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FDA Questions Spray Sunscreen Safety, Efficacy & Monograph Status

This article was originally published in The Rose Sheet

Executive Summary

FDA could exclude increasingly popular spray sunscreens from the final monograph unless firms submit sufficient safety and efficacy data, according to an advanced notice of proposed rulemaking.

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Spray Sunscreens Stay In FDA Enforcement Discretion Shade

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.

Spray Sunscreens Stay In FDA Enforcement Discretion Shade

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.

Spray Sunscreens Stay In FDA Enforcement Discretion Shade

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.

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