FDA Proposes Approval for New Sunscreen Ingredient After 25 Years
The FDA proposes approving bemotrizinol, a new broad-spectrum sunscreen ingredient already common internationally, marking the first U.S. approval in 25 years.
Overview
The U.S. Food and Drug Administration (FDA) is currently proposing the approval of bemotrizinol, a new ingredient for sunscreen products, to enhance UV protection for consumers.
Bemotrizinol is recognized for providing broad-spectrum protection, effectively shielding skin against both harmful UVA and UVB rays, a crucial feature for effective sunscreens.
Bemotrizinol is already a commonly utilized component in sunscreens across Europe, Australia, and various parts of Asia, demonstrating its established international use.
The FDA tightly regulates sunscreen safety and effectiveness as a drug, requiring extensive testing for any new ingredient before U.S. approval.
The U.S. has not approved a new sunscreen ingredient since 1999, making bemotrizinol's potential approval the first in 25 years and a significant regulatory milestone.
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FAQ
Bemotrizinol is a broad-spectrum sunscreen ingredient that protects against both UVA and UVB rays, with absorption peaks at 310 nm and 340 nm, providing comprehensive UV protection. It is known for high photostability, meaning it remains effective longer in sunlight and can stabilize other sunscreen filters.
The FDA tightly regulates sunscreen ingredients as drugs, requiring extensive safety testing including maximal use trials, pharmacokinetics, carcinogenicity, and toxicity studies before approval. This rigorous process has contributed to a 25-year gap in new ingredient approvals, with bemotrizinol being the first potential approval since 1999.
Studies indicate bemotrizinol is safe for human use, with minimal systemic absorption and low photosensitivity. It does not show hormonal effects in vitro, making it safe for use during pregnancy. Adverse effects are rare and mild based on research and its long-standing use internationally.
Bemotrizinol has a favorable safety profile with low skin penetration and no evidence of endocrine disruption, unlike some U.S.-used chemicals such as oxybenzone, which may cause allergic reactions and hormonal effects. Additionally, chemical ingredients like oxybenzone have raised concerns for coral reef damage, leading to bans in certain U.S. regions, while bemotrizinol is considered safer.
Manufacturers should begin research and development now to adapt formulations and testing methods for bemotrizinol, as FDA approval is expected around March 2026. Early preparation will help them gain a first-mover advantage in the U.S. sunscreen market with this broadly effective and photostable ingredient.
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