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News from CRIS: In the news – Bemotrizinol (BEMT)

December 16, 2025

A sunscreen ingredient called bemotrizinol (often shortened to BEMT) has been used for years in other parts of the world, but until now, it hasn’t been available in U.S. sunscreen products. That may be changing.

On December 11, 2025, the U.S. Food and Drug Administration (FDA) announced a proposed order to add bemotrizinol as a permitted active ingredient for OTC sunscreens in the U.S. Historically, the U.S. has fewer UV filter options than many other countries due to specific regulations.

Here’s what bemotrizinol is designed to do, what current safety evidence suggests, and what still has to happen before you can buy it in U.S. sunscreen aisles.

Top Takeaways:

  • Bemotrizinol is a broad-spectrum UV filter (UVA and UVB) and is valued for being highly photostable (it holds up well in sunlight).
  • FDA’s review notes low absorption through skin and that it rarely causes skin irritation, based on the data reviewed.
  • The FDA is proposing bemotrizinol be allowed in U.S. sunscreens up to 6%.
  • A public comment period is open, and comments are accepted from December 12, 2025, through January 26, 2026 (11:59 p.m. ET).

 

What is bemotrizinol, and what is it for?

Bemotrizinol is a synthetic sunscreen active ingredient in some sunscreens, designed to protect skin from both UVA and UVB rays., Ultraviolet radiation contributes to sunburn, premature skin aging, and skin cancer risk over time. The FDA’s announcement states explicitly that bemotrizinol provides UVA and UVB protection and has low skin absorption and infrequent irritation.

In real-world formulation terms, bemotrizinol is often discussed as a UV filter, that can help companies make sunscreens that feel better on skin while still delivering strong UV protection. Its properties are one reason dermatologists and formulators have been interested in bringing it to the U.S.

What do we know about bemotrizinol safety right now?

Low systemic absorption.
One reason bemotrizinol has drawn attention is that it tends to have low absorption through skin, which helps limit systemic exposure. The FDA says the data it reviewed show low levels of absorption through the skin into the body.

The FDA’s supporting scientific review also explains an important benchmark the FDA uses in evaluating sunscreen ingredients: if a well-conducted human pharmacokinetic program shows a steady-state blood level below 0.5 ng/mL, it can affect the additional studies the FDA expects for a GRASE determination.

Irritation appears uncommon in the reviewed data.
In the FDA announcement, bemotrizinol is described as rarely causing skin irritation based on the data reviewed.

“Safe with current evidence” is not the same as “we know everything forever.”
The current data support a favorable safety profile under intended sunscreen use and indicate that continued monitoring/research are warranted, especially as broader use increases and long-term exposure datasets grow. That’s exactly why regulatory review includes public comment and why post-market surveillance exists.

Safety and Efficacy of Bemotrizinol in Sunscreens

Aspect Key Findings
Human absorption Minimal systemic absorption; rare, mild adverse events
Endocrine disruption No evidence of androgen or estrogen receptor binding
Skin compatibility Good compatibility; no significant irritation reported
Photostability Highly photostable and maintains UV protection

 

How is bemotrizinol regulated outside of the U.S.?

Bemotrizinol is approved for use in the EU, Australia, and several other regions at concentrations up to 10%, but is not yet approved in the U.S., where 6% limit is under review.

Why isn’t bemotrizinol already in U.S. sunscreens if other countries use it?

The short version is that the U.S. regulates sunscreens as drugs, and that creates a different pathway with more requirements for new active ingredients.

Over-the-counter monograph drugs (such as many sunscreens) can be marketed without an approved drug application if they meet the conditions of the relevant monograph, such as permitted active ingredients, doses, and labeling requirements.

To add a new active ingredient, the FDA can modify the monograph using an administrative order process (proposed order to a final order).

What will it take to get bemotrizinol to U.S. markets?

Think of the path in two lanes:

Lane A: FDA’s regulatory steps

  1. A request is submitted to the FDA: A company can initiate the process by submitting an OAC Monograph Order Request (OMOR).
  2. The FDA issues a proposed order: Currently, the FDA proposes to add bemotrizinol as a permitted sunscreen active ingredient.
  3. Public comment period (open now): Comments are accepted beginning December 12, 2025, through January 26, 2026 (11:59 p.m. ET) in Docket No. FDA-2025-N-6494.
  4. FDA reviews comments and finalizes its decision: The FDA states that if it concludes bemotrizinol is generally recognized as safe and effective (GRASE) as a sunscreen active ingredient, it will issue a final order to add it to OTC Monograph M020 (the sunscreen monograph).

Lane B: What manufacturers must do (what must happen in labs and factories)
Even after a final order, products don’t appear overnight. Brands still need to:

  • Formulate products that are stable, effective, and cosmetically acceptable at the allowed concentration and within monograph conditions.
  • Run required performance testing (e.g., SPF, broad-spectrum performance, water resistance claims) and ensure results support labeling.
  • Meet OTC drug manufacturing and quality requirements (e.g., consistent ingredient quality, specifications, appropriate controls).
  • Label correctly under the sunscreen monograph’s required format and claims limitations.

In other words, the FDA clearance is the first step, but product development and compliant manufacturing are needed before products are available on the shelves.

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To continue reading the entire blog post, visit: https://cris.msu.edu/news/in-the-news/in-the-news-bemotrizinol-bemt/.