An over-the-counter cosmetic is a product manufactured according to an FDA Monograph.
Monographs define the safety, effectiveness, and labeling of all active ingredients.
All otc cosmetic products must include standard “Drug Facts” information on the back and/or side of the container.
A New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) is required when a product does not conform to a final monograph.
OTC cosmetics are both cosmetics and drug products.
▪ Fluoride Toothpaste.
▪ Dandruff Shampoos.
▪ Skin Protectants.
▪ Topical Analgesics.
Of 16 currently marketed active ingredients:
- 2 ingredients, Zinc Oxide and Titanium Dioxide, are generally recognized as safe and effective (GRASE) and not misbranded for use in sunscreens.
- 2 ingredients, PABA and Trolamine Salicylate, are not GRASE for use in sunscreens due to safety issues.
- 12 ingredients for which there are insufficient safety data to make a positive GRASE determination at this time.
Dosage forms that are GRASE for use as sunscreens include sprays, oils, lotions, creams, gels, butters, pastes, ointments and sticks.
Any establishment, with certain exemptions, engaged in manufacturing, repacking, relabeling or salvaging OTC cosmetic products for U.S. distribution is required to register with the U.S. Food and Drug Administration.
However, manufacturers, repackers and relabelers of certain inactive ingredients such as excipients, colorings, flavorings, emulsifiers, lubricants, preservatives or solvents that become components of over-the-counter cosmetics, are exempt.
Registration is required within five days of introducing OTC cosmetics into commercial distribution. Annual registration renewal must occur between October 1 and December 31 each year.
There are three steps needed to register an establishment and list an over-the-counter cosmetic with the FDA:
1. Establishment registration.
2. Labeler code.
3. Drug product listing(s).
All registered establishments must list all otc cosmetics they produce for U.S. commercial distribution under their own labeler code. This includes active pharmaceutical ingredient manufacturers, other bulk drug manufacturers, contract manufacturers, repackers and relabelers.
The owner, operator, or agent in charge of an establishment, or an individual authorized by one of them, may register that establishment.
Foreign facilities must designate a U.S. Agent such as ITB HOLDINGS LLC, for purposes of communication between the facility and FDA. The U.S. Agent is authorized to register any establishment.
The U.S. Food and Drug Administration will not confirm a registration, provide an FDA Establishment Identification (FEI) number, or provide confirmation of a registration renewal until ITB HOLDINGS LLC confirms it has agreed to serve as U.S. Agent.
FDA will conduct this verification step by sending an email to ITB HOLDINGS LLC. If the FDA does not receive a response to its verification request within 30 calendar days, the registration, registration renewal, update, or cancellation submission will be removed from its database and a new submission will be required.
The FDA recognizes the DUNS Number as an acceptable Unique Facility Identifier (UFI) for the purpose of registrations. The DUNS number is assigned and managed by Dun & Bradstreet (D&B) Inc. DUNS numbers can be obtained or confirmed by visiting D&B’s website.
User Fees are paid to the U.S. Treasury, every fiscal year (FY). Current fees are as follows.
Monograph Drug Facility (MDF) Facility Fee: $26,153.
Contract Manufacturing Organization (CMO) Facility Fee: $17,435.
Service Fees are due each time you seek and request the assistance of an FDA Consultant or U.S. Agent such as ITB HOLDINGS LLC.
Ready to register your company and list your products? Contact ITB HOLDINGS LLC, today.
You may want to use the Live Support Chat available 24/7, for faster responses, in multiple languages.
- Company registration.
- Product listing.
- U.S. Agent Service for foreign companies.
- User Fee is not included.
An otc cosmetic may become misbranded when:
- labeling is false or misleading.
- label fails to provide required information.
- required label information is not properly displayed, and
labeling violates requirements of the Poison Prevention Packaging Act of 1970.
A determination that labeling is “misleading” includes considering both what the label says and what it fails to reveal.
Required label information includes, among others,
(1) the name and physical address of the manufacturer, packer, or distributor
(2) an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count.