COSMETIC PRODUCT LISTING

Overview of Validation Errors

PRODUCT NUMBER	PRODUCT LISTING NUMBER(S)(if previously assigned)*

INSTRUCTIONS

An item followed by an asterisk (*) denotes a required field. Use standard abbreviations wherever possible. Omit all punctuation. For Section IV: List each ingredient on a separate row, in the order that they are listed on the label. Common, usual or chemical name will auto populate as you type along with its UNII. If the ingredient does not auto-populate, continue typing and click out of the field to add the ingredient. If the Unique Ingredient Identifier (UNII) is not known, leave UNII blank.
Successfully validated form can be submitted to FDA in different ways: Using Pragmatic ESG after validation on this form, Electronic Submissions Gateway (ESG) and Cosmetics Direct.
Visit SPL Xforms for troubleshooting help and other advisories. For questions on FDA SPL Xforms, contact spl@fda.hhs.gov. For additional information, see Registration & Listing of Cosmetic Product Facilities and Products.

SECTION I – DOCUMENT TYPE

DOCUMENT TYPE*

INITIAL

CHANGES TO LISTING

Note: If you have previously registered electronically, and you do not have your previously submitted SPL document, you should have received it attached to your registration reminder email. If you cannot find the registration reminder email you may request a copy by sending a message to spl@fda.hhs.gov.

Select your previous registration sent to you in your reminder email.

Note: On Chrome and Firefox you can drag and drop your previous registration right from your email attachment to this file selection field.

Select the previously saved file.

Note: On Chrome and Firefox you can drag and drop your previously saved file onto this file selection field.

De Listing

Note:If you need to de-list your cosmetic product Listing, please insert the correct Document Metadata details and proceed.

Show Document Metadata. Please click the blue Next arrow to advance.

Do you wish to examine the document metadata (This is normally not required.)? Please click the blue Next arrow to advance.

Document Metadata

Document Id

Set Id

Version Number

SECTION II – PRODUCT LISTING

IS THIS A PRODUCT LISTING FOR A SMALL BUSINESS (optional product listing)? YES	RESPONSIBLE PERSON: TYPE OF BUSINESS(As listed on label) MANUFACTURER PACKER DISTRIBUTOR
RESPONSIBLE PERSON NAME* (As listed on label)	PARENT COMPANY NAME(If applicable)
RESPONSIBLE PERSON CONTACT PHONE NUMBER* (Include Country/Area Code) Phone number must be either a US phone number in the form ###-###-####, or an international number with the country code preceded by "+" and followed by "-",then followed by the other digits.	RESPONSIBLE PERSON D&B D-U-N-S NUMBER FOR ADDRESS Listed On Product Label
PRODUCT CATEGORY CODE(S)* (see references on page 4) Choose the Cosmetic Product Categories −+	IMAGE OF LABEL (Attach images of the front and back product labels to this form)
PRODUCT WEBPAGE LINK

PRODUCT NUMBER	PRODUCT NAME* (As listed on label)	DOES THIS PRODUCT CONTAIN FRAGRANCE OR FLAVOR?*(select one or both, if applicable)	IS THIS PRODUCT FOR PROFESSIONAL USE ONLY?	Action
		FRAGRANCE FLAVOR	YES	−+

SECTION III – LIST OF FACILITIES WHERE THE COSMETIC IS MANUFACTURED OR PROCESSED
(See product number/product name provided in Section II)

PRODUCT NUMBER	FDA ESTABLISHMENT IDENTIFIER (FEI) OF EACH FACILITY WHERE THE PRODUCT IS MANUFACTURED OR PROCESSED* (If the facility is exempt from registration, for example because it is a small business, please check the box.* If the exempt facility has no facility registration number, the facility name/address can be provided instead. ) Hint: Uncheck the FEI checkbox and click on the N/A to enter the address details.
	FEI: Enter Facility Name and Address Name: Address: Street: City: State: Postal Code: Country: − +

PRODUCT
NUMBER

FDA ESTABLISHMENT IDENTIFIER (FEI) OF EACH FACILITY WHERE THE PRODUCT IS MANUFACTURED OR PROCESSED*

(If the facility is exempt from registration, for example because it is a small business, please check the box.* If the exempt facility has no facility registration number, the facility name/address can be provided instead. )

Hint: Uncheck the FEI checkbox and click on the N/A to enter the address details.

FEI: −

SECTION IV – LIST OF INGREDIENTS IN THE COSMETIC PRODUCT
(Fragrances and flavors are included in Section II and do not need to be listed here)
Hint: Ingredients for which product numbers are not selected will be automatically added to all products.

INGREDIENT NUMBER	COMMON, USUAL, OR CHEMICAL NAME*	UNIQUE INGREDIENT IDENTIFIER (UNII)	PRODUCT NUMBER(S)*	Action
				−+

SECTION V – CONFIRMATION STATEMENT

The data and information in this submission have been reviewed and, to the best of my knowledge, are certified to be true and accurate. I agree to report changes to this information as required under section 607 of the FD&C Act.

WARNING:A willfully false statement is a criminal offense, U.S. Code, Title 18, Section 1001.

AGREE

SIGNATURE OF SUBMITTER

PRINTED NAME OF SUBMITTER

DATE (mm/dd/yyyy)

SECTION VI – ADDITIONAL CONTACT INFORMATION FOR AUTHORIZED AGENT

ADDITIONAL CONTACT NAME	EMAIL
PHONE NUMBER (Include Country/Area Code) Phone number must be either a US phone number in the form ###-###-####, or an international number with the country code preceded by "+" and followed by "-",then followed by the other digits.	PHONE EXTENSION

REFERENCES

Registration and Listing of Cosmetic Product Facilities and Products:
https://www.fda.gov/cosmetics/registration-listing-cosmetic-product-facilities-and-products

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

Registration and Listing of Cosmetic Product Facilities and Products: Guidance for Industry::
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-registration-and-listing-cosmetic-product-facilities-and-products

Product category code examples:

02B (Bubble baths)

06A2 (Hair conditioners; Rinse-off)

10E (Nail polishes and enamels)

15B3 (Indoor tanning preparations; Spray applications)

How to request an FEI number or determine if an entity already has an FEI number:
https://www.accessdata.fda.gov/scripts/feiportal/index.cfm?action=portal.login

Unique Ingredient Identifiers (UNIIs):
https://precision.fda.gov/uniisearch

DEFINITIONS

MANUFACTURING OR PROCESSING OF A COSMETIC PRODUCT —means engaging in one or more steps in the making of any cosmetic product by chemical, physical, biological, or other procedures, including manipulation, sampling, testing,or control procedures applied to the product.

OPERATOR— means a person, as defined in section 201(e) of the FD&C Act (21 U.S.C 321(e)), who has management authority over an establishment.

OWNER—means a person, as defined in section 201(e) of the FD&C Act (21 U.S.C. 321(e)), who has an ownership interest in an establishment.

RESPONSIBLE PERSON— as defined in section 604(4) of the FD&C Act, means the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label of such cosmetic product in accordance with section 609(a) of the FD&C Act or section 4(a) of the Fair Packaging and Labeling Act.

SMALL BUSINESSES— as defined in section 612 of the FD&C Act, means responsible persons, and owners and operators of facilities, whose average gross annual sales in the U.S. of cosmetic products for the previous 3-year period is less than $1,000,000, adjusted for inflation,and who do not engage in the manufacturing or processing of certain cosmetic products described in section 612(b) of the FD&C Act. A small business is exempt from the registration and listing requirements.

Overview of Validation Errors

Choose the Cosmetic Product Categories

Address:

Submission Result