It’s important that Australians continue to use sunscreens to protect against the harmful effects of UV radiation. This page provides consumers with up-to-date information on current issues relating to sunscreens, including SPF testing.
How sunscreens are regulated in Australia
Given the importance of sunscreens for Australian consumers, the TGA regulates sunscreens with a primary purpose of ultraviolet (UV) radiation protection as therapeutic goods. You can read more about how we regulate sunscreens.
Sunscreen SPF testing
What does the SPF number mean?
The Sun Protection Factor (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. When applied correctly, an:
- SPF 30 sunscreen filters approximately 97% of UVB rays
- SPF 50 sunscreen filters approximately 98% of UVB rays.
The difference in the amount of sun protection between an SPF of 30 and 50 is minimal, and this difference becomes even smaller as the SPF value increases. No sunscreen is ever 100% effective at blocking all UV radiation, which is why sunscreens are not allowed to use the term ‘sunblock’.
CHOICE article on SPF testing
The consumer advocacy group, CHOICE, published a report in June 2025 tested 20 sunscreens against their claimed SPF 50 or 50+ ratings. Of the 20 sunscreens tested:
- one tested SPF 4 (Ultra Violette Lean Screen SPF50+)
- 7 tested between SPF 20 – SPF 30
- 8 tested between SPF 30 – SPF 50
- 3 tested between SPF 50 – SPF 60
- One tested at above SPF 60.
We note that CHOICE reported that 16 out of 20 sunscreens, did not pass the SPF testing. This is because CHOICE said that two SPF 50+ products that tested between SPF 50 and SPF 60 ‘passed’ testing. However, under the current Australian standard, SPF 50+ products must have a test result of at least SPF 60. The TGA therefore considers that 18 out of the 20 products did not meet the testing requirements.
What we are doing about the products in the CHOICE report
Sunscreens are required by law to have accurate and truthful labelling. We are investigating the sunscreens in the CHOICE report that did not support the claimed SPF on the label and are considering whether the issues identified by CHOICE testing have implications for other sunscreens on the Australian market.
Our investigation has involved requiring further information to be provided by the Australian suppliers (also known as sponsors) of the affected products. We are completing a comprehensive review and analysis of the high volume of data received. This involves investigating the reasons for inconsistent SPF test results across the CHOICE testing and testing evidence held by sponsors.
Where we intend 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 choose to take their own action in relation to their product while an investigation is underway, including after receiving a 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.
TGA actions taken to date - cancelled and recalled products
In consultation with us, Ultra Violette has cancelled Ultra Violette Lean Screen SPF50+ (which tested SPF 4) from the Australian Register of Therapeutic Goods (ARTG) and all batches of the product have been recalled from the market.
We have identified 20 products with the same formulation as Ultra Violette Lean Screen SPF50+ that are currently or have recently been in the market and are currently determining whether regulatory action is required for these products.
You can find up to date information in relation to any product recalls on our sunscreens recalls page.
The challenges of SPF testing
We are 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 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
As we do not conduct human or animal testing (in vivo testing), we are unable to perform SPF testing against the ISO 24444 standard. However, we do conduct other testing of sunscreen products, 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.
Moving forward, we note that new in vitro (i.e. not on human subjects) methods have been published by ISO and that these methods appear to improve the consistency of the SPF testing results. The use of in vitro test methods offers significant advantages, as they eliminate the need for human subjects and are generally more efficient. We are considering implementing these methods.
While we do not regulate testing laboratories, we can take steps to ensure sponsors use reliable testing laboratories. We have published advice on our website to support industry in providing additional in vitro testing and selecting reliable laboratories to undertake SPF testing – see Advice for sunscreen sponsors and manufacturers: Acceptance of additional SPF testing information.
Safety of sunscreen ingredients
What ingredients Australian sunscreens can contain
Sunscreens are generally included in the ARTG under the listed medicine framework. Listed therapeutic sunscreens may only contain low-risk ingredients selected from a TGA pre-approved list. These ingredients may have restrictions on how they can be used or how much can be included in products.
TGA investigation of sunscreen ingredients
We have also been monitoring international developments in relation to sunscreen ingredients.
Australian consumers exposure to UV and sunscreen is uniquely different from overseas exposure. To help us consider the safety of sunscreen ingredients in an Australian context, we developed an Australian Sunscreen Exposure Model (ASEM) which reflects how we use sunscreens. Using the ASEM, we have completed a review of seven active ingredients used in sunscreens - see Sunscreen ingredients. Following this review, we are now considering whether we should reduce the permitted levels of three of these ingredients. This is a measured and precautionary response to a theoretical risk identified in animal studies.
The expert clinical advice remains that the benefits of sunscreens available in Australia continue to far outweigh any risks.
Actions consumers should take
What you should do if you have a sunscreen with the same formulation as Ultra Violette Lean Screen SPF50+
You may want to consider using alternative products until the TGA completes its review.
What you should do if you have a recalled sunscreen
If you have a sunscreen that has been recalled from the market, consumers are advised to:
- return affected stock to place of purchase for a refund
- if purchased directly from the company, contact them (via website or email) to claim a refund.
More information can be found on our sunscreens recalls page.
Should you keep using sunscreens?
Yes.
Australia has the highest rates of skin cancer and melanoma in the world with around 2,000 people dying each year. Consumers should protect themselves from the sun in 5 ways – using sunscreen, seeking shade and wearing protective clothing, hats and sunglasses.
What sunscreens you should use
To be legally supplied in Australia, all primary sunscreens must be included in the ARTG. Sponsors must comply with all applicable quality, safety and efficacy regulatory requirements, including being made under good manufacturing practice, only using permitted ingredients and only making permitted indications (health claims). Additionally, if TGA becomes aware of issues with specific sunscreens, we will investigate and take regulatory action as appropriate.
When selecting a sunscreen, you should make sure it has an ‘AUST’ number on the label as this indicates it is in the ARTG. For the purpose of primary UV protection, you should choose a sunscreen that provides an SPF of 30 and above.
Regardless of the SPF value, you should always apply sunscreen according to the instructions on the label. Most people do not use enough sunscreen. It is most important to apply and reapply according to label instructions, especially when sweating or swimming, in addition to taking other measures to avoid UV exposure.
If you experience an adverse event from a sunscreen
If you use sunscreen according to the label instructions and experience an adverse event (like sunburn), we encourage you to report any adverse event to us. This information helps us detect signals for products that may require investigation.