Cosmetic products sold in the US must be compliant with three regulations:
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.
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
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.
Location:
Prominence:
Conspicuousness:
Type Size:
Examples of Statements:
The directions for use must detail how the consumer is to use the product as intended to achieve the benefit.
Warnings must be in bold type and on a contrasting background. The minimum type size for warnings is 1/16” (1.59mm).
Certain types of cosmetic products will require specifically worded warnings:
Cosmetic Aerosols
Feminine Deodorants
Foaming Detergent Bath Products
21 CFR Part 740.10 Warning
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 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.
Location:
Naming & Formatting:
Size & Prominence:
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.’
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:
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.
