USA-FDA Monograph Ingredients (OTC) | Inventory Pedia

In many countries or regions, products that are regulated as cosmetics may be classified as OTC drugs in the United States, such as sunscreen products and anti-dandruff products. The OTC Monograph specifies the active ingredients and their permitted concentrations for each category of OTC products. In the U.S., OTC (Over-the-Counter) drugs are regulated by the FDA under the OTC Monograph System.

There are 33 OTC Monographs included in the list as well as the corresponding ID, published date and title. All the OTC Monographs can be searched by keyword(s) related to therapeutic category, OTC monograph number (e.g. M001), ingredients, or dosage forms.

Regulatory Implications of FDA Monograph Ingredients (OTC)

The FDA OTC Monograph system establishes requirements for active ingredients, concentrations, formulations, labeling, and testing for non-prescription drugs, which is crucial for companies producing related cosmetic products. Products that comply with the monograph are considered GRASE (Generally Recognized as Safe and Effective) and do not require pre-market approval (NDA), allowing them to enter the market directly. However, they must use monograph-approved ingredients at specified concentrations and strictly adhere to labeling and compliance requirements. Therefore, it is strongly recommend that cosmetic companies closely monitor regulatory updates to ensure compliance, mitigate legal risks, and maintain market competitiveness.

How to Search FDA Monograph Ingredients (OTC) (UV Filters)

Click here to search FDA Monograph Ingredients (OTC) (UV Filters) in Cosmetics on GlobalCosIng.

Regulations and Standards

The MoCRA (Modernization of Cosmetics Regulation Act of 2022)
The Federal Food, Drug, and Cosmetic Act (FD&C Act)
Color Additives and Cosmetics

Our Services

The United States Agent
The United States FDA Cosmetic Facility Registration
The United States FDA Cosmetic Product Listing
The United States FDA OTC Drug Registration
The United States Color Additive Batch Certification
The United States Cosmetic/OTC Drug Labeling Review
International Cosmetic Ingredient Name (INCI) Application

If you have any questions, please contact us at cosmetic@cirs-group.com.

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