FDA Cosmetic Labeling Requirements

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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 FDA cosmetic labeling requirements 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.

What are FDA Cosmetic Labeling Requirements?

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

What are the New Labeling Requirements under MoCRA ?

Recent FDA cosmetic regulations, such as the Modernization of Cosmetics Regulation Act MoCRA, have set new cosmetic labeling requirements. 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 in nature.

It is important to note that the responsibility for product formulation lies with the manufacturer. This includes ensuring that all ingredients are permitted, that products do not contain substances on the FDA’s prohibited or restricted lists, and that overall product safety is established.

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?

Please note that our label reviews focus solely on compliance with cosmetic labeling rules and do not replace product testing, safety evaluations, or legal certifications. When you engage with FDA Listing Inc., a cosmetic labeling expert will review your product to ensure it meets the general packaging and labeling requirements outlined in the Fair Packaging and Labeling Act (FPLA).

Next, we conduct a thorough review of each specific health-related claim to ensure it will not fall into the drug category as defined by the FDA drug regulations. We will examine all aspects of direct or indirect claims to determine if they appear substantiated and truthful, and provide interpretations and recommendations for any necessary changes.

We further review your ingredients to ensure proper listing, including INCL formatting. Lastly, we examine your label from both individual regulatory and US customer perspectives. We provide suggestions for appropriate wording based on standard American English and design implications, ensuring your product resonates with the average American customer and thereby enhancing its presence in the US market.

Please feel free to call or email us if you need assistance to comply with FDA cosmetic labeling requirements.

Service Details & Fees

595 USD

5-7 Days

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Frequently Asked Questions (FAQ)

Do I need to keep the FDA Food Facility registration number in all communications and invoice?

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).

Do I need to keep the FDA Food Facility registration number in all communications and invoice?

Frequently Asked Questions (FAQ)

Service Details & Fees

Cosmetic Label Review

595 USD

Time Required

5-7 Days

Current Label Assessment

60 Days Unlimited Revisions

Discount on Multiple Labels