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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.
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 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
FDA VOLUNTARY COSMETIC REGISTRATION PROGRAM
CALIFORNIA SAFE COSMETICS PROGRAM (CSCP)
[email protected] www.usfdacosmetics.net 1
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Cosmetic Product Ingredient Statements (CPIS) Filing Form
Type entries in CAPITAL LETTERS. Enter ingredients in descending
order of predominance by weight. Use standard abbreviations
whenever necessary. Omit all punctuation except in chemical
names. Complete Contract Manufacturer / Private Labeler
Information section if applicable. For Product Category section,
please refer Annexure at the bottom of the form. Leave Type of
Action and Date of Action sections black for a New or Original
Submission. If you are listing or updating more than one product or
if a product contains more than five
ingredients, then please use photocopies of Page 3 (Ingredients
information page). If you need Voluntary Cosmetic Establishments
Registration Form, California Safe Cosmetics
Program (CSCP) Form or any other forms, please download from our
website or contact us.
Company Name:
______________________________________________________________
(Please include Business Entity eg. Ltd., Inc., etc, if any) FDA
Registration Number:
_________________________________________________________
Street Address:
_________________________________________________________________
City: ____________________ State/Province: _____________________
ZIP/Pincode: ________
Country: ______________________________ Website:
_________________________________
Contact Name:
______________________/______________________/______________________
First Name Middle Name Last Name
Designation: ____________________________ Email:
__________________________________
Telephone: _____________________________ Fax:
___________________________________
Brand Name of Product:
___________________________________________________________
Common Name of Product:
_________________________________________________________
Product Category / Subcategory: _________________________ /
__________________________
Type of Action: _____________________________________ Date of
Action: _ - _ : _ - _ : _ _ _ _
INSTRUCTIONS
PRODUCT INFORMATION
PRODUCT INFORMATION
[email protected] www.usfdacosmetics.net 2
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1.
Common or Chemical Name:
___________________________________________________ CAS number:
_____________ Type of Action: __________ Date of Action: _ - _ : _
- _ : _ _ _ _ Whether this ingredient is a Base formulation or
contains Base material? No Yes Base CPIS Number: ______________
Base / Trade Name: ________________________ Company Name:
_________________________________________________________
2.
Common or Chemical Name:
___________________________________________________ CAS number:
_____________ Type of Action: __________ Date of Action: _ - _ : _
- _ : _ _ _ _ Whether this ingredient is a Base formulation or
contains Base material? No Yes Base CPIS Number: ______________
Base / Trade Name: ________________________ Company Name:
_________________________________________________________
3.
Common or Chemical Name:
___________________________________________________ CAS number:
_____________ Type of Action: __________ Date of Action: _ - _ : _
- _ : _ _ _ _ Whether this ingredient is a Base formulation or
contains Base material? No Yes Base CPIS Number: ______________
Base / Trade Name: ________________________ Company Name:
_________________________________________________________
4. Common or Chemical Name:
___________________________________________________ CAS number:
_____________ Type of Action: __________ Date of Action: _ - _ : _
- _ : _ _ _ _ Whether this ingredient is a Base formulation or
contains Base material? No Yes Base CPIS Number: ______________
Base / Trade Name: ________________________ Company Name:
_________________________________________________________
5 Common or Chemical Name:
___________________________________________________ CAS number:
_____________ Type of Action: __________ Date of Action: _ - _ : _
- _ : _ _ _ _ Whether this ingredient is a Base formulation or
contains Base material? No Yes Base CPIS Number: ______________
Base / Trade Name: ________________________ Company Name:
_________________________________________________________
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.}
INGREDIENTS INFORMATION
PAYMENT INFORMATION
[email protected] www.usfdacosmetics.net 3
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Product Category Numbered Numeric and text in Bold (eg: 01. Baby
Products).
Product Sub-category Numbered Alphabet and text is not bold.
(eg: a. Baby Shampoos).
01. Baby Products
a. Baby Shampoos b. Lotions, Oils, Powders, and Creams c. Other
Baby Products
03. Eye Makeup Preparations
a. Eyebrow Pencil b. Eyeliner c. Eye Shadow d. Eye Lotion e. Eye
Makeup Remover f. Mascara g. Other Eye Makeup Preparations
05. Hair Preparations (non-coloring)
a. Hair b. Hair Spray (aerosol fixatives) c. Hair Straighteners
d. Permanent Waves e. Rinses (non-coloring) f. Shampoos
(non-coloring) g. Tonics, Dressings, and Other Hair
Grooming Aids h. Wave Sets i. Other Hair Preparations
02. Bath Preparations
a. Bath Oils, Tablets, and Salts b. Bubble Bath c. Bath Capsules
d. Other Bath Preparations
04. Fragrance Preparations
a. Cologne and Toilet Waters b. Perfumes c. Powders (dusting and
talcum,
excluding aftershave talc) d. Sachets e. Other Fragrance
Preparations
06. Hair Coloring Preparations
a. Hair Dyes and Colors (all types requiring caution statements
and patch tests)
b. Hair Tints c. Hair Rinses (coloring) d. Hair Shampoos
(coloring) e. Hair Color Sprays (aerosol) f. Hair Lighteners with
Color g. Hair Bleaches h. Other Hair Coloring Preparations
PRODUCT CATEGORY ANNEXURE
[email protected] www.usfdacosmetics.net 4
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07. Makeup Preparations (not eye)
a. Blushers (all types) b. Face Powders c. Foundations d. Leg
and Body Paints e. Lipstick f. Makeup Bases g. Rouges h. Makeup
Fixatives i. Other Makeup Preparations
09. Oral Hygiene Products
a. Dentifrices (aerosol, liquid, pastes, and powders)
b. Mouthwashes and Breath Fresheners (liquids and sprays)
c. Other Oral Hygiene Products
11. Shaving Preparations
a. Aftershave Lotion b. Beard Softeners c. Men's Talcum d.
Preshave Lotions (all types) e. Shaving Cream (aerosol, brushless,
and
lather) f. Shaving Soap (cakes, sticks, etc.) g. Other Shaving
Preparations
13. Suntan Preparations
a. Suntan Gels, Creams, and Liquids b. Indoor Tanning
Preparations c. Other Suntan Preparations
08. Manicuring Preparations
a. Basecoats and Undercoats b. Cuticle Softeners c. Nail Creams
and Lotions d. Nail Extenders e. Nail Polish and Enamel f. Nail
Polish and Enamel Removers g. Other Manicuring Preparations
10. Personal Cleanliness
a. Bath Soaps and Detergents b. Deodorants (underarm) c. Douches
d. Feminine Deodorants e. Other Personal Cleanliness Products
12. Skin Care Preparations (Creams, Lotions, Powders, and
Sprays)
a. Cleansing (cold creams, cleansing lotions, liquids, and
pads)
b. Depilatories c. Face and Neck (excluding shaving
preparations) d. Body and Hand (excluding shaving
preparations) e. Foot Powders and Sprays f. Moisturizing g.
Night h. Paste Masks (mud packs) i. Skin Fresheners j. Other Skin
Care Preparations
Comments (If any):
___________________________________________________________________
[email protected] www.usfdacosmetics.net 5
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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_
___________________________________________________________
AGREEMENT
[email protected] www.usfdacosmetics.net 6
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