REGISTRATION OF COSMETIC PRODUCT FACILITY

Overview of Validation Errors

INSTRUCTIONS

An item followed by an asterisk (*) denotes a required field. Omit all punctuation.
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 REGISTRATION

Note: If you have previously registered electronically, and you do not have your previously submitted Establishment Registration 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 Registration

Note:If you need to de-register your cosmetic facility registration, 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 – REGISTRATION

IS THIS A FACILITY REGISTRATION FOR A SMALL BUSINESS (optional registration)? YES
FACILITY NAME*		PARENT COMPANY NAME (If applicable)
FACILITY FEI (FDA Establishment Identifier) NUMBER*		FACILITY D & B D-U-N-S NUMBER
STREET ADDRESS*
CITY*	STATE OR PROVINCE*	ZIP/POSTAL CODE*	COUNTRY*
FACILITY EMAIL*		FACILITY 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.
NAME OF THE OWNER AND/OR OPERATOR OF THE FACILITY*

BRAND NAMES OF COSMETIC PRODUCTS MANUFACTURED OR PROCESSED IN THIS FACILITY*	RESPONSIBLE PERSON NAME* (As listed on label)	PRODUCT CATEGORY CODE(S)* (See references on page 3)	Action
		Choose the Cosmetic Product Categories −+	−+

SECTION III – U.S. AGENT CONTACT INFORMATION
U.S. AGENT NAME* (for foreign facilities)	EMAIL* (If not available, enter “N/A”)
PHONE NUMBER* (Include Country/Area Code) Phone number must be a US phone number in the form ###-###-####.	PHONE EXTENSION

SECTION IV – 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 IV – 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 V – 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

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.

Review

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Validate

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✔ Your SPL file has been Successfully Validated.

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Submit

This document is not eligible to be submitted through the Pragmatic Regulatory Submission - Transmission Service because of missing details. Ensure the following information is complete:

Registrant DUNS number
Registrant contact (additional contact)
Signature

The person signing and registrant contact should be the same, and the same and that is the person who has an approved application for the Pragmatic Regulatory Submission - Transmission Services.

Note: you are submitting data to the federal government.

I am the authorized agent for the responsible person for this facility registration and I certify that the statements made in this facility registration, which I have entered and reviewed are true.

Yes

Submission Result

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This document has been successfully submitted.

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Overview of Validation Errors

Choose the Cosmetic Product Categories

Submission Result