Cosmetics Direct
Cosmetics Direct incorporates the necessary information for registration and listing submissions from the Paper Forms FDA 5066 and 5067 into a standardized electronic format. New users who wish to access the Cosmetics Direct Home Page are required to create a new account by submitting the organization’s basic information such as name, DUNS, address, and contact information. DUNS is only a required field for companies seeking to log in to both CDER Direct and Cosmetics Direct.
On the Home Page, companies are able to see the two types of selections: Registration of Cometic Product Facility and Cosmetic Product Listing.
1) Registration of Cometic Product Facility
Companies can choose to create a new registration using a blank form or import an FDA-accepted SPL in a valid XML zip file.
The mandatory information required for the registration includes (the same as what is stated on Form 5066):
- Facility's name, address and contact information
- Brand names of cosmetic products manufactured or processed in the facility
- Name of the responsible person listed on the products' labels
- Product category code
- Contact information for the U.S. agent (applicable to international companies only)
2) Cosmetic Product Listing
There are also two options: create a new registration using a blank form or import an FDA-accepted SPL in a valid XML zip file. The mandatory information required for the product listing includes (the same as what is mentioned on Form 5067):
- Responsible person: the name listed on the products' labels, the type of business, phone number
- Product: category code, name, the presence of fragrance or flavour
- The facility where the cosmetic is manufactured or processed: FDA Establishment Identifier (FEI) of each facility. (If the facility is a small business and is not required to register, enter the name and address)
- List of ingredients in the cosmetic product: common, usual or chemical name, and ingredient UNII-Name
Source: ChemLinked
Contact Us
If you have any questions regarding cosmetics compliance in the U.S., please feel free to contact us. Email: customer@reach24h.com Tel: +86-400-809-5809
News Source: ChemLinked
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