FDA Proposes First New Sunscreen Active Ingredient in Decades

Washington, D.C., United States, December 2025 - The U.S. Food and Drug Administration (FDA) has proposed adding bemotrizinol as a permitted active ingredient in over-the-counter sunscreens, opening a public consultation that could introduce the first new UV filter to the U.S. sunscreen monograph in more than two decades. The consultation period ended on 26 January 2026 with a high probability of obtaining FDA approval.

The proposal follows a submission by DSM Nutritional Products requesting that the ingredient be recognized as generally recognized as safe and effective (GRASE) for use in sunscreen drug products.

If finalized, the rule would amend the FDA’s OTC sunscreen monograph and allow manufacturers to formulate sunscreens containing bemotrizinol without submitting a separate drug approval application.

Proposed Ingredient

Bemotrizinol (CAS 187393-00-6) is known otherwise by its chemical synonyms, which include 2,2'-(6-(4-Methoxyphenyl)-1,3,5-triazine-2,4-diyl)bis(5-((2-ethylhexyl)oxy)phenol), (1,3,5)-Triazine-2,4-bis-{[4-(2-ethyl-hexyloxy)-2- hydroxy]-phenyl}-6-(4-methoxyphenyl), Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine.

Bemotrizinol is a broad-spectrum UV filter that absorbs both UVA and UVB radiation. The ingredient is widely used globally and is valued by formulators because it:

• Provides strong broad-spectrum protection

• Remains photostable under sunlight

• Works well with other UV filters

• Enables lighter, more cosmetically elegant sunscreen formulations

The FDA’s scientific review found very low systemic absorption, meaning the chemical largely remains on the skin surface when applied as intended.

Toxicological studies reviewed by the agency showed:

• No evidence of carcinogenicity

• No reproductive or developmental toxicity

• Minimal skin irritation

• No endocrine disruption activity

Based on these findings, the FDA determined the ingredient may meet the GRASE standard when used at concentrations up to 6%.

Global comparison

Since sunscreen is treated as an over-the-counter drug, it is being subject to higher scrutiny than sunscreen in other countries, which treat sunscreen as a cosmetic. The chemical has been approved by other regulatory authorities globally. Over 31 countries that follow the EU’s cosmetic regulation, Canada, Japan, and ten Southeast Asian nations permit the use of this chemical as a UV filter. In these countries, the regulated concentration limit is set at 10%, which is higher than the current limit proposed by the FDA.

Implications for Industry

If finalized, the rule could expand formulation options for sunscreen manufacturers in the U.S. “The agency has historically moved too slowly in this area, leaving Americans with fewer options than consumers abroad. We’re continuing to modernize the regulation of sunscreen and other over-the-counter drug products,” said FDA Commissioner Marty Makary, M.D., M.P.H. “Americans deserve timely access to the best safe, effective, and consumer-friendly over-the-counter products available.” 

Companies may be able to develop sunscreens with:

• improved UVA protection

• more photostable formulations

• lighter textures preferred by consumers

The change could also allow international brands to introduce products in the U.S. that are already marketed in Europe and Asia and meet the lower 6% concentration limit.

Because U.S. sunscreens are regulated as OTC drugs, manufacturers would still need to comply with monograph conditions, testing requirements, and drug labeling rules.