On June 9, the Food and Drug Administration approved a new sunscreen filter for American over-the-counter products. The order took effect on August 9. It is the first new filter authorized in the United States since the late 1990s.
In the United States, it is national news. In Europe, that filter has been permitted for years, and we already use it.
It is called bemotrizinol. On the label, you will see it as Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine. If you have our SPF 50 single-dose product at home, you already have it in your hands: it is the second filter in the INCI list. The same molecule can be both a novelty and an established technology: it depends solely on the country where the sunscreen is purchased.
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Elisa Avalle · Founder and dermocosmetics specialist
Cosmetics are also a matter of regulatory geography. Consumers see a cream; behind it are lists of permitted substances, dossiers and systems that do not move at the same speed.
What is bemotrizinol?
It is a broad-spectrum organic filter: it absorbs both UVB and UVA rays and dissipates them. Two characteristics make it interesting for formulators.
The first is photostability: it withstands exposure to light well without degrading quickly, and it can help stabilize other filters present in the same formula. The second is the size of the molecule, which is larger than that of other better-known organic filters: it penetrates the skin very little, so systemic absorption is low. This is precisely the point behind the concerns in the United States in recent years regarding other filters.
That said, and I say this as the founder of a brand that develops sunscreens: no single filter makes a sunscreen good. Protection depends on the complete blend, the concentrations, how the product spreads across the skin and the tests performed on the finished product. A modern ingredient in a mediocre formula remains a mediocre formula.
Why did it take twenty-five years in the United States?
The difference is not scientific; it is one of classification.
In the United States, sunscreens are over-the-counter drugs. A new filter must be included in an FDA monograph through a lengthy, formal process. In Europe, sunscreens are cosmetics, subject to a positive list of permitted filters and a safety assessment. It is a different system, not a more permissive one, but one capable of being updated on a different timetable.
The result is what they call the sunscreen gap in the United States: for years, American consumers bought European or Asian sunscreens online to get the textures and UVA coverage they could not find at home. This authorization shows that the system can move. It does not mean that all European filters will become available in America: one has passed, following a process that began in 2024.
Six percent versus ten: why the numbers do not match
The FDA permits bemotrizinol up to 6%, under precise conditions: the finished product must provide at least SPF 2, the permitted cosmetic forms and possible combinations with other filters are defined, and it is considered safe and effective for adults and children six months and older.
The European Union permits it up to 10%, under Annex VI of the Cosmetics Regulation.
This difference regularly prompts outrage, in both directions. It is not a scientific contradiction: different authorities assess different dossiers, submitted for different uses, within different regulatory frameworks. The limit is not the threshold beyond which a substance becomes dangerous: it is the maximum level for which authorization was requested and obtained within that system. Anyone who uses these differences to claim that one continent is safer than the other is telling a story, not reading a regulation.
No, this is not the time to say “chemical filter”
I already know how this news will be presented in some social media content: a new chemical filter approved in the United States, while mineral filters remain the natural choice.
The division between mineral and chemical filters is convenient for explaining things, but it becomes misleading when it turns into a scale of risk. Zinc oxide and titanium dioxide are also chemical substances. “Chemical” is not a category of hazard; it describes how the molecule works: here, UV energy is absorbed and dissipated; there, it is reflected and partly absorbed.
The useful questions are different: Is the filter authorized under the intended conditions of use? What spectrum does it cover? How photostable is it? How does it behave in the complete formula? I wrote about this in detail when I discussed the fear of chemicals reaching sunscreens, and in the guide to chemical and physical filters.
What is proven and what is not
It has been demonstrated that bemotrizinol absorbs UVA and UVB rays, is photostable, penetrates very little and can be used as a filter under the intended conditions. The FDA considers it generally recognized as safe and effective when the product complies with the updated monograph.
What has not been demonstrated, however, is that every product containing it protects better than any formula that does not. A well-formulated sunscreen using other filters can offer excellent protection. And a sunscreen containing the most modern ingredient in the world still has to pass the same tests as all the others.
My take
This news interests me for a reason that has little to do with America.
Bemotrizinol is not a magic wand: it is one more tool for formulators. And in photoprotection, having more well-assessed tools matters a great deal, because it makes it possible to create products that not only protect, but that people want to apply.
This is the part that is often underestimated. Pleasantness is not a luxury; it is a variable in effectiveness. A sunscreen that leaves the face white, greasy or sticky is applied in insufficient amounts, or is not reapplied, or is not applied at all. At that point, the SPF printed on the packaging is a theoretical number. That is why we worked on the format even before the formula: the pocket-sized single-dose product was born from this problem, the problem of not having sunscreen with you when you need it.
Face Sunscreen SPF 50 Pocket Size, Travel Size (5 pcs) Pocket-sized SPF 50 facial sunscreen in single doses The problem isn’t applying sunscreen. It’s reapplying it. Smalle... Discover Face Sunscreen SPF 50 Pocket Size, Travel Size (5 pcs)
What is the first new filter in twenty-five years for the United States has been familiar to us for some time. This does not mean that one continent is always ahead of the other. It means that regulations follow different paths, and that innovation can reach consumers decades apart.
The interesting thing to watch now is something else: whether this step will pave the way for the other filters already used elsewhere in the world, or whether it will remain an isolated case.
If you are interested in the practical side rather than the regulatory one, the guide to choosing facial sunscreen answers the questions I receive most often.
Elisa Avalle is the founder of LeLang Skin Care, specializing in dermocosmetics at the University of Barcelona. She founded the brand in the Langhe region for Italian pharmacies and para pharmacies.
Sources for this article
01 Food and Drug Administration, final administrative order OTC000039, “Amending Over-the-Counter Monograph M020: Sunscreen Drug Products,” June 9, 2026; published in the Federal Register on June 10, 2026; effective August 9, 2026
02 Regulation (EC) No. 1223/2009 on cosmetic products, Annex VI, list of permitted UV filters
03 Regulation (EU) No. 655/2013, common criteria for claims made about cosmetic products
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