TGA tightens sunscreen rules after SPF testing failures

Australia’s Therapeutic Goods Administration has announced reforms to sunscreen testing and SPF claim rules after laboratory testing found some products fell short of their advertised sun protection factor — a finding that has unsettled consumer confidence in a product category that underpins public health messaging on skin cancer prevention.

This matters because the message we have been giving people for decades — apply SPF 50+ generously, reapply every two hours — rests on the assumption that the number on the bottle means something. When testing finds that some products do not deliver that number under laboratory conditions, the question of what to recommend becomes more complicated.

What happened and what is changing

The TGA’s testing programme, conducted in 2025, found that a portion of products on the Australian market did not achieve their labelled SPF under standardised test conditions. The regulator opened a public consultation from March to May 2026, attracting almost 120 submissions from industry, testing laboratories, health professionals, consumer groups and academics.

Australia has the highest skin cancer incidence in the world. Approximately two in three Australians will develop some form of skin cancer by age 70. Melanoma remains one of the most common cancers diagnosed in this country, particularly in younger age groups. The regulatory stakes of getting sunscreen right are not abstract.

The reforms the TGA has announced address several distinct areas. First, testing requirements will be strengthened to ensure the reliability of SPF claims. Second, quality standards for specific sunscreen ingredients will be introduced. Third, guidance on good manufacturing practice will be reviewed. Fourth — and this is the most consumer-facing change — SPF claim limits will be introduced for cosmetic sunscreens, formally separating products primarily designed for UV protection from products such as tinted moisturisers or BB creams that contain a sun protection ingredient as a secondary function.

This last category has been a long-standing ambiguity in AU sunscreen regulation. Under existing TGA rules, sunscreens primarily intended for UV protection are regulated as therapeutic goods, subject to testing and listing requirements. Cosmetics with a secondary sun-protection function operate under different rules — and the proposed reforms would cap the SPF claims such products can make to better reflect those different standards.

Both-and: the reform and its limits

The expert commentary in The Medical Republic article offers two useful framings.

From Associate Professor Anna Wang at UNSW Sydney: the difference between SPF 30 and SPF 50 is, in practice, a small one. SPF 30 filters approximately 97% of UVB radiation; SPF 50 filters approximately 98%. For most real-world use, the gap is not the variable that determines outcomes — the amount applied, how thoroughly it is applied, and whether it is reapplied are more important. The SPF claim on the bottle is tested under standardised laboratory conditions. Real-world outcomes depend heavily on application behaviour, which no regulatory reform will change.

From Professor Leigh Kinsman at La Trobe University: the regulatory reform, welcome as it is, will take years to flow through to any measurable change in skin cancer burden. The more immediate problem — one that regulation addresses only at the margins — is geographic and socioeconomic inequity in access to dermatology and skin cancer care. The Loddon Mallee region in regional Victoria has a melanoma incidence rate 63% above the state average, a gap that reflects barriers to specialist care, not a lack of awareness about sun protection. Getting sunscreen testing right is a necessary condition for a well-functioning public health system; it is not sufficient to close that gap.

There is a third angle that neither framing fully captures: consumer trust. When testing finds that labelled SPF is unreliable in a subset of products, the damage to the overall message is disproportionate. Patients who have been following sun safety advice correctly may reasonably wonder whether their diligence was wasted. The TGA’s move toward stronger testing is partly a response to that, and partly an attempt to ensure that future SPF claims carry more meaning than they currently do.

2 cents

The reforms announced this week do not change what to do right now. The Cancer Council’s sun safety recommendations remain the same: sunscreen SPF 30 or higher, applied generously to all exposed skin, reapplied every two hours and after swimming or sweating — alongside protective clothing, a broad-brimmed hat, UV-protective sunglasses and seeking shade in the middle of the day.

The practical upshot of the testing findings is to prefer products that have passed recent TGA testing, and to be cautious about assuming that a higher SPF number in a cosmetic product delivers the same protection as the same number in a dedicated therapeutic sunscreen. For daily face use, a dedicated SPF 50+ therapeutic sunscreen that you reapply is more reliable than trusting the sun protection component in a moisturiser or foundation alone.

If you have not already formed the habit of skin checks — self-examination and a GP assessment every one to two years if you have risk factors such as a history of sunburn, fair skin, a family history of melanoma, or many moles — this is a timely prompt. The reforms are about the accuracy of product claims. The underlying risk is real and unchanged.

Verdict: yes — product reliability matters, and the regulatory changes are warranted.

---

Sources cited

1. TGA moves to tighten sunscreen rules — The Medical Republic, 2 November 2026
2. Sunscreens — Therapeutic Goods Administration
3. Sun safety and sunscreen — Cancer Council Australia
4. Skin cancer in Australia — Australian Institute of Health and Welfare