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'Data Gaps' Keep 12 Ingredients Off FDA's Proposed OTC Sunscreen Monograph

 
• By Eileen Francis

FDA proposed final sunscreen monograph identifies zinc oxide and titanium dioxide as GRASE, two other ingredients as non-GRASE and 12 substances with data gaps, meaning firms must provide safety and effectiveness data or reformulate products that rely on inadequately supported UV filters. EWG says the proposal is “exactly the kind of signal that FDA should be providing for the sunscreen industry.”

ComboFeature_Neutrogena,Coppertone,BananaBoat and Jason

OTC sunscreen manufacturers interested in continuing to use 12 active ingredients common in many products must provide a wealth of safety data to FDA under the agency's proposed final sunscreen monograph.

The proposed rule released Feb. 21 also discusses dosage forms, green-lighting most common formats – oils, lotions, creams, gels,...

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More from Regulation

US FDA Facility Inspections, Website Reviews Paused With FY 2026 Budget On Hold

 
• By Malcolm Spicer

Continuing work includes “for cause and certain surveillance inspections of regulated facilities” and “criminal enforcement work and certain civil investigations” as White House mulls layoffs rather than furloughs during federal government shutdown.

OMUFA Reauthorization: US FDA Would Identify Rx-OTC Switch Candidates, Work With Sponsors

 
• By Kate Rawson

Senate “SMART OTC” Act would require the FDA to identify product categories that could be eligible for an Rx-to-OTC switch and create a framework to work with sponsors.

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• By David Ridley

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US FDA Notes Honey Drops Eye Care, Nasal Spray Brain Boost In Recent Warning Letters

 
• By Malcolm Spicer

Recent FDA warning letters hit typical problems in consumer health space such as manufacturing quality control deficiencies, but also note honey offered for eye infections and nasal spray to enhance cognitive function.

More from Policy & Regulation

OMUFA Reauthorization: US FDA Would Identify Rx-OTC Switch Candidates, Work With Sponsors

 
• By Kate Rawson

Senate “SMART OTC” Act would require the FDA to identify product categories that could be eligible for an Rx-to-OTC switch and create a framework to work with sponsors.

Women’s Health: Tranexamic Acid Now Available OTC In France

 
• By David Ridley

Cemag Care may be behind the recent Rx-to-OTC switch of menstrual health treatment tranexamic acid (1000mg) in France.

Shutdown Approaches: US FDA Would Retain Most Of Recently Trimmed Staff

 
• By Derrick Gingery

FDA shutdown plans indicate about 86% of staff would be retained, a rate that is higher than previous plans, but reserve funding would not last more than a few months.