What Are the Latest US FDA Cosmetics Labelling Guidelines?

Allergic reactions caused by exposure to cosmetic ingredients are becoming increasingly common in the United States. These reactions may range from mild irritation to severe responses such as anaphylaxis. While the food industry already follows strict allergen disclosure regulations, the cosmetics industry is now under stronger scrutiny after the implementation of the Modernization of Cosmetics Regulation Act (MoCRA). With MoCRA, the FDA has intensified enforcement around FDA cosmetics labelling requirements, especially allergen disclosures, ingredient declarations, and safety-related information.

As a result, cosmetics manufacturers, private label companies, importers, distributors, and contract manufacturers must comply with the updated MoCRA-compliant cosmetics labelling guidelines to avoid misbranding and regulatory violations. This blog offers an easy-to-understand overview of the latest FDA cosmetic labelling guidelines, helping brands ensure consumer safety and regulatory compliance in the USA.

FDA Allergens List for Cosmetics Products
The FDA recognizes that certain allergens in cosmetics cause most allergic reactions. Under the Fair Packaging and Labeling Act (FPLA), the FDA requires that cosmetic ingredients be clearly declared on the product label. According to FDA guidelines, allergens are broadly categorized into metals, preservatives, dyes, fragrances, and natural rubber. These ingredient classes are responsible for a majority of irritation and sensitivity cases reported by consumers using cosmetics, skincare, and personal care products.

How MoCRA Has Changed FDA Cosmetics Labelling Guidelines
MoCRA is the most significant reform in US cosmetic regulations in decades. It strengthens the FDA’s authority over cosmetics sold in the United States, ensuring higher product transparency and consumer safety. Under MoCRA, every cosmetic company must submit a product listing that includes ingredients, warnings, and facility registration. This rule applies to cosmetics manufacturers, private label brands, third-party manufacturers, US cosmetic importers, and distributors.

One of the biggest updates under MoCRA is the requirement to disclose fragrance allergens on product labels. Brands selling skincare, personal care, and cosmetic products in the US must ensure their labels identify any allergens present in fragrances—an essential step to remain MoCRA-compliant and avoid penalties.

Understanding the New FDA Cosmetics Labelling Requirements
The updated FDA labelling guidelines under MoCRA outline what must be included on every cosmetic product label before it can be sold in the US. Every cosmetic label must clearly display the product identity, its net quantity of contents, and a complete ingredient list using acceptable nomenclature. Business information—including the name and physical address of the manufacturer, packer, or distributor—must be mentioned accurately.

Labelling errors can result in a cosmetic being classified as misbranded, which can lead to regulatory issues. The updated guidelines also define requirements around label placement, font size, visibility, and prominence. With MoCRA in force, the importance of correct cosmetic labelling is higher than ever, especially for brands exporting products to the United States.

Key Considerations for Designing FDA-Compliant Cosmetic Labels
When preparing a cosmetic label for the US market, brands must ensure the label is large enough for mandatory details to be displayed clearly. Ingredients should appear in descending order of predominance, using INCI names where available. Any required warnings, safety instructions, or directions for use must appear in a readable and noticeable manner.

If the product packaging contains multiple labels, the primary display panel must carry core details. It is also important to avoid misleading terminology, as the FDA does not regulate the use of claims like “natural” or “organic.”

The essential label content includes the product name, net quantity, ingredient list, warnings, caution statements, and the manufacturer or distributor’s place of business. These rules apply universally across skincare, cosmetics, oral care, and personal care products being marketed in the USA.

How Ingredients Should Be Listed on Cosmetic Labels (As per MoCRA)
The FDA, under MoCRA, requires that ingredients be listed using INCI names and arranged in descending order of their weight. Ingredients at less than 1% concentration may appear in any order after the major ingredients. The ingredient list must be displayed prominently on the information panel, typically located on the side or back of the packaging.

Color additives must be declared using FDA-approved colorant names. Fragrance and flavor components may be listed collectively, but all fragrance allergens must be disclosed separately. Trade-secret ingredients can be exempted if they meet FDA criteria for confidentiality.

Updated FDA Cosmetics Labelling Requirements (Post-MoCRA)
Under MoCRA, the product’s identity must be clearly stated—whether it is a face wash, moisturizer, serum, shampoo, lipstick, or toothpaste. The net quantity should be listed in weight or numerical count. The complete ingredient declaration is mandatory, including color additives and fragrances. Additionally, the label must mention the name and address of the manufacturer or distributor, along with any required safety warnings.

Fragrance allergens are now compulsory to disclose under MoCRA. This is a major shift for fragrance-rich products such as lotions, mists, serums, creams, and body care products.

How HCP Wellness Helps Brands Achieve MoCRA-Compliant Cosmetics Labelling for the USA Market
As more brands plan to enter the US market, navigating the new MoCRA regulations can feel overwhelming. This is where HCP Wellness, a leading FDA-compliant cosmetics manufacturer, skincare manufacturer, oral care manufacturer, and private label supplier, supports brands end-to-end.

HCP Wellness has extensive experience manufacturing products for US-based companies, export brands, and private label entrepreneurs. With advanced R&D facilities, GMP-certified manufacturing units, and knowledge of MoCRA-compliant documentation, FDA-approved cosmetic labelling, ingredient safety data, technical files, formulation compliance, and USA packaging requirements, HCP helps brands launch products that meet all regulatory standards.

Whether you need custom formulation, third-party manufacturing, private label production, MoCRA-compliant labels, or USA-ready documentation, HCP Wellness ensures smooth, reliable execution. With ultramodern machinery and a strong compliance team, the company provides:
● MoCRA-compliant skincare, cosmetic, oral care & hygiene product manufacturing
● US export-ready labelling support
● Ingredient safety review & formula validation
● Packaging artwork guidance as per FDA layout requirements
● Support for USA importers, distributors, private label brands
● High-quality manufacturing with consistent quality control

Brands across the world trust HCP Wellness for USA private label cosmetics, MoCRA-compliant skincare manufacturing, and export-grade toothpaste production, thanks to its decades of industry expertise and full regulatory support.

If you require MoCRA-ready manufacturing or need help preparing FDA-compliant labels, ingredient lists, safety documentation, or product artwork for the US market, the HCP Wellness compliance team can guide you with ease.

To discuss your private label or export requirements for USA markets, you can contact HCP Wellness at: