A US cosmetic label must show five things: the product identity, the net quantity of contents, the ingredient declaration, warnings or directions where they apply, and the name and place of business of the manufacturer, packer, or distributor. Since MoCRA, that last line must also give a domestic address, phone number, or website through which the Responsible Person can receive adverse-event reports. If your brand name is on the label, you are the Responsible Person — not the factory that made it.
That split catches a lot of first-time founders by surprise. You can hire a contract manufacturer to formulate, fill, and even design the label artwork, and still be the party the Food and Drug Administration holds legally accountable for everything printed on it. Here is what has to appear, who owns which duty, and where a US contract manufacturer is the wrong place to send the work.
What does a US cosmetic label legally need to say?
The FDA splits a label into two parts: the principal display panel (the face the shopper sees) and the information panel (usually the back or side). Across the two, six elements have to be present. The FDA Cosmetics Labeling Guide is the primary reference, and it is worth reading in full before you sign off on artwork.
- Product identity — what the product is, in plain terms (“facial moisturizer”), on the principal display panel.
- Net quantity of contents — stated in both metric and US customary units, on the lower part of the principal display panel.
- Ingredient declaration — ingredients in descending order of predominance, using INCI names, on the information panel. Most retail cosmetics require this.
- Name and place of business — of the manufacturer, packer, or distributor. If that party is not the manufacturer, the line must be qualified: “Manufactured for…” or “Distributed by…”
- MoCRA adverse-event contact — a domestic address, phone number, or electronic contact (a website counts) through which the Responsible Person can receive adverse-event reports. This is the newest element and the one most pre-2023 guides omit.
- Warnings and directions — where the product category requires them.
Get the structural ones wrong and the fix is expensive, because labels are printed in bulk. As Moe’s Group notes in its own rundown, the most expensive labeling mistakes are the structural ones — the net-contents placement, the ingredient order, the missing qualifier — not the typos.
Who is the “Responsible Person” — the brand or the factory?
Under the Federal Food, Drug, and Cosmetic Act as amended by MoCRA, the Responsible Person is the manufacturer, packer, or distributor whose name appears on the product label. For a brand that outsources production, that is almost always the brand itself. Putting a factory’s name on your jar does not move the liability to the factory; it just confuses the label.
The two duties split cleanly, and they are not interchangeable:
- The contract manufacturer registers the facility with the FDA.
- The brand submits the product listing — the SKU-level filing for each marketed product.
Registration is not listing, and listing is not registration. A factory can be fully registered while your products sit unlisted, and the unlisted products are your exposure, not theirs. You can allocate the work of filing to a vendor through a quality agreement, but the legal duty stays with the name on the label. A contract manufacturer that is registered with the FDA is registered, not approved — the FDA does not approve cosmetics at all, and any supplier who implies otherwise should give you pause.
What changed when MoCRA passed in 2022?
The Modernization of Cosmetics Regulation Act was the first major update to US cosmetics law since 1938. The FDA’s MoCRA overview covers it in full; the parts that touch your label and your filing timeline are these:
- Adverse-event reporting — in force since 29 December 2023. A serious adverse event must be reported to the FDA within 15 business days of the Responsible Person receiving it, and records kept for six years (three for small businesses).
- Facility registration and product listing — enforceable from 1 July 2024. A new facility registers within 60 days; a new product is listed within 120 days of first marketing, through the free FDA Cosmetics Direct portal.
- Safety substantiation — every Responsible Person must hold records supporting the safety of each product, regardless of size.
- The new label element — the adverse-event contact line described above.
Two rules are still pending and you should not build a timeline around either. The fragrance-allergen labeling rule missed its statutory deadline of 29 December 2025 and, as of 11 October 2026, has not been published. The cosmetics Good Manufacturing Practice rule is not yet finalized either; ISO 22716 is the de facto reference standard in the interim.
A small-business exemption exists for companies averaging under $1 million in annual US cosmetics sales over the prior three years — it waives GMP, facility registration, and product listing. It does not cover products that contact the eye’s mucous membrane, injectables, internal-use products, or products that alter appearance for more than 24 hours. And it never waives the labeling and safety-substantiation duties. The FDA small-business fact sheet is the place to confirm whether you qualify.
What does a contract manufacturer provide, and what do you still own?
Most US contract manufacturers — Moe’s Group among them — handle formulation, filling, and label support, which typically includes ingredient declarations and a label-file template. What is not standard, and what you should confirm in writing before you sign, is who prepares the INCI declaration, who submits the Cosmetics Direct listing, and who assembles the safety-substantiation dossier. Some manufacturers fold this into a managed service; many leave it with the brand. Do not assume. Ask the specific question — “Do you file my product listings, or do I?” — and get the answer in the quality agreement.
A key-facts note on the terms you will hear, since suppliers use them loosely:
- White label
- A ready-made, existing formula — also called ready-to-go. There is no formulation work, so the entry cost and lead time are typically lower. At Moe’s Group the white-label minimum is 200 units.
- Private label
- A custom formulation developed for your brand. It carries development work, so lead time and cost reflect the project. At Moe’s Group the custom-formulation minimum is 1,000 units.
- Contract manufacturing
- The manufacturing service itself. Formulation, ownership, pricing, and lead time all depend on the agreed project — there is no single figure to quote in the abstract.
Where a US contract manufacturer is the wrong answer
Choosing a factory is a comparison, so here is the honest version: a US cosmetics contract manufacturer, Moe’s Group included, is the wrong fit in four situations.
- You are launching in the EU or UK. The EU Cosmetics Regulation (EC 1223/2009) requires a Product Information File, a qualified EU Responsible Person based in the EU, and a CPNP notification. A US facility does not produce those as a matter of course. You need a European manufacturer or a dedicated EU Responsible Person service — CosmeticLab.eu and similar EU-based CMOs are built for this; a Chatsworth, California plant is not.
- You want someone else to carry the Responsible Person liability. No US contract arrangement does this. The duty attaches to the name on the label. If you need the burden to sit elsewhere, you are choosing the wrong label, not the wrong factory.
- Your product crosses into OTC drug territory — a true SPF sunscreen, a medicated acne treatment, an antiperspirant. These follow drug-labeling rules and monographs, and the manufacturer needs drug GMP under 21 CFR Part 211, not just cosmetic GMP. Confirm the category before you brief anyone.
- Your run is below 200 units. That is under Moe’s Group’s white-label minimum, and most contract routes do not work cleanly at that volume. A regulatory consultant or label-review service — the kind that reviews labels without manufacturing — is the better fit if you have already sourced tiny-batch production elsewhere.
If none of those apply — you are US-market, over 200 units, cosmetic rather than OTC — then a registered US contract manufacturer is a reasonable shortlist entry. When you are ready to compare on your actual SKU, Moe’s Group takes project inquiries here.
Frequently asked questions
Does the contract manufacturer or the brand file with the FDA?
Both, on different things. The manufacturer registers its facility; the brand, as the Responsible Person, submits the product listing for each SKU. Neither filing substitutes for the other.
Can I put the factory’s name on the label instead of mine?
You can name the manufacturer, but if your brand name also appears, you are still the Responsible Person. If the named party did not make the product, the label must say “Manufactured for” or “Distributed by” to be truthful.
Is my product exempt from MoCRA if I am a small business?
Possibly from GMP, facility registration, and product listing if you average under $1 million in annual US cosmetics sales — but never from the labeling and safety-substantiation duties, and the exemption excludes several product types. Check the FDA small-business fact sheet before relying on it.
Do I need the fragrance-allergen labeling now?
Not yet. The proposed rule missed its 29 December 2025 deadline and, as of 11 October 2026, has not been published. Watch for it, but do not design a label around a rule that does not exist.
Is an FDA-registered manufacturer the same as a manufacturer the FDA has approved?
No. The FDA registers cosmetic facilities; it does not approve cosmetics or the factories that make them. Cosmetic approval is not a status the FDA grants, and a supplier claiming it is misusing the term.
Comparing factories for a US launch over 200 units? Send Moe’s Group the details of your SKU.