FDA LISTING INC: EXPERIENCED ADVISORS FOR FULL-SERVICE FDA REGISTRATION & COMPLIANCE
+1 212 444 8202
U.S. FDA Registration
& Labeling Compliance Assistance
Importance of Proper Cosmetic Labeling
Click the button below to see the service steps in an easy-to-follow graphic format.
Importance of Proper Cosmetic Labeling
Accurate and FDA-compliant cosmetic labels and claims are essential for achieving commercial success in the United States. Adhering to labeling regulations ensures compliance with FDA standards, helping cosmetic manufacturers, packagers, labelers, and brand owners avoid legal consequences, such as FDA enforcement actions. This safeguards US consumer safety, maintains supply chain stability, and strengthens a cosmetic brand’s long-term reputation.
Labeling issues are often the leading cause of delays in U.S. customs release or FDA import detentions. Incorrect or incomplete labeling can cause significant delays, disrupt supply chains, and increase costs. Accurate cosmetic labeling is essential to avoid these problems and ensure smooth import and distribution.
FDA Cosmetic Labeling Requirments
The FDA defines cosmetics as products applied to the human body to cleanse, enhance attractiveness, or change appearance without impacting the body’s structure or functions. Based on this definition, an improper therapeutic claim on a cosmetic product violates the FDA regulation. The differences between a cosmetic claim and a drug claim can be very subtle, and failure to understand the distinction can result in enforcement actions by the FDA.
Here are the key elements to consider in cosmetic label design:
● Format, Font Size, the Order of Information
● Principal Display Requirements
● Product Identity and Health Claims Statements
● Ingredients Listing Requirements
● Warning Statement Requirements
● Quantity & Place of Business Requirements
● Adverse Event Reporting Contact
New Cosmetic Label Requirments under MoCRA & More
Recent FDA cosmetic regulations, such as the Modernization of Cosmetics Regulation Act MoCRA, have set new requirements for cosmetic labeling. These include incorporating a Responsible Person’s contact information and a domestic address, declaring specific information about products for professional use, and detailing fragrance allergens.
Cosmetic ingredients must be listed according to the widely accepted International Nomenclature Cosmetic Ingredient (INCI). When formulating a cosmetic product, a manufacturer must avoid using harmful ingredients listed on the FDA’s Prohibited & Restricted Ingredients list. Cosmetics cannot include active medicinal ingredients, so any claims made about the product must be toned down to be purely cosmetic.
Furthermore, using concise and easy-to-understand language on the cosmetic label is critical, as technical terms or complex wording could confuse or mislead consumers. Given the available surface area, complying with the minimum font size requirements on the cosmetic label is vital. Cautions and warnings are another indispensable part of the cosmetic label; specific precautionary measures such as preliminary skin tests or self-pressurized container warnings are good examples.
How Can We Assist?
When you engage with FDA Listing Inc., a cosmetic labeling expert will review your product to ensure it meets the general packing and labeling requirements known as the Fair Packaging and Labeling Act (FPLA).
Next, we conduct a comprehensive review of each specific health-related claim to ensure it will not fall into the drug category as defined by the FDA drug regulations. Our thorough approach leaves no stone unturned, examining all aspects of direct or indirect claims to see if they seem substantiated and truthful and making interpretations and recommendations for changes as required.
We further review your ingredients for proper listing and cross-check them with the FDA’s available cosmetic ingredient resources. Lastly, we look at your label from the individual regulatory and US customer perspectives. We provide suggestions for proper wordings based on standard American English and design implications and interpretations in the eyes of an average American customer, ensuring your product resonates in the US market. Please feel free to call or email us if you need assistance.
Service Details & Fees
Cosmetic Label Review
Time Required
Current Label Assessment
60 Days Unlimited Revisions
Discount on Multiple Labels
595 USD
5-7 Days
_______ Related Services _______
Frequently Asked Questions (FAQ)
U.S. FDA requires filling of Prior Notice before food shipments enter the United States. This will include Prior Notice for food samples for trade shows or consumption. After filling the Prior Notice, you will be assigned with a confirmation number that will be used by your U.S. customs broker for the shipment release. A Prior Notice can also be filed by your own compnay or international transit firms as well as shipment companies (DHL, FedEx, TNT, etc).
U.S. FDA requires filling of Prior Notice before food shipments enter the United States. This will include Prior Notice for food samples for trade shows or consumption. After filling the Prior Notice, you will be assigned with a confirmation number that will be used by your U.S. customs broker for the shipment release. A Prior Notice can also be filed by your own compnay or international transit firms as well as shipment companies (DHL, FedEx, TNT, etc).
U.S. FDA requires filling of Prior Notice before food shipments enter the United States. This will include Prior Notice for food samples for trade shows or consumption. After filling the Prior Notice, you will be assigned with a confirmation number that will be used by your U.S. customs broker for the shipment release. A Prior Notice can also be filed by your own compnay or international transit firms as well as shipment companies (DHL, FedEx, TNT, etc).
U.S. FDA requires filling of Prior Notice before food shipments enter the United States. This will include Prior Notice for food samples for trade shows or consumption. After filling the Prior Notice, you will be assigned with a confirmation number that will be used by your U.S. customs broker for the shipment release. A Prior Notice can also be filed by your own compnay or international transit firms as well as shipment companies (DHL, FedEx, TNT, etc).
U.S. FDA requires filling of Prior Notice before food shipments enter the United States. This will include Prior Notice for food samples for trade shows or consumption. After filling the Prior Notice, you will be assigned with a confirmation number that will be used by your U.S. customs broker for the shipment release. A Prior Notice can also be filed by your own compnay or international transit firms as well as shipment companies (DHL, FedEx, TNT, etc).
Frequently Asked Questions (FAQ)
U.S. FDA requires filling of Prior Notice before food shipments enter the United States. This will include Prior Notice for food samples for trade shows or consumption. After filling the Prior Notice, you will be assigned with a confirmation number that will be used by your U.S. customs broker for the shipment release. A Prior Notice can also be filed by your own compnay or international transit firms as well as shipment companies (DHL, FedEx, TNT, etc).
U.S. FDA requires filling of Prior Notice before food shipments enter the United States. This will include Prior Notice for food samples for trade shows or consumption. After filling the Prior Notice, you will be assigned with a confirmation number that will be used by your U.S. customs broker for the shipment release. A Prior Notice can also be filed by your own compnay or international transit firms as well as shipment companies (DHL, FedEx, TNT, etc).
U.S. FDA requires filling of Prior Notice before food shipments enter the United States. This will include Prior Notice for food samples for trade shows or consumption. After filling the Prior Notice, you will be assigned with a confirmation number that will be used by your U.S. customs broker for the shipment release. A Prior Notice can also be filed by your own compnay or international transit firms as well as shipment companies (DHL, FedEx, TNT, etc).
Service Details & Fees
Cosmetic Label Review
595 USD
Time Required
5-7 Days
Current Label Assessment
60 Days Unlimited Revisions
Discount on Multiple Labels
_______ Related Services _______