FDA 5067 Cosmetic Product Listing

This is a DESIGN PROOF ONLY. Any fields and/or checkboxes
are non-functional and for position only. Functional fields will be
inserted by technical staff once the form design is approved.

All fillable fields in this
form must be ALL CAPS
OMB Control No. 0910-XXXX
Expiration Date: Month XX, 20XX
See PRA Statement Page 4

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

COSMETIC PRODUCT LISTING

FOR FDA USE ONLY ON INITIAL
LISTINGS

(In accordance with section 607(c) of the Federal
Food, Drug, and Cosmetic Act (FD&C Act))
PRODUCT NUMBER

LISTING DATE (mm/dd/yyyy)

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

1
2
3

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. For Section IV: List
each ingredient on a separate row, in the order that they are listed on the label. If the Unique Ingredient Identifier (UNII) is not known, leave UNII
blank. List additional ingredients on a separate page-2 of Form FDA 5067. 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*
INITIAL
CHANGES TO LISTING
DISCONTINUATION OF LISTING

F
O
O

R
P
N

UPDATE TO CONTENT (annual)

G
I
S
E

ABBREVIATED RENEWAL (By checking this box, you are certifying that no changes have been made to your product listing since the
previous listing was submitted)

D

SECTION II – PRODUCT LISTING

IS THIS A PRODUCT LISTING FOR A SMALL BUSINESS
RESPONSIBLE PERSON: TYPE OF BUSINESS
(optional product listing)? (As listed on label)
YES
NO
MANUFACTURER
PACKER
DISTRIBUTOR
RESPONSIBLE PERSON NAME* (As listed on label)

PARENT COMPANY NAME (If applicable)

RESPONSIBLE PERSON CONTACT PHONE NUMBER*
(Include Area/Country Code)

RESPONSIBLE PERSON D&B D-U-N-S NUMBER FOR ADDRESS
Listed On Product Label

PRODUCT CATEGORY CODE(S)* (see references on page 4)

IMAGE OF LABEL (Attach images of the front and back product labels
to this form)

PRODUCT WEBPAGE LINK
DOES THIS PRODUCT CONTAIN
FRAGRANCE OR FLAVOR?*
(select one or both, if applicable)

PRODUCT
PRODUCT NAME* (As listed on label)
NUMBER

IS THIS PRODUCT
FOR PROFESSIONAL
USE ONLY?

1

FRAGRANCE

FLAVOR

YES

NO

2

FRAGRANCE

FLAVOR

YES

NO

3

FRAGRANCE

FLAVOR

YES

NO

(continued on next page)

Form FDA 5067 (8/23)

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PSC Publishing Services (301) 443-6740

EF

This is a DESIGN PROOF ONLY. Any fields and/or checkboxes
are non-functional and for position only. Functional fields will be
inserted by technical staff once the form design is approved.
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(IES) WHERE THE PRODUCT IS MANUFACTURED
OR PROCESSED (if the facility is a small business and is not required to register, please enter the name and address of
the facility)*

1
2
3

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)

INGREDIENT
COMMON, USUAL, OR CHEMICAL NAME*
NUMBER

UNIQUE INGREDIENT
PRODUCT NUMBER(S)
IDENTIFIER (UNII)

1

1;

2;

3;

ALL

2

1;

2;

3;

ALL

3

1;

2;

3;

ALL

1;

2;

3;

ALL

1;

2;

3;

ALL

1;

2;

3;

ALL

1;

2;

3;

ALL

1;

2;

3;

ALL

1;

2;

3;

ALL

10

1;

2;

3;

ALL

11

1;

2;

3;

ALL

12

1;

2;

3;

ALL

13

1;

2;

3;

ALL

14

1;

2;

3;

ALL

15

1;

2;

3;

ALL

16

1;

2;

3;

ALL

17

1;

2;

3;

ALL

18

1;

2;

3;

ALL

19

1;

2;

3;

ALL

20

1;

2;

3;

ALL

21

1;

2;

3;

ALL

4
5
6
7
8
9

P
N

SIG

DE

RO

OF

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Form FDA 5067 (8/23)

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This is a DESIGN PROOF ONLY. Any fields and/or checkboxes
are non-functional and for position only. Functional fields will be
inserted by technical staff once the form design is approved.
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.

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 VI – ADDITIONAL CONTACT INFORMATION FOR AUTHORIZED AGENT
ADDITIONAL CONTACT NAME

EMAIL

PHONE NUMBER (Include Area/Country Code)

PHONE EXTENSION

R
P
N

G
I
S
E

D

F
O
O

(continued on next page)

Form FDA 5067 (8/23)

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This is a DESIGN PROOF ONLY. Any fields and/or checkboxes
are non-functional and for position only. Functional fields will be
inserted by technical staff once the form design is approved.
REFERENCES
Registration and Listing of Cosmetic Product Facilities
and Products
https://www.fda.gov/cosmetics

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)

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

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.

F
O
O

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.

R
P
N

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.

G
I
S
E

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.

D

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Form FDA 5067 (8/23)

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