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 In this section:

                Registration & Listing of Cosmetic Product Facilities and Products

Registration & Listing of Cosmetic Product Facilities and Products

                        Cosmetics Direct
          Cosmetic Product Categories and Codes
          Form FDA 5066 - Registration of Cosmetic Product Facility
          Form FDA 5067 - Cosmetic Product Listing Home
          Cosmetics
          Registration & Listing of Cosmetic Product Facilities and Products
          Cosmetics DirectRegistration & Listing of Cosmetic Product Facilities and Products Cosmetics Direct
  
  					Electronic Submission Portal
	
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    PrintCosmetics Direct is an electronic submissions portal for the registration & listing of cosmetic product facilities and products. It is an FDA Structured Product Labeling (SPL) authoring tool, for cosmetic product facility registration and cosmetic product listing, that contains user friendly data entry forms, performs initial validations, creates and saves the SPL submission, and submits the SPL to FDA for internal processing without having to use the Electronic Submissions Gateway (ESG).

SPL, an established document sanctioned by health level seven (HL7) for the exchange of product and facility-related information, serves as a foundational reference for regulatory guidance documents and product labeling content exchange. It enforces control over crucial product information, resulting in a standard for product labeling. The FDA has adopted SPL to enhance patient/customer safety and product usability within its consumer base. In 2005, the FDA mandated the use of XML compliant with the SPL standard for electronic submissions. This standard defines the content and structure of product labeling required for submission to the FDA. Consistent structure and standard terminology are employed to enhance the accuracy and reliability of product information. For additional information, see the **Structured Product Labeling (SPL) Implementation Guide with Validation Procedures**.

Launch Cosmetics Direct

Download the User Guide

Resources

Modernization of Cosmetics Regulation Act of 2022 (MoCRA)
	Registration & Listing of Cosmetic Product Facilities and Products
	Guidance for Industry: Registration and Listing of Cosmetic Product Facilities and Products
	Cosmetic Product Categories and CodesAnnouncements

12/18/2023 - FDA Issues Final Guidance on Registration and Listing of Cosmetic Product Facilities and Products
	12/18/2023 - FDA Announces Launch of Cosmetics Direct for Electronic Registration and Listing of Cosmetic Product Facilities and Products

                                                                                  Content current as of:
      12/18/2023
              
              
Regulated Product(s)
		 CosmeticsRegistration & Listing of Cosmetic Product Facilities and Products

          
                        Cosmetics Direct
          Cosmetic Product Categories and Codes
          Form FDA 5066 - Registration of Cosmetic Product Facility
          Form FDA 5067 - Cosmetic Product Listing
 
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