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Sunrise For Sunscreen Innovation Act – FDA Seeks Comment On TEA Decisions

This article was originally published in The Tan Sheet

Executive Summary

Under the Sunscreen Innovation Act, FDA’s tentative determinations on sunscreen ingredients TEAs are deemed proposed orders and must be made available for comment. The agency seeks input on six insufficient-data letters issued to sunscreen TEA sponsors in 2014.

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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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