Cosmetics × USA
Private label cosmetics for the US market
MoCRA gave US cosmetics registration, listing and safety records. For a new brand the bigger risk is still a claim that turns a cream into a drug.
Private label cosmetics in the USA under MoCRA
To launch private label cosmetics in the USA, the company named on the label, which MoCRA calls the responsible person, must list each product with FDA including its ingredients and update listings annually, keep records supporting adequate safety substantiation, and report serious adverse events to FDA within 15 business days. The facility that manufactures or processes the product must be registered with FDA and renew every two years. FDA does not approve cosmetics before sale, apart from certain colour additives, but the label must follow FDA rules such as an ingredient declaration in descending order of predominance and the name and place of business of the manufacturer, packer or distributor.
Intended use decides whether a product is a cosmetic, a drug, or both. FDA’s own examples include antidandruff shampoo, antiperspirant deodorant and moisturiser with sun protection claims: each is a drug as well as a cosmetic, so drug rules such as OTC monograph requirements apply on top. If the brand idea depends on treating acne or on an SPF number, plan a drug pathway from the start or change the idea.
Some MoCRA rules are still to come. The law requires FDA to establish good manufacturing practice regulations for cosmetic facilities and fragrance allergen labelling rules; a proposed rule on asbestos testing for talc-containing cosmetics was withdrawn in November 2025. Certain small businesses are exempt from GMP, registration and listing, but not for products used around the eye, injected, intended for internal use, or meant to alter appearance for more than 24 hours. See the US market guide for import and tariff questions and private label cosmetics for formula routes. What you read here is general guidance, and a licensed US regulatory adviser confirms classification, label and safety file in a project.
US requirements for a private label cosmetic
Federal rules under the FD&C Act as amended by MoCRA.
| Requirement | What it means | Who is responsible | Timing or cost driver |
|---|---|---|---|
| Facility registration | Establishments that manufacture or process cosmetics for the US register, including importer establishments that do so | The facility operator, often your contract manufacturer | Renewal every two years; confirm your producer’s status before ordering |
| Product listing | Each marketed product listed with its ingredients | Responsible person | Annual updates; each variant adds work |
| Safety substantiation | Records supporting the product’s safety; no specific test is mandated and animal testing is not required | Responsible person | Existing ingredient data plus tests on your formula |
| Serious adverse events | Report within 15 business days with a copy of the label; send new medical information received within a year in the same window | Responsible person | A monitored contact route and a filing process |
| Label | Ingredient declaration in descending order of predominance; name and place of business; other FDA and packaging law content | Responsible person | Artwork rework when the formula changes |
| Drug borderline | Products intended to treat or prevent, such as SPF or antidandruff, are also drugs | Brand owner | OTC requirements, testing and a different factory profile |
Small-business exemptions exist, but they exclude several product types and do not touch labelling, safety substantiation or adverse event reporting.
Before the first US shipment
The questions an informed buyer or importer will ask.
- Classification decided for each product: cosmetic, drug, or both
- Product listings prepared with full ingredient lists
- Safety substantiation file assembled for the final formula
- Label with ingredient declaration, net quantity, and name and place of business
- Claims reviewed against the drug line, including marketplace copy and influencer briefs
- Serious adverse event procedure in place, with the 15-business-day clock
- US trademark filed in the cosmetics class, as described in US trademark registration
Launch sequence for a US cosmetics brand
MoCRA does not set a pre-market waiting period. Formula, testing and pack decide the calendar.
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1
Define claims and classification
List every claim you want, then decide which products stay cosmetics. Anything that treats, prevents or protects against the sun is planned as a drug.
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2
Select the manufacturer
We compare selected contract manufacturers on registration status, documentation and minimums in our <a href="/services/private-label-manufacturing/">manufacturing stage</a>.
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3
Build the safety file
Collect raw material data and run stability and compatibility tests on the final pack. Keep it as the safety substantiation record.
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4
Label and list
Finalise artwork, then submit product listings once the label and ingredients are fixed.
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5
Import and launch
Name the importer and customs broker, and model landed cost at the current duty rate. Duty-free de minimis treatment has been suspended for all countries since 29 August 2025.
Frequently asked questions
Do cosmetics need FDA approval in the US?
No pre-market approval is required for cosmetics, except for certain colour additives. Under MoCRA, though, facilities must register, responsible persons must list products and keep safety substantiation records, and serious adverse events must be reported within 15 business days.
Who is the responsible person for a private label cosmetic?
The manufacturer, packer or distributor whose name appears on the label. For a private label brand that is usually the brand owner, even when a contract laboratory makes the product.
Is my moisturiser with SPF a cosmetic?
It is a cosmetic and a drug. FDA lists moisturisers and makeup with sun protection claims among combination products, so sunscreen drug requirements apply in addition to cosmetic rules.
Does MoCRA apply to small brands?
Partly. Certain small businesses are exempt from GMP, facility registration and product listing, but not for eye-area, injected, internal-use or long-wear products. Labelling, safety substantiation and adverse event reporting still apply.
Have a product idea? Check it before you buy stock.
Send a short brief. We tell you what we think, including when we think you should not do it.
Tell us about your brand
A few lines are enough: what you want to sell, where and to whom. We reply with an honest view of feasibility, the stages you need and the next step.
- No obligation: the first review of your idea is free
- If we think the idea will not pay back, we say so
- Your idea stays confidential; we can sign an NDA
What happens next
- 1We review your briefand may ask a few questions
- 2A short callabout goals, budget and limits
- 3Written proposalstages, scope, fees and timing
- 4First stage startswith a decision gate at its end
- usually 300–1 000 units per product in a first order
- usually 6–12 months from brief to first sales
- EU company, contract under Polish law