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Choosing an SPF Laboratory: Lessons From Australia’s Sunscreen Testing Failures

Writer: Australian Sunscreen Council
Australian Sunscreen Council
3 hours ago
4 min read

The Therapeutic Goods Administration does not accredit SPF laboratories, so the choice rests with sponsors. Dr Leslie Laquieze explains the TGA’s seven-tier ranking of laboratories, why mineral sunscreens are especially challenging to test, and what every company should demand from a test report.



By Dr Leslie Laquieze, PharmD, MSc, PhD, MBA, Expert Member, Australian Sunscreen Council


When a sunscreen fails independent testing, the first question is often not about the formula, but about the laboratory that certified it. Australia’s 2025 SPF testing controversy showed how much depends on that choice.


What happened

In June 2025, CHOICE reported that 16 of 20 popular SPF 50 or 50+ sunscreens did not meet their SPF claims in its testing. According to the TGA’s page Sunscreen SPF testing – information for consumers, one product tested at SPF 4 and seven tested between SPF 20 and SPF 30.

The Therapeutic Goods Administration has since stated on its page Sunscreen SPF testing – information for sponsors that it “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,” and that it “will generally give less weight to evidence where the TGA has concerns about its reliability.”

The TGA’s page on sunscreens using the same base formulation as Ultra Violette Lean Screen records that its review of that group of products was complete, with a table finalised as at 17 December 2025 listing cancellations from the ARTG and recalls. The ABC reported in June 2026 that the TGA told Senate estimates it was still investigating 15 of the 16 sunscreens CHOICE had identified.


Why mineral sunscreens are especially challenging to test

In-vivo SPF testing of mineral sunscreens can be especially challenging, because the method depends on applying a uniform layer of product at 2 mg/cm², and each laboratory’s own interpretation of how to achieve that layer varies. The TGA itself lists “potential variability in sunscreen application applied by different technicians” among the factors contributing to variability in ISO 24444 results, on its page Sunscreen SPF testing – information for consumers.

In the experience of Australian Sunscreen Council members, application differences can contribute to substantial inter-laboratory variation. Where the layer is not spread evenly, thinner areas let more UV through and may produce earlier erythema at those sites. Application technique is therefore one factor to investigate alongside sample identity, product variability, study conduct and biological variability; it should not be assumed to explain every discordant result.

For mineral sunscreens in particular, sponsors should ask every laboratory how it achieves and verifies a uniform layer, and should obtain evidence of uniform application in each study.


The TGA’s tiered weighting of laboratories

The TGA’s Advice for sunscreen sponsors and manufacturers of 23 September 2025 sets out “a tiered weighting system when evaluating SPF testing evidence,” encouraging sponsors to select laboratories in the following order of preference:

1.       “AS ISO/IEC 17025:2018 … accreditation with the sunscreen SPF testing method(s) explicitly included within the scope.”

2.       “ISO/IEC 17025 accreditation in the same field of testing (e.g., cosmetic or pharmaceutical testing).”

3.       “ISO/IEC 17025 accreditation in another field or Good Laboratory Practice certification.”

4.       “GMP certification or clearance not for sunscreen SPF testing.”

5.       “ISO 9001 accreditation.”

6.       “No formal accreditation but evidence as set out in the table below from the laboratory which supports the reliability of the testing.”

7.       “Laboratories with no accreditation and no evidence to demonstrate reliability.”

The TGA adds that where a laboratory “sits towards the bottom of the list,” sponsors “should consider whether additional evidence or scientific justification should be obtained.”

The regulator may go further. Its March 2026 consultation paper states that “the TGA does not currently regulate or accredit testing facilities, the onus of responsibility for selecting an appropriate laboratory rests with the sponsor,” and notes that most SPF laboratories do not hold ISO 17025 accreditation and most are overseas. It canvasses requiring SPF results to come from an accredited or certified laboratory, and requiring sponsors to submit SPF data at listing or make it public.


What to obtain from every laboratory

Control point

Evidence to obtain

Competence

Relevant accreditation, experience with the product type, applicator qualifications, training records and operator authorisation.

Application

The laboratory’s written application procedure and evidence that a uniform layer was achieved on each test site.

Traceability

Product code, batch, formula, manufacture date, density, storage, sample receipt and test dates.

Protocol

Method version, application parameters, environment, validity criteria, exclusions and deviations.

Data

Individual values, calculations, statistics, instrument records and audit trail.

Quality assurance

Validation, reference materials, trending, proficiency tests, audits and CAPA.

Governance

Predefined repetition rules, and no selective retesting until a desired result is obtained.

Read the individual data

A mean SPF tells you little about reliability. Individual volunteer results should show plausible biological variation; results that are implausibly uniform, or widely scattered, warrant questions. Sponsors should review raw data themselves, or have an independent expert do so, before relying on a report.


Act on doubt promptly

The TGA’s sponsor guidance is direct: “If you become aware of information that casts doubt on your claims, you should gather additional information (such as further SPF testing) promptly to ensure that you continue to hold evidence to support your claims.” Sponsors that used PCR are “encouraged to review the guidance on assessing laboratory reliability and re-evaluate their SPF test results.”


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, “Sunscreen SPF testing – information for sponsors”: https://www.tga.gov.au/products/medicines/therapeutic-sunscreens/manufacturing/sunscreen-spf-testing-information-sponsors

·         Therapeutic Goods Administration, “Sunscreens using the same base formulation as Ultra Violette Lean Screen SPF 50+ sunscreen”: https://www.tga.gov.au/resources/explore-topic/sunscreens/sunscreens-using-same-base-formulation-ultra-violette-lean-screen-spf-50-sunscreen

·         Therapeutic Goods Administration, “Advice for sunscreen sponsors and manufacturers”, 23 September 2025: https://www.tga.gov.au/products/medicines/therapeutic-sunscreens/manufacturing/advice-sunscreen-sponsors-and-manufacturers-acceptance-additional-spf-testing-information


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.

 
 
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