Cosmetic labelling: FDA (MoCRA) and EU/UK requirements

Cosmetic labels look simple: a name, a few claims, an ingredient list. In practice, they carry a set of required information that differs between the United States, the European Union and the United Kingdom, and US rules changed significantly with the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). This guide sets out what usually has to appear on a cosmetic label in each market and how to plan packaging that works across them.

It is general guidance, not legal advice. Whether a product is a cosmetic at all depends on its intended use and claims; some products, such as sunscreens and antiperspirants in the US, are regulated as drugs. Use the official sources linked below and confirm your label with a qualified adviser.

United States: FDA and MoCRA

In the US, cosmetics are regulated by the FDA under the Federal Food, Drug, and Cosmetic Act and the Fair Packaging and Labeling Act. Labelling rules are in 21 CFR Part 701 and related sections.

Required label elements

On the principal display panel of the outer container:

• Statement of identity: the common name of the product, or a descriptive name, such as "Moisturizing Face Cream".
• Net quantity of contents: in both metric and US customary units, in the bottom 30% of the panel, with minimum type sizes based on panel area.

On an information panel:

• Ingredient declaration: ingredients in descending order of predominance, with some flexibility for ingredients at 1% or less and for colours. See our INCI guide for detail.
• Name and place of business of the manufacturer, packer or distributor, qualified where needed with "Manufactured for" or "Distributed by".
• Warnings, where required, such as for aerosol products, feminine deodorant sprays or products whose safety has not been substantiated.

If a product has an outer carton and an inner container, both may need certain information.

What MoCRA added

MoCRA gave the FDA new powers and added requirements for cosmetic companies. Several affect labels or the information behind them:

• Adverse event contact. Labels must include a domestic address, domestic phone number or electronic contact information, such as a website, through which the responsible person can receive reports of adverse events.
• Fragrance allergens. MoCRA directs the FDA to issue rules requiring fragrance allergens to be identified on labels. Watch for the final rule and its compliance date.
• Professional use. Products intended only for use by licensed professionals must be labelled clearly to say so.
• Facility registration and product listing. Not a label requirement, but companies must register facilities and list products with the FDA.
• Safety substantiation and adverse event reporting. The responsible person must ensure adequate substantiation of safety and report serious adverse events.

MoCRA's requirements have phased in over several years, and some details depend on FDA rules still being finalised. Check the FDA's MoCRA page for current status.

European Union: Regulation (EC) No 1223/2009

In the EU, cosmetic products are governed by the Cosmetics Regulation. Article 19 sets out what must appear on the container and packaging. Most items must be on both, in indelible, easily legible and visible lettering:

1. Name and address of the Responsible Person, who must be established in the EU. An abbreviated address is allowed if the person can be identified.
2. Country of origin for imported products.
3. Nominal content by weight or volume, with exceptions for small packages, free samples and some products sold by number.
4. Date of minimum durability if the product lasts 30 months or less, shown with an hourglass symbol or "best used before the end of". If it lasts longer, a period after opening (PAO) symbol, the open jar with a number of months, shows how long it can be used after opening.
5. Precautions for use, including those listed in the annexes to the Regulation for specific ingredients.
6. Batch number or other reference for identifying the product.
7. Function of the product, unless clear from its presentation.
8. List of ingredients, which may appear on the outer packaging only.

When it is impossible for practical reasons to put some information on the label, for example on very small products, it can appear on an enclosed leaflet, label, tape, tag or card, with a symbol (a hand pointing to an open book) on the container referring to it.

Language

Member states can require that certain information, such as precautions, function and content, be in their official language or languages. If you sell across several EU countries, plan for multi-language labels or market-specific versions.

Claims

Cosmetic claims in the EU must meet common criteria set out in Commission Regulation (EU) No 655/2013, including legal compliance, truthfulness, evidential support, honesty, fairness and informed decision-making. Claims such as "free from" or "hypoallergenic" need particular care.

United Kingdom

In Great Britain, cosmetics follow UK rules that are based on the EU Regulation. The label requirements are very similar, with key differences:

• The label must name a UK Responsible Person with a UK address.
• Products must be notified on the UK's SCPN portal before sale.
• Rules can diverge from the EU over time.

Northern Ireland continues to follow EU cosmetics rules under the Windsor Framework, so products sold there need an EU or NI Responsible Person.

Side-by-side checklist

| Item | US | EU | UK (GB) | |---|---|---|---| | Product identity or function | Statement of identity on PDP | Function, unless obvious | Function, unless obvious | | Net quantity | Metric and US units, bottom 30% of PDP | Metric, nominal content | Metric, nominal content | | Ingredients | Descending order, on outer pack | INCI, descending order | INCI, descending order | | Responsible business | Manufacturer, packer or distributor | EU Responsible Person | UK Responsible Person | | Adverse event contact | Domestic contact required (MoCRA) | Responsible Person | Responsible Person | | Durability | Not generally required | Best before or PAO symbol | Best before or PAO symbol | | Batch number | Not federally required | Required | Required | | Country of origin | Required for imports under customs rules | Required for imports | Required for imports |

Designing for several markets

A single label for the US, EU and UK is possible but needs planning:

• Reserve space for several addresses and contact details.
• Use INCI names for ingredients, which are accepted in the EU and UK and widely used in the US, while checking where US rules require different names.
• Combine durability marks carefully; PAO symbols are not required in the US but are usually fine to include.
• Check net quantity formats for each market.
• Allow for languages if you sell in non-English-speaking EU countries.

Alternatively, design a shared front panel with market-specific back panels or stickers. This can be simpler when requirements differ significantly.

Common cosmetic label mistakes

• No adverse event contact on US packs. Older labels may predate the MoCRA requirement for a domestic contact.
• The wrong Responsible Person. An EU address on products sold in Great Britain, or a UK address on products sold in the EU.
• Missing batch numbers. Often left off small containers in the EU and UK, where they are required.
• Durability marks used incorrectly. A PAO symbol on a product that lasts 30 months or less, which needs a best-before date instead.
• Drug claims on cosmetics. Words such as "treats acne", "heals" or "anti-inflammatory" can turn a cosmetic into a drug in the US or a medicine in the EU and UK.
• Precautions in the wrong place. Warnings required by the EU annexes for specific ingredients missing from the container when there is no outer box.

Small containers and samples

Lip balms, sample sachets and miniatures have very little space. The rules allow some flexibility. In the EU and UK, certain information can appear only on the outer packaging, or on an enclosed leaflet, tag or card with the hand-and-book symbol. In the US, some information can appear on an outer container or tag. Plan these options early, because they change the structure of the packaging as well as the artwork.

How we help

We design cosmetic and skincare packaging and make cartons and rigid boxes in our own factory. We lay out the label text you supply, plan panel space for each market and check legibility at actual size. We do not decide what your label must say or confirm compliance; final regulatory review stays with you and your Responsible Person or adviser.

See our cosmetic packaging design and skincare packaging design services, or get a free quote for your range.

Official sources

• FDA: Cosmetics labeling regulations
• FDA: Modernization of Cosmetics Regulation Act of 2022 (MoCRA)
• 21 CFR Part 701: Cosmetic labeling (eCFR)
• EUR-Lex: Regulation (EC) No 1223/2009 on cosmetic products
• GOV.UK: Making cosmetic products available in Great Britain

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Questions

What changed for cosmetic labels under MoCRA?

MoCRA added requirements including a domestic US address, phone number or electronic contact on the label for adverse event reports, and directed the FDA to set rules on fragrance allergen labelling.

Does an EU cosmetic label need a Responsible Person?

Yes. The name and address of the EU Responsible Person must appear on the label. The UK requires a UK Responsible Person for Great Britain.

What is the open jar symbol?

The period-after-opening symbol shows how long a product stays good after opening. In the EU it is used when the minimum durability is more than 30 months.

Can one label work for the US, EU and UK?

Often, with careful planning, but contact details, ingredient naming and some warnings differ. Plan the panels for every market before design.