• March 4, 2019
  • WTO

Sunscreen Drug Products for Over-the-Counter Human Use (72 page(s), in English)



Title of document
Sunscreen Drug Products for Over-the-Counter Human Use (72 page(s), in English)

Description
The Food and Drug Administration (FDA or Agency) is issuing this proposed rule to put into effect a final monograph for nonprescription, over-the-counter (OTC) sunscreen drug products. This proposed rule describes the conditions under which FDA proposes that OTC sunscreen monograph products are generally recognized as safe and effective (GRASE) and not misbranded. It is being published as part of the ongoing review of OTC drug products conducted by FDA. It is also being published to comply with the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Sunscreen Innovation Act (SIA).

Notifying member: United States of America

NotificationG/TBT/N/USA/1443

Objective tag
Consumer information, labelling

Documents


Agency responsible
Food and Drug Administration (FDA), Health and Human Services (HHS) [1468]

Timing:

  • Submission: 01/03/2019
  • Reception: 04/03/2019
  • Distribution: 04/03/2019
  • Final date for comments: 28/05/2019
  • Proposed date of adoption: N/A

                   

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