Bemotrizinol Sunscreen: FDA's First New US Filter in More Than 20 Years

For more than two decades, US sunscreen shoppers have been limited to an aging set of organic filters plus zinc oxide and titanium dioxide, while Europe and Asia have used newer broad-spectrum triazines. On 10 June 2026, FDA issued Final Administrative Order OTC000039, adding bemotrizinol (BEMT) — also sold globally as Tinosorb S / PARSOL Shield — to Over-the-Counter Monograph M020 as GRASE at concentrations up to 6 percent for adults and children 6 months of age and older.

Two regulatory firsts matter, and two consumer inferences do not:

1. It is the first new sunscreen active added to the US OTC monograph since the late 1990s (FDA press, 9 June 2026).
2. It is the first new active ingredient added to any OTC monograph through the CARES Act administrative-order process (FD&C Act section 505G).
3. The order's effective date is 9 August 2026. That is legal permission to market compliant products, not a warehouse inventory date.
4. Zinc oxide and titanium dioxide remain GRASE. Bemotrizinol does not retire mineral sunscreen, especially on freshly wounded post-procedure skin.

As of 22 August 2026 — 13 days after the effective date — you should still expect empty US drugstore shelves, exclusivity-limited first SKUs, and imported EU/Korean BEMT formulas that are not automatically legal here.

What did FDA actually add, and can you buy it in the US right now?

Final Administrative Order OTC000039 (announced in the Federal Register on 10 June 2026; FDA press dated 9 June 2026) adds bemotrizinol to Monograph M020 as GRASE at up to 6% for adults and children 6 months and older. The order took effect 9 August 2026. Manufacturers may now formulate compliant Drug Facts–labeled sunscreens. Mass-market US retail stock was not verified as of 22 August 2026. FDA's consumer sunscreen page still says the manufacturer determines when products appear on shelves.

DSM-Firmenich holds 18-month OMOR exclusivity covering the requestor and licensees. Legal explainers (Venable, Spencer Fane, AJMC) describe that window as running from the order's effective date, so early US products should come from DSM or licensed partners (Kenvue has said Neutrogena/Aveeno intend to use it). A manufacturer quote that exclusivity "starts at first commercialization" is a press dispute; this page follows the order-effective-date reading in those legal summaries, not a courtroom holding.

The regulatory pathway: CARES Act OMOR, not an NDA

Sunscreen actives in the United States are OTC drugs, not MoCRA cosmetics. That is why this page links MoCRA deadlines once and then stays on M020.

The old monograph process required years of notice-and-comment rulemaking. The CARES Act replaced it with an Over-the-Counter Monograph Order Request (OMOR) under section 505G.

• OMOR: DSM Nutritional Products LLC submitted a Tier 1 OMOR on 23 September 2024.
• Proposed order: FDA published proposed order OTC000039 on 12 December 2025 (90 FR 57765), with comments through 26 January 2026.
• Final order: Issued 10 June 2026, effective 9 August 2026. FDA's Federal Register notice states that after considering comments, FDA did not make changes to the final order. DSM submitted extra aerosol data; FDA still found that package insufficient (Venable).

Why bemotrizinol does not appear in Drugs@FDA

A scan of the Drugs@FDA product table (51,653 rows, snapshot 16 August 2026) returned zero matches for bemotrizinol, Tinosorb, PARSOL, or bis-ethylhexyloxyphenol. That is the expected result: BEMT is a monograph active, not an NDA/ANDA drug. Any manufacturer operating within DSM's exclusivity/license and M020 can put it on a Drug Facts panel without a product-by-product NDA.

Photochemistry: broad-spectrum and photostable — without invented percentages

FDA's 9 June 2026 press describes bemotrizinol as providing UVA and UVB protection with low absorption through the skin. That is the claim this page treats as official.

Older US organic filters, especially avobenzone, are photounstable unless formulated with a stabilizer (commonly octocrylene). Bemotrizinol is used globally as a photostable broad-spectrum triazine and as a stabilizer for avobenzone. The FDA press and the Federal Register notice of OTC000039 do not publish a photostability percentage; this page does not invent one. For absorption-versus-scatter photobiology, see mineral vs chemical sunscreen.

Dermal pharmacokinetics: MUsT and the 0.5 ng/mL threshold

Matta et al. (JAMA 2019) showed that several older organic filters exceeded FDA's 0.5 ng/mL MUsT plasma threshold after maximal application. That threshold is a trigger for extra nonclinical work, not a toxicology bright line. The mineral-versus-chemical post already walks through those numbers; this page adds the BEMT trials FDA actually had on file.

FDA reviewed three completed human studies:

Applicant materials in the OTC000039 support file (DSM response to IR#20) describe a large, highly lipophilic molecule (molecular weight about 628 Da; logP about 7–11) and state that MUsT plasma concentrations rarely exceeded 0.5 ng/mL. Treat that sentence as applicant-submitted characterization FDA had on file, not as a published CSR mean Cmax. PubMed 36738872 is a preliminary clinical PK evaluation of bemotrizinol for the US monograph — a PK paper, not a photochemistry review.

The updated GRASE matrix

Before June 2026, the modern GRASE Category I list that this site published (7 July 2026) named only zinc oxide and titanium dioxide. After OTC000039, Category I sunscreen actives are zinc oxide, titanium dioxide, and bemotrizinol. The twelve Category III organic filters did not become GRASE. PABA and trolamine salicylate remain Category II (not GRASE). Bemotrizinol may not be combined with those two Category II actives (Spencer Fane read of the order; Federal Register combination language).

Bemotrizinol is the first organic filter with a current US GRASE designation under the post-2019 M020 framework. It is not "the first chemical sunscreen FDA ever allowed"; older organic filters were in the historic monograph and were later placed in Category III pending data.

Permitted dosage forms and the aerosol exclusion

Copy the Federal Register list, not a spa menu:

Allowed: oil, lotion, cream, gel, butter, paste, ointment, stick, and spray if and only if the spray uses no propellant or isolates the propellant from the drug product so they never contact.

Not allowed: propellant-based aerosol sprays and powder. FDA found DSM's aerosol stability data insufficient. That is a US monograph limit, not proof that every European BEMT mist is dangerous.

What does not change after a laser, peel, or for melasma

GRASE BEMT is a daily-wear expansion. It is not a post-procedure default.

Freshly wounded skin. Ablative resurfacing, medium-depth peels, and RF microneedling leave an open or thinned barrier. Bemotrizinol's MUsT package is intact-skin PK. It has not been established as the first dressing on de-epithelialized skin. Inert zinc oxide remains the conservative first 1–2 weeks after those procedures — see the mineral post's protocol.

Melasma and Fitzpatrick IV–VI PIH. Bemotrizinol absorbs UV. It does not absorb high-energy visible light. Patients who pigment from HEV still need tinted mineral sunscreen with iron oxides. BEMT does not erase that rule.

Imported EU and Korean BEMT sunscreens. Many pair bemotrizinol with bisoctrizole, Uvinul A Plus, Mexoryl SX, or other filters that remain Category III or unlisted in M020. GRASE status for BEMT alone does not legalize those companion filters for US sale. Look for a US Drug Facts panel that lists bemotrizinol (up to 6%), not an INCI decoder screenshot.

Frequently asked questions

Which sunscreens contain bemotrizinol in the US?

As of 22 August 2026, US Drug Facts–labeled mass-market SKUs were not verified on shelves. Amazon hits for "bemotrizinol sunscreen" are not a monograph compliance check. Expect first launches from DSM licensees, including Kenvue brands that have announced intent.

When will bemotrizinol sunscreen be available in the US?

Legal marketing from 9 August 2026. Commercial lots depend on exclusivity, filling lines, and retailer resets. Late 2026 into the 2027 season is a reasonable planning window, not a labeled date.

Can I buy sunscreen with bemotrizinol online?

You can buy foreign BEMT formulas. They often contain non-M020 companion filters. A US-compliant product will say bemotrizinol on a Drug Facts panel at up to 6%.

Is bemotrizinol the best sunscreen?

No single filter is "best." BEMT is GRASE, photostable, and broad-spectrum. Mineral zinc oxide remains GRASE, still preferred on compromised skin, and still required (with iron oxides) when visible light drives pigment. "Best" is the formula you will apply generously, that matches your phototype and procedure status, and that is legal in the country where you buy it.

Is bemotrizinol safe for children?

OTC000039 GRASE-designates it for adults and children 6 months and older. Infants under 6 months still belong in shade and clothing first, consistent with pediatric sun-safety guidance — not a new exception created by this order.

Does bemotrizinol leave a white cast?

It is an oil-soluble organic absorber, so it should not leave a zinc-style chalk film. White cast from a finished product still depends on any mineral pigment also in the formula.

Sources

1. U.S. Food and Drug Administration (FDA) Press Announcement: FDA Expands Sunscreen Options for the First Time in More Than 20 Years (June 9, 2026). Available at: https://www.fda.gov/news-events/press-announcements/fda-expands-sunscreen-options-first-time-20-years
2. FDA Understanding Over-the-Counter Medicines: Sunscreen: How to Help Protect Your Skin from the Sun (Content Current: June 9, 2026). Available at: https://www.fda.gov/drugs/understanding-over-counter-medicines/sunscreen-how-help-protect-your-skin-sun
3. Federal Register: Notice of availability of Final Administrative Order OTC000039 (June 10, 2026; 91 FR 35220). Available at: https://www.federalregister.gov/documents/2026/06/10/2026-11578/amending-over-the-counter-monograph-m020-sunscreen-drug-products-for-over-the-counter-human-use-and
4. Federal Register: Notice of proposed order OTC000039 (December 12, 2025). Available at: https://www.federalregister.gov/documents/2025/12/12/2025-22649/amending-over-the-counter-monograph-m020-sunscreen-drug-products-for-over-the-counter-human-use
5. FDA OTC Monographs@FDA Support Document: DSM Nutritional Products Response to FDA Information Request IR#20 in Support of OTC000039. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/omuf/order/supportDoc/OTC000039/1.2_Cover_Letter/rev_Cover%20Ltr%20Response%20to%20MFG%20400105%20IR20_final_Redacted_090026f88e12e73c.pdf
6. ClinicalTrials.gov: Pharmacokinetic Evaluation of Bemotrizinol 6% in a Sunscreen MUsT (NCT05277376). Available at: https://clinicaltrials.gov/study/NCT05277376
7. ClinicalTrials.gov: Bemotrizinol UV Filter Part 1 Clinical PK MUsT (NCT04355286). Available at: https://clinicaltrials.gov/study/NCT04355286
8. ClinicalTrials.gov: Dermal Irritation, Sensitization, and Cumulative Irritation of 6% Bemotrizinol (NCT05260359). Available at: https://clinicaltrials.gov/study/NCT05260359
9. PubMed: Preliminary clinical pharmacokinetic evaluation of bemotrizinol (PMID 36738872). Available at: https://pubmed.ncbi.nlm.nih.gov/36738872/
10. American Journal of Managed Care (AJMC): 5 Questions Dermatology Patients May Have About Newly Approved Bemotrizinol. Available at: https://www.ajmc.com/view/5-questions-dermatology-patients-may-have-about-newly-approved-bemotrizinol
11. Spencer Fane: FDA's First New Sunscreen Active Ingredient in Decades (June 29, 2026). Available at: https://www.spencerfane.com/insight/fdas-first-new-sunscreen-active-ingredient-in-decades-regulatory-exclusivity-and-commercial-implications
12. Venable: FDA Clears the Way for Bemotrizinol (June 16, 2026). Available at: https://www.venable.com/insights/publications/2026/06/fda-clears-the-way-for-bemotrizinol-first-new-otc