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Australian Sunscreen Council lodges expert submission to TGA public consultation

Updated: Aug 29


Australian Sunscreen Council lodges expert submission to TGA public consultation

18 August 2025 — Brisbane


Led by Dr Yousuf Mohammed — Research Leader at The University of Queensland; Chair- American Association of Pharmaceutical Sciences, Topical Transdermal community (TTC); Wonder of Science – Flying Scientist; author of 100+ publications and 45+ invited talks; contributor to 80+ regulatory guidance's — the ASC has lodged an evidence-based submission recommending tighter limits on legacy UV filters to better protect Australians.


Contributors: Dr Craig Downs, Dr Denis Dudley, and Dr Joseph DiNardo — internationally recognised experts spanning toxicology, dermatology, environmental science, and product safety — provided key scientific input and review.


What we asked the TGA to do

  • Homosalate: cap at ≤ 0.28% (Schedule 5, Option 1).

  • Oxybenzone (benzophenone-3): cap at ≤ 1.0% (Schedule 5, Option 1).

  • Benzophenone: 0% allowable (no 383 ppm exemption) given its genotoxic and photo-DNA-damage potential.

These positions reflect real-world Australian use (high-frequency, large-surface application) and are grounded in the Australian Sunscreen Exposure Model (ASEM).


Our expert assessment of current risk

Formulations relying on concentrations above the proposed limits do not provide an adequate margin of safety for typical Australian use patterns and are an active concern for the general population.


Guidance for consumers during the consultation

  • If your sunscreen lists homosalate above 0.28% or oxybenzone above 1.0%, current evidence says it cannot be considered safe for use in Australian conditions—please cease use.

  • Octocrylene can degrade into benzophenone, a suspected carcinogen. The State of California lists benzophenone as a carcinogen and has no established “safe” exposure level for it. If you are concerned — and a brand cannot provide recent test data confirming non-detect benzophenone — it is prudent to avoid sunscreens using octocrylene.

  • Clinical advice remains that shade and physical protection (clothing, hats, avoiding peak UV) are more effective than sunscreen; sunscreen should be used as a last resort when high exposure is unavoidable.

  • If you’re unsure, consult your GP or dermatologist.


What industry should do now

To minimise risk while the TGA finalises scheduling decisions, ASC recommends that sponsors and manufacturers:

  1. Audit portfolios and supply chains for formulas/batches exceeding 0.28% homosalate or 1.0% oxybenzone, and for any benzophenone presence.

  2. Pause release of affected batches and prioritise reformulation to compliant levels.

  3. Notify retailers and consumers transparently where reformulation or withdrawal is underway.

  4. Tighten raw-material controls and verification testing to prevent future introduction of non-compliant actives.


About the ASC

The Australian Sunscreen Council is the peak voice of a $500m domestic industry serving Australians and exporting to more than 42 countries. We champion evidence-based standards, transparency, and innovation so every Australian can rely on safe, effective sun protection.


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