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)

[email protected] 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): ___________________________________________________ (Please include Business Entity eg. Ltd., Inc., etc, if any) Street Address: __________________________________________________________________ City: ____________________ State/Province: _____________________ ZIP/Pincode: _________

Country: ______________________________ Website: __________________________________

INSTRUCTIONS

COMPANY INFORMATION

TYPE OF SUBMISSION


Contact Name: ______________________/______________________/______________________ First Name Middle Name Last Name

Designation: ____________________________ Email: __________________________________

Telephone: _____________________________ Fax: ___________________________________

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: __________________________________

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


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)


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)

Reportable Chemical Ingredient Name CAS number Chemical

Concentration

Unit of Measure

(mg/g or mg/mL) 1.

2.

3.

4.

5.

PRODUCT INFORMATION

INGREDIENTS INFORMATION

PRODUCT COMPONENT INFORMATION


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: ______________

Reportable Chemical Ingredient Name CAS number 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: ______________


Color Scent Flavor

Color Scent Flavor

Color Scent Flavor

Color Scent Flavor

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


Color Scent Flavor

Color Scent Flavor

Color Scent Flavor

Color Scent Flavor

COLOR – SCENT – FLAVOR (C-S-F) 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: ________________________________________________________________


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


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


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


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
