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The Office of Cosmetics and Colors has developed an on-line registration system, intended to make it easier to participate in the VCRP. You may still use paper forms, following these instructions. However, we currently are experiencing significant delays processing paper VCRP forms in a timely manner because of resource constraints. We strongly encourage you to participate in the VCRP using the online program. Thank you.
Welcome to the Voluntary Cosmetic Registration Program. These instructions are designed to guide you step by step through the registration process. Please read the instructions - both the introduction and the instructions for each individual form - completely before you attempt to fill out these forms.
Forms are available online in fillable PDF and MS Word format: (Help for PDFs and MS Word Document viewers)
To receive forms and instructions by mail, you may contact OCAC at (301) 436-1130. You also may fax a request for forms and instructions to OCAC at (301) 436-2980, or mail your request to:
Voluntary Cosmetics Registration Program
HFS-125
Office of Cosmetics and Colors
Center for Food Safety and Applied Nutrition
Food and Drug Administration
5100 Paint Branch Parkway
College Park, MD 20740-3835
You also may request forms from your nearest FDA district office.
Please read the instructions - both these introductory notes and the instructions for each individual form - completely before you attempt to fill out these forms.
This introduction provides general information on using the following forms:
Forms FDA 2512 and 2512a - Cosmetic Product Ingredient Statement (CPIS), and
Form FDA 2514 - Discontinuance of Commercial Distribution of Cosmetic Product
Forms FDA 2512 and 2512a go together. Use Form FDA 2512 for listing your brand names. Use Form FDA 2512a for listing specific ingredients.
Use Form FDA 2514 to notify FDA that you are discontinuing a formulation.
(You also may use the VCRP to register your establishment using Form FDA 2511. Instructions for filing Form FDA 2511 appear on the back of preprinted forms and accompany forms downloaded from the FDA Web site.)
Any firm, whether domestic or foreign, that manufactures or distributes cosmetics in the United States may file Forms FDA 2512 and 2512a. Additionally, a private labeler or packer of a cosmetic may file these forms.
You should file these forms within 60 days from the date of commercial distribution of the cosmetic product in the United States.
Any firm, once having filed a CPIS form, is responsible for maintaining an accurate filing with FDA for that product.
Please notify FDA of changes in a brand name or ingredients within 60 days from an amended product's commercial distribution. Please submit other amendments within one year.
A firm, once having filed a CPIS form, should notify FDA when the cosmetic formulation is no longer in commercial distribution.
You should notify FDA within 180 days after a product has been removed from commercial distribution.
You may obtain printed forms from your nearest FDA District Office or by contacting the Office of Cosmetics and Colors at (301) 436-1257. You also may download forms from the FDA Web site.
Information voluntarily disclosed to FDA is available to the public unless:
If you consider the identity of an ingredient confidential, you must follow these steps:
If you do not request confidentiality, the information becomes the property of FDA. For complete information on confidentiality of registration information, please refer to Title 21 of the Code of Federal Regulations, Part 720.8 (21 CFR 720.8).
After receiving and accepting CPIS Forms FDA 2512 and 2512a for a product, FDA will assign the product a CPIS number. CPIS numbers are intended only for use in the VCRP. Assignment of a CPIS number does not in any way denote FDA approval of the firm or its product. Any representation in labeling, advertising, or trade literature that creates an impression of such official approval is considered misleading (21 CFR 720.9).
Type entries in CAPITAL LETTERS, starting at the extreme left of each space provided.
Use standard abbreviations whenever possible.
Omit all punctuation except in chemical names.
FDA does not expect the typing of forms to be perfect. You will note that several of the "Sample Submissions" contain "typing errors" that have simply been "XXXXed" or "----- ed" out. We have tried to leave room in each block for typing errors to be crossed out and retyped. If you find there is no room in a brand name block or ingredient block for the information to be corrected, "XXXX" out the block and use the next available block. Pen corrections are also acceptable if they are legible.
Sign and date the completed forms. FDA cannot accept unsigned forms and will return them unprocessed.
If your are using preprinted forms mailed to you by FDA, remove the REGISTRANT'S COPY from each completed form and retain it for your records. Do not separate the remaining two parts. If you have printed forms from FDA's Web site, make two copies of each completed form. Keep one copy for your records. Mail the original and one copy to FDA.
Staple together Form FDA 2512 and one or more Forms FDA 2512a pertaining to the same CPIS; attach, where appropriate, the supporting statement for confidentiality; and send them to:
Voluntary Cosmetics Registration Program
HFS-125
Food and Drug Administration
5100 Paint Branch Parkway
College Park, MD 20740-3835
FDA will acknowledge its receipt and acceptance of the forms you have filed by returning the OFFICIAL RECEIPT to you after FDA personnel have finished reviewing them. The OFFICIAL RECEIPT is located at the bottom of Form 2512. If you print forms from FDA's Web site, the receipt will print out as a page of Form 2512.
If your submission is complete, FDA will return the OFFICIAL RECEIPT to you marked COMPLETE, listing the Cosmetic Product Ingredient Statement Number (CPIS NO.) assigned to the submission.
If your submission is incomplete, FDA will return the forms to you, along with a request for the additional information needed to complete the submission. After FDA receives the requested information, FDA will send you the OFFICIAL RECEIPT marked COMPLETE, listing the CPIS NO.
Check the box marked "ORIGINAL" in the upper right corner if you are using the form for an original submission of a cosmetic product formulation.
Enter the firm name exactly as it appears on the label of the cosmetic formulation being filed.
Indicate whether the firm listed in Block 01 manufactures, packages, and/or distributes the cosmetic product formulation. Please check all that apply.
Please provide the complete mailing address of the firm listed in Block 01, including the street address and number, city, state, and domestic or foreign zip codes, as well as province/country for locations outside of the U.S. Post Office boxes are acceptable.
If the cosmetic product formulation being submitted is not manufactured by the firm listed in Block 01, you may list the name of the Private Label Manufacturer in Block 11.
If the cosmetic product formulation is being submitted by the Private Label Manufacturer for the firm listed in Block 01, you must enter the filing Private Label Manufacturer in Block 11.
If the firm listed in Block 11 is owned by another firm, please provide the name of this parent company.
Please provide the complete mailing address of the firm listed in Block 11, including the street address and number, city, state, and domestic or foreign zip code, as well as province/country for locations outside of the U.S. Post Office boxes are acceptable.
NOTE: When you are filing two or more original submissions at the same time for the firm listed in Block 01, you need complete Blocks 03, 04, 12, and 13 on the first submission only. If you file more submissions in the future, follow the same procedure, completing these blocks for the first of any multiple submissions that you file at the same time.
If the submission is being filed by the company listed in Block 01, enter "0 1 " in the two spaces provided. If the submission is being filed by the company listed in Block 11, enter "1 1" in the two spaces provided.
Select a single Product Category Code that most closely identifies the intended purpose or function of the cosmetic product formulation.
List the brand name(s) of the cosmetic product(s) sharing this cosmetic product formulation as they appear on the product label.
Brand names submitted on the same Form FDA 2512 must belong to the company listed in Block 01, have the same Product Category Code, and have the same formulation.
Shaded cosmetics -- meaning a line of products differing only in color additive composition, and whose Product Category Codes begin with "03," "07" or "08" -- may be filed as "(ALL SHADES)" rather than listing each shade separately.
However, each shade of a line of hair colors (Product Category Codes beginning with "06") must be filed on separate submissions.
If you are listing more than eight brand names, use a second Form FDA 2512.
Leave this block blank on original submissions.
Leave this block blank on original submissions.
State the name and title of the person authorized by the filer to disclose the information to FDA.
Provide the telephone number, including the area code and any extension, of the authorized individual named in Block 19.
The authorized individual must sign and date Form FDA 2512. FDA cannot accept an unsigned submission.
Page ____ of ____ pages
Leave this item blank until all pages of your submission are ready to number.
FDA will use the Official Receipt, located at the bottom of Form FDA 2512, to notify you that we have received your VCRP submission. If you print forms from FDA's Web site, the receipt will print out as a page of Form 2512.
Prepare the Official Receipt as follows:
BRAND NAME OF COSMETIC PRODUCT
Enter the brand name of the cosmetic product you are filing. If you are filing more than one cosmetic product, enter the first product brand name listed on Form FDA 2512.
TYPE OF SUBMISSION
Check the box marked "ORIGINAL" in the upper right corner of Form FDA 2512a if you are using this form for the original submission of a cosmetic product formulation.
The preferred listing in Block 1 is the COMMON or USUAL name for the ingredient. If none is available, list the CHEMICAL name. If a common, usual, or chemical name is not listed in any of the Sources for Cosmetic Ingredient Nomenclature, list the TRADE NAME of the material in Block 7 and the name of the supplier in Block 8.
If an ingredient is a reaction product of two or more chemicals, list either the reaction product as a single ingredient, if you know it, or the reacting chemicals. For example:
You may either list "SODIUM STEARATE," or list "SODIUM HYDROXIDE" and "STEARIC ACID" as separate ingredients.
If an ingredient is a fragrance or flavor compound, list the compound as the common name "FRAGRANCE" or "FLAVOR."
If you are listing more than ten ingredients, use a second Form FDA 2512a.
If necessary, check the Sources for Cosmetic Ingredient Nomenclature to locate sources for names of cosmetic ingredients.
If you know the Chemical Abstract Service Number (CAS No.) or Recognized Disclosure Number (FDA-assigned RD No.), you may list it here. If you do not know the number, please check the list of CAS and RD Numbers for Most Frequently Used Cosmetic Ingredients.
If you cannot find the CAS No. or RD No. for the ingredient, you may leave this block blank.
List all numbers as 9-digit numbers. For example:
List 99-76-3 as 000099763.
Also list 99763 as 000099763.
Leave this block blank on original submissions.
Leave this block blank on original submissions.
If you consider the identity of an ingredient confidential, place an "X" in Block 05 and attach to the submission, in triplicate, a statement of the factual and legal grounds supporting the request for confidentiality. Title 21 CFR, Part 720.8 (21 CFR 720.8), Confidentiality of Statements, discusses how to prepare a Request for Confidentiality.
Information voluntarily disclosed to FDA is available to the public unless:
If the ingredient is a base formulation and has been assigned a Base CPIS number, enter the number here. Base CPIS submissions are covered in Section E, How to File Base Formulations on Forms FDA 2512 and 2512a.
If the common, usual, or chemical name in Block 1 is not listed in any of the accepted Sources for Cosmetic Ingredient Nomenclature, list the trade name as additional information.
If the ingredient is a base formulation and has been assigned a Base CPIS number, enter the base name as it appears on its Form FDA 2512 submission. Base CPIS submissions are covered in Section E, How to File Base Formulations on Forms FDA 2512 and 2512a.
When you list a Base Name or Trade Name in Block 7, you must enter in Block 8 the name of the company supplying the ingredient.
Place your submission in order, with Form FDA 2512 placed before Form FDA 2512a. If you have used a second Form FDA 2512 or Form FDA 2512a, the second form should follow the first of the same type.
Count the total number of forms in the submission and complete the page numbering sequence at the bottom right of each form. The first page will be "Page 1 of X Pages" where X is the total number of forms in the submission. The next page will be "Page 2 of X pages," and so on.
Remove the back page, REGISTRANT'S COPY, and keep it for your files. DO NOT separate the MASTER FILE COPY from the DATA PROCESSING COPY. If you have printed copies of forms posted on the Web, make two copies of each page you have filled out. Keep one copy for your own records. Mail the original and one copy to FDA.
Staple the entire submission together in page order. DO NOT use paper clips because the forms can become separated in the mail and will be returned unprocessed.
Once more make sure that the submission is signed and dated. FDA cannot accept an unsigned submission.
These instructions will guide you step by step through Forms FDA 2512 and 2512a to amend a Cosmetic Product Ingredient Statement (CPIS) submission.
If you are amending information found only on Form FDA 2512, you need only submit a Form FDA 2512. If you need to amend ingredient information, you must submit Forms FDA 2512 and 2512a.
Check the box marked "AMENDED" in the upper right corner if you are amending a CPIS.
Enter the 7-digit CPIS number and Filing Date as found on the Official Receipt that you received as acknowledgment of filing your original submission.
Enter the firm name exactly as it appears on the label of the cosmetic formulation being filed.
Leave this item blank unless you are amending this information.
If you are amending this information, indicate whether the firm listed in Block 01 manufactures, packages, and/or distributes the cosmetic product formulation. Please check all items that apply.
Leave this item blank unless you are amending this information.
If you are amending this information, please provide the name of the parent company if the firm listed in Block 01 is owned by another firm.
Leave this item blank unless you are amending this information.
If you are amending this information, please provide the complete mailing address of the firm listed in Block 01, including the street address and number, city, state, and domestic or foreign zip codes, as well as province/country for locations outside of the U.S. Post Office boxes are acceptable.
If the cosmetic product formulation being submitted is not manufactured by the firm listed in Block 01, you may list the private label manufacturer's name in Block 11.
If the cosmetic product formulation is being submitted by the private label manufacturer for the firm listed in Block 01, you must list the private label manufacturer in Block 11.
Leave this item blank unless you are amending this information.
If you are amending this information, please provide the name of the parent company if the firm listed in Block 11 is owned by another firm.
Leave this item blank unless you are amending this information.
If you are amending this information, please provide the complete mailing address of the firm listed in Block 11, including the street address and number, city, state, domestic or foreign zip codes, and province/country for locations outside of the U.S. Post Office boxes are acceptable.
If the submission is being filed by the company listed in Block 01, enter "01" in the two spaces provided. If the submission is being filed by the company listed in Block 11, enter "11" in the two spaces provided.
Leave this item blank unless you are amending this information.
If you are amending this information, select a single Product Category Code that most closely identifies the intended purpose or function of the cosmetic product formulation.
Use Block 16 to identify brand names and Blocks 17 and 18 to note how and when brand names have changed.
If you are not amending brand names:
Please read the following general instructions before amending, deleting, or adding brand names:
Changing brand names:
Deleting brand names:
NOTE: Do not confuse deleting a brand name with discontinuing a product formulation. You may file an amended Form FDA 2512 to delete one or more brand names from a product formulation on file with FDA. If the formulation is no longer in commercial distribution, file a Form FDA 2514 - Discontinuance of Commercial Distribution of Cosmetic Product, not an amendment deleting the product brand name.
Adding brand names:
State the name and title of the person authorized by the filer to disclose the information to FDA.
Provide the telephone number, including the area code and any extension, of the authorized individual.
The authorized individual must sign and date Form FDA 2512. FDA cannot accept an unsigned submission.
Page ____ of ____ pages
Leave this item blank until the complete submission is ready to number.
Prepare the Official Receipt as follows:
BRAND NAME OF COSMETIC PRODUCT
Enter the brand name of the cosmetic product that you are changing, deleting, or adding to your cosmetic filing. If you are filing more than one cosmetic product, enter the first product brand name listed on Form FDA 2512. If you are not amending brand names, enter the brand name listed on the Official Receipt submitted with the original submission.
Use Form FDA 2512a to file amendments to ingredients. If you are NOT amending ingredients, you do not need to file a Form FDA 2512a.
TYPE OF SUBMISSION:
Check the box marked "AMENDED" in the upper right corner.
FDA CPIS NO. and FILING DATE: Enter the same 7-digit CPIS number and filing date as entered on Form FDA 2512.
Deleting Ingredients
Adding Ingredients
DO NOT list the entire formulation as filed originally. Instead, starting in the first available INGRED NO., list the ingredient(s) to be added to the formulation, as follows:
The preferred listing in Block 1 is the common or usual name for the ingredient. If none is available, you may list the chemical name. If a common, usual, or chemical name is not available, you may enter the TRADE NAME of the material in Block 7.
If necessary, check Sources for Cosmetic Ingredient Nomenclature for names of cosmetic ingredients.
If an ingredient is a reaction product of two or more chemicals, either list the reaction product as a single ingredient, if known, or list the reacting chemicals. Example: You may either list "SODIUM STEARATE," or list "SODIUM HYDROXIDE" and "STEARIC ACID" as separate ingredients.
If an ingredient is an undisclosed proprietary fragrance or flavor compound, purchased from an outside supplier, list the compound as the common name "FRAGRANCE" or "FLAVOR."
If you are listing more than ten ingredients, use a second Form FDA 2512a.
If you know the Chemical Abstract Service Number (CAS No.) or Recognized Disclosure Number (FDA-assigned RD No.), you may list it here. If you do not know the number, please check the list of CAS and RD Numbers for Most Frequently Used Cosmetic Ingredients.
If you cannot find the CAS No., you may leave the item blank.
List all CAS Numbers as 9-digit numbers.
For example:
List 99-76-3 as 000099763.
Also list 99763 as 000099763.
Enter "ADD".
Enter the date when the ingredient was added to the formulation.
If your firm considers the identity of an ingredient confidential, place an "X" in Block 05 and attach to the submission, in triplicate, a statement of the factual and legal grounds supporting the request for confidentiality. Title 21 CFR, Part 720.8 (CFR 21 720.8), Confidentiality of Statements, discusses preparation of a Request for Confidentiality.
Information voluntarily disclosed to FDA is available to the public unless:
If the ingredient is a base formulation and has been assigned a Base CPIS number, enter the number here. Base CPIS submissions are covered in Section E, How to File Base Formulations on Forms FDA 2512 and 2512A.
If the common, usual, or chemical name entered in Block 1 is not listed in any of the accepted Sources for Ingredient Nomenclature, you may list the trade name as additional information.
If the ingredient is a base formulation and has been assigned a Base CPIS number, enter the base name as it appears on its Form FDA 2512 submission. Base CPIS submissions are covered in Section E, How to File Base Formulations on Forms FDA 2512 and 2512a.
When a Base Name or Trade Name is provided in Block 7, enter the name of the company supplying the ingredient.
Place the submission in order, with Form FDA 2512 placed before Form FDA 2512a. If you have used a second Form FDA 2512 or Form FDA 2512a, the second form should follow the first of the same type.
Count the total number of forms in the submission and complete the page numbering sequence at the bottom right of each form. The first page will be "Page 1 of X Pages" where X is the total number of forms in the submission. The next page will be Page 2, and so on.
If you are using preprinted forms mailed to you by FDA, remove the back page, REGISTRANT'S COPY, and keep it for your files. DO NOT separate the MASTER FILE COPY from the DATA PROCESSING COPY. If you are using forms printed from FDA's Web page, make two copies of each completed form. Keep one copy for your records. Mail the original and one copy to FDA.
Staple the entire submission together in page order. DO NOT use paper clips, because the forms can become separated in the mail and will be returned unprocessed.
Once more make sure that the submission is signed and dated. FDA cannot accept an unsigned submission.
NOTE: Submission of Form FDA 2514 will discontinue an entire Cosmetic Product Ingredient Statement (CPIS). All Brand Names reported under this CPIS Number will be discontinued. If more than one cosmetic product has been filed under the CPIS and you wish to delete one or more of the Brand Names, but not all of them, file an amended Form FDA 2512 deleting those cosmetic products that are no longer manufactured.
Enter the 7-digit CPIS number as found on the Official Receipt that you received as acknowledgment of filing your original submission.
Enter the Filing Date as found on the Official Receipt that you received as acknowledgment of filing your original submission.
Enter the date when the formulation was removed from commercial distribution.
Enter the firm name exactly as it appeared on the label of the cosmetic formulation being discontinued.
List any Brand Name of a Cosmetic Product sharing the cosmetic product formulation, as it appeared when filed, to verify that the proper filing is being discontinued.
Any comments concerning the discontinuance may be stated in Block 6.
State the name and title of the person authorized by the filer to disclose the information to FDA. Provide the telephone number, including the area code and any extension, of the authorized individual.
The authorized individual must sign and date Form FDA 2514. FDA can not accept an unsigned submission.
If you are using preprinted forms mailed to you by FDA, remove the back page, REGISTRANT'S COPY, and keep it for your files. DO NOT separate the MASTER FILE COPY from the DATA PROCESSING COPY. If you have printed your form FDA 2514 from FDA's Web site, make two copies of each completed form. Keep one copy for your records. Mail the original and one copy to FDA. FDA will not send an Official Receipt or acknowledgment for submission of a discontinuance.
Once more make sure that the submission is signed and dated. FDA cannot accept an unsigned submission.
There are three other ways to discontinue a listing in the VCRP:
TYPE OF SUBMISSION: Check the box marked "DISC" in the upper right corner of Form FDA 2512 to discontinue a submission of a cosmetic product formulation.
FDA CPIS NO.
Enter the 7-digit CPIS number as found on the Official Receipt that you received as acknowledgment of filing your original submission.
FILING DATE
Enter the Filing Date as found on the Official Receipt received as acknowledgment of filing your original submission.
1. NAME OF MANUFACTURER/PACKER/DISTRIBUTOR (On Label)
Enter the firm name exactly as it appeared on the label of the cosmetic formulation being discontinued.
16. BRAND NAME OF COSMETIC PRODUCT
List in the space for BRAND NO. 01 any Brand Name of a Cosmetic Product sharing the cosmetic product formulation, as it appeared when filed, to verify that the proper filing is being discontinued.
Enter in the space for BRAND NO. 02, "AND ALL OTHER PRODUCTS LISTED UNDER THIS CPIS NUMBER".
17. TYPE OF ACTION
Enter "DISC".
18. DATE OF ACTION
Enter date formulation was removed from commercial distribution.
19. TYPE NAME AND TITLE OF AUTHORIZED INDIVIDUAL
State the name and title of the person authorized by the filer to disclose the information to FDA.
20. TELEPHONE NO.
Provide the authorized individual's telephone number, including the area code and any extension.
21. SIGNATURE AND DATE
The authorized individual must sign and date Form FDA 2514. FDA cannot accept an unsigned submission.
A base formulation is a partial or complete cosmetic formulation shared by two or more cosmetic products manufactured by a private label manufacturer. Private label manufacturers may greatly facilitate the filing of cosmetic products for their clients by filing their base formulations using Forms FDA 2512 and 2512a. The private label manufacturers then list a base formulation as a single ingredient when filing cosmetic product formulations for their clients.
Base formulations are used to facilitate multiple filings by private label manufacturers and will not be accepted by FDA unless accompanied by three or more cosmetic product ingredient statement submissions using them.
A base formulation is prepared and filed in exactly the same manner as any other cosmetic filing except the following four items:
A. TYPE OF SUBMISSION:
Check the boxes marked "Original" and "Base" in the upper right corner on Form FDA 2512.
B. 01. NAME OF MANUFACTURER/PACKER/DISTRIBUTOR (On Label)
Enter the private label manufacturer's firm name.
C. 15. PRODUCT CATEGORY CODE
Select the Product Category Code that most closely identifies the intended purpose or function of the cosmetic product formulation that the base formulation will be used in.
D. 16. BRAND NAME OF COSMETIC PRODUCT
List in the space for Brand No. 01 the base formulation name chosen by the Private Label Manufacturer for this base formulation. You may list only one base formulation on a base formulation submission.
Form FDA 2512
Prepare and file the Form FDA 2512 in exactly the same manner as any other cosmetic filing.
Form FDA 2512a
Because the base formulation comprises most or all of the ingredients of the finished cosmetic product being filed, it should be entered in INGRED NO. 01.
6. BASE CPIS NO.
When you are filing the first three or more cosmetic product formulations with the original base formulation, leave the BASE CPIS NO. blank since the number has yet to be assigned. Use a heavy clip or rubber band to secure the cosmetic product formulations to the base formulation.
With later cosmetic product formulations enter the 7-digit CPIS number as found on the Official Receipt that you received as acknowledgment of your base formulation filing.
7. BASE NAME
Enter the base formulation name as filed.
8. COMPANY NAME
Enter the name of private label manufacturer.
If there are any other ingredients that have been added to the base formulation that are unique to the product, such as color, fragrance, or flavor they should be listed starting in INGRED NO. 02.
Use this list to determine the Product Category Code that you enter in Block 15 of Form FDA 2512. Each Product Category Code consists of a two-digit number, which indicates the general category, and a letter, which indicates the specific type of product. For example, to find the Product Category Code for a baby shampoo, note that "Baby Products" are category "01." Baby shampoos are listed in this category as item "A." Therefore, the Product Category Code for a baby shampoo is "01A."
01. Baby Products
02. Bath Preparations
03. Eye Makeup Preparations
04. Fragrance Preparations
05. Hair Preparations (non-coloring)
06. Hair Coloring Preparations
07. Makeup Preparations (not eye)
08. Manicuring Preparations
09. Oral Hygiene Products
10. Personal Cleanliness
11. Shaving Preparations
12. Skin Care Preparations (Creams, Lotions, Powders, and Sprays)
13. Suntan Preparations
The Cosmetic, Toiletry and Fragrance Association, Inc.
1101 17th Street, N.W.
Washington, DC 20036
If a monograph lists both a "generic" CAS No. and an RD No., report the RD No. in Block 2 of the Form FDA 2512a.
If neither a CAS NO. nor a RD No. is listed, report the CTFA Adopted Name in Block 1 as the Common, Usual, or Chemical Name, and provide the Trade Name and Supplier in Blocks 7 and 8 on the Form FDA 2512a.United States Pharmacopoeial Convention, Inc.
12601 Twinbrook Parkway
Rockville, MD 20852
United States Pharmacopoeial Convention, Inc.
12601 Twinbrook Parkway
Rockville, MD 20852
Merck & Co., Inc.
Rahway, NJ 07065
A limited supply of the ingredient listings is available upon request from the Cosmetics Registration Section. However, FDA recommends using the following list of CAS and RD Numbers For Most Frequently Used Cosmetic Ingredients.
000077894 Acetyl Triethyl Citrate | 039236469 Imidazolidinyl Urea |
061788496 Acetylated Lanolin Alcohol | 001332372 Iron Oxides |
977021796 Alcohol Denatured 39C | 000067630 Isopropyl Alcohol |
977021810 Alcohol, Denatured 40 | 063393931 Isopropyl Lanolate |
000097596 Allantoin | 000110270 Isopropyl Myristate |
000123308 Aminophenol, P- | 000142916 Isopropyl Palmitate |
001336216 Ammonium Hydroxide | 001332587 Kaolin |
000050817 Ascorbic Acid | 008020846 Lanolin |
008006404 Beeswax, White | 008027336 Lanolin Alcohols |
008012893 Beeswax, Yellow | 070321630 Lanolin Oil |
025013165 BHA (Butylated Hydroxyanisole) | 008006540 Lanolin, Anhydrous |
000128370 BHT (Butylated Hydroxytoluene) | 008002435 Lecithin |
007787599 Bismuth Oxychloride | 001327431 Magnesium Aluminum Silicate |
000123864 Butyl Acetate | 000546930 Magnesium Carbonate |
000094268 Butylparaben | 000099763 Methylparaben |
000076222 Camphor | 012001262 Mica |
008006448 Candelilla Wax | 063231607 Microcrystalline Wax |
009007163 Carbomer-934 | 008012951 Mineral Oil, Heavy |
008015869 Carnauba Wax | 977000137 Mineral Oil, Light |
008001794 Castor Oil | 000112801 Oleic Acid |
009004324 Cellulose Gum | 000143282 Oleyl Alcohol |
008001750 Ceresin | 012198935 Ozokerite |
036653824 Cetyl Alcohol | 008002742 Paraffin |
000540103 Cetyl Palmitate | 008027325 Petrolatum, White |
012001999 Chromium Hydroxide Green | 008009038 Petrolatum, Yellow |
000077929 Citric Acid | 000106503 Phenylenediamine, P- |
004403901 DC Green #5 | 007664382 Phosphoric Acid |
000633965 DC Orange #4 | 009005645 Polysorbate 20 |
977011678 DC Red #6-Barium Lake | 009005678 Polysorbate 60 |
977011689 DC Red #7-Calcium Lake | 009003398 Povidone |
015086949 DC Red #21 | 000057556 Propylene Gylcol |
003567666 DC Red #33 | 000094133 Propylparaben |
977058755 DC Yellow #5-Aluminum Lake | 004080313 Quaternium-15 |
008004920 DC Yellow #10 | 000108463 Resorcinol |
000084742 Dibutyl Phthalate | 007647145 Sodium chloride |
009006659 Dimethicone | 000151213 Sodium Lauryl Sulfate |
000141786 Ethyl Acetate | 008007430 Sorbitan Sesquioleate |
003844459 FDC Blue #1 | 000111013 Squalane |
004548532 FDC Red #4 | 000057114 Stearic Acid |
001934210 FDC Yellow #5 | 000112925 Stearyl Alcohol |
002783940 FDC Yellow #6 | 014807966 Talc |
014038438 Ferric Ferrocyanide | 013463677 Titanium Dioxide |
001309371 Ferric Oxide | 000102716 Triethanolamine |
008006073 Formaldehyde Solution (Formalin) | 057455375 Ultramarine Blue |
000056815 Glycerin | 007732185 Water |
031566311 Glyceryl Monostearate | 001314132 Zinc Oxide |
009004620 Hydroxyethylcellulose | 000557051 Zinc Stearate |
*All Numbers starting with 977 are RD numbers.