Cosmetic labeling requirements in the US, Canada, EU and UK share one core: product identity, net quantity, the responsible company and its contact, an INCI ingredient list in descending order, required warnings, country of origin for imports, and in the EU and UK a batch number and durability marking. Details differ by market, and three allergen deadlines land in 2026.
What a cosmetic label must include
The four regulators ask for the same eight things:
Identity: the product's name or function.
Net quantity of contents.
Who is named: the responsible person, dealer, manufacturer or distributor.
Contact details for that company.
Ingredients: INCI names in descending order.
Warnings, and in Canada directions for safe use.
Country of origin for imports.
In the EU and Great Britain, a batch number and a durability date or period-after-opening symbol.
Under the Federal Food, Drug, and Cosmetic Act as FDA explains it, a cosmetic is intended to cleanse, beautify, promote attractiveness or alter the appearance; a product also intended to treat or prevent disease or affect the body's structure or function is a drug too. US sunscreens and other over-the-counter drugs follow drug labeling rules, not covered here.
This is general guidance for brand founders, not legal advice. Every point below is attributed to its regulator.
Why labels trip up new brands
The label is usually designed before the formula is locked, and printed before anyone has read three rule books. The first run arrives with an ingredient list in the wrong order, a Canadian carton in English only, or an EU jar with no period-after-opening symbol.
FDA states that a cosmetic is misbranded if its labeling is false or misleading, or if it omits the name and place of business or the net quantity. In Canada, Health Canada asks for copies of labels and inserts alongside the Cosmetic Notification Form, and a changed product name, company or contact line means a revised notification within 10 days, so a wrong label can hold up a launch twice. A wrong label is a stalled launch.
United States: FDA cosmetic labeling requirements
Principal display panel: identity and net quantity
Under FDA's Cosmetics Labeling Guide, the principal display panel (PDP) carries the identity statement and the net quantity. The identity statement must be in bold type (21 CFR 701.11). Net quantity sits within the bottom 30 percent of the PDP, in a minimum type size that rises with panel area, starting at 1/16 inch (21 CFR 701.13).
Information panel: name and place of business, ingredients, warnings
Name and place of business means the corporate name and street address; if the company on the label is not the manufacturer, "Manufactured for" or "Distributed by" must precede the name (21 CFR 701.12). The ingredient declaration (21 CFR 701.3) runs in descending order; ingredients at 1 percent or less may follow in any order, color additives may come last, and fragrance may be declared as "fragrance". Warnings are required "whenever necessary or appropriate to prevent a health hazard" (21 CFR 740), in bold on a contrasting background.
Country of origin and language
Imported products must state the English name of the country of origin, under the Tariff Act of 1930. Required statements must be in English, and also in any other language the label uses (21 CFR 701.2).
What MoCRA added to the label
Under MoCRA the "responsible person" is "the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label". Section 609 requires a domestic address, domestic phone number or electronic contact for adverse event reports; law-firm and industry summaries, not FDA's own page, date this to 29 December 2024. Professional-use products add a statement that the product is for use only by licensed professionals. FDA has not yet issued its fragrance allergen rule as of this writing. Registration and listing are in our MoCRA explainer.
Canada: bilingual labels and the INCI list
Health Canada's "Labelling of cosmetics" page lists the required elements, and its Industry Guide gives the detail.
What must be in English and French
The identity appears in English and French on the principal display panel; a single expression that reads in both languages, "parfum" for example, counts as bilingual. Net quantity is metric and bilingual, in bold numerals, with a minimum character height from 1.6 mm. Warnings and directions for safe use are bilingual too.
Dealer identity, contact information and imports
The dealer's identity and principal place of business goes anywhere on the outer label except the bottom. For imports, the dealer may be identified outside Canada, or a Canadian dealer shown after "imported by" or "imported for". The inner label carries a consumer contact, which Health Canada says should be able to respond in both official languages.
Ingredient list rules
Ingredients above 1% are listed in descending order by weight, those at 1% or less in any order, and colorants last. "Parfum" is the accepted term for fragrance ("fragrance" alone is not acceptable) and "aroma" for flavor. The list carries no marketing words and is not required in both languages.
Fragrance allergen dates
Fragrance allergens are named outside "parfum" above 0.01% in rinse-off and 0.001% in leave-on products: 12 April 2026 for List 1 (24 allergens) on all products, 1 August 2026 for List 2 on new products, 1 August 2028 for List 2 on existing products.
The Cosmetic Notification Form goes to Health Canada within 10 days of first sale in Canada, with copies of the labels and inserts supplied alongside it; filing does not approve the product. See our Health Canada cosmetic notification guide.
European Union and Great Britain
The Article 19 label elements
Article 19 of Regulation (EC) No 1223/2009 requires the container and packaging to bear the name and address of the responsible person ("the country of origin shall be specified for imported cosmetic products"), the nominal content, the durability marking, particular precautions for use, the batch number, the function "unless it is clear from its presentation", and a list headed "ingredients" in descending order of weight, with ingredients under 1% in any order, "parfum" or "aroma" for perfume, and "(nano)" after nanomaterials per the European Commission. Language rules are set nationally. Notification runs through the CPNP, covered in our US, Canada and EU compliance guide.
Durability date or period after opening
Article 19(1)(c) requires the date of minimum durability. Over 30 months, the label instead shows the period after opening, which the HPRA describes as an open-jar symbol followed by the period in months and/or years.
Fragrance allergens from 2026
Regulation (EU) 2023/1545 expands individual allergen labeling to what the HPRA describes as "more than 80 fragrance allergens". Products placed on the market after 31 July 2026 must comply; products placed before then may be made available until 31 July 2028.
Great Britain after Brexit
UK government guidance requires a Responsible Person who "must have a UK established address", and the label must carry that name and address and "the country of origin if the product is imported to the UK". The retained Article 19 has a seven-year transition from 31 December 2020 under which pre-exit EU details still satisfy the requirement; check the current position before printing.
The three-market label at a glance
Each line reads US; Canada; EU and GB.
Identity. Bold statement on the PDP; bilingual on the PDP; the function, unless clear.
Net quantity. Bottom 30 percent of the PDP; metric and bilingual; nominal content.
Who is named. Manufacturer, packer or distributor; the dealer; the responsible person (UK established address in GB).
Contact. MoCRA adverse-event contact; bilingual consumer contact on the inner label; the responsible person's address.
Ingredients. INCI, descending order, 1% rule everywhere; "fragrance" in the US, "parfum" in Canada, "parfum" or "aroma" plus "(nano)" in the EU and GB.
Warnings. Where needed to prevent a health hazard; bilingual, with directions for safe use; precautions for use.
Origin. English country name for imports; dealer outside Canada or import wording; country of origin for imports.
Durability or batch. Not among FDA's or Health Canada's listed elements; batch number plus durability date or open-jar symbol in the EU and GB.
Who supplies what: your manufacturer and your brand
From the factory come the INCI list, derived from the locked formula (a Hong Shin project locks formula and ingredient data before notification); the batch number (every batch is made under ISO 22716 cosmetic GMP, and batch records are in our ISO 22716 guide); the stability data behind the durability decision, from in-house stability and preservative testing; and a certificate of analysis with every batch.
With the brand stay the responsible person, dealer or "Manufactured for" name and address, the contact line, claims and artwork, and the notifications. Hong Shin provides regulatory support and filing for all four markets and can handle the Canadian notification for you, but the brand owns the label and the name on it is yours.
"Made in Taiwan" and "Made in South Korea" on your label
Hong Shin is Canadian-owned and manufactures in South Korea and Taiwan. SPF serums and cream serums run on the South Korea lines, so a Korea-route product carries the South Korean origin and a Taiwan-line product the Taiwanese one; never claim a single origin for a range that splits across both. The US, EU and GB require the country of origin on imports, and Health Canada accepts a geographic origin statement beside the dealer's details, so a range on both routes needs two origin variants of the artwork.
Pre-print label checklist
United States (FDA):
Bold identity statement on the PDP.
Net quantity in the bottom 30 percent.
"Manufactured for" or "Distributed by" with name and address.
INCI in descending order, 1 percent rule.
Required warnings, English country of origin, MoCRA contact.
Canada (Health Canada):
Identity in English and French on the PDP.
Metric, bilingual net quantity in bold numerals.
Dealer identity, not on the bottom, with import wording.
Bilingual consumer contact on the inner label.
INCI with "parfum", List 1 allergens outside it, bilingual warnings and directions.
European Union and Great Britain:
Responsible person's name and address (UK established address for GB).
Country of origin for imports.
Nominal content and batch number.
Durability date, or the open-jar symbol over 30 months.
"Ingredients" list with "parfum" or "aroma" and "(nano)", precautions, and the expanded allergen list for products placed after 31 July 2026.
How Hong Shin supports your labeling
Hong Shin has operated since 2012 and ships to 16 countries, with ISO 22716 (cosmetic GMP), ISO 9001, SEDEX, BSCI and US FDA facility registration. Every batch ships with a certificate of analysis. We provide regulatory support and consulting for Health Canada NPN and cosmetic notification, US FDA and MoCRA, EU CPNP and UK SCPN. First-run MOQ is from 1,500 units per SKU on the Taiwan lines and from 3,000 on the South Korea lines; Taiwan-line lead time is 10 to 12 weeks from formula sign-off. A costed quote and specification follows within five business days of your brief. Start with our private label program or contact us with your markets.
Frequently asked questions
Does the FDA approve cosmetic labels before sale?
No. FDA registers facilities and product listings; it does not approve cosmetics. The responsible person named on the label is accountable for it.
Do cosmetic labels in Canada have to be bilingual?
Health Canada requires the identity, warnings and directions for safe use in English and French. The INCI list itself is not required in both languages, but "parfum" and "aroma" are the accepted terms.
What is the 1% rule on an ingredient list?
Ingredients above 1% are listed in descending order; those at 1% or less may follow in any order, with colorants last. FDA, Health Canada and Article 19 of the EU regulation apply the same principle.
Rules change, and the regulator's current text governs; check it before any artwork goes to print.