Description
This guidance provides recommendations and instructions to assist persons submitting cosmetic product facility registrations and product listings to FDA. This guidance document explains, among other things:
Scope & Applicability
Product Classes
10Category including moisturizing and cleansing products
Not expected to be listed as cosmetic products
Not expected to be listed as cosmetic products
Classified as cosmetic products requiring listing
Category including permanent and temporary tattoo inks
Category including indoor tanning and airbrush applications
Preparation of cosmetic ingredients for use in a finished product; Products subject to registration and listing requirements under the FD&C Act; Products subject to registration and listing requirements under MoCRA.
Defined in section 201(g) of the FD&C Act; Articles intended for use in diagnosis, cure, mitigation, treatment, or prevention of disease; Product classification based on chemical action or specific intended uses like altering pH
Category including nail polishes and extenders
Category including dentifrices and mouthwashes
Stakeholders
9Individual authorized to determine and document eligibility; Individual who may be consulted regarding plasma dilution situations.
Assists FDA in communications with foreign establishments
Must comply with registration if meeting facility/responsible person definitions
Entity responsible for submitting NDINs
Entity whose name appears on the label
Entity responsible for submitting NDINs
External entity responsible for manufacturing activities
Target audience for the compliance guide
Required contact for foreign facilities during registration
Regulatory Context
Attributes
3The frequency (every two years) required for facility registration renewal.
Date a paper submission physically arrives at the FDA
Provides information about the type or kind of cosmetic product
Identified Hazards
Hazards
1Products coming into contact with the eye membrane
Related CFR Sections (3)
- 21CFR10.115§ 10.115 Good guidance practices.
(a) What are good guidance practices? Good guidance practices (GGP's) are FDA's policies and procedures for developing, issuing, and using guidance documents.Read full regulation →
- 21CFR701.11§ 701.11 Identity labeling.
(a) The principal display panel of a cosmetic in package form shall bear as one of its principal features a statement of the identity of the commodity.Read full regulation →
- 21CFR701.3§ 701.3 Designation of ingredients.
(a) The label on each package of a cosmetic shall bear a declaration of the name of each ingredient in descending order of predominance, except that fragrance or flavor may be listed as fragrance or flavor. An ingredient which is both fragrance and flavor shall be designated by each of the functionsRead full regulation →
See Also (8)
- Draft Guidance for Industry: New Dietary Ingredient Notification Master Files for Dietary Supplements (Status: Draft)
- Questions and Answers Regarding Mandatory Cosmetics Recalls: Guidance for Industry : Draft Guidance for Industry (Status: Draft)
- CPG Sec. 460.300 Return of Unused Prescription Drugs to Pharmacy Stock (Status: Final)
- CPG Sec. 444.100 Recovery of Investigational New Drugs from Clinical Investigators (Status: Final)
- CPG Sec. 400.900 Class I Recalls of Prescription Drugs (Status: Final)
- CPG Sec. 454.100 OTC Ear Drop Preparations (Status: Final)
- CPG Sec. 430.300 Labeling Shipping Containers of Drugs (Status: Final)
- CPG Sec. 455.100 Inert Glandular Preparations *(OTC)*, Inadequate Full Disclosure and Claims (Status: Final)