FDA 5066 Registration of Cosmetic Product Facility

OMB No. 0910-XXXX
Expiration Date: Month XX, 20XX
See PRA Statement on Page 3

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

REGISTRATION OF COSMETIC PRODUCT FACILITY
(In accordance with section 607(a) and (b) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act))

FOR FDA USE ONLY ON INITIAL
REGISTRATIONS
REGISTRATION DATE (mm/dd/yyyy)

INSTRUCTIONS
For faster processing please use the electronic submission portal at: https://direct.fda.gov. Type all entries in CAPITAL LETTERS. An
item followed by an asterisk (*) denotes a required field. Use standard abbreviations wherever possible. Omit all punctuation. Complete a
separate Form FDA 5066 for each facility location. Mail completed form to: DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD
AND DRUG ADMINISTRATION, Office of Cosmetics and Colors, Registration and Listing of Cosmetic Product Facilities and Products
Program (HFS-125), 5001 Campus Drive, College Park, MD 20740-3835 or email it to RLC-PaperSubmissions@fda.hhs.gov.
SECTION I – DOCUMENT TYPE
DOCUMENT TYPE*

Designer note: This form will be made
as a “508 compliant” Adobe Acroform
PDF with entry fields after FDA (along
with OMB, if applicable) gives final
approval to this “layout design” version.

INITIAL
AMENDED
C
 HANGES TO REGISTRATION
CANCELLATION OF REGISTRATION
BIENNIAL REGISTRATION RENEWAL

A
 BBREVIATED REGISTRATION RENEWAL (By checking this box, you are certifying that no changes have been made to your registration since the
previous registration was submitted)

OF
O
IS THIS A FACILITY REGISTRATION FOR A SMALL BUSINESS
PR(optional registration)?
SECTION II – REGISTRATION
YES

NO

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*

FACILITY EMAIL*

COUNTRY* (If other than USA)

FACILITY PHONE NUMBER* (Include Area/Country Code)

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)

1.
2.
3.

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FORM FDA 5066 (8/23)

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PSC Publishing Services (301) 443-6740

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SECTION III – U.S. AGENT CONTACT INFORMATION
U.S. AGENT NAME* (for foreign facilities)

EMAIL* (If not available, enter “N/A”)

PHONE NUMBER* (Include Area Code)

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 and renew as required under section 607 of the FD&C Act.

AGREE

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

PHONE EXTENSION

F

O
RO

P

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FORM FDA 5066 (8/23)

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REFERENCES
Registration and Listing of Cosmetic Product Facilities and
Products:
https://www.fda.gov/cosmetics
Registration and Listing of Cosmetic Product Facilities and
Products: Guidance for Industry:
http://www.fda.gov/
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

Cosmetic product category codes:
https://www.fda.gov/cosmetics
Product category code examples:
02B (Bubble baths)
06A2 (Hair conditioners; Rinse-off)
10E (Nail polishes and enamels)
15B3 (Indoor tanning preparations; Spray applications)

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.

F

O
RO

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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.
THE INFORMATION BELOW APPLIES ONLY TO REQUIREMENTS OF THE PAPERWORK REDUCTION ACT OF 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average between 15 and 30 minutes per response, including the time
to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of
information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for
reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
“An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a
currently valid OMB control number.”

FORM FDA 5066 (8/23)

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PSC Publishing Services (301) 443-6740

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