U.S.

FDA Cosmetic registration is an FDA post-market reporting system for use by manufacturers,
packers, and distributors of cosmetic products that are in commercial distribution in the US. There are
two parts in FDA Voluntary Cosmetic Registration Program. Voluntary Cosmetic Establishments
Registration and Cosmetic Product Ingredient Statements (CPIS) Filing.
The State of California has imposed additional requirements for cosmetic products intended for use in
California.
Qpro Regulatory Services are always happy to assist you. Complete the following questionnaire which
is self explanatory. Please feel free to contact us if you have any queries.
FDA VOLUNTARY COSMETIC REGISTRATION PROGRAM
U.S. FDA Voluntary Cosmetic Registration Program is Post-market reporting system. A company can
participate in Voluntary Cosmetic Registration Program only if their products are in commercial
distribution in USA.

Whether your company products are in commercial distribution in USA?

Yes
No
If Yes, please provide Products names that are in commercial distribution in USA.
Product Names: _______________________________________________________________
CALIFORNIA SAFE COSMETICS PROGRAM (CSCP)
California Safe Cosmetics Program reporting is required if the products are sold in California and the
product ingredients contain any level (concentration) of a chemical known or suspected to cause cancer or
reproductive harm.

Whether your cosmetic products are sold in California?

Yes
No
Do your products contain an ingredient known or suspected by an authoritative scientific body
cited in the California Safe Cosmetics Act of 2005 (the Act) to cause cancer or reproductive harm?
Yes
No
If Yes, please provide Products names that are in commercial distribution in USA.
Ingredients or Chemical Names:___________________________________________________
Comments (If any): ___________________________________________________________________
By: ________________________________________________

Date: _ _ - _ _ - 201_

Signature

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California Safe Cosmetics Program Form

INSTRUCTIONS

Type entries in CAPITAL LETTERS.

Do not use any abbreviations. Omit all punctuation except in chemical names.
Not all ingredients in a cosmetic product must be reported. Only ingredients known or
suspected by an authoritative scientific body to cause cancer or reproductive harm must be
reported.
If the formula of a product is different or a change in product name with no change in formula
will consider as a new product.
Complete Contract Manufacturer / Private Labeler Information section if applicable.
Leave Type of Action and Date of Action sections black for a New or Original Submission.
Please include ingredients that are specific to individual colors, scents, or flavors of this
product.
If you need Voluntary Cosmetic Establishments Registration Form, Cosmetic Product
Ingredient Statements (CPIS) Filing Form or any other forms, please download from our
website or contact us.
TYPE OF SUBMISSION
Original

Amendment

Cancellation

For Amendment or Cancellation:

FDA Registration number: ______________________ FDA CPIS number: ________________
Filing Date: _ _ - _ _ - _ _ _ _

Discontinuance Date: _ _ - _ _ - _ _ _ _

COMPANY INFORMATION
Establishment Name: ______________________________________________________________
(Please include Business Entity eg. Ltd., Inc., etc, if any)

Business Type:

Manufacturer

Company Type:

Public Company

Packer

Distributor

Others: ____________________

Private Company

FDA Central File Number / Federal Establishment ID (if applicable): ___________ / ___________
Name of Parent Company (if any): ___________________________________________________
(Please include Business Entity eg. Ltd., Inc., etc, if any)

Street Address: __________________________________________________________________

City: ____________________ State/Province: _____________________ ZIP/Pincode: _________
Country: ______________________________ Website: __________________________________
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CONTACT INFORMATION
Contact Name: ______________________/______________________/______________________
First Name

Middle Name

Last Name

Designation: ____________________________ Email: __________________________________

Telephone: _____________________________ Fax: ___________________________________
MANUFACTURER INFORMATION
(Leave black if same as Company Information above)
Manufacturer Name: ______________________________________________________________
(Please include Business Entity eg. Ltd., Inc., etc, if any)

Contact Person Name: _____________________________________________

Designation: ____________________________ Email: __________________________________
Telephone: _____________________________ Fax: ___________________________________
Street Address: __________________________________________________________________
City: ____________________ State/Province: _____________________ ZIP/Pincode: _________
Country: ______________________________ Website: __________________________________
DOING BUSINESS AS
Sl. No

Other Business Trading Names (Doing Business As)

Type of Action

1.
2.
3.
4.
5.
6.
7.
8.
9.
10.

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OTHER COMPANIES NAMES

(If appears on Product label)
Sl. No

1.

Other Companies Names that appears on Product Label

Company Name: __________________________________________________________
Manufacturer

2.

Distributor

Others: _________________________

Packer

Distributor

Others: _________________________

Packer

Distributor

Others: _________________________

Packer

Distributor

Others: _________________________

Packer

Distributor

Others: _________________________

Company Name: __________________________________________________________

Manufacturer

9.

Packer

Company Name: __________________________________________________________

Manufacturer

8.

Others: _________________________

Company Name: __________________________________________________________

Manufacturer

7.

Distributor

Company Name: __________________________________________________________

Manufacturer

6.

Packer

Company Name: __________________________________________________________

Manufacturer

5.

Others: _________________________

Company Name: __________________________________________________________

Manufacturer

4.

Distributor

Company Name: __________________________________________________________

Manufacturer

3.

Packer

Packer

Distributor

Others: _________________________

Company Name: __________________________________________________________

Manufacturer

Packer

Distributor

Others: _________________________

10. Company Name: __________________________________________________________

Manufacturer

Packer

Distributor

Others: _________________________

11. Company Name: __________________________________________________________

Manufacturer

Packer

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Distributor

Others: _________________________

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PRODUCT INFORMATION
Product Name: ___________________________________________________________________
Brand Name: ____________________________________________________________________
Product application areas:
Body (general)
Body Cavity (anal)
Body Cavity (oral)
Body Cavity (vaginal)
Elbows or Knees Eye Area
Face
Feet
Hair or Scalp
Hands
Legs
Lips
Nails
Other (Specify): ______________________________________________
Product Form:
Cream/Gel/Foam
Spray - Aerosol

Liquid
Spray - Non-Aerosol

Powder
Stick or pencil
Other (Specify): __________________________

PRODUCT COMPONENT INFORMATION

Does your product contain a component (i.e., fragrance, color, etc.) supplied by another
company?
No
Yes (if Yes, please provide the following information)
Company Name: ______________________________ Contact Name: ____________________
Email: ______________________________________ Telephone: _______________________
Physical Address:______________________________________ City: ____________________
State/Province: _____________________ ZIP/Pincode: _______ Country: _________________
Reportable Chemical Ingredient Name

Chemical
Concentration

CAS number

Unit of Measure
(mg/g or mg/mL)

INGREDIENTS INFORMATION
Reportable Chemical Ingredient Name

CAS number

Chemical

Unit of Measure

Concentration (mg/g or mg/mL)

1.
2.
3.
4.
5.

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COLOR SCENT FLAVOR (C-S-F) INFORMATION

Instructions:
* Color, scent, and flavor names should be listed as they appear to the consumer on the product label.
* All three attributes (color, scent, flavor) are NOT required; you may enter just a color, a scent, a flavor,
or any combination of the three.

CSF combination: Color: _______________ Scent: _______________ Flavor: ______________

1.
Reportable Chemical Ingredient Name

Concentration

CAS number (mg/g or mg/mL)

Present in
Color
Flavor
Color
Flavor

Scent

Color
Flavor

Scent

Color
Flavor

Scent

Scent

2. CSF combination: Color: _______________ Scent: _______________ Flavor: ______________

Reportable Chemical Ingredient Name

Concentration

CAS number (mg/g or mg/mL)

Present in
Color
Flavor
Color
Flavor

Scent

Color
Flavor

Scent

Color
Flavor

Scent

Scent

3. CSF combination: Color: _______________ Scent: _______________ Flavor: ______________

Reportable Chemical Ingredient Name

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Concentration

CAS number (mg/g or mg/mL)

Present in
Color
Flavor
Color
Flavor

Scent

Color
Flavor

Scent

Color
Flavor

Scent

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Scent

KITS AND COLLECTIONS INFORMATION

Instructions:
* Kit and Collection names should be listed as they appear to the consumer on the product label.
1.

Kits Name: ________________________________________________________________

Product is part in this Kit.
CSF combination is present in this Kit: Color: _______ Scent: _______ Flavor: ______

2.

Kits Name: ________________________________________________________________

Product is part in this Kit.
CSF combination is present in this Kit: Color: _______ Scent: _______ Flavor: ______

3.

Kits Name: ________________________________________________________________

Product is part in this Kit.
CSF combination is present in this Kit: Color: _______ Scent: _______ Flavor: ______

4.

Kits Name: ________________________________________________________________

Product is part in this Kit.
CSF combination is present in this Kit: Color: _______ Scent: _______ Flavor: ______

1.

Collection Name: __________________________________________________________

Product is part in this Collection.
CSF combination is present in this Collections: Color:______ Scent:_____ Flavor:_____

2.

Collection Name: __________________________________________________________

Product is part in this Collection.
CSF combination is present in this Collections: Color:______ Scent:_____ Flavor:_____

3.

Collection Name: __________________________________________________________

Product is part in this Collection.
CSF combination is present in this Collections: Color:______ Scent:_____ Flavor:_____

4.

Collection Name: __________________________________________________________

Product is part in this Collection.
CSF combination is present in this Collections: Color:______ Scent:_____ Flavor:_____

Comments (If any): ___________________________________________________________________

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PRODUCT CATEGORY
Instructions:
* Select all applicable categories that best describe your cosmetic product.

Baby Products
Baby Shampoos
Diaper Rash Treatment

Baby Skin Care

Other Baby Products

Baby Wash/Soap

Bath Products
Bath Additives
Scrubs and Exfoliants

Body Washes and Soaps

Other Bath Products

Bubble and Foam Bath Products

Fragrances
Cologne
Perfumes/Eaux de Parfum

Perfumes - Oils and Lotions Perfumes - Solids and Powders

Toilet Water/Eaux de Toilette Other Fragrances

Hair Care Products (non-coloring)

Hair Conditioners (leave-in) Hair Conditioners (rinse-out) Hair Rinses (non-coloring)
Hair Shampoos (making a cosmetic claim)
Hair Shampoos with Anti-Dandruff properties
Hair Straighteners
Hair Styling Products
Permanent Waves and Wave Sets
Other Hair Care Product
Nail Products
Artificial Nails and Related Products
Basecoats and Undercoats
Cuticle Softeners
Nail Creams and Lotions
Nail Decoration
Nail Polish and Enamel
Nail Polish and Enamel Removers
UV Gel Nail Polish
Other Nail Products
Oral Hygiene Products
Mouthwashes and Breath Fresheners
Teeth Whitening Products
Personal Care Products
Antiperspirants (making a cosmetic claim)
Feminine Deodorants
Lubricants (e.g. personal, sexual, massage oil)
Other Personal Care Product

Teeth Cleaning Products

Other Oral Hygiene Product

Douches
Hand Cleansers and Sanitizers
Underarm Deodorants

(Contd...)

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Shaving Products
Aftershave Products
Shaving Cream and other Beard Softeners
Anti-Wrinkle/Anti-Aging Products (making a cosmetic claim) Depilatories
Facial Cream
Facial Masks
Foot Powders and Sprays
Nighttime Skin Care Powders (excluding aftershave, baby powder, and makeup face powder)
Skin Astringent (making a cosmetic claim)
Skin Bleaching (making a cosmetic claim)
Skin Cleansers
Skin Fresheners Skin Moisturizers (making a cosmetic claim)
Skin Toner (making a cosmetic claim)
Sprays (excluding fragrances)
Other Skin Care Product
Hair Coloring Products
Hair Bleaches
Hair Color Sprays (aerosol)
Hair Conditioners (rinse-out) Hair Dyes and Colors
Hair Shampoos (making a cosmetic claim)
Products Related to Hair Coloring
Makeup Products (non-permanent)
Blushes
Eye Shadow
Face Powders
Foundations and Bases
Lip Color - Lipsticks, Liners, and Pencils
Makeup Fixatives
Makeup Preparations
Paints (e.g. facial, body)
Rouges
Sun-Related Products
Indoor Tanning Products
Suntan Enhancers

Hair Conditioners (leave-in)

Hair Lighteners with Color
Hair Tints and Rinses (coloring)
Other Hair Coloring Product

Eyeliner/Eyebrow Pencils
Lip Balm (making a cosmetic claim)
Lip Gloss/Shine
Mascara/Eyelash Products
Other Makeup Product

Sunscreen (making a cosmetic claim)

Other Sun-Related Product

Tattoos and Permanent Makeup

Tattoos and Permanent Makeup
PAYMENT INFORMATION
PayPal Transaction Number (ID): ___________________________________________________
Date of Payment: _ _ - _ _ - 201__
{Please contact us for Payment related queries or any other information. We are always happy to assist you.}

Comments (If any): ___________________________________________________________________

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AGREEMENT
Qpro Regulatory Services and the undersigned party have today entered into an agreement
regarding the provision of consultancy services on the terms and conditions laid out in this
Agreement.

In rendering consulting services under this Agreement, Qpro Regulatory Services shall conform
to standards of work and business ethics. However, Qpro Regulatory Services shall bear no
liability or otherwise be responsible for complete assurance and delays in the provision of
Services.

The Client agrees to provide accurate and sufficient information, adequate technical assistance
and documentation, required for Qpro Regulatory Services to be able to perform the Services.
The Client shall promptly provide further information Qpro Regulatory Services reasonably
deems relevant to perform the task.

The Client is solely responsible for the scientific accuracy, material facts and completeness of
information provided to Qpro Regulatory Services.

The Client shall pay to Qpro Regulatory Services fees at the rate specified in the Purchase
Order.

The Parties agree to make all reasonable efforts, in good faith, to resolve any dispute arising
from implementation of this agreement through informal discussions and the development of
mutual satisfactory options.

Qpro Regulatory Services liability in whatever kind or nature cannot exceed the fee for
performing the task.

This Agreement shall terminate automatically upon completion by Qpro Regulatory Services of
the Services required by this Agreement or 30 calendar days from the effective date of this
agreement.

Qpro Regulatory Services is a Private business entity and is not affiliated with U.S. FDA.

By: _______________________________ Company Name: ________________________________

Signature
_______________________________________________________________________________
Authorized Person Name
_______________________________________________________________________________
Designation
Date: _ _ - _ _ - 201_

___________________________________________________________

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