Bemotrizinol: The First New Sunscreen Ingredient in 25 Years, Explained

Bemotrizinol: The First New Sunscreen Ingredient in 25 Years, Explained

For a quarter century, the list of active sunscreen ingredients available to American consumers sat frozen in time. No new UV filters. No new chemistry. No new choices — while shoppers in Europe, Asia, and Australia enjoyed access to a generation of more advanced options. That changed on a single date: June 9, 2026. Here is everything the science currently tells us about the molecule that broke the stalemate.

What exactly is bemotrizinol, and why is the FDA approval such a big deal?

For the first time in more than 25 years, the U.S. Food and Drug Administration approved a new active ingredient for sunscreen — bemotrizinol — on June 9, 2026, adding it to the over-the-counter (OTC) sunscreen monograph. The action marks the first addition to the OTC sunscreen monograph since the late 1990s, and makes bemotrizinol the first new sunscreen active ingredient added through the streamlined administrative order process established by the CARES Act.

The chemical — bemotrizinol, also known as BEMT — will give American consumers access to a level of ultraviolet A (UVA) protection that has until now been unavailable on U.S. store shelves. Sunscreen is classified as a cosmetic product in other countries, but the U.S. recognizes sunscreen as an OTC drug that must meet FDA-regulated efficacy and safety standards, which explains why the approval process took so long.

Bemotrizinol has been used safely in sunscreens across Europe and Asia since 1999, under brand names including Tinosorb® S by BASF and Parsol® Shield by DSM. The original application for FDA approval was filed in 2005 under a regulatory process that has since been discontinued; DSM then submitted its most recent request to the FDA in 2024, under an updated regulatory process established by the CARES Act.

How does bemotrizinol actually protect skin from UV radiation?

Bemotrizinol is a synthetic sunscreen active ingredient designed to protect skin from both UVA and UVB rays — the two bands of ultraviolet radiation that contribute to sunburn, premature skin aging, and skin cancer risk over time. It has absorption peaks at approximately 310 nm in the UVB range and 340 nm in the UVA range, helping cover important parts of the ultraviolet spectrum.

Bemotrizinol offers a stable, non-mineral option that does not break down in the sun — unlike avobenzone, one of two previously approved UVA filters. This property, called photostability (the ability of a molecule to maintain its UV-absorbing structure after prolonged sun exposure), is one of bemotrizinol's most clinically meaningful advantages. When a filter degrades, SPF protection drops in real time on the skin — a risk bemotrizinol is specifically engineered to avoid.

Unlike the other chemical UV filters used in sunscreens in the U.S., bemotrizinol protects against both UVA rays (which cause premature aging) and UVB rays (which cause sunburns). It also breaks down more slowly when exposed to the sun, and its molecules are larger, meaning it is absorbed less into the bloodstream.

Is bemotrizinol safe — and what did the FDA's review actually find?

The FDA approved its addition to the OTC sunscreen monograph following a review showing low skin absorption and a low rate of skin irritation. The key regulatory standard applied was GRASE — "Generally Recognized As Safe and Effective" — the threshold the FDA requires all OTC drug ingredients to meet before sale to consumers.

Systemic absorption (how much of a topically applied ingredient enters the bloodstream) was a focal point of the review. Data submitted to the FDA confirms that at concentrations up to 6%, bemotrizinol is minimally absorbed through the skin, with average absorption levels below the concentration the FDA considers indicative of systemic exposure. It has minimal systemic absorption, rarely exceeding the FDA threshold of 0.5 ng/mL.

"This larger molecule of bemotrizinol doesn't penetrate the skin as easily, so you have less systemic absorption, potentially making it safer," said Christopher Bunick, MD, PhD, associate professor of dermatology at Yale School of Medicine. The ingredient has amassed a 27-year safety track record abroad, though some of those jurisdictions have weaker data requirements than the U.S.

How did the regulatory process actually work, and why did it take so long?

The regulatory review process leading up to this approval took more than two decades. The bottleneck was structural: before the CARES Act of 2020, there was no clear, time-bound pathway for adding new ingredients to the sunscreen monograph.

The FDA issued a proposed order on December 11, 2025, with a public comment period closing January 26, 2026. DSM Nutritional Products, LLC, submitted the OTC monograph order request to add bemotrizinol at concentrations up to 6% as a new active ingredient, and the FDA finalized the action within 7 months of issuing the proposed order. Bemotrizinol is the first new ingredient added to any OTC monograph under the CARES Act process.

The FDA finalized this action within seven months of issuing the proposed order — an unusually swift turnaround for a drug-class ingredient review, and a signal that the modernized pathway can function efficiently when the underlying safety data is robust.

What does bemotrizinol mean for people with sensitive skin or skin of color?

Unlike mineral sunscreens, bemotrizinol does not leave a white cast. It is suitable for sensitive skin, with a low risk of irritation and minimal systemic absorption. Formulations can be lighter and less likely to leave a white cast, especially compared to mineral-only sunscreens.

This approval matters for every American, but it is especially meaningful for patients with skin of color. Chemical UV filters tend to be more cosmetically elegant, meaning they can be formulated into thinner, more wearable textures without the opaque white film that deters many people from consistent sunscreen use.

Bemotrizinol is permitted for topical use in oils, lotions, creams, as well as in some non-aerosol spray formats, giving formulators significant flexibility to create products that suit diverse skin tones and textures.

When and where can you actually buy a sunscreen with bemotrizinol?

The FDA final order took effect on August 9, 2026. The first sunscreen products with bemotrizinol are expected to be available in the U.S. in fall 2026. For the first 18 months, only one manufacturer has been approved by the FDA to make bemotrizinol.

DSM Nutritional Products LLC, part of DSM-Firmenich, holds an 18-month exclusivity period for this ingredient in the U.S. market, including its licensees, assignees, or successors. After that period, other manufacturers may be able to use it as well. The company will then sell the ingredient to sunscreen manufacturers, and several have already announced agreements to roll it into their products.

BEMT could be widely adopted into sunscreen formulations, since it is allowed for use in combination with almost all currently approved active ingredients. The only restriction on using the filter is a ban on combining it with two other UV filters: para-aminobenzoic acid (PABA) and trolamine salicylate.

Why does any of this matter for skin cancer risk?

In the U.S., skin cancer is the fifth most common cancer, with over 5 million cases diagnosed annually. The annual incidence rate of skin cancers continues to rise, with rates tripling since 1975 (8.8 cases per 100,000 people) compared to 2023 (28.3 cases per 100,000 people), with an estimated 112,000 new cases projected in 2026.

In recent years there has been a backlash against sunscreen on social media, prompted by concerns that other chemical sunscreen ingredients can be more readily absorbed into the blood. Medical experts have been alarmed by this trend because skin cancer is the most common form of cancer. Bemotrizinol's molecular profile — broad-spectrum, photostable, and minimally absorbed — directly addresses each of those concerns, potentially giving hesitant consumers a new reason to reach for SPF daily.

FAQ: Bemotrizinol & FDA Approval 2026
What is bemotrizinol, and what other names does it go by?
Bemotrizinol is a broad-spectrum chemical UV filter that absorbs both UVA and UVB radiation. It is also known by the abbreviation BEMT, and is marketed internationally under the brand names Tinosorb® S and PARSOL® Shield. The FDA approved it on June 9, 2026, as the first new active ingredient added to the U.S. OTC sunscreen monograph since the late 1990s.
What concentration of bemotrizinol is the FDA allowing?
The FDA finalized the addition of bemotrizinol to the OTC sunscreen monograph, approving the broad-spectrum UV filter for use at concentrations up to 6% in adults and children 6 months or older.
Is bemotrizinol safer than other chemical sunscreen ingredients?
Bemotrizinol does not break down as quickly as many existing chemical sunscreen ingredients and is less absorbable in your skin. Clinical data submitted to the FDA showed average systemic absorption levels below 0.5 ng/mL — below the FDA's own threshold for concern about systemic exposure. That larger molecular size is the key physical reason for the reduced absorption.
Why did it take over 20 years for the FDA to approve bemotrizinol?
The U.S. classifies sunscreens as OTC drugs rather than cosmetics, requiring a more rigorous evidence package than most other countries. The original application was filed in 2005 under a now-discontinued regulatory pathway. The process only reached the finish line after DSM-Firmenich resubmitted in 2024 under the CARES Act's streamlined monograph-order process, which gave the FDA a binding 7-month review timeline after the public comment period closed.
Can bemotrizinol be combined with other sunscreen actives?
BEMT is allowed for use in combination with almost all currently approved active ingredients. The only restriction is a ban on combining it with para-aminobenzoic acid (PABA) and trolamine salicylate — two filters the FDA had already proposed removing from the GRASE category in prior rulemakings.
Does bemotrizinol leave a white cast on the skin?
Unlike mineral sunscreens, bemotrizinol does not leave a white cast. Because it is a chemical filter rather than a physical mineral pigment, it dissolves into the formulation base and becomes transparent on the skin — an important cosmetic advantage for deeper skin tones and for daily wearability in lighter formulas.
When will products with bemotrizinol be available in the United States?
Consumers in the United States can expect new products featuring PARSOL Shield by the end of 2026, with broader availability to follow. During the first 18 months after approval, DSM Nutritional Products LLC holds exclusive rights to supply the ingredient in the U.S. market, after which other manufacturers can source and formulate with it independently.

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