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FDA Labelling Guideline for Cosmetics: What Companies Need to Know Before Selling in the U.S.
- Daniel Jiménez
- 3 hours ago
- 5 min read
Entering the U.S. cosmetic market is an exciting opportunity, but labeling compliance is often one of the first regulatory hurdles brands encounter. Unlike some jurisdictions, the United States does not require preapproval of cosmetic products before they are marketed. However, this does not mean labeling rules are simple - or optional.
Cosmetic labeling is heavily regulated under federal law, and non‑compliant products may be considered misbranded, leading to import refusals, warning letters, market recalls or enforcement actions.
This article explains the key FDA labeling principles for cosmetics, what companies should understand before launching, and why compliance is often more complex than initially appears.
Table of contents
The Regulatory Framework Behind FDA Cosmetic Labeling
Cosmetic labeling in the United States is primarily governed by three legal pillars:
• Federal Food, Drug, and Cosmetic Act (FD&C Act)
• Fair Packaging and Labeling Act (FPLA)
• FDA regulations under 21 CFR Parts 701 and 740
These laws aim to protect consumers from misleading information and ensure transparency regarding product content and safety.
Importantly, the FDA regulates labeling, meaning not only the physical label but also any written or graphic material accompanying the product. This includes packaging, inserts, and sometimes marketing claims linked to the product presentation.
The Two Core Label Sections: PDP and Information Panel
One of the most fundamental concepts in U.S. labeling (and one frequently misunderstood by international brands) is the distinction between the Principal Display Panel (PDP) and the Information Panel.
The Principal Display Panel is typically the part of the packaging most visible to consumers at the point of sale. It must include key identifying information such as:
• Product identity
• Nature or function of the product
• Net quantity of contents
The remaining required information may appear on the Information Panel, which usually sits adjacent to the PDP and includes company details, ingredients, and other regulatory statements.
Product Identity: More Than Just a Marketing Name
The identity statement must clearly describe what the product is and what it does. This requirement may seem simple, but it intersects directly with one of the most critical regulatory risks in the U.S.: cosmetic vs. drug classification.
Claims suggesting therapeutic or physiological effects — such as treating acne, repairing skin damage, or stimulating collagen — may cause a cosmetic to be regulated as an over‑the‑counter drug instead.
The distinction between cosmetic and drug claims is one of the most frequent causes of regulatory action in the U.S. market.
Net Quantity of Contents: Technical Rules That Matter
The net quantity declaration must accurately reflect the amount of product in the package and follow specific formatting requirements regarding measurement units, placement on the package, and visibility and prominence.
For liquids, volume units are used; for solids or semi‑solids, weight units apply. U.S. customary units are mandatory, although metric equivalents may also be included.
Many companies underestimate the complexity of this requirement, particularly when adapting labels originally designed for EU or Asian markets.
Name and Place of Business: Who Is Responsible?
Cosmetic labels must identify the name and address of the manufacturer, packer, or distributor responsible for marketing the product.
If the company listed is not the manufacturer, wording such as “Manufactured for” or “Distributed by” is typically required to avoid misleading consumers.
This requirement becomes particularly relevant for private label brands, importers, international distributors, and contract manufacturing arrangements.
Ingredient Declaration: Transparency with Specific Rules
Ingredient labeling is mandatory for most retail cosmetic products in the United States.
Ingredients must generally be listed in descending order of predominance, with certain regulatory nuances for ingredients present at low concentrations and for color additives.
While the U.S. system shares similarities with EU INCI labeling, there are important differences that can affect global label harmonization strategies.
Warnings and Safety Statements: When Are They Required?
Some cosmetic categories require specific warnings, particularly when misuse pose a safety risk.
Additionally, if product safety has not been adequately substantiated, the label must include a statement indicating that safety has not been determined.
Companies sometimes overlook this requirement when relying on supplier data or incomplete safety documentation.
Language and Readability Requirements
All mandatory label information must appear in English for products marketed in the United States and must be presented prominently and clearly to consumers.
Typography, contrast, and legibility all play a role in determining compliance — aspects that may seem purely aesthetic but can have regulatory implications.
Imported Cosmetics: Country of Origin and Additional Considerations
For imported cosmetics, country of origin marking is typically required under U.S. customs laws.
Although not strictly an FDA requirement, failure to comply may still result in border issues or market access delays.
Common Labeling Mistakes Seen in the U.S. Market
Across international projects, several recurring compliance issues appear:
· Druglike claims on cosmetic labels
· Incorrect or missing net quantity formatting
· Improper ingredient declaration order
· Missing company qualification wording (“distributed by”)
· Non‑compliant placement of mandatory information
· Labels copied from EU versions without adaptation
How U.S. Labeling Differs from EU and UK Requirements?
For companies operating globally, understanding regulatory differences is essential.
For example, the EU requires additional elements such as durability dates or Period After Opening symbols, which are not mandatory in the U.S. unless relevant. EU labeling is also linked to Responsible Person obligations and product notification systems.
Although frameworks share similarities, assuming that one label works worldwide is rarely correct.
The Impact of MoCRA on Cosmetic Labeling
The Modernization of Cosmetics Regulation Act (MoCRA) represents the most significant update to U.S. cosmetic regulation in decades.
Among other provisions, MoCRA introduces new requirements related to adverse event reporting, safety substantiation expectations, facility registration and product listing, and potential future labeling updates.
Companies entering the U.S. market should consider these evolving requirements when designing labels today.
Why Cosmetic Label Compliance Is Often More Complex Than Expected?
At first glance, FDA labeling requirements may appear straightforward. However, in practice, compliance involves regulatory interpretation, claims assessment, safety documentation alignment, cross‑border regulatory strategy, and risk management decisions.
Labeling is not simply a design task — it is a regulatory decision‑making process.
Final Thoughts
The U.S. cosmetic market offers significant opportunities, but labeling compliance is one of the most critical aspects of regulatory readiness.
Understanding the FDA framework is the first step, but achieving compliance often requires deeper expertise, particularly for international brands navigating multiple regulatory systems simultaneously.
If your company is planning to enter the U.S. market, update existing labels, or verify compliance under current FDA and MoCRA requirements, Belab Services can support you.
Our regulatory specialists provide:
• FDA cosmetic label compliance assessments
• Claims and classification risk evaluation
• Global label harmonization strategies (USA, EU, UK and worldwide)
• Regulatory support for market entry and ongoing compliance
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