The TGA’s sunscreen ingredient review
Keep using sunscreen. The TGA says its benefits far outweigh any risks, and nothing here says a product is unsafe: the limits are proposals.
Since 2025 the TGA has been reviewing UV filters used in Australian sunscreens. Five of the first seven it looked at need no change. For homosalate and oxybenzone it has proposed lower limits, and since September 2026 it has been consulting on 4-MBC too. None of this is final: each proposal goes to an interim decision, more comment, then a final decision with time for products to change.
Timeline
The TGA publishes a literature review of seven sunscreen actives it chose for priority review. TGA
Safety reviews of the seven actives and of benzophenone are published. Five actives need no change; the TGA proposes limits on homosalate and oxybenzone, and a cap on benzophenone, which can form as sunscreen ages. TGA
Public consultation opens on three options each for homosalate and oxybenzone. It closes on 12 August 2025. TGA
The joint advisory committees on medicines and chemicals scheduling discuss the proposals and the submissions, and send them on to their November meeting. TGA
The committees discuss homosalate, oxybenzone and benzophenone again. The TGA says the interim decisions will be published on their own, later. TGA
The TGA reviews 4-MBC, prompted by decisions of sunscreen regulators overseas. TGA
A study of urine samples from Queensland, in Environmental Science & Technology, reports homosalate in children’s samples and makes the news. The TGA’s advice stays the same: keep using sunscreen. Environmental Science & Technology
Consultation opens on 4-MBC: two TGA options (0.39%, or face and hand products only) and a ban proposed by two private applicants. It closes on 12 October 2026. TGA
The joint committees meet to consider 4-MBC (meeting #45). TGA
Interim decision on homosalate, oxybenzone and benzophenone, published for comment. If limits go ahead, products get a set time to change. TGA
Interim decision on 4-MBC, published for comment. TGA
Homosalate, the options
| Option | What it would allow | Limit |
|---|---|---|
| 1 | 0.28% or less in any sunscreen | 0.28% |
| 2 | 0.68% or less, and only in sunscreens for the face and hands | 0.68% |
| 3 | 2.7% or less, and only in face and hand sunscreens for people 18 and over | 2.7% |
Today’s maximum in listed sunscreens: 15%. Source: the TGA’s consultation (8 July 2025 to 12 August 2025). Interim decision due by the end of 2026.
The proposed wording
Option 1. HOMOSALATE in therapeutic sunscreens and cosmetic preparations except in preparations containing 0.28% or less of homosalate.
Option 2. HOMOSALATE in therapeutic sunscreen and cosmetic preparations except: (a) in therapeutic sunscreen preparations for application to the face and hands containing 0.68% or less of homosalate; or (b) in cosmetic preparations for application to the face and hands containing 4.35% or less of homosalate.
Option 3. HOMOSALATE in therapeutic sunscreens and cosmetics preparations except in preparations: (a) for use by persons aged 18 years and over; and (b) for application to the face and hands; and (c) containing 2.7% or less of homosalate.
By the TGA’s count, 471 medicines on the register listed it as an active on 26 June 2025 (all listed medicines, 65 of them for export only). In our table today:
Oxybenzone, the options
| Option | What it would allow | Limit |
|---|---|---|
| 1 | 1% or less in any sunscreen | 1% |
| 2 | 2.5% or less, and only in sunscreens for the face and hands | 2.5% |
| 3 | 9.8% or less, and only in face and hand sunscreens for people 18 and over | 9.8% |
Today’s maximum in listed sunscreens: 10%. Source: the TGA’s consultation (8 July 2025 to 12 August 2025). Interim decision due by the end of 2026.
The proposed wording
Option 1. OXYBENZONE in therapeutic sunscreens and cosmetic preparations except in preparations containing 1% or less of oxybenzone.
Option 2. OXYBENZONE in sunscreens and cosmetic preparations except: (a) in therapeutic sunscreen preparations for application to the face and hands containing 2.5% or less oxybenzone; or (b) in cosmetic preparations for application to the face and hands containing 6.0% or less oxybenzone.
Option 3. OXYBENZONE in therapeutic sunscreens and cosmetics preparations except in preparations: (a) for use by persons aged 18 years and over; and (b) for application to the face and hands; and (c) containing 9.8% or less of oxybenzone.
By the TGA’s count, 39 medicines on the register listed it as an active on 26 June 2025 (37 listed medicines (2 for export only) and 2 over-the-counter medicines). In our table today:
4-MBC, the options
| Option | What it would allow | Limit |
|---|---|---|
| 1 | 0.39% or less in any sunscreen | 0.39% |
| 2 | 0.95% or less in face and hand sunscreens, or 3.8% or less in face and hand sunscreens for people 18 and over | 0.95% / 3.8% |
| 3proposed by two applicants | Not allowed at all (proposed by two private applicants, not the TGA) | none allowed |
Today’s maximum in listed sunscreens: 4%. Source: the TGA’s consultation (11 September 2026 to 12 October 2026). Interim decision due in 2027.
The proposed wording
Option 1. 4-METHYLBENZYLIDENE CAMPHOR in therapeutic sunscreens and cosmetic preparations except in preparations containing 0.39% or less of 4-methylbenzylidene camphor.
Option 2. 4-METHYLBENZYLIDENE CAMPHOR in therapeutic sunscreens and cosmetic preparations except: a) in therapeutic sunscreens for application to the face and hands containing 0.95% or less of 4-methylbenzylidene camphor; or b) in therapeutic sunscreens for application to the face and hands (i) containing 3.8% or less of 4-methylbenzylidene camphor; and (ii) for use by persons aged 18 years and over; or c) in cosmetic preparations for application to the face and hands containing 3.3% or less of 4-methylbenzylidene camphor.
Option 3. 4-METHYLBENZYLIDENE CAMPHOR in therapeutic goods or cosmetic products. (Schedule 10)
By the TGA’s count, 107 medicines on the register listed it as an active on 25 August 2026 (95 listed medicines and 12 listed medicines for export only). In our table today:
Tell me when the TGA decides
One email the day the TGA publishes its interim decision, with what it means for the products in this table.
Questions
When will the TGA decide on homosalate and oxybenzone?
The TGA says the interim decision will be published for consultation by the end of 2026. A final decision follows that consultation, and products then get a set time to change.
Will my sunscreen be recalled?
The TGA has said it is not proposing any warnings, bans or recalls of products. If limits go ahead, products over them will have time to reformulate.
Why is the TGA reviewing these ingredients?
As a precaution. Its safety review found the margin of safety for homosalate and oxybenzone was below its benchmark for body sunscreens used every day at today’s maximum amounts. The signals come from animal studies at high doses, not from studies in people.
We read the TGA’s pages and consultation papers on 21 October 2026 and update this page the day anything changes.