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FDA's Sunscreen Data Guidance Lacks Risk/Benefit Balance – Stakeholders

This article was originally published in The Rose Sheet

Executive Summary

FDA's proposal that sunscreen ingredient sponsors seeking GRASE status conduct maximal usage trials to assess potential for systemic absorption will delay consumer access to new broad-spectrum sunscreens without a sound scientific basis, PASS says in comments on FDA draft guidance. The American Cancer Society and American Academy of Dermatology Association express similar concerns.

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