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FDA Approves First New Sunscreen Ingredient in 27 Years

The FDA has approved bemotrizinol, the first new sunscreen ingredient in 27 years, providing broader UVA protection and improved stability.

Published September 5, 2026 at 8:00 PM EDT

The short answer

The FDA has approved bemotrizinol, the first new sunscreen ingredient in 27 years, providing broader UVA protection and improved stability. The U.S. Food and Drug Administration (FDA) has approved the chemical bemotrizinol for use as an active ingredient in over-the-counter sunscreens. This marks the first time in 27 years that a new sunscreen filter has been cleared for the American market.

FDA Approves First New Sunscreen Ingredient in 27 Years

The Facts

Who
Food and Drug Administration (FDA) and DSM-Firmenich
What
Approval of new sunscreen ingredient bemotrizinol
When
August and September 2026
Where
United States
Why
To provide better UVA protection and increase sunscreen compliance through improved photostability and cosmetic feel.

Timeline of what happened

Key dates and decisions, in the order they occurred.

  1. January 1, 1988

    FDA approves avobenzone for broad use

  2. January 1, 2002

    FDA introduces Time and Extent Application (TEA) process

  3. January 1, 2006

    Ecamsule approved for specific products only

  4. January 1, 2014

    Sunscreen Innovation Act passed to expedite reviews

  5. January 1, 2020

    CARES Act modernizes OTC drug framework

  6. August 14, 2026

    Stanford Medicine experts discuss bemotrizinol approval

  7. September 1, 2026

    Expected retail availability of bemotrizinol products

The U.S. Food and Drug Administration (FDA) has approved the chemical bemotrizinol for use as an active ingredient in over-the-counter sunscreens. This marks the first time in 27 years that a new sunscreen filter has been cleared for the American market. The ingredient, also known as BEMT or by the brand name Parsol Shield, is expected to appear in consumer products starting in September 2026.

Dermatologists from Stanford Medicine stated that the approval addresses a gap in ultraviolet A (UVA) protection. While existing U.S. sunscreens typically filter light up to 370 nanometers, bemotrizinol covers the UVA spectrum up to 400 nanometers. The chemical was originally developed by Swiss chemists in the 1990s and has been available in other countries since approximately 2000.

Unlike many other regions that regulate sunscreen as a cosmetic, the U.S. classifies it as an over-the-counter drug. This classification required the manufacturer, DSM-Firmenich, to conduct safety and efficacy testing, including human and animal studies. The FDA review considered studies that showed no evidence of endocrine disruption, increased cancer risk, or concerning skin irritation. Because the bemotrizinol molecule is large, researchers found it is minimally absorbed through the skin.

The FDA cleared the ingredient for use on children as young as six months. Susan Swetter, MD, of Stanford Medicine, noted that risk models suggest regular sunscreen use in the first 18 years of life could reduce adult skin cancer rates by approximately 80%. Currently, skin cancer remains a health concern; researchers noted that in the late 1980s, individuals had higher rates of skin cancer on the driving side of their faces due to UVA penetration through glass.

The regulatory effort involved more than two decades of review and an investment of at least $18 million by DSM-Firmenich. The company conducted studies involving nearly 500 people to satisfy FDA requirements. Because bemotrizinol is highly photostable, it does not break down as quickly in sunlight as existing chemical filters like avobenzone, which can degrade in 30 minutes. Stanford Medicine experts noted that new formulations may feel less greasy and do not leave the white cast or clothing stains associated with mineral barriers like zinc oxide.

The FDA has granted DSM-Firmenich exclusive U.S. marketing rights for 18 months to allow the company to recoup its testing costs. While the specific retail price for these new products has not been reported, the presence of an option described by experts as "cosmetically elegant" and long-lasting may increase overall compliance with sun protection guidance. Following this, dermatologists expressed hope that other filters used abroad, such as Tinosorb M or Mexoryl, may eventually reach the U.S. market. The first products containing Parsol Shield are scheduled to be available starting in September 2026.

Summaries are written by The Plain Record to state the facts of a story plainly and without political slant. Drafted with AI assistance and checked against the source record before publication. See how we report, or report a correction.

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Questions readers ask

What happened: FDA Approves First New Sunscreen Ingredient in 27 Years?

The U.S. Food and Drug Administration (FDA) has approved the chemical bemotrizinol for use as an active ingredient in over-the-counter sunscreens. This marks the first time in 27 years that a new sunscreen filter has been cleared for the American market.

Who is involved?

Food and Drug Administration (FDA) and DSM-Firmenich

When did this happen?

August and September 2026

Where did this happen?

United States

Why does this matter?

To provide better UVA protection and increase sunscreen compliance through improved photostability and cosmetic feel.