Description
U.S.Department of Health and Human ServicesFood and Drug AdministrationCenter for Drug Evaluation and Research (CDER)
Scope & Applicability
Product Classes
1Products granted a stay of compliance for Drug Facts regulation
Stakeholders
1Entity type with specific compliance dates
Regulatory Context
Attributes
1A claim indicating protection against both UVA and UVB radiation.
Identified Hazards
Hazards
1UVA radiation contributes to skin aging and cancer.
Related CFR Sections (2)
- 21CFR201.66§ 201.66 Format and content requirements for over-the-counter (OTC) drug product labeling.
(a) Scope. This section sets forth the content and format requirements for the labeling of all OTC drug products. Where an OTC drug product is the subject of an applicable monograph or regulation that contains content and format requirements that conflict with this section, the content and format reRead full regulation →
- 21CFR201.327§ 201.327 Over-the-counter sunscreen drug products; required labeling based on effectiveness testing.
The following provisions apply to sunscreen products containing aminobenzoic acid, avobenzone, cinoxate, dioxybenzone, ensulizole, homosalate, meradimate, octinoxate, octisalate, octocrylene, oxybenzone, padimate O, sulisobenzone, titanium dioxide, trolamine salicylate, or zinc oxide, alone or in coRead full regulation →
Related Warning Letters (10)
- 2025-12-23
CGMP/Active Pharmaceutical Ingredient (API)/Adulterated/Misbranded
Darmerica, LLC
- 2025-08-12
OTC/Unapproved New Drug/Misbranded
Supergoop!
- 2025-08-12
OTC/Unapproved New Drug/Misbranded
Vacation Inc.
- 2025-08-12
OTC/Unapproved New Drug/Misbranded
K & Care Organics
- 2025-08-12
OTC/Unapproved New Drug/Misbranded
Fallien Cosmeceuticals Ltd. dba Fallene Ltd.
- 2025-05-27
Failure to List/Misbranded
Shenzhen Hengkaifeng Commerce and Trade Co., Ltd
- 2025-04-29
Electronic Drug Registration and Listing System (eDRLS)/Violations
Prodose, Inc. formerly known as Spirit Pharmaceuticals LLC
- 2025-03-18
OTC/Unapproved New Drug/Misbranded
Waxhead Sun Defense Company
- 2025-03-18
Unapproved New Drugs/Misbranded/OTC
CoLabs Intl. Corp
- 2025-03-18
Unapproved New Drugs/Misbranded/OTC
Kabana Skin Care
See Also (8)
- Standards for Securing the Drug Supply Chain - Standardized Numerical Identification for Prescription Drug Packages: Guidance for Industry (Status: Final)
- CPG Sec. 400.210, Radiofrequency Identification Feasibility Studies and Pilot Programs for Drugs (Status: Final)
- Nuclear Pharmacy Guideline Criteria for Determining When to Register as a Drug Establishment (Status: Final)
- Guidance for Industry: Exports Under the FDA Export Reform and Enhancement Act of 1996 : Guidance for Industry (Status: Final)
- For the Submission of Chemistry, Manufacturing and Controls and Establishment Description Information for Human Blood and Blood Components Intended for Transfusion or for Further Manufacture and For the Completion of the Form FDA 356h: Guidance for Industry (Status: Final)
- Changes to an Approved NDA or ANDA: Questions and Answers: Guidance for Industry (Status: Final)
- Cooperative Manufacturing Arrangements for Licensed Biologics: Guidance for Industry (Status: Final)
- Providing Regulatory Submissions in Electronic Format – Drug Establishment Registration and Drug Listing (Status: Final)