Only DSM and its licensees may sell a bemotrizinol sunscreen until February 2028
Five bemotrizinol sunscreens are on the FDA drug register and none of them could be bought on September 3, 2026. Coverage of the new filter usually explains the chemistry. The rule that decides who is allowed to sell one is in a different document, and it is four sentences long.
It sits in Section V of the FDA's final order, and it says something narrower than "DSM has a monopoly": the exclusivity runs to DSM and to DSM's licensees. That single clause is why two brands already have products on the register eighteen months before the exclusivity expires.
The sentence that decides it
Final Administrative Order OTC000039, Section V
"Section 505G(b)(5)(C)(i) of the Act establishes that this final order shall have the effect of authorizing solely DSM Nutritional Products LLC (or the licensees, assignees, or successors in interest of DSM with respect to the subject of this final order) to market drugs incorporating changes described in section 505G(b)(5)(C)(i) subject to this order. The statute provides that this exclusivity shall last for a period of 18 months following the effective date of this final order and beginning on the date DSM may lawfully market drugs pursuant to this order."
Quoted from the order issued June 10, 2026. The order is a work of the US federal government. Read September 3, 2026.
Three things follow from it.
- The holder is DSM Nutritional Products LLC, the company that asked the FDA to add bemotrizinol in the first place, in a request filed on September 23, 2024.
- It covers DSM's licensees, assignees and successors too. A brand that has an arrangement with DSM is inside the exclusivity, not blocked by it.
- It runs 18 months from the order's effective date, which the order sets at August 9, 2026. That puts the end at about February 9, 2028. The order itself does not print an end date.
The timeline
| Date | What happened | Source |
|---|---|---|
| 2024-09-23 | DSM Nutritional Products files a Tier 1 monograph order request to add bemotrizinol at up to 6% | Order, Section I |
| 2026-06-10 | FDA issues final order OTC000039, adding bemotrizinol to the sunscreen monograph | Order, cover |
| 2026-08-09 | Order takes effect. The 18-month exclusivity starts | Order, Sections V and VI |
| 2026-08-09 | Ultra Violette's Unblock Screen is entered on the drug register the same day | FDA NDC directory |
| 2026-08-13 | Kenvue enters two Neutrogena bemotrizinol sunscreens | FDA NDC directory |
| 2026-09-01 | Ultra Violette's Fave Screen is entered | FDA NDC directory |
| 2028-02-09 | 18 months after the effective date. Our arithmetic, not a date printed in the order | - |
Why two brands are already on the register
If the exclusivity belonged to DSM alone, no other company could have a bemotrizinol sunscreen on the register before 2028. Two do. Ultra Violette filed on the day the order took effect, and Kenvue filed two Neutrogena products four days later.
The licensee clause is what makes that possible. Under the order's own wording, a company marketing a bemotrizinol sunscreen during this window is either DSM or somebody standing in DSM's shoes. The order does not publish who those companies are, and neither Ultra Violette nor Kenvue has published the terms, so we cannot show you the paperwork. What we can show you is that the filings exist and the clause exists.
There is a related loose end. The FDA register also carries bemotrizinol as a raw material from two suppliers: DSM, twice, on August 9, and BASF's Kaohsiung plant in Taiwan on August 28. Whether a sunscreen made with somebody else's bemotrizinol sits inside or outside this exclusivity is not something the order spells out, and we are not going to guess at it.
Four other things the order decided
The exclusivity gets the attention, but the same document sets conditions that change which products can exist at all. None of these appears in the consumer coverage we read.
- No aerosol sprays. Bemotrizinol is permitted in oil, lotion, cream, gel, butter, paste, ointment, stick and spray - but a spray only counts if it uses no propellant, such as a pump spray, or keeps the propellant fully isolated from the formula, such as a bag-on-valve can. FDA concluded the data did not support a propellant-based aerosol.
- No powders. Other sunscreen actives in the monograph are permitted in powder form. Bemotrizinol is not on that list. So no brush-on mineral-style powder with this filter.
- Not with PABA or trolamine salicylate. A sunscreen combining bemotrizinol with either of those two ingredients is not covered by the monograph.
- 6% means 6%. The order says up to 6 percent and states that FDA reads this as up to and including 6 percent. Neutrogena's two filings sit exactly on that ceiling.
This is why every bemotrizinol product filed so far is a lotion or a cream. The dosage forms that would make an obvious summer product - the aerosol can, the powder - are the two the order rules out.
What this does not explain
Exclusivity explains who may sell. It does not explain why the one product that reached the market stopped being sold. Ultra Violette's Unblock Screen was buyable on the brand's own store on September 2 and had gone back to a waitlist by September 3, which is a stock or commercial decision, not a regulatory one. Nothing in the order changed in between.
It also does not tell you when any particular product goes on sale. A licence is permission, not a launch date.
What we could not confirm
- Whether Ultra Violette or Kenvue holds a licence from DSM, and on what terms. Neither has published this, and the order does not name licensees.
- Whether the exclusivity reaches a sunscreen made with bemotrizinol from a supplier other than DSM. The order does not address it.
- The exact last day of the exclusivity. February 9, 2028 is our arithmetic from the effective date; the order gives the length, not the end date.
- Whether the order has been disputed, which the order says would change when it takes effect. We found no sign of a dispute, but we did not check a docket for one.
Questions
Does this mean only one brand can sell bemotrizinol sunscreen?
When does the exclusivity end?
Is that why I cannot buy one yet?
Will there be a bemotrizinol spray?
Sources
- Exclusivity, effective date, permitted concentration, dosage forms and excluded combinations - FDA Final Administrative Order OTC000039, issued June 10, 2026, Sections I, IV, V and VI; read September 3, 2026
- The order in the Federal Register - Amending Over-the-Counter Monograph M020, published June 10, 2026
- FDA announcement of the addition - FDA Expands Sunscreen Options for the First Time in 20 Years, read September 3, 2026
- Register dates and raw-material filings, queried for bemotrizinol - openFDA drug/ndc API, read September 3, 2026
Source links are not affiliate links. This page reads a public federal order and records what it says. It is not legal advice, it is not advice about your skin, and it does not describe what any product will do.
