Cosmetic Packaging Design: FDA Requirements, INCI Lists, and EU Compliance

Cosmetic labelling in the US has historically been among the less prescriptive regulatory regimes in the personal care industry. That changed meaningfully with the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), which gave the FDA new authority over cosmetic facility registration, safety substantiation, serious adverse event reporting, and product recall.

For packaging design purposes, the fundamental labelling requirements remain governed by the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act (FPLA). This guide covers what goes on the label, where it goes, and how US requirements differ from EU standards for brands selling internationally.

The US Regulatory Framework for Cosmetics

A cosmetic is defined under the FD&C Act as "articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance." This covers: skincare, haircare, makeup, nail products, deodorants, moisturisers, perfumes, mouthwash, toothpaste, and shampoo.

Cosmetics do not require FDA pre-market approval — unlike drugs. You don't submit your formula for review before you launch. The responsibility for product safety sits with the manufacturer and brand owner.

When does a cosmetic become a drug? When it makes a therapeutic claim. A moisturiser that claims to "hydrate the skin" is a cosmetic. A moisturiser that claims to "treat dry skin caused by eczema" is making a drug claim and falls under drug regulations — which require pre-approval, GMP compliance as a drug manufacturer, and a Drug Facts panel rather than a cosmetic label. The boundary between cosmetic claim and drug claim matters enormously for your label.

Mandatory Elements on a US Cosmetic Label

1. Identity of the Product (Statement of Identity)

The principal display panel must include a statement identifying the product. This can be the product name if the name accurately identifies the product ("Hydrating Face Serum," "Volumising Mascara") or an additional descriptor if the name alone doesn't communicate the product type.

2. Net Quantity of Contents

Required on the principal display panel. Must be in both metric and imperial (US customary) units. Regulated size requirements apply proportional to the PDP area (21 CFR 701.13).

3. Distributor/Manufacturer Name and Address

The name and principal place of business must appear on the label. If the distributor is not the manufacturer, a qualifying phrase is required: "Manufactured by," "Distributed by," or "Manufactured for."

Under MoCRA, cosmetic facility registration requirements also apply — manufacturers and processors of cosmetics for distribution in the US must register with the FDA. While this is a business compliance requirement rather than a label element, it's relevant for any brand source from a contract manufacturer.

4. Ingredient List (INCI Order)

The ingredient list is required on all cosmetic products marketed in the US. The ingredients must be:

• Listed in descending order of predominance — the ingredient present in the greatest amount by weight is listed first
• Identified using the INCI (International Nomenclature of Cosmetic Ingredients) name for each ingredient

INCI naming is the global standard for cosmetic ingredient identification — it provides a consistent, international name for each ingredient regardless of what common names brands prefer to use. "Retinol" is INCI; "Vitamin A" is not. "Tocopherol" is INCI; "Vitamin E" is not. Some ingredients have multiple INCI names depending on form or source.

Ingredients present at 1% or less can be listed in any order after all ingredients present at more than 1%. Colour additives can be listed last regardless of amount.

Fragrance and flavour ingredients are permitted to be listed simply as "Fragrance" or "Flavor" rather than individual components, protecting proprietary formulations. However, MoCRA has provisions that may require fragrance allergen disclosure beyond the general "Fragrance" listing — watch for FDA guidance on this.

5. Warnings and Cautions

Where applicable to the product type, mandatory warnings must appear. These include:

• Flammability warnings for aerosols and products containing flammable solvents
• Keep out of reach of children (when applicable)
• Eye product warnings: "If irritation develops, discontinue use and consult a physician"
• Specific warnings for products used near eyes, on broken skin, or during pregnancy
• Sunscreen warnings and drug-cosmetic hybrid warnings (sunscreen is regulated as an OTC drug in the US, not a cosmetic — it requires Drug Facts panel format)

6. Country of Origin

Not uniformly required for all cosmetics in the US, but required by US Customs for imported goods. Many brands include it voluntarily or because specific retail partners require it.

The INCI Ingredient List in Practice

Building a correct INCI ingredient list requires starting from your formula with exact percentages, then translating each ingredient to its correct INCI name and ordering them properly.

Common mistakes in cosmetic ingredient lists:

Using common names instead of INCI names "Shea butter" is how consumers know the ingredient. On the label: "Butyrospermum Parkii (Shea) Butter" — the INCI name, with the common name optionally in parentheses. Using only the common name is technically non-compliant with US labelling requirements.

Wrong ordering Brands often want to list their hero active ingredient first because it's a selling point. If that ingredient is present at 0.1% and water is the base of the formula at 70%, water goes first and the hero active ingredient goes near the end. The ordering requirement is not optional.

Missing sub-ingredients If your formula uses a pre-blended ingredient (a commercial blend of multiple raw materials), each constituent raw material must appear in the ingredient list at its correct position by weight — not just the trade name of the blend.

Not updating for formula changes Formula changes must trigger a label review. A preservative swap, a concentration change of an active ingredient, a new fragrance supplier — all of these can change both the ingredient identities and their ordering. The label must match the formula as actually manufactured.

Cosmetic Claims: The Drug Boundary

The line between cosmetic and drug claims is the most commercially important compliance question for cosmetic brands. The FDA's published guidance and enforcement actions define where it is.

Cosmetic claims (permitted without drug registration):

• "Moisturises skin"
• "Reduces the appearance of fine lines" (appearance claim — not treating an underlying condition)
• "Brightens skin tone"
• "Strengthens hair"
• "Defines lashes"
• "Volumising" / "Lengthening"
• "Long-lasting"

Drug claims (require OTC drug approval or NDA):

• "Treats acne" — acne is a skin condition; treating it is a drug claim
• "Reduces wrinkles" (not "appearance of wrinkles" — the distinction matters)
• "Prevents hair loss" — hair loss has medical causes; prevention implies treatment
• "Kills bacteria that cause odour" — killing bacteria is a drug action (though deodorants are typically regulated as cosmetics and antiperspirants as OTC drugs)
• "Heals dry, cracked skin"
• "Treats rosacea"

The "appearance of" hedge is real but finite. "Reduces the appearance of fine lines" is a cosmetic claim. "Reduces fine lines" implies actual tissue change and gets closer to drug territory. The FTC also has jurisdiction here — if the claim implies efficacy the product cannot deliver, that's deceptive advertising.

EU Cosmetics Regulation 1223/2009

If you're selling cosmetics in the European Union (or the UK post-Brexit under its adopted equivalent), the regulatory framework is more demanding than the FDA regime in several respects.

Responsible Person

Every cosmetic product placed on the EU market must have a designated "Responsible Person" — an EU-based entity (manufacturer, distributor, or appointed representative) who assumes regulatory responsibility for the product's compliance. This is a business requirement with label implications: the Responsible Person's name and address must appear on the label.

Product Information File (PIF)

The Responsible Person must maintain a Product Information File before placing the product on the market. The PIF includes: product description, safety assessment, method of manufacture, evidence of claimed effects, and data on animal testing. The safety assessment must be conducted by a qualified cosmetic safety assessor.

Mandatory Label Elements Under EU Cosmetics Regulation

• Name and address of the Responsible Person
• Country of origin (for products manufactured outside the EU)
• Net content by weight or volume (in metric, for pre-packaged products where relevant)
• Date of minimum durability ("best before" date) — mandatory for products with shelf life of 30 months or less; for products with longer shelf life, a Period After Opening (PAO) symbol is required instead
• Special precautions for use — any warnings or conditions of use
• Batch number or reference to allow identification of the manufactured lot
• Function of the product — unless apparent from the presentation
• List of ingredients — in INCI nomenclature, in descending order of weight at time of manufacture; the heading "Ingredients" is mandatory

Period After Opening (PAO) symbol — For products with a minimum durability exceeding 30 months, a PAO symbol (the open jar icon) with a number and "M" (months) must appear: "12M" means the product is safe to use for 12 months after opening. This symbol is widely recognised and required for most skincare, haircare, and makeup products sold in the EU.

Ingredient list on outer packaging vs primary container — If the outer packaging (box) carries the full required information but the primary container (the tube, bottle, or jar inside) is too small to carry all elements, EU regulation permits certain information to be on the outer packaging only. The primary container must still carry, at minimum: the responsible person's name, the reference to identify the product, and expiration or PAO markings.

EU Banned and Restricted Ingredients

The EU Cosmetics Regulation Annexes list over 1,300 substances that are prohibited or restricted in cosmetic products in the EU. Many ingredients that are permitted in US cosmetics are restricted or banned in the EU. If you're formulating for both markets, you need to verify your formula against the EU Annex lists before packaging design begins — discovering a prohibited ingredient after the artwork is finalised means a reformulation and a relabel.

Notable examples of ingredients restricted in EU but permitted in US cosmetics: certain parabens at higher concentrations, some fragrance allergens, certain preservatives. This list evolves as the EU updates its Annexes.

UK Post-Brexit Cosmetic Labelling

The UK operates under its own Cosmetic Products Enforcement Regulations (CPER), which mirrors the EU Cosmetics Regulation 1223/2009 but with a UK-specific Responsible Person requirement (the RP must be UK-based, not EU-based, for products sold in the UK). If you're selling in both the EU and UK post-Brexit, you technically need separate responsible persons for each jurisdiction, which often means different addresses on the label.

Designing Cosmetic Labels That Work

Cosmetic labelling has among the most complex hierarchy challenges of any packaged product category:

• The mandatory INCI list can be very long (a complex skincare formula may have 30–50 ingredients)
• The EU PAO symbol and batch number must be present but aren't visual selling points
• The Responsible Person address may need to appear twice (for EU and UK) on dual-market labels
• Active ingredients often have proprietary names the brand wants to promote alongside their INCI names

Type size realities: EU regulation requires a minimum 1.2mm x-height for ingredient list text (applying to the body of the letters, not the cap height). On small containers — a 15ml eye cream, a lip gloss tube — fitting all required information at compliant type sizes is a genuine design challenge. Small containers can use alternative information delivery methods (enclosed leaflet, folded label, website QR code for ingredients) but must still meet primary container requirements.

INCI list design best practices:

• Set in a light-weight sans-serif for maximum legibility at small sizes
• Don't compress the tracking (letter-spacing) — it reduces legibility at 6–7pt sizes
• If including common names alongside INCI names, consider a format like "Aqua (Water)" or "Water (Aqua)" — both are used in the market
• Test the ingredient list panel at 1:1 actual size before signing off on the layout

Checklist: US Cosmetic Label

Principal Display Panel:

• Statement of identity
• Net content in both metric and imperial

Information Panel:

• Manufacturer/distributor name and US address
• Ingredient list in INCI nomenclature, descending order by weight
• All applicable mandatory warnings
• Barcode (not FDA required, but required by retail)

Claims review:

• No drug claims (therapeutic, treatment, or cure language)
• All structure/function or appearance claims are truthful

Checklist: EU/UK Cosmetic Label

• Responsible Person name and address (EU address for EU market; UK address for UK market)
• Country of origin (if manufactured outside EU/UK)
• Net content in metric
• Date of minimum durability OR Period After Opening (PAO) symbol
• Batch number
• Function of product
• Ingredient list in INCI nomenclature, under "Ingredients" heading
• Special precautions for use
• Formula verified against EU Annex prohibited/restricted substances

FAQ

Does my cosmetic product need FDA approval before I sell it? No. Unlike drugs, cosmetics do not require pre-market FDA approval. You are responsible for ensuring your product is safe and your label complies with FDA and FTC requirements. Under MoCRA (2022), you must register your cosmetic manufacturing/processing facility with FDA and submit a list of marketed products.

What's the difference between a cosmetic and an OTC drug? If a product makes claims to treat, prevent, or cure a condition, it may be regulated as an OTC drug. Sunscreen, anti-dandruff shampoo, fluoride toothpaste, and antiperspirant deodorants are examples of products regulated as OTC drugs (not cosmetics). OTC drugs require Drug Facts panel labelling and compliance with OTC drug monographs.

Can I use trademarked ingredient names instead of INCI names on my label? No. FDA regulations require INCI nomenclature for cosmetic ingredient lists. Trademarked ingredient names (e.g., "Matrixyl," "Argireline," "Hyaluronic Sphere Complex") can appear in marketing copy on the label but not within the INCI ingredient list. In the ingredient list, you list the INCI name of the active in the trade-named blend.

Do I need a different label for the EU and the US? In most cases, yes — the EU Cosmetics Regulation has requirements (Responsible Person address, PAO symbol, format of ingredient list) that differ from FDA requirements, and the required information appears in different formats. Some brands design a single label that satisfies both regimes, but this requires careful planning and typically means the label carries more information than either market alone requires.