The TGA has declined to set a numerical tolerance for SPF re-test results below label claim. Instead it assesses your whole body of evidence. Here's what sunscreen sponsors need to hold.

The question every sunscreen sponsor eventually asks

You re-test a sunscreen and the result comes back below the labelled SPF. Not wildly below — but below. Is that a problem?

Sponsors have been pressing the TGA for a clear answer: what margin of error is acceptable? Is there a threshold? A confidence interval you can point to?

The TGA's position, restated most recently in July 2026, is that it will not set a single numerical threshold or fixed confidence interval. There is no tolerance figure to work to.

That's frustrating if you wanted a bright line. But it's not the absence of an answer — it's a different kind of answer, and understanding it matters.

What the TGA assesses instead

Rather than a number, the TGA assesses whether your evidence "supports" the labelled SPF claim, judged against:

  • Your overall body of evidence — not a single test result in isolation
  • The credibility and reliability of the testing performed — which laboratory, which method, how robust
  • Your existing obligations as a sponsor to hold current evidence supporting your claims
  • Your obligation to notify the TGA if evidence indicates a product may be less effective than represented

Two points from the TGA's position deserve particular attention.

Testing must link to the finished product actually on the market. Not a similar formulation, not an earlier version — the product consumers are buying.

You must be able to demonstrate you considered new information. If a re-test raises a question about your claimed SPF, the TGA expects to see that you engaged with it. Filing an inconvenient result away is precisely the behaviour this framing is designed to catch.

Why this is stricter than a numerical threshold, not looser

It's tempting to read "no fixed threshold" as latitude. It isn't. A number would let you demonstrate compliance mechanically — result within tolerance, obligation discharged.

Instead, the TGA is asking a judgement question: does your total evidence genuinely support the claim on your pack? That puts weight on the quality of your testing programme, your laboratory selection, and your documented reasoning when results vary.

It also means two sponsors with identical numerical results could be in different positions — one with a robust evidence file and a documented assessment, one with a single test and no follow-up.

The context sponsors shouldn't ignore

This sits against a backdrop of real enforcement. Following SPF testing shortfalls, a group of sunscreens sharing a base formulation were cancelled from the ARTG and recalled in 2026. Sunscreen is also named among the TGA's compliance priority areas, and the TGA has been establishing a Sunscreen Expert Working Group to advise on quality, efficacy and testing paradigms.

The direction is unmistakable: more scrutiny of whether SPF claims are genuinely supported.

What sunscreen sponsors should do

  • Ensure your SPF testing relates to the finished, marketed product — and that you can evidence that link.
  • Document your laboratory selection rationale, consistent with the TGA's published advice on choosing a reliable testing laboratory.
  • Have a written process for handling an unfavourable re-test — what you assess, who decides, what triggers notification to the TGA.
  • Treat your evidence as a file, not a certificate. The question is whether the body of evidence supports the claim, so it needs to be maintained.
  • Factor in the AS/NZS 2604:2021 transition, since re-testing obligations and the standard change are converging on the same products.

How Engel Hellyer & Partners can help

Sunscreen is one of our deepest specialisms. Our director John Attard sits on the CS-042 committee behind the AS/NZS 2604 sunscreen standard, has delivered GMP refresher training in sunscreen manufacture, and conducts clients' internal audits including accompanying TGA auditors — so we work on both the evidence and the systems that produce it.

We help sponsors build SPF evidence files that stand up to scrutiny, assess what an unfavourable re-test actually means for a listing, and decide when notification is required.

If you'd like your sunscreen evidence reviewed before the TGA asks to see it, we're happy to take a look.

This article is general information only and does not constitute regulatory advice for any specific product. Regulator positions and requirements change; confirm the current position before acting.

Further reading

Primary guidance from the Therapeutic Goods Administration:

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Written by 
Dr Renée Badenhop
Renee received a Bachelor of Science at the University of Sydney and a Bachelor of Science (Honours) at Macquarie University and in 1997 she was awarded a PhD (Medicine) at the University of NSW. In 2005 she completed a Master’s Degree in Industrial Property at the University of Technology. Renee has been Director at Engel Hellyer & Partners since 2013.