Bemotrizinol: The Sunscreen Filter Americans Search by Name

Bemotrizinol sunscreen has a new regulatory status in the United States. The FDA issued a final administrative order on 10 June 2026 adding bemotrizinol to the sunscreen monograph at concentrations of up to 6%, for adults and for children aged 6 months and older. The order was set to take effect on 9 August 2026.

The claim that European sunscreens are better is a claim about a standard. Europe's UVA standard is stricter than the current US test. But a 2026 study of 38 sunscreens from Europe, Latin America, Oceania and Asia found that about a third failed the European ratio, including some sold in Europe.

This article covers why people search a filter by its chemical name, what bemotrizinol does, the US filter gap and where FDA review stands now, how PA, PPD and broad spectrum compare, and how to read an imported label. It reports regulatory positions and evaluates claims. It does not issue clearance, and it does not tell you what to buy.

Why People Search a Filter by Name

Bemotrizinol, whose chemical name is bis-ethylhexyloxyphenol methoxyphenyl triazine, is sold abroad under trade names that appear on ingredient lists. The FDA's scientific review states that sunscreens containing it are marketed on all continents except Antarctica and have been sold in some jurisdictions for at least 20 years. It adds that most jurisdictions regulate sunscreens as cosmetics, whereas the United States regulates them as drugs.

That difference is why an ingredient on a foreign label could not appear on a US one. Before the order, the same review states, drug products containing bemotrizinol could not be legally marketed in the United States. Trade press reported the June action as the first newly allowed US sunscreen active in roughly two decades.

People searching the chemical name are most likely reading ingredient lists, a habit our article on sunscreen without the white cast describes. That reading is the article's inference, not a sourced finding. Texture claims on the same labels are covered in our article on lightweight sunscreens.

What Bemotrizinol Does

The FDA review describes bemotrizinol as an organic UV filter with high photostability and broad-spectrum coverage across UVB (280 to 320 nm) and UVA (320 to 400 nm). It states that the filter is stable in UV light, unlike many filters that degrade, and that it stabilises avobenzone. It has a molecular weight of 627.81 g/mol and is insoluble in polar solvents.

A filter is an ingredient, and protection belongs to the finished product. The FDA review explains that the broad spectrum test is applied to the finished drug product, often containing more than one active ingredient, and is not used to rate an ingredient. The final order sets the ingredient's floor: a bemotrizinol product must reach a minimum SPF of 2. In the efficacy studies, formulations at 1.5% and 3% each had a mean SPF above 2.

So a bemotrizinol sunscreen's label line "contains bemotrizinol" says nothing on its own about the SPF or UVA level of the product. It also says nothing about visible light. Organic filters do not block it, a point our article on sunscreen for hyperpigmentation covers.

The FDA's final order states it reviewed human clinical and nonclinical studies and concluded there was adequate evidence from two independent human efficacy studies, and adequate evidence of safety at concentrations up to 6% for adults and for children aged 6 months and older. Those are the FDA's conclusions, in its words, and they are a regulatory determination.

The absorption data are more detailed than the headline. In the maximal usage trial, 162 healthy adults applied 6% bemotrizinol formulations four times a day for four days to 75% of the body surface. Of the plasma samples, 31.4% had quantifiable levels, and about 3% of samples exceeded 0.5 ng/mL, a threshold the FDA uses to decide whether a separate systemic carcinogenicity study is needed. Of the 162 people, 68 (42%) had at least one sample at or above 0.5 ng/mL, mostly a single sample, and four samples exceeded 5 ng/mL, up to 17.4 ng/mL, which the FDA treated as outliers. The FDA concluded that steady-state blood levels were below 0.5 ng/mL, called the absorption sporadic and low, and found no irritation, phototoxicity or photoallergy in its dermal studies.

The final order also records a disagreement. A commenter argued there were data gaps, including breast milk and long-term paediatric use. The FDA responded that it did not see a gap and that paediatric data were limited but not needed in the form requested. Both positions are reported here as they stand.

The US Filter Gap

The FDA's question-and-answer page explains the starting point. The deemed final order that came into existence in March 2020 considers sunscreens containing 16 sunscreen active ingredients GRASE, meaning generally recognized as safe and effective, which is the FDA's regulatory term. A 2021 proposed order would keep only zinc oxide and titanium dioxide as GRASE and says 12 other ingredients need more data, which the FDA states is not a conclusion that they are unsafe.

New ingredients now enter through an administrative order process created by the CARES Act. For bemotrizinol, DSM Nutritional Products submitted its request on 23 September 2024, and the FDA filed it in December 2024. The FDA proposed the order on 12 December 2025 and issued the final order on 10 June 2026 without changes after public comments.

Where FDA Review Stands Now

The status on the day of writing, from the FDA's own pages:

• Bemotrizinol. The final order (OTC000039) was issued on 10 June 2026 and states that it takes effect on 9 August 2026, or, if disputed, as the law provides. No notice of a dispute was found. The FDA question-and-answer page, current as of 10 September 2026, lists the order as having added bemotrizinol.
• Conditions. The permitted concentration is up to 6%. Products may be oils, lotions, creams, gels, butters, pastes, ointments, sticks and sprays, and sprays must contain no propellant or keep it isolated. Powders and propellant aerosols were left out because the data did not support them. Combinations with PABA or trolamine salicylate are not GRASE.
• Exclusivity. The order authorises only DSM Nutritional Products, or its licensees, to market bemotrizinol drugs under it for 18 months from the date it may lawfully market.
• PABA and trolamine salicylate. A separate final order on 10 September 2026 removed these two ingredients from the monograph.
• The broader 2021 proposal is still pending. It would require sunscreens at SPF 15 and above to pass broad spectrum, including a new UVA I/UV ratio of 0.7 or higher. The FDA states that a final order cannot take effect sooner than one year after issuance, and that bemotrizinol products would have to meet it if it is finalised.
• Market. Trade press reported on 1 September 2026 that the first US bemotrizinol sunscreen had launched, citing company statements. That is a company claim, reported secondhand.

PA, PPD and Broad Spectrum

Four yardsticks are in use, and they measure different things.

SPF measures protection against UVB-driven redness, tested at 2 mg/cm². Our article on sunscreen by skin type covers what that implies for the amount applied.

US broad spectrum is currently a pass/fail test of the finished product. The monograph text defines the critical wavelength as the point where the integral of the absorbance curve reaches 90% of the integral over 290 to 400 nm, and classifies a mean critical wavelength of 370 nm or greater as broad spectrum protection.

The European standard is a ratio. A 2026 study describes EU guidelines as requiring that UVA protection factor be at least one third of the labelled SPF, that is, an SPF to UVA-PF ratio of 3 or less. The same paper says Australia and Mercosur countries have also adopted the ratio and require a critical wavelength of 370 nm or more. For an SPF 50+ product, the study used SPF 60 for the ratio, which puts the UVA-PF floor at 20.

PA and PPD. The persistent pigment darkening (PPD) method, ISO 24442, measures the dose of UVA that produces lasting darkening with and without a sunscreen. It is described as a biological endpoint and the gold standard in vivo method. Japan's PA system, widely used in Asian markets and so often seen on what shoppers search for as a Korean mineral sunscreen, grades the result in four steps, PA+ to PA++++, from some to very high UVA protection. A review notes that Japan treats sunscreens as cosmetics and that the PA grade comes from voluntary industry standards set by the Japan Cosmetic Industry Association. The sources opened do not give the PPD cut-offs for each PA grade, and other pages give figures that differ slightly, so none are stated here.

The practical difference is that the EU ratio ties UVA to the SPF of the same product, while PA is a separate UVA grade. As reasoning, not a sourced rule, an SPF 15 product at PA+++ and an SPF 50 product at PA+++ can both be accurate and still protect differently, because PA does not show how much above its threshold a product sits.

The Figure Audited: "European Sunscreens Are Better"

The plan asked for the UVA standards to be compared, not the brands. They have been, and the brands then turn out to matter little.

The US test requires a critical wavelength of 370 nm or more. The EU requires a ratio of one third and, in the countries that adopted it, the critical wavelength as well. On this measure the EU standard is the stricter one. The 2026 study states that the EU standard is a more stringent guarantee of UVA protection than the critical wavelength approach, which it calls an arbitrary measure of UVA filtration bandwidth, not a given level of biological protection.

Two studies with opposite sources of funding tested products against these standards. Neither is neutral.

A 2022 study tested 51 US sunscreens, all labelled broad spectrum, with the in vitro ISO 24443 method at a commercial laboratory. It found 94% would pass the current US critical wavelength test, 67% the proposed UVA I/UV test, and 35% the EU ratio. Without a correction coefficient in the ISO method, only 9 of 51 passed the EU ratio. The study was run by a non-profit that publicly ranks sunscreens, with laboratory testing paid for by a foundation grant.

A 2026 study tested 38 sunscreens at SPF 50 or higher from Europe, Latin America, Oceania and Asia with the in vivo ISO 24442 method. It found UVA-PF between 3.6 and 46.6, with 68% (26 of 38) passing the EU ratio and one third failing, including several products sold in Europe. The mean UVA-PF was 22.6 for European products, 21.9 for Latin American and 16.3 for Asian and Australian. It was funded by a sunscreen maker, and the tests were done at centres validated to its parent company's standards.

The two studies cannot be compared directly. They used different methods (in vitro and in vivo), different products and different years, and each has an interest.

Verdict: the claim is true of the standard and not reliable for brands. The EU requirement is stricter than the US critical wavelength test. But in the one study that tested products from several regions, a third failed it, and the one study that tested US products found most failing it in vitro. Where a product was made does not tell you whether it passes. A stated UVA-PF or PPD value, with the method named, is more informative than the continent.

Buying Imports

Many shoppers meet bemotrizinol through products from Korea, Japan, Europe or Australia. Shoppers who search for a Korean mineral sunscreen are asking about a label word, not a filter list; the filter list is the ingredient panel, and our article on sunscreen without the white cast covers why mineral versus chemical is a poor frame. That is reasoning, not a sourced finding.

On the regulatory position, the FDA order sets conditions for US-marketed drug products: a concentration up to 6%, permitted dosage forms, a minimum SPF and US labelling. A product formulated for another market follows that market's rules, which in most jurisdictions are cosmetic rules. The order's exclusivity provision authorises solely DSM and its licensees to market bemotrizinol drugs under it for 18 months. No FDA statement on personal imports was found, and this article does not say whether any particular import is lawful or advisable.

A label can be judged on what it states.

• The filter list. The ingredient panel names the filters in the chemical or trade form, and the chemical name above is the one used by the FDA.
• A UVA value, not just a word. A numeric UVA-PF or PPD, or a PA grade, says more than "broad spectrum", and the test method (ISO 24442 or 24443) should be named.
• The SPF and the UVA claim together. The EU ratio ties them, and PA does not.
• A concentration. In the US the order's ceiling is 6%.
• Visible light. Bemotrizinol is not a visible-light blocker, so a claim about visible light needs a tint or pigment, not this filter.

Conclusion

Bemotrizinol sunscreen can be marketed in the United States under an FDA order that was due to take effect on 9 August 2026 and, as far as the FDA's pages show, did, at up to 6%, with 18 months of exclusivity for DSM and its licensees. The FDA found adequate evidence on efficacy and safety. Its own absorption data show sporadic, low levels, with 42% of trial participants having at least one sample above its 0.5 ng/mL threshold.

The broader 2021 proposal, including a stricter US UVA test, is still pending. The European standard is stricter than the current US one, though a third of the international products tested failed it and most US products tested in vitro did. A stated UVA value and a named method tell you more than where a sunscreen was made.

If a new sunscreen is added to a routine, a dated photo of the skin in the same place and light, kept in an album or in an app like Skinic, shows whether the skin is reacting. It cannot say whether a sunscreen meets a standard. For questions about a reaction or about use in children, ask your own clinician.