Sunscreen reforms in Australia explained

When you choose a sunscreen, you should be able to trust the protection claimed on the label. Australia’s Therapeutic Goods Administration (TGA) is developing reforms intended to strengthen that confidence, with work covering how sunscreens are tested, the quality of their ingredients and the way they are manufactured. TGA: strengthening sunscreen regulation

The package was outlined on 27 October 2026, following a public consultation earlier in the year. The changes are still being developed, and some may require further consultation or legislative amendments before they take effect. TGA: sunscreen reforms

This article was edited with AI assistance. Sources were checked on 10 November 2026 (UTC); the article has not been independently reviewed by an Australian regulatory professional.

What the SPF number tells you

Sun protection factor, or SPF, indicates how well a sunscreen protects against sunburn, which is mainly caused by ultraviolet B (UVB) radiation. The rating comes from testing under controlled conditions. The TGA says that, when applied correctly, SPF30 filters about 97% of UVB rays and SPF50 about 98%. No sunscreen blocks all UV radiation. TGA: SPF testing information for consumers

“Broad spectrum” means a sunscreen also protects against ultraviolet A (UVA) radiation. Both UVA and UVB can contribute to skin cancer. TGA: reading sunscreen labels

The number is useful when choosing a product, but protection in everyday life also depends on how much you apply and how well you maintain that coverage. Swimming, sweating and towel drying can all make reapplication necessary. Cancer Council Australia: sunscreen advice

Why two SPF tests can give different results

One established SPF testing method uses human volunteers. Researchers apply sunscreen under controlled conditions, expose test areas to UV and assess the skin’s response. That process includes several sources of variation. TGA: SPF testing information for consumers

The TGA identifies differences in how people’s skin responds, even among volunteers with the same skin type. Technicians can also differ in how they apply sunscreen and how they judge redness, which is assessed visually. These factors can contribute to different SPF results for the same product.

In 2025, consumer organisation CHOICE reported that some sunscreens did not meet their labelled SPF in its testing. The TGA began investigating the products and the reasons for inconsistent results. Testing variability is one consideration; it does not by itself explain every result. TGA: SPF testing information for consumers

A result below the labelled SPF therefore needs careful investigation. In its October 2026 statement on Consumer NZ sunscreen testing, the TGA said an individual result should be considered alongside the full testing history and other evidence supporting the claim. A difference alone does not establish that a sunscreen provides no protection or is unsafe. TGA: statement on Consumer NZ sunscreen testing

The TGA already requires sponsors of listed sunscreens, the businesses responsible for those products, to hold evidence supporting their claims. If new information casts doubt on a claim, they should promptly gather further evidence, which can include additional testing. TGA: SPF testing information for sponsors

How the testing requirements could change

The TGA plans to strengthen several parts of the testing system:

• Enable sponsors to use in vitro testing, carried out outside the human body, or in vivo testing involving people, where appropriate. The applicable methods and implementation details still need to be worked through.
• Strengthen laboratory accreditation.
• Refer directly to testing standards from the International Organization for Standardization (ISO) in legislation.
• Require SPF testing of the finished product at listing and periodically while it remains on the Australian Register of Therapeutic Goods (ARTG).
• Require testing data to be submitted to the TGA at listing, where it would be held confidentially. TGA: sunscreen reforms

Testing the finished product matters because the sunscreen on the shelf may differ from an earlier laboratory formula. Production may have been scaled up, the formula changed or manufacturing moved to another site. Periodic testing would also help assess performance over time. TGA: consultation response

The October consultation response identifies practical details that still need clarification, including how often testing should occur, which product changes should trigger another test and how variability should be assessed. These details will matter to how the new requirements work.

Formulators and regulatory teams can review how existing SPF evidence relates to the marketed formula and any changes made since it was tested. Current requirements still apply while the reforms are being developed.

Why ingredient quality matters

Sunscreen performance depends on its ingredients and how they behave in the formulation. In its consultation paper, the TGA gives examples of possible quality requirements: the range of particle sizes in zinc oxide, how evenly particles are dispersed, and the purity of chemical UV filters. TGA: March 2026 consultation paper

These characteristics can influence how reliably the finished sunscreen performs. The proposed work would establish clearer quality requirements for particular ingredients. The examples are areas for development, not a final set of specifications.

The reform work focuses on ingredient quality and performance. The TGA considers ingredient safety through a separate process. Its therapeutic sunscreen guidance, last updated on 9 November 2026, describes using the Australian Sunscreen Exposure Model to assess new ingredients that can absorb through the skin. That assessment is separate from the October reform package. TGA: therapeutic sunscreen guidance

Clearer guidance for manufacturers

Manufacturing controls help a sunscreen perform consistently from batch to batch and over time. The TGA explains that starting materials and manufacturing conditions can vary, while sunscreens are expected to support their label claims through to the end of their shelf life. A history of test results can help identify when a product’s performance has changed. TGA: sunscreen regulation webinar

Therapeutic sunscreens already have manufacturing requirements. The planned review of good manufacturing practice (GMP) guidance is intended to make expectations and responsibilities clearer and support consistent product quality. It should help businesses understand what they need to control and who is responsible. TGA: sunscreen regulation in Australia

Cosmetics and SPF labels are also under review

Some products offer sun protection as a secondary purpose. Certain foundations with SPF, for example, are treated as cosmetics and sit outside the TGA’s therapeutic sunscreen framework. The TGA plans a consistent limit on SPF claims for these cosmetic sunscreens to make their distinction from primary sunscreens clearer. Its reform summary does not specify a final numerical limit. TGA: sunscreen regulation; TGA: sunscreen reforms

Changes to how SPF ratings appear on labels are at an earlier stage. Stakeholders expressed mixed views, and the TGA says it will undertake further review and consultation before progressing proposed labelling changes. For more on the broader market-entry requirements, see our guide to launching cosmetics in Australia.

What you can do now

Keep sunscreen in your sun protection routine. Cancer Council Australia recommends using sun protection when the UV index is 3 or above, and choosing broad-spectrum, water-resistant SPF50 or SPF50+ sunscreen. Use it alongside other protection against UV. Cancer Council Australia: sunscreen advice

A few habits make that protection more reliable:

• Apply enough. An average adult needs about seven teaspoons, or 35 mL, for full-body coverage.
• Apply it 20 minutes before going outside, and reapply every two hours and immediately after swimming, sweating or towel drying.
• Check the expiry date and follow the storage instructions. Avoid leaving sunscreen in a hot car.
• Use clothing, a broad-brimmed hat, shade and sunglasses as well as sunscreen.

Look for an AUST number on a therapeutic sunscreen’s label, which identifies its inclusion in the ARTG. Most therapeutic sunscreens are listed medicines. Their sponsors certify that they meet applicable requirements, but the TGA does not individually evaluate each listed sunscreen before it enters the market. If you are concerned about a particular product, check the TGA’s recall advice and follow the instructions for any affected product or batch. TGA: sunscreen regulation; TGA: sunscreen updates and recalls

What happens next

The TGA will update its reform page as the work progresses. The timing and detailed requirements still need to be worked through. For sunscreen users, the intended benefit is more dependable evidence behind the label and greater confidence in the product they apply. TGA: strengthening sunscreen regulation

Sources

Sources checked on 10 November 2026 (UTC). The March and April material provides background to the reforms; the October announcements set out the direction being developed.

1. TGA: Sunscreen reforms.
2. TGA: Strengthening sunscreen regulation.
3. TGA: Reading sunscreen labels.
4. TGA: SPF testing information for consumers.
5. TGA: Statement on Consumer NZ sunscreen testing.
6. TGA: SPF testing information for sponsors.
7. TGA: Consultation response and proposed reforms, October 2026.
8. TGA: Consultation paper, March 2026.
9. TGA: Sunscreen regulation webinar, April 2026.
10. TGA: Sunscreen regulation in Australia.
11. Cancer Council Australia: Choosing, applying and storing sunscreen.
12. TGA: Sunscreen updates and recalls.
13. TGA: Understanding the regulation of therapeutic sunscreens.