US California Safe Cosmetics Program reporting Form_Qpro Regulatory Services

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)
qproregulatoryservices@gmail.com www.usfdacosmetics.net
1

California Safe Cosmetics Program Form
∗ 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.
Original Amendment Cancellation
For Amendment or Cancellation:
FDA Registration number: ______________________ FDA CPIS number: ________________
Filing Date: _ _ - _ _ - _ _ _ _ Discontinuance Date: _ _ - _ _ - _ _ _ _
Establishment Name: ______________________________________________________________
(Please include Business Entity eg. Ltd., Inc., etc, if any)
Business Type: Manufacturer Packer Distributor Others: ____________________
Company Type: Public Company Private Company
FDA Central File Number / Federal Establishment ID (if applicable): ___________ / ___________
Name of Parent Company (if any): ___________________________________________________
Street Address: __________________________________________________________________
City: ____________________ State/Province: _____________________ ZIP/Pincode: _________
Country: ______________________________ Website: __________________________________
INSTRUCTIONS
COMPANY INFORMATION
TYPE OF SUBMISSION
2

Contact Name: ______________________/______________________/______________________
First Name Middle Name Last Name
Designation: ____________________________ Email: __________________________________
Telephone: _____________________________ Fax: ___________________________________
Manufacturer Name: ______________________________________________________________
Contact Person Name: _____________________________________________
Designation: ____________________________ Email: __________________________________
Telephone: _____________________________ Fax: ___________________________________
Street Address: __________________________________________________________________
City: ____________________ State/Province: _____________________ ZIP/Pincode: _________
Country: ______________________________ Website: __________________________________
Sl. No Other Business Trading Names (Doing Business As) Type of Action
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
CONTACT INFORMATION
MANUFACTURER INFORMATION
(Leave black if same as Company Information above)
DOING BUSINESS AS
3

Sl. No Other Companies Names that appears on Product Label
1. Company Name: __________________________________________________________
Manufacturer Packer Distributor Others: _________________________
2. Company Name: __________________________________________________________
3. Company Name: __________________________________________________________
4. Company Name: __________________________________________________________
5. Company Name: __________________________________________________________
6. Company Name: __________________________________________________________
7. Company Name: __________________________________________________________
8. Company Name: __________________________________________________________
9. Company Name: __________________________________________________________
10. Company Name: __________________________________________________________
11. Company Name: __________________________________________________________
OTHER COMPANIES NAMES
(If appears on Product label)
4

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 Liquid Powder Stick or pencil
Spray - Aerosol Spray - Non-Aerosol Other (Specify): __________________________
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 CAS number
Chemical
Concentration
Unit of Measure
(mg/g or mg/mL)
Chemical
Concentration
Unit of Measure
(mg/g or mg/mL)
1.
2.
3.
4.
5.
PRODUCT INFORMATION
INGREDIENTS INFORMATION
PRODUCT COMPONENT INFORMATION
5

1.
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: ______________
Concentration
(mg/g or mg/mL)
Present in
Color Scent
Flavor
Color Scent
Flavor
Color Scent
Flavor
Color Scent
Flavor
2. CSF combination: Color: _______________ Scent: _______________ Flavor: ______________
Concentration
(mg/g or mg/mL)
Present in
Color Scent
Flavor
Color Scent
Flavor
Color Scent
Flavor
Color Scent
Flavor
3. CSF combination: Color: _______________ Scent: _______________ Flavor: ______________
Concentration
(mg/g or mg/mL)
Present in
Color Scent
Flavor
Color Scent
Flavor
Color Scent
Flavor
Color Scent
Flavor
COLOR – SCENT – FLAVOR (C-S-F) INFORMATION
6

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: ________________________________________________________________
3. Kits Name: ________________________________________________________________
4. Kits Name: ________________________________________________________________
1. Collection Name: __________________________________________________________
Product is part in this Collection.
CSF combination is present in this Collections: Color:______ Scent:_____ Flavor:_____
2. Collection Name: __________________________________________________________
3. Collection Name: __________________________________________________________
4. Collection Name: __________________________________________________________
Comments (If any): ___________________________________________________________________
KITS AND COLLECTIONS INFORMATION
7

Instructions:
* Select all applicable categories that best describe your cosmetic product.
Baby Products
Baby Shampoos Baby Skin Care Baby Wash/Soap
Diaper Rash Treatment Other Baby Products
Bath Products
Bath Additives Body Washes and Soaps Bubble and Foam Bath Products
Scrubs and Exfoliants Other Bath Products
Fragrances
Cologne Perfumes - Oils and Lotions Perfumes - Solids and Powders
Perfumes/Eaux de Parfum 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 Cleaning Products
Teeth Whitening Products Other Oral Hygiene Product
Personal Care Products
Antiperspirants (making a cosmetic claim) Douches
Feminine Deodorants Hand Cleansers and Sanitizers
Lubricants (e.g. personal, sexual, massage oil) Underarm Deodorants
Other Personal Care Product
(Contd...)
PRODUCT CATEGORY
8

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 (leave-in)
Hair Conditioners (rinse-out) Hair Dyes and Colors Hair Lighteners with Color
Hair Shampoos (making a cosmetic claim) Hair Tints and Rinses (coloring)
Products Related to Hair Coloring Other Hair Coloring Product
Makeup Products (non-permanent)
Blushes Eye Shadow Eyeliner/Eyebrow Pencils
Face Powders Foundations and Bases Lip Balm (making a cosmetic claim)
Lip Color - Lipsticks, Liners, and Pencils Lip Gloss/Shine
Makeup Fixatives Makeup Preparations Mascara/Eyelash Products
Paints (e.g. facial, body) Rouges Other Makeup Product
Sun-Related Products
Indoor Tanning Products Sunscreen (making a cosmetic claim)
Suntan Enhancers Other Sun-Related Product
Tattoos and Permanent Makeup
Tattoos and Permanent Makeup
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): ___________________________________________________________________
PAYMENT INFORMATION
9

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
10

US California Safe Cosmetics Program reporting Form_Qpro Regulatory Services

Recommended

Recommended

More Related Content

Viewers also liked

Viewers also liked (8)

Similar to US California Safe Cosmetics Program reporting Form_Qpro Regulatory Services

Similar to US California Safe Cosmetics Program reporting Form_Qpro Regulatory Services (20)

Recently uploaded

Recently uploaded (20)

US California Safe Cosmetics Program reporting Form_Qpro Regulatory Services