US Cosmetic Labeling Compliance: Key Regulations and MoCRA Requirements

Cosmetic products sold in the US must be compliant with three regulations:

1. Food, Drug & Cosmetic Acid 1938 (FD&C Act)
2. Fair Packaging & Labelling Act
3. Modernization of Cosmetics Regulation Act (MoCRA)

The FD&C Act is in place to ensure consumers are protected from unsafe or deceptively labelled products. The Fair Packaging & Labelling Act is there to provide consumers with accurate information about the quantity of contents. This Act applies to various industries including cosmetics. MoCRA is the newest regulation which applies to cosmetics sold in the US, it includes additional new labelling requirements which also need to be included on the product label. 

Principal Display Panel (PDP)

The PDP is the part of the label that the consumers sees when the product is displayed for retail sale. This usually tends to be the front label of the secondary/outer carton and takes up the entire side of that packaging. It is not possible for a product sold without a secondary/outer carton to have a PDP, therefore the rules for PDPs do not apply to products sold with primary/inner labelling only. 

Labelling requirements such as the font/type size and location of the net quantity of contents are based on the surface area of bearing the PDP. 

Other panels are referred to as ‘information panels’ as they include the other information which is required on a cosmetic product label. The bottom panels of a secondary/outer label are not considered as PDPs unless this is picked up by hand when selected for purchase. 

For small packaging such as compacts and those containing 1/4oz or less of product, the PDP can be a tear away tag, tape affixed to the container or it can be a display panel of a card affixed to the container.

The below tables show which labelling information needs to be on which label and which panel of the label.

Secondary/Outer Labelling Requirements

Primary/Inner Labelling Requirements - for products packaged within a secondary/outer

Primary/Inner Labelling Requirements - for products not packaged within a secondary/outer

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Product Identity

This refers to the function of the product which must be displayed on the label. For example, a moisturiser or other appropriately descriptive name. It may also be expressed in the form of an illustration. The statement must be in bold and must be parallel to the base on which the product rests when displayed in retailers. 

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Net Quantity of Contents

Location:

• If the product is sold in a secondary carton, the net contents statement must appear within the bottom 30% of the PDP of the secondary carton, parallel in line to the base on which the package rests & on the information panel of the inner container
• The bottom location requirement is waived for PDPs of 5 sq. in. or less.
• For decorative containers or those with less than 1/4 oz., the declaration is to appear on the tag, tape or display card.

Prominence:

• The declaration must be a distinct item, separated from other printed matter by a space equal to at least the height of the lettering used in the declaration and twice the width of the letter ‘N’

Conspicuousness:

• The type must be easily legible & in distinct contrast to background and other matter on the package
• The letter height must be at least that of the lower case letter “o” and the aspect ratio of height to width must not exceed 3:1.

Type Size:

• PDP less than 5 sq. in. - 1/16” (1.59mm)
• PDP 5-25 sq. in. - 1/8” (3.18mm)
• PDP 25-100 sq. in. - 3/16” (4.76mm)
• PDP >100 sq. in. - 1/4” (12.7mm)

Examples of Statements:

• Net contents 30ml/1 fl. oz.
• 30ml/1 fl. oz. Net
• 30ml/4 fl. oz.

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Directions for Safe Use

The directions for use must detail how the consumer is to use the product as intended to achieve the benefit. 

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Warnings

Warnings must be in bold type and on a contrasting background. The minimum type size for warnings is 1/16” (1.59mm). 

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Certain types of cosmetic products will require specifically worded warnings:

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Cosmetic Aerosols

• A cosmetic packaged in a self-pressurised container and intended to be expelled from the package under pressure must bear the following warning - ‘Warning - Avoid spraying in eyes. Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120°F. Keep out of reach of children.’ (21 CFR 740.11 (a))
• The words ‘Avoid spaying in eyes’ can be omitted if the product is not expelled as a spray e.g. aerosol shaving cream
• The word ‘puncture’ may be replaced by the word ‘break’ if the product is packaged in a glass container
• If the product is intended for use by children, the phrase ‘except under adult supervision’ may be added at the end of the last sentence of the warning.
• If the propellant of a cosmetic packaged in a self-pressurised container consists in whole or in part of a halocarbon or hydrocarbon, the label must bear the following second warning ; ‘Warning - Use only as directed. Intention misuses by deliberately concentrating and inhaling the contents can be harmful or fatal’ (21 CFR 440.11 (b))

Feminine Deodorants

• A feminine deodorant spray which is defined as ‘any spray deodorant product whose labelling represents or suggests that the product is for use in the female genital area or for use all over the body’ must display the following warning - ‘Caution - For external use only. Spray at least 8 inches from the skin. Do not apply to broken, irritated or itching skin. Persistent, unusual odor or discharge may indicate conditions for which a physician should be consulted. Discontinue use immediately if rash, irritation or discomfort develops’
• The use of the word ‘hygiene’ or ‘hygienic’ or similar words renders any such product misbranded.

Foaming Detergent Bath Products

• A foaming detergent bath product which not clearly labelled as intended for use exclusively as adults and is defined as ‘any product intended to be added to a bath for the purpose of producing foam that contains a surface-active agent serving as a detergent or foam ing ingredient’ must display the following warning - ‘Caution - Use only as directed. Excessive use of prolonged exposure may cause irritation to skin and urinary tract. Discontinue use if rash, redness or itching occurs. Consult your physician if irritation persists. Keep out of reach of children.’

21 CFR Part 740.10 Warning

• A cosmetic is considered misbranded if its safety has not been adequately substantiated and it does not bear the following statement on the PDP - ‘Warning - The safety of this product has not been determined’

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Name & Place of Business & US RP

The name and place of business on the label can be that of the manufacturer, packer or distributor. A cosmetic brand is usually the distributor, unless they are also manufacturing the product themselves. If there is a name and address present which is not of the manufacturer this address should be preceded by statements such as ‘Distributed by…’

Under MoCRA, there is a requirement for the US Responsible Person (RP) to be indicated on the label. The US RP is the manufacturer, packer or distributor. As one of these is already required to be on the packaging, the requirement should already be met and the US RP identified. MoCRA provides additional information on the contact information of the US RP which should be displayed on the label. The following should be displayed on the label:

• The name of the US RP - this can be a business/brand name, there is no requirement to name an individual; &
• Domestic physical address - virtual addresses are not permitted; OR
• Domestic phone number; OR
• Electronic Contact Information - such as a website or email address.

The main purpose of having contact information on the product label is to ensure that consumers can report adverse and serious adverse events to the US RP. 

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Ingredients List

Location:

• The ingredients list can appear on any information panel of the package where there is a secondary/outer carton
• If there is a secondary/outer carton, the ingredients list is not required on the primary/inner label
• If there is no secondary/outer carton, the ingredients list is to appear on the primary/inner

Naming & Formatting:

• INCI names to be used
• EU & US names can be harmonised e.g. ‘Water (Aqua)’ or ‘Beeswax (Cera Alba)‘
• Must be listed in descending order of prominence, anything below 1% can be listed in any order after those above 1%
• Colourants are to be listed at the end of the ingredients list
• There is a new requirement under MoCRA to label EU Fragrance allergens on the US INCI. These rules are due to be published by the FDA in December 2024. It is not known whether the extended allergen list will need to be included. 

Size & Prominence:

• The minimum type size is a minimum height of 1/16” (1.59mm)

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Other Label Requirements

Country of Origin

If a cosmetic product is imported in the US for safe, the product must label the English name of the country of origin in accordance with Tariff Act 1930

Batch Code

The batch code must be present on the product packaging, this is usually added during the manufacturing process. The batch code must be traceable and does not need to follow a specific format. 

Expiry Date/Period After Opening (PAO)

The expiry date can be displayed as MMYYYY or a PAO symbol can be used based on the product’s stability testing and recommendations following this. 

Professional Use

Under MoCRA, products for professional use must bear specific labelling from 29th December 2023. There must be a clear statement on the product which is clear and prominently displayed. It must indicate that the product shall be administered or used only by licensed professionals. ‘Professional’ is defined as ‘an individual who is licensed by an Official State authority to practise in the field of cosmetology, nail care, barbing or esthetician.’

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Product Claims

The cosmetic product labelling will usually include some product claims. These claims are not reviewed or approved by the FDA prior to sale of the product and there is no FDA list of approved claims for cosmetic products. All cosmetic product claims must be truthful and not misleading, they cannot be related to the treatment and prevention of disease or affecting the structure or function of the body as these claims would be viewed as drug/medicinal claims by the FDA. All cosmetic claims must be substantiated appropriately. 

A cosmetic product in the US cannot claim the following:

• Anti-perspiring, anti-acne, anti-dandruff, anti-cavity, anti-breakage
• Whitening
• Hair growth
• Protection of broken skin
• Sun protection

Digital Labelling

There are currently no plans for the US Cosmetic Labelling information to be available to the public digitally under MoCRA. All of the required information discussed above must be present on the cosmetic product labels. QR codes may be used to duplicate the information already present on the product labels but it does not replace this information. 

It is recommended that product labels are reviewed and approved by the US Responsible Person and someone has a competent level of technical knowledge pertaining to the regulation of sale of cosmetic products in the US.