-to-end manufacturing operations for sunscreen products and evaluated whether Wild Child Laboratories continued to meet the relevant GMP standards.

Specifically, the inspection scope included the control of ingredients and materials, the qualification of suppliers, the manufacturing activities and supporting validation, a review of the overall quality system and laboratory testing.

While some non-serious GMP deficiencies were identified during the inspection, we did not identify manufacturing issues that could explain the low SPF results. Wild Child were able to provide evidence that sunscreen products manufactured met the formulation of the products listed on the ARTG.

It is not uncommon for deficiencies to be identified during GMP inspections, and these deficiencies do not necessarily suggest a problem with product quality. Consistent with most international regulators, if the TGA identifies GMP deficiencies during inspections, manufacturers address these deficiencies as part of a corrective and preventative action (CAPA) plan. The plan outlines the manufacturer’s commitment and strategy for addressing identified deficiencies. Its appropriateness is evaluated by the TGA prior to acceptance.

In circumstances where the TGA identifies more serious deficiencies or an unacceptable CAPA plan is received, we may take regulatory action as appropriate to address any product quality or safety issues. Further information on GMP deficiencies can be found on our website.

Market status of sunscreens using the same base formulation

Sunscreens affected by this issue are set out in the below table. This table is current as at 26 November 2025. This table will regularly be updated to reflect the status of the goods. Further information for consumers can also be found at Sunscreen SPF testing - information for consumers.