What an SPF 50+ Claim Really Requires in Australia
An SPF test result of 55 is a high level of protection, but it does not support an SPF 50+ label in Australia. Dr Leslie Laquieze explains the in-vivo SPF method, the threshold that matters, and how to build a safety margin into high-SPF products.
By Dr Leslie Laquieze, PharmD, MSc, PhD, MBA, Expert Member, Australian Sunscreen Council
SPF 50+ is the most popular claim on Australian shelves, and the one most exposed to failure. The reason is simple: the threshold is higher than many people assume, and the test used to establish it is known to be variable.
The threshold: at least SPF 60
The Therapeutic Goods Administration states plainly on its page Sunscreen SPF testing – information for consumers that “under the current Australian standard, SPF 50+ products must have a test result of at least SPF 60.” The labelling table in the TGA’s Australian Regulatory Guidelines for Sunscreens shows the same structure: a tested SPF of 30 to 59 supports a label claim of 30, 40 or 50 (“high protection”), while a tested SPF of “60 or higher” supports “50+” (“very high protection”).
This is why CHOICE and the TGA reached different counts from the same 2025 test results. CHOICE treated two SPF 50+ products that tested between SPF 50 and 60 as passes; the TGA, applying the Australian threshold, concluded that 18 of 20 products did not meet the testing requirements.
The method: ISO 24444:2019
ISO 24444:2019, with its applicable amendment, remains the in-vivo SPF method invoked by the Australian framework. The TGA’s Australian Regulatory Guidelines for Sunscreens state that “the SPF of therapeutic sunscreens must be determined by testing on human skin in accordance with the Australian Sunscreen Standard.”
The TGA’s March 2026 consultation paper on improving sunscreen regulation summarises how the test works: typically 10 to 20 volunteers; 2 mg/cm² of product applied to test sites; five to six subsites exposed to increasing UV doses; and redness assessed 16 to 24 hours later. SPF is the ratio of the minimal erythemal dose on protected skin to that on unprotected skin. The paper describes “significant variability” in results, increasing as SPF values increase, and says that changes made in the 2019 version of ISO 24444 to improve reproducibility “have not been sufficient.” It also uses the example that a test result of SPF 55 may be considered non-compliant for an SPF 50+ claim, “despite providing a high level of UVB protection.”
Putting the numbers in perspective
According to the same TGA consultation paper, when applied correctly, SPF 30 filters approximately 97 per cent of UVB rays and SPF 50 approximately 98 per cent. The SPF scale is not linear, and the difference in protection becomes smaller at higher values. A senior TGA official made the same point at a Senate estimates hearing, as reported by the ABC in June 2026. This matters for consumer communication: a product that misses the SPF 50+ threshold may still offer high protection. It does not, however, excuse an inaccurate label.
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Best practice for an SPF 50+ dossier
· Test a traceable final-formula batch made using a representative process and held under controlled conditions.
· Obtain the full data, not just the mean. Request anonymised individual values, statistics, inclusion and exclusion rules, application records, deviations and irradiator calibration information.
· Build in a performance margin. Avoid positioning a formula just above the threshold. Because in-vivo variability increases at high SPF values, a formula that tests at 61 once is fragile; plan for a margin and a predefined investigation strategy.
· Do not shop for results. Do not select the most favourable laboratory or result after testing. Weight all evidence by laboratory competence, method, traceability and documentation quality.
· Remember the base formula is not the product. The TGA’s consultation paper observes that “after a product’s formulation is scaled up for commercial manufacturing, sponsors typically do not re-test the SPF performance of the final, market-ready batches.” Sponsors who confirm SPF on commercial batches are ahead of a likely reform.
What reliable reports look like
A credible SPF report identifies the exact product code, batch, formula version, manufacturing date, density, storage conditions, sample receipt date and test dates. It names the method edition and amendment, the application parameters, environmental conditions and validity criteria. It includes all individual subject results, any exclusions with reasons, the calculations and statistics, and the reference sunscreen results. A report that offers only a final mean value should be treated as incomplete.
Key points
· In Australia, SPF 50+ requires a test result of at least SPF 60.
· In-vivo SPF testing is variable, especially at high SPF values; design formulas with a margin.
· Demand individual subject data and full traceability in every report.
· Confirm performance on commercial batches, not only on a development base.
Sources
· Therapeutic Goods Administration, “Sunscreen SPF testing – information for consumers”: https://www.tga.gov.au/resources/explore-topic/sunscreens/sunscreen-spf-testing-information-consumers
· Therapeutic Goods Administration, “Australian Regulatory Guidelines for Sunscreens”, Version 3.0, May 2023: https://www.tga.gov.au/sites/default/files/australian-regulatory-guidelines-for-sunscreens.pdf
· Therapeutic Goods Administration, “Seeking feedback on improvements to the regulation of sunscreens in Australia”, consultation paper, March 2026: https://consultations.tga.gov.au/tga/improvements-to-regulation-of-sunscreens-in-aus/user_uploads/final---consultation---seeking-feedback-on-improvements-to-the-regulation-of-sunscreens-in-australia---v1-march-2026-2.pdf
· ABC News, “TGA still investigating sunscreens that Choice testing found fell short”, 5 June 2026: https://www.abc.net.au/news/2026-06-05/sunscreen-tga-investigation-senate-estimates/106763354
About the Author
Dr Leslie Laquieze (PharmD, MSc, PhD, MBA) is a pharmacist-scientist and international expert in sunscreen testing, photoprotection, skin pharmacology and dermocosmetic claim substantiation. An expert member of the Australian Sunscreen Council, she has led Kosmoscience Europe since 2018, supporting the evaluation, substantiation and regulatory positioning of cosmetic and dermatological products across international markets.
This article reflects the opinion of Dr Leslie Laquieze. Readers are recommended to seek expert legal advice on all issues discussed.
