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FDA Questions Spray Sunscreen Safety, Efficacy And Monograph Status

This article was originally published in The Tan 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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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.”

Existing Sunscreen Monograph Ingredients Could Fail Proposed Safety Standards

FDA’s proposed safety standards for sunscreen monograph ingredients might not align with safety evidence supporting current monograph ingredients. Without a safeguard, such as a grandfather clause, these ingredients could face challenges if FDA adopts stricter standards, NDAC committee members worry.

Existing Sunscreen Monograph Ingredients Could Fail Proposed Safety Standards

FDA’s proposed safety standards for sunscreen monograph ingredients might not align with safety evidence supporting current monograph ingredients. Without a safeguard, such as a grandfather clause, these ingredients could face challenges if FDA adopts stricter standards, NDAC committee members worry.

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