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Label Update 1 × $99.00
Subtotal: $99.00
OTC COSMETICS
Fluoride toothpaste | Antiperspirants | Dandruff shampoos | Sunscreens
OTC Cosmetics
$350.00
Domestic and foreign establishments that manufacture, process, pack, or hold over-the-counter (OTC) cosmetic products for sale in the United States, are required to register with U.S. Food and Drug Administration.
Click here for additional information. You may also use the Live Support Chat for any question, 24/7.
We expect you to provide the following with your payment:
- Full company name, complete physical address (street, city, state, postal code, country)
- Company DUNS Number
- Name, telephone and email of CEO / Manager
- Products details
- FDA compliant labels
- U.S. Toll Free Number
FDA REGISTRATION
LOW ANNUAL SERVICE | FEES
LIMITED
OFFER
$350.00
U.S. Agent Service included.
OMUFA User Fees are additional.
Monograph Drug Facility (MDF) Facility Fee:
$34,166 (FY 2024).
Contract Manufacturing Organization (CMO) Facility Fee:
$22,777 (FY 2024).
Here is a list of OTC cosmetics with an FDA monograph:
Topical Acne Drug Products for Over-the-Counter Human Use.
Skin Protectant Drug Products for Over-the-Counter Human Use.
External Analgesic Drug Products for Over-the-Counter Human Use.
Antiperspirant Drug Products for Over-the-Counter Human Use.
Drug Products for the Control of Dandruff, Seborrheic Dermatitis, and Psoriasis for Over-the-Counter Human Use.
Sunscreen Drug Products for Over-the-Counter Human Use.
Deodorant Drug Products for Internal Use for Over-the-Counter Human Use.
