Creating a Cosmetic Product Listing File

A responsible person must list each marketed cosmetic product with FDA, including product ingredients, and provide any updates annually.

Responsible person means the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label of such cosmetic product:

https://www.fda.gov/cosmetics/registration-listing-cosmetic-product-facilities-and-products 

Cosmetic Manufacturers and/or processors must have a submitted Cosmetic Facility Registration file on record with the FDA which include a reference to the Cosmetic Product(s) being produced at that facility before the Cosmetic Product Listing file(s) for the associated Cosmetic Product(s) can be submitted to the FDA for registration. See: 

Creating a Cosmetic Facility Registration File

To create a new Cosmetic Product Listing File click the "Create New Product" link on the Products page.

Clicking the "Create New Product" link will open a new "Product Detail" page for population for the new product.

Populate the New Product form with the product’s associated Labeler, Product Name, SPL Title, and Image Title. Then click the "Save" button. The New Product record will be saved and the following message will display on the screen: “The record was successfully updated.” Once the new product record has been saved, click the "Product Listing Data" button to save the associated Establishment(s)/Facilities to the Product via the "Establishment:" dropdown menu on the  "Establishment" Tab.

Once the Establishment(s)/Facilities have been saved, click the "Product Data Elements" button. 

Clicking the "Product Data Elements" button will then load the main Manufactured Product Data Validation page for the product. Click to select the "New Manufactured Product" link to being creating a new Manufactured Product.

Clicking the "New Manufactured Product" link will open a new Manufactured Product detail tab/page displaying a blank form field.

Populate the form fields to create a new Cometic Manufactured Product by 1st setting the Marketing Category to "Cosmetic". This will update the page with the inclusion of a Cosmetic Category for selection, and a Cosmetic Sub-Category for selection. Populate the remaining appliable displayed fields in the form and then click the Save button.

Clicking the Save button will then open the access to populate the "Active Ingredients"(if applicable) tab, the "Inactive Ingredients" tab, and the "Routes of Admin." tab. After populating the applicable data in those tabs click the "Back To Manufactured Product List" button located on any of the tabs to be brought back to the main Manufactured Product Data Validation page for the product.

With the Cosmetic data populated there will now display on the main Manufactured Product Data Validation page a "Create/View Cosmetic Products Listing(s)" link.

Click the "Create/View Cosmetic Products Listing(s)" link. This will open the "Create/View Cosmetic Products Listing(s)" window that is used to create and download Cosmetic Product Listing Files under the set product. The set product's existing Cosmetic Product Listing Files are listed in descending order based on version number.

To create a Cosmetic Product Listing file populate the "Submission Type:" dropdown menu and the "Effective Date:" field(the "Version No:" field is automatically incremented by the application.). With those fields populated a Review file can be created by clicking the "Create SPL Review File" button, this will automatically download a review file, this file will not be saved to SPL Portal so please save the review file to your chosen location in order to access it in the future.

Click the “Create Cosmetic Product Listing File” button to create a new Cosmetic Product Listing File. Once the file has been generated, click the download icon to download the completed file; click the Submit icon to submit the file to the FDA.