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As per our previous statement on 21 August 2025, the TGA is currently investigating a CHOICE report on Sunscreen SPF testing. This update provides information for consumers.
CHOICE article on Sunscreen SPF testing
The consumer advocacy group, CHOICE, published a report in June 2025 which found that 16 sunscreens of the 20 they tested did not meet their claimed Sun Protection Factor (SPF) 50+ ratings. Of these 16 sunscreens:
- one tested SPF 4 (Ultra Violette Lean Screen SPF50+)
- 7 tested above SPF 20
- 8 tested above SPF 30.
What the TGA is doing about the products included in the CHOICE report
Sunscreens are required by law to have accurate and truthful labelling. The TGA is investigating the sunscreens where the CHOICE testing did not support the claimed SPF on the label. The TGA is also investigating whether the issues identified by the CHOICE testing have implications for other sunscreens on the Australian market.
This investigation has involved requiring further information to be provided by the Australian suppliers (also known as sponsors) of the affected products. Where the TGA intends to take regulatory action, we are also required to give the sponsor of each product a fair opportunity to respond before making a final decision.
Sponsors may also choose to take their own action in relation to their product while an investigation is underway, including after receiving notification of a proposed course of action from TGA. Where sponsors choose to take such action, the TGA will work with them to implement the appropriate outcome.
We are completing a comprehensive review and analysis of the high volume of data received from sponsors. This involves investigating the reasons for inconsistent SPF test results across the CHOICE testing and testing evidence held by sponsors.
Actions taken to date
In consultation with the TGA, Ultra Violette has recalled all batches of Ultra Violette Lean Screen SPF50+ (which tested SPF 4) and cancelled the product from the Australian Register of Therapeutic Goods (ARTG).
The TGA is reviewing other sunscreens in the ARTG that may have similar formulas to determine whether any regulatory action should be taken for these products. We will publish information on our website when this review is complete.
What does the SPF number mean in practice?
No sunscreen is ever 100% effective at blocking all UV radiation, which is why sunscreens are not allowed to use the term ‘sunblock’. The SPF value for a sunscreen indicates how much longer it will take for a person exposed to the sun to suffer from sunburn or the other adverse effects of sun exposure compared to a person who is not wearing any sunscreen at all.
When applied correctly, an SPF 30 sunscreen filters approximately 97% of UVB rays, while an SPF 50 sunscreen filters approximately 98%. The difference in protection between an SPF of 30 and 50 is small, and this difference becomes even smaller as the SPF value increases. Even an SPF 20 sunscreen still filters approximately 95% of UVB rays and therefore provides a much better level of sun protection than no sunscreen at all.
Regardless of the SPF value, you should always apply sunscreen according to the instructions on the label, especially when sweating or swimming. Most people do not use enough sunscreen. However, if you use sunscreen according to the label instructions and still experience an adverse event (like sunburn), we encourage you to report this to the TGA (further information below).
Even sunscreen that effectively protects at SPF 50 allows 2% of UVB rays to penetrate your skin. As such, it is important to also use other measures to protect against harmful rays such as seeking shade, wearing protective clothing, a hat, and sunglasses.
How sunscreens are regulated in Australia
Given the importance of sunscreens for Australian consumers, the TGA regulates sunscreens with a primary purpose of UV protection as therapeutic goods. You can read more here about how we regulate sunscreens.
The challenges of SPF testing
The TGA is also considering what measures we can put in place to increase the consistency of SPF testing for all therapeutic sunscreen products in Australia.
The current internationally accepted International Organisation for Standardisation (ISO) method of sunscreen SPF testing [(ISO 24444:2019, Cosmetics — Sun protection test methods — In vivo determination of the sun protection factor (SPF)] uses human subjects.
Variability of SPF test results associated with the ISO 24444 test is a known problem internationally and domestically. Factors that contribute to the variability of this method include:
- the response may differ from one person to another with the same skin type.
- potential variability in sunscreen application applied by different technicians.
- the degree of skin redness is assessed by eye and may differ between technicians.
Testing by TGA Laboratories
The TGA acknowledges CHOICE’s recommendation that we conduct our own SPF testing.
The TGA conducts some testing of sunscreen products in-house, such as laboratory broad spectrum performance testing as per the Australian Standard (AS/NZS 2604). While the SPF number on a sunscreen mostly tells you how well it protects against UVB, broad spectrum testing ensures the product also shields you from UVA rays— which could cause long-term skin damage and can lead to skin cancer.
As the TGA does not conduct human or animal testing (in vivo testing), we are unable to perform SPF testing against the ISO 24444 standard. Moving forward, we are investigating the viability of the TGA conducting in vitro sunscreen testing (i.e. not on human subjects) in house.
The use of in vitro test methods offers significant advantages, as they eliminate the need for human subjects and are generally more cost-effective and efficient to carry out. The TGA notes that new in vitro methods have been published by ISO and that these methods appear to improve the consistency of the SPF testing results. From a regulatory perspective, an in vitro method may be more easily performed as a regular (such as batch release) test during manufacture and can be used by the TGA to monitor sunscreens on the market.
Implementation of these methods are currently under consideration by the TGA, noting that there are still significant challenges with the methods that are currently available.
If you experience an adverse event from a sunscreen
We encourage consumers to report any adverse event on the TGA website.