Bemotrizinol sunscreens have been in the FDA's database since 2010 - 19 labels, four of them export only

Every account of the 2026 decision says the same thing: bemotrizinol is the first new sunscreen filter the FDA has added since the 1990s, and it has not been used in the United States. The second half of that is worth checking, because the FDA publishes the label of every drug filed with it, and a search of that database for bemotrizinol returns 19 labels. The oldest was published on October 9, 2010.

That does not mean the filter was quietly legal here for sixteen years. It means the database holds filings of several different kinds, and only one of those kinds describes a product a US shopper could legally have bought. Four of the 19 are filed by L'Oreal USA Products as export only. Two carry the notice the FDA puts on unapproved drugs. Seven predate the framework the 2026 order amends. This page lists all of them and says which is which.

Three databases, three different counts

The number you get depends on which federal search you run, and none of the three is the whole picture. All were read on September 7, 2026.

• DailyMed, searched by ingredient name: 19 labels. This includes labels that are no longer current, which is why it reaches back to 2010.
• The National Drug Code Directory: 11 entries. Eight finished sunscreens and three bulk-ingredient filings, two from DSM Nutritional Products and one from BASF Taiwan's Kaohsiung plant. This list holds only entries that are currently listed.
• The openFDA label endpoint: 8. The same eight finished products.

The two lists do not nest. Two Spanish filings by Anubis Cosmetics SL appear in the drug code directory but not in the DailyMed ingredient search, because that search reads the label title and those titles name other filters. So 19 is not a total. It is what one specific query returns, and we say which query.

Every label that names bemotrizinol

What the five categories mean

The marketing category is the filer's own statement of the legal basis for the product. It is the column that decides what a filing is worth.

• OTC Monograph Drug - 4 labels, all from 2026. Filed after the order took effect on August 9, 2026. These are the only ones here that claim the monograph as amended. We track them separately.
• Export only - 4 labels, all filed by L'Oreal USA Products. A product made in the United States for sale somewhere else. Ombrelle is L'Oreal's Canadian sunscreen line, and all four labels also list drometrizole trisiloxane, a filter the US monograph does not permit. The Kiehl's label is on its fourteenth version, published January 9, 2026. There are 24 export-only labels in total, and every one of them is L'Oreal.
• OTC monograph not final - 7 labels, from 2010 to 2020. Filed while the sunscreen monograph was still being rewritten. Six of the seven come from Korean companies, five of them LG Household and Healthcare brands.
• OTC monograph final - 2 labels, from 2011 and 2012. The pre-2020 designation for a product claiming an existing final monograph.
• Unapproved drug other - 2 labels, both Dr.Jucre. DailyMed displays a notice on these pages: "This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA."

What a filing is, and what it is not

Filing a label with the FDA is a registration step. A company that makes or imports a drug for the US market lists it, and the agency publishes what the company wrote. An over-the-counter sunscreen label is not reviewed by the FDA before it appears in the database. That is why a filing can carry a filter the monograph does not permit, and why a label can say export only.

So bemotrizinol appearing in 19 labels since 2010 does not contradict the 2026 order. The order changed whether a sunscreen containing bemotrizinol may be sold in the United States without an approved application. The database was only ever a record of what companies filed.

What it does show is that the ingredient has been moving through US paperwork for sixteen years, including through the US arm of the largest beauty company in the world, while the public account has been that it was not used here.

What we could not confirm

• Whether any of the 15 pre-2026 products was ever offered for sale in the United States. An export-only filing points away from it, but the filing does not say where a product was sold.
• Why the two Anubis Cosmetics filings appear in the drug code directory and not in the DailyMed ingredient search. The ingredient tables in those two records are also internally inconsistent: names and strengths do not line up, so we do not quote a bemotrizinol percentage for them.
• Whether the L'Oreal filings relate to any DSM licence. The exclusivity in the 2026 order runs to DSM and its licensees, and licence holders are not published.
• Whether Celgen Mild Sun and Lapothicell state a bemotrizinol strength anywhere. Neither label gives one in a machine-readable field or in its text.

Sources

• The 19 labels, their publication dates and versions - DailyMed SPL service, searched for bemotrizinol, read September 7, 2026
• Marketing category and filed strength for each label - the SPL XML behind each of the 19 records, read September 7, 2026
• The unapproved-drug notice quoted above - DailyMed page for Dr.Jucre Rebirth Sun Protection, read September 7, 2026
• The 11 current entries, including the bulk-ingredient filings - openFDA drug/ndc API, read September 7, 2026
• The order that changed the legal position - FDA Final Administrative Order OTC000039, issued June 10, 2026

Source links are not affiliate links. This page reports what public federal records say and how we queried them. It is not legal advice, it is not advice about your skin, and it does not describe what any product will do.