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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.
Some sunscreen active ingredients not currently marketed in the United States have been available in products in other countries for more than a decade, and companies that manufacture some of these sunscreen ingredients have sought to bring these ingredients to the U.S. market. In the United States, sunscreen is considered an over-the-counter (OTC) drug, which is a drug available to consumers without a prescription.
Under the OTC monograph process, FDA reviews active ingredients and other conditions to determine whether they are generally recognized as safe and effective (GRASE) for use in an OTC drug, such as sunscreen. If FDA finds an active ingredient to be GRASE for use in a particular category of OTC drugs, OTC drug products that contain such ingredients do not need individual preapproval from FDA to be marketed, assuming compliance with applicable regulations.
Cosmetic products labeled with sunscreen claims (including an SPF value) are regulated as drugs.
All sunscreen products must have Sunscreen in the name, regardless of the brand / commercial name.
The terms “sunblock,” “sweatproof” and “waterproof” are no longer allowed on sunscreen labels.
List of acceptable active ingredients
in products that are labeled as sunscreen with these maximum concentrations:
■ Aminobenzoic acid (PABA), 15 percent
■ Avobenzone, 3 percent
■ Cinoxate, 3 percent
■ Dioxybenzone, 3 percent
■ Ensulizole (Phenylbenzimidazole Sulfonic Acid), 4 percent
■ Homosalate, 15 percent
■ Meradimate (Methyl Anthranilate), 5 percent
■ Octinoxate (Octyl Methoxycinnamate), 7.5 percent
■ Octisalate (Octyl Salicylate), 5 percent
■ Octocrylene, 10 percent
■ Oxybenzone, 6 percent
■ Padimate O, 8 percent
■ Sulisobenzone, 10 percent
■ Titanium dioxide, 25 percent
■ Trolamine salicylate, 12 percent
■ Zinc oxide, 24 percent
For active ingredients that have previously been marketed only in other countries or in drug products individually approved for the U.S. market through an NDA (New Drug Application), FDA’s time and extent application (TEA) process provides a pathway for FDA to determine whether an ingredient is GRASE and can be marketed under the OTC monograph process.
More than 100,000 OTC drugs are marketed under the OTC monograph process which is not yet associated with FDA fees, and about 400 are approved to be marketed under NDAs.
In fiscal year 2017, the fee for an application requiring review of clinical data was $2,038,100 under NDAs.
Once an active ingredient is determined to be GRASE and added to the OTC monograph, then anyone can market products using that active ingredient, as there is no period of market exclusivity granted to sponsors.
Until a monograph is finalized and goes into effect, the FDA generally does not object to marketing of these drugs, unless failure to take regulatory action against marketing of the drugs poses a potential hazard to the consumer.
The Sunscreen Innovation Act (SIA) altered the process FDA is required to use for its review of sunscreen active ingredients and established time frames for the agency’s review. SIA requires FDA to finalize the sunscreen monograph by November 26, 2019.
■ NDC (National Drug Code)
■ Cosmetic establishment registration (Annual)
■ Cosmetic product listing (One)
■ OTC product listing (One)
■ U.S. Agent Service (Annual)
CLICK HERE TO REGISTER
Administrative Review and Submission Service do not include
an evaluation of your science, data or technology.
(*) 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
Payment methods accepted
PayPal, Local European Payments
Debit and Credit Cards
Electronic Invoice, Bank Wire
■ Federal Food, Drug, and Cosmetic Act (FD&C Act)
■ 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.
OTC Monographs are not subject to user fee, yet.
(Over-the-Counter Monograph Drug User Fee Act or OMUFA)
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
■ Assisting FDA in scheduling inspections of the foreign establishment.
Color Additives exempt from Certification and permitted for use in Cosmetics
|Color Additive||Eye Area||Generally
|External Use||Specific Limitations
|Bismuth citrate||No||No||Subject to limitations||Hair on the scalp|
|Chromium oxide greens||Yes||No||Yes|
|Dihydroxyacetone||No||No||Subject to limitations||For use in tanning preparations|
|No||No||Subject to limitations||Shampoos|
|Henna||No||No||Subject to limitations||Hair on the scalp|
|Lead acetate||No||No||Subject to limitations||Hair on the scalp; ≤0.6% lead|
|No||No||Subject to limitations||Externally applied facial makeup and nail polish; <10%; for infrequent use (e.g., Halloween)|
|No||No||Subject to limitations||Dentifrices; ≤0.1%|
|Silver||No||No||Subject to limitations||Fingernail polish; ≤1%|
What is a monograph?
A monograph includes the name of the ingredient or preparation, the definition, packaging, storage, labeling requirements, and the specification.
The specification consists of a series of tests, procedures for the tests, and acceptance criteria.
What is an excipient?
An excipient is a type of raw material that is present in a drug product and thus has direct patient contact. It is not an active pharmaceutical ingredient (API).
Excipients include inert materials such as bulking agents, stabilizing agents, preservatives, salts, or solvents.
An excipient must be evaluated for safety unless it has been approved as a “generally recognized as safe” (GRAS) material or is on a list of approved excipients.
List of OTC (Over-the-Counter) cosmetic products that are governed by an FDA Monograph.
1. Anti-acne products
This monograph describes 40 different ingredients that can be used for anti-acne. Rule was finalized in 1990 although there was some action in 2010 on Benzoyl Peroxide.
2. Toothpaste & anti-cavity products
This monograph gives a list of over 20 ingredients that can be used to fight cavities. The final rule was issued in 1995.
3. Topical anti-fungal
Products that are topically applied to places that need anti-fungal effects (diaper rash, feet, etc). Final rule was originally passed in 1993.
4. Anti-microbial products
There is a long list of ingredients that can be used for topical anti-microbial products. For most of the antimicrobial ingredients, the final rule has not yet been issued.
This monograph is for products that are designed to stop sweating. The final monograph was originally issued in 2003. It lists 26 active ingredients.
These are classified as skin protectants. The final rule was originally issued in 2003.
8. Dandruff products
The final monograph was issued in 1991 & revised in 1992.
9. Hair growth / hair loss
The final monograph for these types of products was issued in 1989. In 1994, Minoxidil was switched from a perscription drug to an OTC. It is the only non-perscription option.
10. Nailbiting products
There is a monograph for products that are designed to stop people from biting their nails. The final monograph was issued in 1993.
These products are designed to treat the condition of psoriasis. The tentative monograph was issued in 1986 and has yet to be finalized. Only a couple of active ingredients are allowed including Coal Tar and Salicylic acid.
12. Skin bleaching
Skin lightening products are OTCs in the US. The tentative final monograph was issued in 1982 but it has yet to be finalized. There are only 2 active ingredients acceptable for skin lightening.
The final monograph was issued in 2011.
14. Topical analgesic
These products find a wide variety of application and cover products such as those designed for diaper rash, cold sore treatments, poison ivy treatments, and others.
15. Wart remover
Products that are used to remove warts. The final monograph was issued in 1990 but updated in 1994. Thirteen active ingredients are listed.
Complete list of all the FDA Monographs.
OTC drugs Q&A.
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.
The worldwide cosmetics market, estimated at a total of $243 billion, was stronger in 2016, with growth of +4.0%.
A shift of preference towards natural and organic beauty products, particularly in U.S. and E.U, fosters the growth of the cosmetics market.
Rising demand for natural, herbal and organic beauty products creates potential opportunities for manufacturers to innovate and develop new products in accordance to consumer preferences.
FDA registration number is not required for importing cosmetics into the United States, unless your product is also a drug (OTC).