Nonprescription Sunscreen Drug Products-Format and Content of Data Submissions; Guidance for Industry; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Nonprescription Sunscreen Drug Products--Format and Content of Data Submissions.'' This guidance addresses FDA's current thinking on the format and content of information provided to support a request for a determination whether a nonprescription sunscreen active ingredient is generally recognized as safe and effective (GRASE), as provided under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Sunscreen Innovation Act (SIA).