date:Nov 23, 2015
ilability of a draft guidance for industry entitled “Over-the-Counter Sunscreens: Safety and Effectiveness Data.” This draft guidance addresses FDA's current thinking regarding the safety and effectiveness data needed to determine whether a nonprescription sunscreen active ingredient or combination of active ingredients evaluated under the SIA is GRASE and not misbranded when used under specified conditions. The guidance also addresses FDA's current thinking about an approach to safety-related