Spray Sunscreens Stay In FDA Enforcement Discretion Shade

 
• By Malcolm Spicer

CDER's enforcement policy guidance for OTC monograph sunscreens clarifies that spray sunscreens are included in the agency's enforcement discretion. But CDER closes the door on other dosage forms that it also identified in its 2011 ANPR for whether delivery formats other than lotions, creams or other traditional forms would be eligible for the monograph.

An FDA guidance lifts a cloud of uncertainty hanging over the future of OTC spray sunscreens while also closing a curtain on the use of other non-traditional delivery formats with the products.

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