Cosmetics | FDA Registration | Products Listing | www.itbhdg.com

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    LIMITED OFFER

    * Establishment Registration
    * Products Listing
    * U.S. Agent Service (Foreign Companies)
    * $750.00 USD | Initial Registration Fee

    * $400.00 USD | Annual Fee

    Government Fees are extra.

INVOICE

  • Perfumes, Lipsticks, Fingernail Polishes
  • Eye and Facial Makeup
  • Shampoos, Hair Colors, Deodorants, Skin Moisturizers


JUST YOU KNOW

FDA does not have the legal authority to approve cosmetics before they go on the market, but approves color additives used in them (except coal tar hair dyes).

Under the law, cosmetics must not be "adulterated" or "misbranded". They must be safe for consumers when used according to directions on the label, and they must be properly labeled.

Companies and individuals who market cosmetics have a legal responsibility for the safety and labeling of their products.

FDA can take action against a cosmetic on the market if reliable information shows it is adulterated or misbranded.



FDA REGISTRATION of your OTC (Over-the-Counter) Startup manufacturing sunscreens | www.m.itbhdg.com | www.itbhdg.com

Cosmetic products labeled with sunscreen claims (including an SPF value) are regulated as drugs.



ESTABLISHMENT REGISTRATION


WHAT'S INCLUDED?


Determination of FDA code and regulation
Cosmetic establishment registration
Cosmetic product listing
OTC (Over-the-Counter) Monograph registration
OTC product listing
U.S. Agent Service



Cosmetic Establishment Registration | www.itbhdg.com/english/cosmetics.html | Save time and money @ ITB HOLDINGS LLC

CLICK HERE TO REGISTER




Administrative Review and Submission Service do not include
an evaluation of your science, data or technology.


REQUIRED INFORMATION
(*) Full company's name (as registered locally)
(*) Street address, city, postal / zip code, state, country
(*) Full name of CEO / Manager
(*) Telephone number of CEO / Manager
(*) Email of CEO / Manager
(*) Product details

SUBMIT COMPANY INFORMATION



REQUEST AN INVOICE



Payment methods accepted

PayPal, Local European Payments
Debit and Credit Cards
Electronic Invoice, Bank Wire








Legislation

1. Federal Food, Drug, and Cosmetic Act (FD&C Act)

2. Fair Packaging and Labeling Act (FPLA).

FDA regulates cosmetics under the authority of these laws.


The FD&C Act defines cosmetics by their intended use
as "articles intended to be rubbed, poured, sprinkled, or sprayed on
introduced into, or otherwise applied to the human body for cleansing
beautifying, promoting attractiveness, or altering the appearance.


Among the products included in this definition are:

skin moisturizers, perfumes, lipsticks

fingernail polishes, eye and facial makeup

cleansing shampoos, permanent waves

hair colors and deodorants

any substance intended for use as a component of a cosmetic product.


Soap is not included.


If the product is intended for a therapeutic use, such as treating or preventing disease, or to affect the structure or function of the body, it’s a drug.

 

Fair Packaging and Labeling Act (FPLA)


Because the FPLA applies only to consumer products (sold in stores, online, or person to person), the requirement for a list of ingredients does not apply to products distributed only
* as free samples
* for professional use
* for institutional use, such as at schools, hospitals, or the workplace.

If a cosmetic product is marketed to consumers, the ingredients must be listed by their common or usual names, generally in descending order of predominance. FDA does not accept alternatives as substitutes.



Voluntary Cosmetic Registration Program (VCRP)


The VCRP applies only to cosmetic products being sold to consumers in the United States.

It does not apply to cosmetic products for professional use only, such as products used in beauty salons, spas, or skin care clinics.

It also does not apply to products that are not for sale.

Companies participating in the VCRP support safety review processes by the FDA, provide information about cosmetic products and ingredients, their frequency of use, and businesses engaged in their manufacture and distribution.

The VCRP is not a cosmetic approval program or a promotional tool.


Cosmetics are not subject to FDA premarket approval.

Registration of a cosmetic establishment, assignment of an establishment registration number, listing a cosmetic product, or assignment of a CPIS number does not mean that FDA has approved the firm or its products.

CONTACT

Government Fees

* Establishment Registration Fee | Annual

* Product Review Fee | Initial

Due between October 1 and December 31, each year, for products considered drugs.

OTC Monographs are not subject to user fee, yet (Over-the-Counter Monograph Drug User Fee Act or OMUFA).

ANY QUESTION?



United States Agent for Foreign Establishments

All foreign establishments must notify FDA of the name, address, phone, and email address of their United States agent.

Even if an establishment manufactures various medical devices, drugs, biological products, or cosmetics, each establishment can identify only one United States agent.


Responsibilities of the United States Agent

* Assisting FDA in communications with the foreign establishment
* Responding to questions concerning the foreign establishment's products that are imported or offered for import into the United States, and
* Assisting FDA in scheduling inspections of the foreign establishment.




FDA COMPLIANCE


Color Additives exempt from Certification and permitted for use in Cosmetics

Color Additive Eye Area Generally
(Includes
Lipsticks)
External Use Specific Limitations
and Comments

Aluminum powder Yes No Yes  
Annatto Yes Yes Yes  
Bismuth citrate No No Subject to limitations Hair on the scalp
Bismuth oxychloride Yes Yes Yes  
Bronze powder Yes Yes Yes  
Caramel Yes Yes Yes  
Carmine Yes Yes Yes  
β-Carotene Yes Yes Yes  
Chromium
hydroxide green
Yes No Yes  
Chromium oxide greens Yes No Yes  
Copper powder Yes Yes Yes  
Dihydroxyacetone No No Subject to limitations For use in tanning preparations
Disodium
EDTA-copper
No No Subject to limitations Shampoos
Ferric ammonium
ferrocyanide
Yes No Yes  
Ferric ferrocyanide Yes No Yes  
Guaiazulene No No Yes  
Guanine Yes Yes Yes  
Henna No No Subject to limitations Hair on the scalp
Iron oxides Yes Yes Yes  
Lead acetate No No Subject to limitations Hair on the scalp; ≤0.6% lead
Luminescent
zinc sulfide
No No Subject to limitations Externally applied facial makeup and nail polish; <10%; for infrequent use (e.g., Halloween)
Manganese violet Yes Yes Yes  
Mica Yes Yes Yes  
Potassium sodium
copper chlorophyllin
(chlorophyllin-copper
complex)
No No Subject to limitations Dentifrices; ≤0.1%
Pyrophyllite No No Yes  
Silver No No Subject to limitations Fingernail polish; ≤1%
Titanium dioxide Yes Yes Yes  
Ultramarines Yes No Yes  
Zinc oxide Yes Yes Yes  



Misbranding by Reference to Establishment Registration Number

Any representation in labeling or advertising that creates an impression of official approval because of registration or possession of a registration number is considered misleading.

Misleading labeling makes a cosmetic misbranded, and marketing a misbranded cosmetic is against the law.



INITIAL IMPORTER SERVICE

FDA registration number is not required for importing cosmetics into the United States, unless your product is also a drug (OTC).

Interested in this service?
Please contact us at
T: +1 855 510 2240
T : +1 855 389 7344
T : +44 800 610 1577
Contact Form