Beyond the SPF Number: How to Build Sunscreen Evidence That Stands Up in Australia
A single SPF result is not a sunscreen dossier. Dr Leslie Laquieze explains the “Best Available Evidence” approach that sponsors and manufacturers should use to support every claim on an Australian sunscreen label.
Reviewed and updated 20 October 2026
By Dr Leslie Laquieze, PharmD, MSc, PhD, MBA, Expert Member, Australian Sunscreen Council
Australian consumers rely on the number on a sunscreen label more than almost any other piece of product information. That trust was tested in 2025, when the consumer group CHOICE reported in its June 2025 media release that 16 of 20 popular SPF 50 or 50+ sunscreens did not meet their SPF claims in its testing. The Therapeutic Goods Administration, applying the Australian threshold for SPF 50+, went further: its page Sunscreen SPF testing – information for consumers states that “the TGA therefore considers that 18 out of the 20 products did not meet the testing requirements.”
The lesson for the industry is clear. A sunscreen company must be able to show not only that a product once obtained a result, but that the result came from the correct method, a competent laboratory and a representative batch, and that a governance system is in place to detect when something changes.
What “Best Available Evidence” means
Best Available Evidence does not mean performing every possible test. It means selecting the strongest proportionate evidence for the product, the claim, the market and the level of uncertainty, while documenting what remains unknown.
In Australia, this should be a triangulated model. The regulatory baseline comes first. Additional validated methods then explain or secure performance. Clinical, use-condition or mechanistic data support only the benefit they actually measured.
The evidence hierarchy
Evidence level | Role | Recommended position |
Applicable TGA and AS/NZS framework | Compliance and claim eligibility | Mandatory starting point; verify the version, amendment and transition arrangements. |
Method recognised by the Australian framework | Pivotal SPF, UVA or water-resistance evidence | Use the exact version, with validity criteria and a complete report. |
Additional validated method | Robustness, comparison and investigation | Strongly recommended for high-risk claims and discordant results. |
Clinical or use-condition study | Real-world relevance | Supports tolerance, application or a targeted benefit; does not replace protection-factor testing. |
Ex-vivo or cellular model | Mechanism and biological plausibility | Emerging or mechanistic evidence; strictly limit extrapolation. |
Internal screen or analogy | Prototype selection and hypotheses | A research and development tool; insufficient alone for a strong commercial claim. |
Five decisions to make before any testing starts
Most failed or fragile dossiers can be traced to decisions that were never made explicitly. Before a laboratory is engaged, the following questions should be resolved and recorded:
· Product status. Is the product a primary therapeutic sunscreen, a therapeutic secondary sunscreen or an excluded cosmetic secondary sunscreen? The answer determines Australian Register of Therapeutic Goods (ARTG) inclusion, the applicable standard, Good Manufacturing Practice (GMP) obligations, indications and advertising.
· Australian claims. Will the label claim SPF 50+, broad spectrum, a water-resistance duration, or face, child, sport or sensitive-skin suitability? Each wording must map to identified evidence and an acceptance criterion.
· Representative formula. Is the tested batch identical to the commercial formula and process? This determines whether a report is valid and whether a bridging strategy is needed.
· Method risk. Does the product have an unusual matrix, high viscosity, volatility, pigments, or a stick, powder or aerosol format? These factors drive laboratory choice, pretesting and film controls.
· Multiple markets. Will the same dossier support the European Union, the United States, Brazil or other jurisdictions? Build a matrix of jurisdiction, claim and method. Do not assume that acceptance in one market transfers to another.
A staged programme, not a single test
A defensible programme moves through five stages:
1. Development: in-vitro SPF and UVA screening, photostability, rheology, dispersion and targeted stress testing to optimise the filter system and film formation.
2. Pre-validation: testing of the final or near-final formula, pilot batches, packaging and shades, and assessment of water and heat risk, before the pivotal study.
3. Claim validation: the applicable Australian method, a qualified laboratory, a predefined protocol, individual subject data and a complete report.
4. Independent robustness: an additional validated method and/or a second laboratory, particularly for SPF 50/50+, unusual formats or high-risk claims.
5. Lifecycle: stability, trend analysis, change control, complaint review, corrective and preventive action (CAPA), periodic checks and trigger-based revalidation.
Why this matters now
The regulatory environment is moving in the same direction. On 26 March 2026, the TGA opened a consultation titled Seeking improvements to the regulation of sunscreens in Australia, proposing options to improve the reliability and transparency of SPF testing, strengthen oversight of testing laboratories, and enhance lifecycle quality assurance, including periodic testing. The TGA’s media release notes that “Australia has the highest rates of skin cancer and melanoma in the world, with around 2,000 people dying each year.” Submissions closed on 23 May 2026, and no final decision had been announced as at the date of this article.
Companies that build their evidence on a Best Available Evidence model now will be better placed for whatever reforms follow, and better able to defend their claims if questioned by the regulator, retailers or consumers.
Key points
· Treat the Australian regulatory framework as the mandatory starting point, not the whole programme.
· Map every label and advertising claim to a specific piece of evidence and an acceptance criterion.
· Use additional validated methods to secure high-risk claims, not to replace required evidence.
· Keep mechanistic and cellular evidence in its proper place: it supports plausibility, not label claims on its own.
Sources
· CHOICE, “16 of 20 sunscreens didn’t meet SPF claims in CHOICE test”, 12 June 2025: https://www.choice.com.au/about-us/media/media-releases/2025/june/16-of-20-sunscreens-didnt-meet-spf-claims-in-choice-test
· 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, “Improving the regulation of sunscreens in Australia”, media release, 26 March 2026: https://www.tga.gov.au/news/media-releases/improving-regulation-sunscreens-australia
About the Author
This article reflects the opinion of Dr Leslie Laquieze. Readers are recommended to seek expert legal advice on all issues discussed.
