Cosmetic Ingredient Review...Created Date 11/19/2010 1:26:44 PM
US FDA Cosmetic Product Ingredient Statements Filing_CPIS_Form_Qpro Regulatory Services
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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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Transcript of US FDA Cosmetic Product Ingredient Statements Filing_CPIS_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
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
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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
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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
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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): ___________________________________________________________________
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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
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