Bemotrizinol: a sunscreen filter Europe and Asia have long used, now US-approved
The US FDA added bemotrizinol by final order on 9 June 2026, effective 9 August, at up to 6%. The EU and ASEAN allow 10%. Why it took so long and what it means.
- The US FDA issued a final order adding bemotrizinol to its permitted sunscreen ingredients on 9 June 2026. It took effect on 9 August 2026, at up to 6%.
- It's the first new active added to the US sunscreen list since the late 1990s. It protects against both UVA and UVB and is absorbed into the body very little.
- Europe and ASEAN have long listed it as a permitted UV filter at up to 10%. On cosmetic labels it's called Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine.
- The delay came from the US treating sunscreen as a drug, not a cosmetic, which makes the review much heavier. It wasn't because the ingredient was only just found to be safe.
Bemotrizinol is a sunscreen filter that Europe and many Asian countries have used for years, but it only became permitted in the United States when the FDA issued its final order on 9 June 2026. The order took effect on 9 August 2026, allowing up to 6%. The news doesn’t mean the sunscreens sold elsewhere were unsafe. It shows how much slower the US system has been, and it explains why sunscreens in different countries contain different filters.
What bemotrizinol is
Bemotrizinol is an organic (often called “chemical”) UV filter. On cosmetic labels in Europe and Asia its INCI name is Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, sometimes shortened to BEMT.
What the FDA concluded:
- It protects against both UVA and UVB (broad spectrum).
- It has low absorption through the skin into the body.
- It has a low rate of skin irritation.
- It is generally recognised as safe and effective (GRASE) for adults and children 6 months and older.
Permitted forms are oil, lotion, cream, gel, butter, paste, ointment, stick and spray. Sprays must have no propellant, or keep the propellant separate from the product inside the container.
Timeline: why it took so long
| Year | What happened |
|---|---|
| around 2000 | in use in Europe |
| 2005 | the maker first asks to add it to the US list; the request stalls for nearly 20 years |
| 2014 | the US passes the Sunscreen Innovation Act, but no new filter gets through |
| 2020 | the CARES Act reforms the over-the-counter (OTC) drug process |
| 23 Sep 2024 | a new request is filed under the CARES Act process |
| 12 Dec 2025 | FDA proposes the order; comments open until 26 Jan 2026 |
| 9 Jun 2026 | FDA issues the final order |
| 9 Aug 2026 | the order takes effect |
The main reason is that the US regulates sunscreen as an OTC drug, while the EU and ASEAN treat it as a cosmetic. A new drug ingredient has to meet much heavier data requirements.
The 2014 law was meant to speed things up, but nothing passed. A law-firm analysis says the FDA asked for animal testing and new standards such as the Maximum Usage Trial (MUsT) that didn’t match the methods used elsewhere. The 2020 CARES Act then added user fees to fund reviews and let companies talk to the FDA during the review. Bemotrizinol is the first ingredient to come through that route.
The US approval was slow because of the legal process, not because the ingredient was only just found to be safe.
US vs EU vs ASEAN
| US | EU | ASEAN | |
|---|---|---|---|
| Sunscreen classed as | OTC drug | cosmetic | cosmetic |
| Bemotrizinol limit | 6% | 10% | 10% |
| Permitted since | 9 Aug 2026 | around 2000 | on the UV filter list (Annex VII) |
On both the EU and ASEAN UV filter lists it’s entry 25, at a 10% maximum. Thailand issues its own list of permitted sunscreen agents and updates it in line with the ASEAN list from time to time. To know whether a sunscreen you own contains it, check the ingredient list.
Worked example: 6% vs 10% in one tube
Turn the limits into grams for a 50 g tube.
- US limit, 6%: 50 × 0.06 = 3 g
- EU and ASEAN limit, 10%: 50 × 0.10 = 5 g
- A 2 g difference, so a US formula can hold 60% of what a European one can.
Don’t read this as “a 10% formula always protects better”. SPF and PA come from testing the whole formula, which usually combines several filters, not from one ingredient.
What happens after 9 August 2026
- The company that filed the request gets 18 months of exclusive marketing from the effective date, so other US makers can likely use it more widely from around early 2028.
- Legal analysts expect this order to serve as a template for reviewing the next sunscreen filters.
- If you live outside the US, nothing changes. The news reshapes the US market; sunscreens sold in Asia and Europe fall under different cosmetic rules.
Common mistakes
- Thinking the “new” filter is new to the world. It’s new to the US but has been used in Europe for more than 20 years.
- Assuming the US was slow because of a safety problem. The main reason was the legal process.
- Choosing a sunscreen for one ingredient. Look at the whole picture: broad spectrum, SPF 30 or higher, PA, and a texture you’ll actually wear every day.
- Applying too little and trusting a good filter to cover it. However good the filter, using less than 2 mg/cm² gives lower protection than the label. See Sunscreen SPF vs PA: how much to use.
- Putting up with a reaction. Any filter can irritate someone. If you get redness, itching or swelling, stop and ask a doctor or pharmacist.
Sources
- FDA Expands Sunscreen Options for the First Time in 20 Years — U.S. FDA
- Final Administrative Order OTC000039 (bemotrizinol) — U.S. FDA
- FDA Proposes First New Sunscreen Ingredient in Decades — Holland & Knight
- 5 questions dermatology patients may have about newly approved bemotrizinol — AJMC
- ASEAN Cosmetic Directive Annex VII: list of UV filters (Dec 2025) — ASEAN
- Regulation (EC) No 1223/2009 Annex VI: UV filters — legislation.gov.uk
FAQ
Are sunscreens with bemotrizinol better than others?
Not automatically. Protection depends on the whole formula and how much you apply. This filter covers UVA and UVB and is quite stable in sunlight, but a sunscreen without it still protects well if it's broad spectrum, high enough in SPF and applied generously.
Can I find sunscreens with it outside the US?
It's on the ASEAN and EU lists of permitted UV filters. The easiest check is to look for Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine in the ingredient list.
Can children use it?
The US FDA considers it safe and effective for adults and children 6 months and older. For babies under 6 months, or children with sensitive skin, ask a doctor first.
General guidance. Products differ between brands: always follow the label. If you react to a product, see a doctor.