Guidance for Industry:  
Registration and Listing of Cosmetic 
Product Facilities and Products 
 
 
 
Additional copies are available from: 
Office of the Chief Scientist 
Food and Drug Administration 
10903 New Hampshire Ave., Bldg. 1, Room 3317 
Silver Spring, MD 20903 
(Tel) 301-796-4880 
https://www.fda.gov/cosmetics/cosmetics-guidance-regulation/cosmetics-guidance-documents 
 
 
 
Appendix B of this guidance that describes frequently asked questions and answers is being 
distributed for comment purposes only. 
 
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure 
that FDA considers your comment on the Appendix B before we begin work on the final version 
of Appendix B, submit either electronic or written comments on this document within 30 days of 
publication in the Federal Register of the notice announcing the availability of the guidance.  
 
Submit electronic comments to http://www/regulations.gov.  Submit written comments on the 
guidance to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852.  All comments should be identified with the 
docket number FDA-2023-D-1716 as listed in the notice of availability that publishes in the 
Federal Register.  
  
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Office of the Chief Scientist 
 
December 2023 
 
    Contains Nonbinding Recommendations 
 
 
 
Table of Contents 
 
I.  INTRODUCTION................................................................................................................. 3 
II.  BACKGROUND ................................................................................................................... 3 
III.  QUESTIONS AND ANSWERS ........................................................................................... 4 
APPENDIX A .............................................................................................................................. 14 
APPENDIX B .............................................................................................................................. 18 
 
 
 
 
  2  Contains Nonbinding Recommendations 
 
 
Registration and Listing of Cosmetic 
Product Facilities and Products: 
Guidance for Industry
1 
  
 
This guidance represents the current thinking of the Food and Drug Administration (FDA or 
Agency) on this topic. It does not establish any rights for any person and is not binding on FDA 
or the public. You can use an alternative approach if it satisfies the requirements of the applicable 
statutes and regulations. To discuss an alternative approach, contact the FDA office responsible 
for this guidance as listed on the title page.   
 
I.  Introduction 
 
This guidance provides recommendations and instructions to assist persons submitting cosmetic 
product facility registrations and product listings to FDA.  This guidance document explains, 
among other things: 
 
  The statutory requirement to submit cosmetic product facility registrations and product 
listings;  
  Definitions;  
  Who is responsible for making the submissions;  
  What information to include in the submissions; 
  How to make the submissions; and 
  When to make the submissions. 
 
FDA's guidance documents, including this guidance, do not establish legally enforceable 
responsibilities.  Instead, guidances describe our current thinking on a topic and should be 
viewed only as recommendations, unless specific regulatory or statutory requirements are cited.  
The use of the word should in FDA guidances means that something is suggested or 
recommended, but not required.  
 
II.  Background 
 
On December 29, 2022, the President signed the Consolidated Appropriations Act, 2023 (Pub. L. 
117-328) into law, which included the Modernization of Cosmetics Regulation Act of 2022 
(MoCRA).  Among other provisions, MoCRA added section 607 to the Federal Food, Drug, and 
Cosmetic Act (FD&C Act), establishing requirements for cosmetic product facility registration 
and product listing. 
 
1 This guidance has been prepared by the Office of Cosmetics and Colors, in the Center for Food Safety and Applied 
Nutrition, and the Office of the Chief Scientist at the U.S. Food and Drug Administration.   
  3  Contains Nonbinding Recommendations 
 
 
 
Section 607(a) of the FD&C Act requires every person that owns or operates a facility that 
engages in the manufacturing or processing of a cosmetic product for distribution in the United 
States to register each facility with FDA.   
 
Section 607(c) of the FD&C Act requires that for each cosmetic product, the responsible person 
must submit to FDA a cosmetic product listing. 
 
FDA previously had a voluntary cosmetic registration program (see 21 CFR Parts 710 and 720).  
FDA ended its voluntary registration program as of March 27, 2023, while we worked toward 
establishing a new system, including a submission portal for the cosmetic product facility 
registrations and product listings mandated by MoCRA.2 Information in the voluntary cosmetic 
registration program will not be transferred to this new system. Because the information in the 
voluntary cosmetic registration program differs from the information required to be submitted 
under MoCRA, FDA does not consider previous submissions to the voluntary cosmetic 
registration program to satisfy the registration and listing requirements mandated by MoCRA.  
 
FDA has developed an electronic submission portal, Cosmetics Direct, to help streamline 
submission and receipt of registration and product listing information under section 607 of the 
FD&C Act.  FDA has developed paper forms (FDA Form 5066 and 5067) as an alternative 
submission tool. As an additional alternative, users may transmit submissions through FDAs 
Electronic Submissions Gateway (ESG) as described in section III.E. below. FDA strongly 
encourages electronic submissions to facilitate efficiency and timeliness of data submission and 
management for the agency.  Cosmetics Direct, technical assistance documents and paper 
submission forms can be accessed at: https://www.fda.gov/cosmetics/registration-listing-
cosmetic-product-facilities-and-products. 
 
Certain small businesses, as defined in section 612 of the FD&C Act, are not required to register 
facilities and list cosmetic product(s) (refer to section III.A. and III.B. below).  
 
Failure to register or submit listing information in accordance with section 607 of the FD&C Act 
is a prohibited act under section 301(hhh) of the FD&C Act (21 U.S.C. 331(hhh)).  
 
III.  Questions and Answers 
 
A. What definitions apply? 
 
We plan to use the following definitions in implementing the registration and product listing 
requirements of section 607 of the FD&C Act: 
 
 
2 For more information, refer to FDAs Constituent Update FDA Has Stopped Accepting Submissions to the 
Voluntary Cosmetic Registration Program (VCRP) at: https://www.fda.gov/food/cfsan-constituent-updates/fda-has-
stopped-accepting-submissions-voluntary-cosmetic-registration-program-vcrp.   
  4  Contains Nonbinding Recommendations 
 
 
CONTRACT MANUFACTURER.  means a facility that manufactures or processes a cosmetic 
product on behalf of another entity. 
 
COSMETIC PRODUCT.  as defined in section 604(2) of the FD&C Act, means a preparation 
of cosmetic ingredients with a qualitatively and quantitatively set composition for use in a 
finished product. 
 
DUNS NUMBER.   The Data Universal Numbering System (DUNS) number is a unique nine-
digit identification number provided by Dun & Bradstreet (D&B). The DUNS Number is site-
specific. Therefore, each distinct physical location of an entity (such as branches, divisions, and 
headquarters) may be assigned a DUNS number. 
 
FACILITY.  as defined in section 604(3) of the FD&C Act, includes any establishment 
(including an establishment of an importer) that manufactures or processes cosmetic products 
distributed in the United States.  
 
This term does not include any of the following: 
 
(i) Beauty shops and salons, unless such establishment manufactures or processes 
cosmetic products at that location; 
(ii) Cosmetic product retailers, including individual sales representatives, direct sellers 
(as defined in section 3508(b)(2) of the Internal Revenue Code of 1986), retail 
distribution facilities, and pharmacies, unless such establishment manufactures or 
processes cosmetic products that are not sold directly to consumers at that location; 
(iii) Hospitals, physicians offices, and health care clinics; 
(iv) Public health agencies and other nonprofit entities that provide cosmetic products 
directly to the consumer; 
(v) Entities (such as hotels and airlines) that provide complimentary cosmetic products to 
customers incidental to other services; 
(vi) Trade shows and other venues where cosmetic product samples are provided free of 
charge; 
(vii) An establishment that manufactures or processes cosmetic products that are solely 
for use in research or evaluation, including for production testing and not offered for 
retail sale; 
(viii) An establishment that solely performs one or more of the following with respect to 
cosmetic products:  
  Labeling,  
  Relabeling,  
  Packaging,  
  Repackaging,  
  Holding,  
  Distributing.  
  5  Contains Nonbinding Recommendations 
 
 
For purposes of determining whether an establishment solely performs one or more of the 
activities listed under (viii), the terms packaging and repackaging do not include filling a 
product container with a cosmetic product. 
 
FEI.  is an acronym which stands for FDA Establishment Identifier. It is also known as the 
Firm or Facility Establishment Identifier. The FEI number is a unique identifier assigned by the 
FDA to identify firms associated with FDA-regulated products.  FDA intends to use a facilitys 
FEI number as the cosmetic product facilitys registration number. 
 
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,3 
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.   
 
Under section 612(b) of the FD&C Act, regardless of their average gross annual sales, 
businesses that engage in the manufacturing or processing of the following are not 
exempt from the registration and listing requirements: 
 
  Cosmetic products that regularly come into contact with mucus membrane of the 
eye under conditions of use that are customary or usual; 
  Cosmetic products that are injected; 
  Cosmetic products that are intended for internal use; or 
 
3 We recommend using the Implicit Price Deflator for GDP, updated annually by the Bureau of Economic Analysis, 
when adjusting for inflation.  Please refer to: 
https://apps.bea.gov/iTable/?reqid=19&step=3&isuri=1&1921=survey&1903=13. 
  6  Contains Nonbinding Recommendations 
 
 
  Cosmetic products that are intended to alter appearance for more than 24 hours 
under conditions of use that are customary or usual and removal by the consumer 
is not part of such conditions of use that are customary or usual. 
 
 
B. Who registers a facility and submits product listing information under 
section 607 of the FD&C Act? 
 
1. Registration of a Facility 
Section 607(a)(1) of the FD&C Act requires every person that owns or operates a facility that 
engages in the manufacturing or processing of a cosmetic product for distribution in the 
United States to register each facility, except in the following instances: 
 
  A facility that is exempt from registration as a small business as described section 
III.A. above; 
  A facility that is also subject to the requirements in chapter V of the FD&C Act (for 
drugs and devices) unless the facility also manufactures or processes cosmetic 
products that are not subject to the requirements of chapter V of the FD&C Act (see 
section 613 of the FD&C Act).  
 
As provided under section 607(a)(3) of the FD&C Act, if a facility manufactures or processes 
cosmetic products on behalf of a responsible person (i.e., a contract manufacturer), only a 
single registration is required for such facility even if the facility is manufacturing or 
processing its own cosmetic products or cosmetic products on behalf of more than one 
responsible person.  A responsible person whose products are manufactured or processed at 
such facility may submit the facility registration for such facility.  Under this approach, an 
owner or operator of a contract manufacturing facility would not register such facility if the 
responsible person submitted the facility registration. 
 
2. Product Listing 
Section 607(c) of the FD&C Act requires that for each cosmetic product, the responsible 
person must submit a cosmetic product listing, or ensure such submission is made, except in 
the following instances: 
 
  The responsible person that is exempt as a small business as described in section 
III.A. above; 
  The cosmetic product that is also subject to the requirements in chapter V of the 
FD&C Act (for drugs and devices). For example, if the product is both a drug and a 
cosmetic product under the FD&C Act, a cosmetic product listing is not required to 
be submitted for such product (see section 613 of the FD&C Act), but the listed 
product should be identified as both a drug and a cosmetic in the drug listing 
submission.  
 
  7  Contains Nonbinding Recommendations 
 
 
C. What information is submitted as part of facility registration and product 
listing under section 607 of the FD&C Act? 
 
1. Registration 
Under sections 607(a) and 607(b)(2) of the FD&C Act, the following information must be 
submitted in a facility registration:  
 
  the name of the owner and/or operator of the facility; 
  the facilitys name, physical address, email address, and telephone number; 
  with respect to any foreign facility, the contact for the United States agent4 of the 
facility (name and phone number), and, if available, the electronic contact 
information (email); 
  the facility registration number, if any, previously assigned by FDA;5 
  all brand names under which cosmetic products manufactured or processed in the 
facility are sold;   
  the product category or categories (refer to Appendix A below) and responsible 
person for each cosmetic product manufactured or processed at the facility; and 
  type of submission (initial, amended, biennial renewal, or abbreviated renewal, for 
further information see discussion in section III.F.1). 
 
Obtaining the assigned facility registration number is the first step before starting the 
registration submission.   
 
FDA also requests that the following additional optional information be submitted: 
 
4 With respect to a foreign facility, a United States agent (U.S. agent) is required for registration purposes.  The 
U.S. agent is the person, which includes an individual or business entity, that resides in the U.S. or maintains a U.S. 
place of business and is physically present in the U.S. A U.S. agent should not be a mailbox, answering machine or 
service, or other place where an individual acting as the foreign facilitys agent is not physically present. 
5 The facility registration number is the FDA Establishment Identifier (FEI). To facilitate the registration process, 
the owner or operator of a facility will need to obtain an FEI number before submitting the facility registration. 
Request for issuance of FEI numbers associated with registration for cosmetic product facilities are typically 
processed in 7-10 business days. A facility that was previously assigned an FEI number in connection with other 
business with FDA should use the same FEI number and should not request a new FEI. For more information, 
including how to determine if an entity already has an FEI number, refer to the webpage at: 
https://www.accessdata.fda.gov/scripts/feiportal/index.cfm?action=portal.login. If your entity does not have an FEI 
number assigned by FDA, send a request to feiportal@fda.hhs.gov and provide the following information: 
  Legal firm name 
  Any alternate firm names, including those used for "doing business as" purposes 
  Physical address 
  Designated mailing address 
  Name and contact information of the designated contact person 
  A comprehensive list of activities conducted at this specific location (e.g., drug manufacturing, food 
packaging, etc.) 
  Any registration numbers associated with other FDA Center(s), if applicable 
  Any former names the firm was known by 
  Any previous addresses linked to the firm 
  8  Contains Nonbinding Recommendations 
 
 
 
  parent company name (if applicable); 
  facility DUNS Number; and 
  additional contact information for individuals associated with the registration. 
 
In addition, FDA requests that individuals submitting registration and listing information to 
attest to the accuracy and veracity of the information submitted.  
 
2. Product Listing 
 
Under section 607(c) of the FD&C Act, the following information must be submitted in a 
cosmetic product listing: 
 
  the facility registration number of each facility where the cosmetic product is 
manufactured or processed;6 
  the name and contact number of the responsible person and the name for the cosmetic 
product, as such name appears on the label; 
  the applicable cosmetic category or categories for the cosmetic product (refer to 
Appendix A below); 
  a list of ingredients in the cosmetic product, including any fragrances, flavors, or 
colors, with each ingredient identified by the name, as required under section 701.3 of 
title 21, Code of Federal Regulations (or any successor regulations), or by the 
common or usual name of the ingredient; 
  the product listing number, if any previously assigned; and 
  type of submission (initial, update to content (annual), abbreviated renewal). 
 
Under section 607(c)(4)(B), a single listing submission for a cosmetic product may include 
multiple cosmetic products with identical formulations, or formulations that differ only with 
respect to colors, fragrances or flavors, or quantity of contents. 
 
FDA also requests that the following additional optional information be submitted: 
 
  parent company name (if applicable); 
  type of business (as listed on the label), i.e., manufacturer, packer, or distributor; 
  image of the label (currently jpg files are accepted); 
  product webpage link; 
  whether the cosmetic product is for professional use only; 
  responsible person DUNS Number for address listed on product label;  
  Unique Ingredient Identifiers (UNIIs)7; and 
 
6 The responsible person will need to obtain the relevant facility registration number(s) for each facility where its 
cosmetic products are manufactured or processed, because the facility registration number(s) is required for the 
product listing submission.  If the facility is exempt from registration, for example because it is a small business, and 
has no facility registration number, then facility name/address can be provided instead. 
7 For more information and to search for UNIIs please refer to the webpage at: https://precision.fda.gov/uniisearch. 
For UNII requests contact:  FDA-SRS@fda.hhs.gov. 
  9  Contains Nonbinding Recommendations 
 
 
  additional contact information for individuals associated with the listing. 
 
In addition, FDA requests that individuals submitting registration and listing information 
attest to the accuracy and veracity of the information submitted. 
 
D. Is cosmetic product facility registration and cosmetic product listing 
information submitted under section 607 of the FD&C Act available for 
public disclosure? 
 
The product listing number will not be available for public disclosure (section 607(d) of the 
FD&C Act).  Further, under section 607(e) of the FD&C Act, FDA will not disclose information 
from a facility registration on the brand names under which cosmetic products manufactured or 
processed in the facility are sold, or from a product listing on the facility registration number of 
the facility where the cosmetic product is manufactured or processed, in response to a request 
under the Freedom of Information Act (FOIA) (5 U.S.C. 552).  All other information from 
cosmetic product facility registration and listing would be available for public disclosure 
consistent with the FOIA, FDAs disclosure regulations under 21 CFR Part 20, and other 
applicable federal law.  FDA intends to make relevant information from cosmetic product facility 
registration and listing available to the public to the extent permitted by law. 
 
E. How do you submit registration and product listing information required 
under section 607 of the FD&C Act? 
 
Cosmetics Direct is an electronic submission portal designed to help streamline submission and 
receipt of registration and product listing information required by section 607 of the FD&C Act. 
While electronic submission is not required, FDA strongly encourages electronic submissions to 
facilitate efficiency and timeliness of data submission and management for the agency. 
Registration and listing data are submitted electronically using structured product labeling 
(SPL)8 format.  Future updates to industry submissions are intended to be efficient to submit 
because information from a previous submission can be applied without re-entering all 
information. Technical assistance will be available for users by contacting a help desk for 
Cosmetics Direct. 
 
As an alternative, users may transmit SPL-formatted submissions through FDAs Electronic 
Submissions Gateway (ESG),9 or any SPL authoring software including Xforms.10 The FDA 
ESG system requires users to apply for a free account before submitting data, a process which 
can take one to three weeks. FDA therefore urges those who are planning to use the ESG to 
 
8 The Structured Product Labeling (SPL) is a document markup standard approved by Health Level Seven (HL7) 
and adopted by FDA as a mechanism for exchanging product and facility information. 
9 For more information on FDAs Electronic Submissions Gateway, please refer to the webpage at 
https://www.fda.gov/industry/electronic-submissions-gateway  
10 For more information on Xforms, please refer to the webpage at https://www.fda.gov/industry/structured-product-
labeling-resources/spl-xforms In addition, the technical details on using SPL for registration and listing are available 
in the FDAs SPL Implementation Guide available at https://www.fda.gov/media/84201/download. 
 
  10  Contains Nonbinding Recommendations 
 
 
apply for ESG accounts well in advance of the deadline for data submission. Technical 
assistance is available for users by contacting the ESG at ESGHelpDesk@fda.hhs.gov 
 
FDA developed paper forms (FDA Form 5066 and 5067) as another alternative submission tool. 
Both the Cosmetics Direct and the paper forms are accessible at 
https://www.fda.gov/cosmetics/registration-listing-cosmetic-product-facilities-and-products. 
 
F. When must you register and list under section 607 of the FD&C Act? 
 
1. Registration 
 
a.   Initial Registration 
Every person that, on December 29, 2022, owns or operates a facility that engages in the 
manufacturing or processing of a cosmetic product for distribution in the United States 
must register each facility no later than December 29, 2023 (section 607(a)(1)(A) of the 
FD&C Act).   
Every person that owns or operates a facility that first engages, after December 29, 2022, 
in manufacturing or processing of a cosmetic product for distribution in the United States, 
must register such facility within 60 days of first engaging in such activity or by February 
27, 2024, whichever is later (section 607(a)(1)(B) of the FD&C Act). 
Note: On November 8, 2023, FDA issued a guidance for industry titled Compliance 
Policy for Cosmetic Product Facility Registration and Cosmetic Product Listing. This 
guidance explains that FDA does not intend to enforce the requirements under section 
607 of the FD&C Act related to cosmetic product facility registration until July 1, 2024. 
b.  Amended Registration 
Every person who is required to register must update their registration within 60 days of 
any changes to the information required for registration (section 607(a)(4) of the FD&C 
Act) (an amended registration).  This includes any changes that result in cancellation of 
the registration. 
c.   Renewal of Registration 
Every person who is required to register a facility must renew such registration biennially 
(i.e., every two years) (section 607(a)(2) of the FD&C Act). 
FDA is providing for an abbreviated renewal of registrations when there have not been 
any updates to the registration since the most recent facility registration submission, as 
required under section 607(a)(4) of the FD&C Act. 
 
Note:  In the case of a contract manufacturer, a facility registration may be submitted by the 
contract manufacturer or any responsible person whose products are manufactured or processed 
at such facility (section 607(a)(3) of the FD&C Act).  Also, note that the renewal period and 
timeframe to submit updates for a cosmetics product facility registration may be different than 
for other FDA-regulated products for which the facility may also be required to register.  
 
  11  Contains Nonbinding Recommendations 
 
 
2. Product Listing 
a.  Initial Listing 
The responsible person of a cosmetic product that is marketed on December 29, 2022, 
must submit a cosmetic product listing, or ensure such submission is made, not later than 
December 29, 2023, or for a cosmetic product that is first marketed after December 29, 
2022, within 120 days of marketing such product in interstate commerce (section 
607(c)(2) of the FD&C Act).  Consistent with the approach for registration of a facility 
that starts manufacturing or processing cosmetic products after December 29, 2022 
(section 607(a)(1)(B) of the FD&C Act), FDA expects the product listing for a cosmetic 
product first marketed after December 29, 2022, to be submitted within 120 days of 
marketing the product, or within 120 days of December 29, 2023 (which is April 27, 
2024), whichever is later. 
Note: On November 8, 2023, FDA issued a guidance for industry titled Compliance 
Policy for Cosmetic Product Facility Registration and Cosmetic Product Listing. This 
guidance explains that FDA does not intend to enforce the requirements under section 
607 of the FD&C Act related to cosmetic product listing until July 1, 2024. 
 
b.  Update to Content and Renewal 
 
The responsible person must provide any updates to such listing annually (section 
607(c)(5) of the FD&C Act).  This includes an update that the product was discontinued. 
FDA is providing for an abbreviated process for the renewal of any cosmetic product 
listing, as required under section 607(c)(3), for which there has been no change since the 
responsible person submitted the previous listing. 
 
G. What if my product is both a drug and a cosmetic product?  Do have I 
have to comply with cosmetic product facility registration and cosmetic 
product listing requirements under section 607 of the FD&C Act?   
 
A cosmetic product that is also a drug is not subject to the listing requirements under section 607 
of the FD&C Act. Likewise, a facility that manufactures or processes cosmetic products that are 
also drugs is not subject to the registration requirement under section 607 unless it also 
manufactures or processes cosmetic products that are not also drugs (see section 613 of the 
FD&C Act). Cosmetic product facility registration and product listing are available using the 
same electronic submission process available to register an establishment and list a drug with 
FDA. This will help to streamline the process of submitting registration and listing information 
for cosmetics facilities and products for entities that also submit drug establishment and listing 
information. 
 
 
 
  12  Contains Nonbinding Recommendations 
 
 
H. Does FDA charge a fee to submit a registration or product listing under 
section 607 of the FD&C Act? 
 
No.  There is no fee to submit a registration or product listing to FDA under section 607 of the 
FD&C Act.   
  13  Contains Nonbinding Recommendations 
 
 
APPENDIX A 
  
Cosmetic Product Categories and Codes  
 
(01) Baby products.  
(a) Baby shampoos.  
(b) Lotions, oils, powders, and creams.  
(c) Baby wipes. 
(d) Other baby products. 
1.  Leave-on. 
2.  Rinse-off. 
(02) Bath preparations.  
(a) Bath oils, tablets, and salts.  
(b) Bubble baths.  
(c) Bath capsules.  
(d) Other bath preparations.  
(03) Eye makeup preparations (other than childrens eye makeup preparations). 
(a) Eyebrow pencils.  
(b) Eyeliners.  
(c) Eye shadows.  
(d) Eye lotions.  
(e) Eye makeup removers.  
(f) False eyelashes.  
(g) Mascaras.  
(h) Eyelash and eyebrow adhesives, glues, and sealants.   
(i) Eyelash and eyebrow preparations (primers, conditioners, serums, fortifiers). 
(j) Eyelash cleansers. 
(k) Other eye makeup preparations.  
(04) Childrens eye makeup preparations. 
(a) Childrens eyeshadows. 
(b) Other childrens eye makeup. 
(05) Fragrance preparations.  
(a) Colognes and toilet waters.  
(b) Perfumes.  
(c) Powders (dusting and talcum) (excluding aftershave talc).  
(d) Other fragrance preparations.  
(06) Hair preparations (non-coloring).  
(a) Hair conditioners. 
1.  Leave-on. 
2.  Rinse-off.   
(b) Hair sprays (aerosol fixatives).  
(c) Hair straighteners.  
(d) Permanent waves.  
(e) Rinses (non-coloring).  
(f) Shampoos (non-coloring). 
  14  Contains Nonbinding Recommendations 
 
 
1.  Leave-on. 
2.  Rinse-off.  
(g) Tonics, dressings, and other hair grooming aids.  
(h) Wave sets.  
(i) Other hair preparations. 
1.  Leave-on. 
2.  Rinse-off. 
(07) Hair coloring preparations.  
(a) Hair dyes and colors (all types requiring caution statement and patch test).  
(b) Hair tints.  
(c) Hair rinses (coloring). 
1.  Leave-on. 
2.  Rinse-off. 
(d) Hair shampoos (coloring).  
1.  Leave-on. 
2.  Rinse-off. 
(e) Hair color sprays (aerosol).  
(f) Hair lighteners with color.  
(g) Hair bleaches.  
(h) Eyelash and eyebrow dyes. 
(i) Other hair coloring preparations.  
1.  Leave-on. 
2.  Rinse-off. 
(08) Makeup preparations (not eye)(other than makeup preparations for children). 
(a) Blushers and rouges (all types).  
(b) Face powders.  
(c) Foundations. 
1.  Traditional applications. 
2.  Airbrush applications. 
(d) Leg and body paints.  
1.  Traditional applications. 
2.  Airbrush applications. 
(e) Lipsticks and lip glosses. 
(f) Makeup bases.  
1.  Traditional applications. 
2.  Airbrush applications. 
(g) Makeup fixatives.  
(h) Other makeup preparations.  
1.  Traditional applications. 
2.  Airbrush applications. 
(09) Makeup preparations for children (not eye).  
(a) Childrens blushers and rouges (all types).  
(b) Childrens face paints. 
(c) Childrens face powders.  
(d) Childrens foundations. 
(e) Childrens lipsticks and lip glosses. 
  15  Contains Nonbinding Recommendations 
 
 
(f) Childrens color hairsprays. 
(g) Other childrens makeup. 
(10) Manicuring preparations.  
(a) Basecoats and undercoats.  
(b) Cuticle softeners.  
(c) Nail creams and lotions.  
(d) Nail extenders.  
(e) Nail polishes and enamels.  
(f) Nail polish and enamel removers.  
(g) Other manicuring preparations.  
(11) Oral products.  
(a) Dentifrices (aerosols, liquids, pastes, and powders).  
(b) Mouthwashes and breath fresheners (liquids and sprays).  
(c) Other oral products.  
(12) Personal cleanliness.  
(a) Bath soaps and body washes.  
(b) Deodorants (underarm). 
1.  Sticks, roll-ons, gels, creams, and wipes.  
2.  Sprays.  
(c) Douches.  
(d) Feminine deodorants.  
1.  Leave-on. 
2.  Rinse-off.  
(e) Disposable wipes. 
(f) Other personal cleanliness products. 
1.  Leave-on. 
2.  Rinse-off.  
(13) Shaving preparations.  
(a) Aftershave lotions.  
(b) Beard softeners.  
(c) Men's talcum.  
(d) Pre-shave lotions (all types).  
(e) Shaving creams (aerosol, brushless, and lather).  
(f) Shaving soaps (cakes, sticks, etc.).  
(g) Other shaving preparation products.  
(14) Skin care preparations, (creams, lotions, powder, and sprays).  
(a) Cleansing (cold creams, cleansing lotions, liquids, and pads).  
(b) Depilatories.  
(c) Face and neck (excluding shaving preparations). 
1.  Leave-on. 
2.  Rinse-off.  
(d) Body and hand (excluding shaving preparations). 
1.  Leave-on. 
2.  Rinse-off.  
(e) Foot powders and sprays.  
(f) Moisturizing.  
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(g) Night.  
(h) Paste masks (mud packs).  
(i) Skin fresheners.  
(j) Other skin care preparations. 
1.  Leave-on. 
2.  Rinse-off.  
(15) Suntan preparations.  
(a) Suntan gels, creams, and liquids.  
(b) Indoor tanning preparations. 
1.  Traditional applications (creams, lotions, etc.). 
2.  Airbrush applications. 
3.  Spray applications. 
4.  Professional airbrush tanning applications. 
5.  Professional spray tanning applications. 
(c) Other suntan preparations. 
(16) Tattoo preparations.  
(a) Permanent tattoo inks.  
(b) Temporary tattoo inks. 
(c) Other tattoo preparations. 
(17) Other preparations (i.e., those preparations that do not fit another category). 
   
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    APPENDIX B11 
 
Frequently Asked Questions and Answers 
 
 
Q1. Do owners and operators of facilities that only manufacture or process cosmetic 
ingredients need to register their facilities?  Does a responsible person need to submit a 
product listing for cosmetic ingredients?  
 
A.  No, at this time, FDA only expects non-exempt facilities to register if they manufacture or 
process the final formulation of cosmetic ingredients (including a final formulation that 
includes a single ingredient).  This includes final formulations that have not yet been 
packaged.  FDA only expects non-exempt responsible persons to list cosmetic products that 
are marketed for users (e.g., consumers or professional use).   
 
Q2. Can a consultant be a responsible person under section 607 of the FD&C Act? 
A.  A consultant can only be a responsible person if they meet the definition of responsible 
person in section 604(4) of the FD&C Act. A 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. 
 
Q3. Can a company located outside of the U.S. be the responsible person?  
A.  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. A company located outside of the U.S. could be a 
responsible person so long as they are the manufacturer, packer, or distributor of the 
cosmetic product.  However, we note that, under section 609(a) of the FD&C Act, each 
cosmetic product shall bear a label that includes a domestic address, domestic phone number, 
or electronic contact information, which may be a website, through which the responsible 
person can receive adverse event reports with respect to such cosmetic product.  We 
recommend that firms consider when selecting electronic contact information, such as an 
email address or a website (whether foreign or domestic), how they can best respond to these 
reports and meet maintenance, inspection, and reporting requirements under section 605 of 
the FD&C Act. 
Q4. Is the brand name the same as the product name?  
A. No. FDA does not consider the brand name and product name to be the same.  
 
11 This section of the guidance, Appendix B (designated with a shaded background), is being distributed for 
comment purposes only. 
  18  Contains Nonbinding Recommendations 
 
 
The product name is generally considered the statement of identity, as required under 21 CFR 
701.11. The statement of identity provides information about the type or kind of cosmetic 
product in the package to help the consumer understand the functional use of the product.   
The brand name is the distinguishing name used by a company to identify a commercial product 
on the product label.  The brand name may be proprietary and/or registered as a trademark. 
Q5. What are examples of products whose manufacture does not qualify the responsible 
person or facility for the small business exemptions under section 612 of the FD&C 
Act?  
 
A. Section 612 of the FD&C Act provides exemptions to certain small businesses from the 
requirements of sections 606 (Good Manufacturing Practice) and 607 (Registration and 
Product Listing). However, such exemptions from the requirements of sections 606 and 607 
of the FD&C Act do not apply to any responsible person or facility engaged in the 
manufacturing or processing of any of the following products listed in section 612(b) of the 
FD&C Act: 
 
(1) Cosmetic products that regularly come into contact with mucus membrane of the eye under 
conditions of use that are customary or usual.  
 
(2) Cosmetic products that are injected.  
 
(3) Cosmetic products that are intended for internal use.  
 
(4) Cosmetic products that are intended to alter appearance for more than 24 hours under 
conditions of use that are customary or usual and removal by the consumer is not part of such 
conditions of use that are customary or usual. 
 
Q6. What are examples of products that regularly come into contact with the mucus 
membrane of the eye? 
 
A. While there may be certain exceptions, an eye makeup remover, a liquid or mucosal eyeliner, 
or a false eyelash adhesive may regularly come into contact with the mucous membrane of 
the eye under conditions of use that are customary or usual, such that they would not qualify 
the small business exemption (see section 612(b)(1) of the FD&C Act).  However, facial 
cleaners, moisturizers, and serums generally would not be expected to regularly come into 
contact with the mucous membrane of the eye under conditions of use that are customary or 
usual. 
 
Q7. What are examples of products that are intended to alter appearance for more than 24 
hours? 
  
A.  Examples of cosmetic products that are intended to alter the appearance for more than 24 
hours and removal by the consumer is not part of such conditions of use that are customary 
or usual, as described in section 612(b)(4) of the FD&C Act, may include certain nail 
polishes, some hair products, some eyebrow dyes, and certain leave-on skin preparations.  To 
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determine if a product falls under section 612(b)(4) of the FD&C Act one should consider 
product labeling, including directions for use, as well as the uses of the product that are not 
indicated in the labeling but are customary or usual.   
 
Q8. If a facility engages in the manufacturing or processing of cosmetic products listed in 
section 612(b) of the FD&C Act, does the facility need to include information required 
under section 607(b)(2)(D) and (E) for only the cosmetic products listed in section 612(b), 
or for all of the cosmetic products manufactured or processed by the facility?  
 
A.  The exemptions in section 612 of the FD&C Act apply to responsible persons and owners 
and operators of facilities that meet the definition of a small business in section 612(a).  
Thus, a facility is required to include information required under section 607(b)(2)(D) and 
(E) for all of the cosmetic products manufactured or processed by the facility if a facility 
manufactures or processes any of the following cosmetic products:  
 
(1) Cosmetic products that regularly come into contact with mucus membrane of the eye under 
conditions of use that are customary or usual.  
 
(2) Cosmetic products that are injected.  
 
(3) Cosmetic products that are intended for internal use.  
 
(4) Cosmetic products that are intended to alter appearance for more than 24 hours under 
conditions of use that are customary or usual and removal by the consumer is not part of such 
conditions of use that are customary or usual. 
 
 
Q9. Where can I submit documentation that my business meets the small business 
exemption in order to receive an exemption certificate from FDA? 
 
A.  FDA is not generally asking companies to submit this information nor does FDA provide 
small business exemption certificates for cosmetic product facilities or responsible persons.   
 
Q10. Does an importer need to register and/or list under 607 of the FD&C Act? 
 
A.  If an importer meets the definition of a facility and/or a responsible person in section 604 of 
the FD&C Act, and does not meet any exemption, then they must comply with any 
applicable registration or listing requirements.  Otherwise, the importer is not required to 
register or list. 
 Q11. Does a laboratory that only performs testing on cosmetic products used for research 
and development need to register? 
A.  No. If a laboratory tests cosmetic products that are solely for use in research, development, or 
evaluation, and that are not offered for retail sale, it does not need to register because it is an 
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establishment that is not included in the definition of facility in section III.B. above (see 
section 604(3)(B)(vii) of the FD&C Act).  
Q12. Does a laboratory that performs cosmetic product batch release testing need to 
register? 
A. Yes. Cosmetic product batch release testing is part of manufacturing and processing. 
Laboratories conducting this testing are considered facilities subject to the registration 
requirements. 
 
Q13. My company owns 2 buildings with 2 addresses, and 1 of the buildings is for storage 
only. Do we need to register the building used only for storage?  
 
A.  No. An establishment that solely performs storage (holding) with respect to cosmetic 
products is not required to register under section 607 of the FD&C Act.  
 
Q14. If a contract manufacturer of cosmetic products is located outside of the United States 
are they required to be registered with the FDA under section 607 of the FD&C Act? Is 
there an exemption from registration if the contract manufacturer follows ISO22716?  
 
A.  If a contract manufacturer manufactures or processes cosmetic product(s) distributed in the 
United States, then the contract manufacturing facility must be registered with the FDA, even 
if the contract manufacturer is located outside of the United States.  More information, 
including on exemptions, are described in section III above. There is not an exemption from 
registration for following ISO22716.   
 
Q15. Do hair coloring preparations (including hair dyes) need to be listed? 
A.  Yes. Hair coloring preparations, including hair dyes, are cosmetic products and therefore 
need to be listed, unless an exemption applies.   
 
Q16. Do hairbrushes and wigs need to be listed? 
  
A. No. We do not expect hairbrushes and wigs to be listed.  
 
Q17. My cosmetic products dont fit into any of the product categories provided in 
Appendix A.  Therefore, what product category and code should be used?    
 
A.  We recommend that you select the product category and code in Appendix A (above) that 
match most closely and use the other category and code if another category and code does 
not appear to fit. Keep in mind that products intended for use in the eye area should be 
entered into an eye area product category.  
 
      FDA intends to periodically update the product categories and codes.  Any proposed update 
to the product categories and codes FDA intends to publish as draft guidance on our website, 
with a notice in the Federal Register announcing that the draft guidance document is 
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available. After providing an opportunity for public comment on the draft guidance, FDA 
will: 
 
(A) Review any comments received and prepare the final version of the guidance document that 
incorporates suggested changes, when appropriate; 
 
(B) Publish a notice in the Federal Register announcing that the guidance document is 
available; 
 
 
(C) Post the guidance document on the Internet and make it available in hard copy; and 
 
(D) Implement the guidance document. 
 
Q18.  What is the receipt date for registrations and listings submitted via paper form? 
 
A.  When FDA receives a paper submission, the submission is assigned a receipt date. The 
receipt date for a paper submission is the date on which the submission is deemed to have 
arrived at FDA. A paper submission is deemed to have arrived at FDA on the date on which 
it arrived physically at the appropriate receiving unit, while open for business, for the FDA 
unit that will review the submission. If paper registration and listing forms are mailed, we 
recommend using a method that includes tracking. 
 
      FDA encourages electronic submission of registration and listing for cosmetic product 
facilities and products.  
 
Q19. The cosmetic establishment registration is to be renewed biennially. Does this mean 
the biennial renewal has to be done every two years from the date of initial 
registration? 
 
A.  Yes, a cosmetic product facility needs to renew its registration every two years from the date 
of initial registration. 
 
 
 
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