Do you need a license to sell skincare?
Reviewed by our formulation chemist team. Updated October 2026.
A clear yes or no for the US, UK, EU, Canada and Australia, then what you need instead of a license: the registrations, notifications and local permits that actually apply, whether you make the product yourself or use a manufacturer.
No major market requires a government license to sell ordinary skincare (cosmetics). Instead, each one requires registrations and a legally responsible person: in the US, a MoCRA product listing and facility registration (small businesses under USD 1 million a year in US cosmetic sales are exempt) plus state and local business licenses and sales tax permits; in the UK and EU, a Responsible Person, a safety assessment and a notification before sale; in Canada, a Cosmetic Notification Form within 10 days of the first sale; in Australia, registration of the importer or maker with AICIS. A license or approval is needed only when the product is a drug or therapeutic good, for example a US sunscreen or an acne treatment.
Yes or no, market by market
| Market | License to sell cosmetics? | What you need instead (as of October 2026) |
|---|---|---|
| United States | No federal license | MoCRA product listing and facility registration unless exempt as a small business; safety substantiation; a compliant label; state and local business licenses and sales tax permits where they apply |
| United Kingdom (Great Britain) | No | A UK Responsible Person with a UK address, a safety assessment, a product information file and a notification through the Submit Cosmetic Product Notifications service before sale |
| European Union | No | An EU Responsible Person, a CPSR signed by a safety assessor, a PIF and a CPNP notification before sale |
| Canada | No | A Cosmetic Notification Form filed with Health Canada within 10 days after the first sale; bilingual labels |
| Australia | No license to sell | Registration of the business that imports or makes cosmetics with AICIS before it starts, whatever the value; ingredient labeling under the ACCC standard |
| Any market, drug or therapeutic products | Yes, for the product or site | For example US OTC drug rules for sunscreen and acne products, Canadian drug or natural health product licenses, Australian ARTG listing for therapeutic sunscreens |
Separately from product rules, every business needs the normal things: a business registration or company, a tax ID, and sales tax, VAT or GST registration once it applies. Our business setup by country guide covers those step by step, so this page only points to them.
First question: cosmetic or drug?
Whether you need a license depends less on where you sell than on what your product claims to do. A cosmetic cleans, beautifies or changes appearance. A drug treats or prevents a disease or affects the body's structure or function. The intended use, shown by your claims, decides.
| Product and claim | US status | License or approval needed? |
|---|---|---|
| Hydrating serum, "moisturizes and softens skin" | Cosmetic | No; MoCRA duties apply |
| Sunscreen, "SPF 50, broad spectrum" | OTC drug | Drug establishment registration, drug listing, Drug Facts label, OTC monograph compliance |
| Cleanser with salicylic acid, "treats acne" | OTC drug | Same as above |
| Cream, "reduces the appearance of fine lines" | Cosmetic | No |
| Cream, "boosts collagen production" or "repairs skin cells" | Likely a drug claim | Rewrite the claim or treat it as a drug |
| True soap (mostly fat and alkali, sold only for cleaning) | Consumer product, regulated by the CPSC rather than FDA | No; extra claims (moisturizing, deodorant) make it a cosmetic or drug |
See our cosmetic vs drug claims guide and the sunscreen regulation guide before you write any claim.
United States
Do you need an FDA license to sell skincare? No. FDA does not license cosmetic businesses and does not approve cosmetics before sale (color additives aside). FDA's own fact sheet for small and home-based businesses says it is not against the law to make cosmetics at home, and that you are legally responsible for making sure they are safe and properly labeled. What applies instead:
- MoCRA product listing
The responsible person (the company named on the label, usually your brand) lists each cosmetic product with FDA, including its ingredients, and updates the listing every year. No fee.
- Facility registration
The owner or operator of each facility that manufactures or processes cosmetics for the US registers it with FDA and renews every 2 years. If a manufacturer makes your product, the factory registers its own facility.
- The small business exemption
A business whose average gross annual US cosmetic sales over the previous 3 years are under USD 1 million (adjusted for inflation) is exempt from registration and listing, unless it makes higher-risk products, such as products that regularly contact the eye's mucous membrane, injected products, products for internal use, or products meant to change appearance for more than 24 hours. Adverse event reporting, safety substantiation and label duties still apply to everyone.
- Safety and records
Keep records that substantiate safety, and report serious adverse events to FDA within 15 business days. See our MoCRA compliance guide.
- The label
Ingredient list, net quantity, the name and US address or phone number of the responsible person (a PO box or website alone is not enough), and the contact for adverse event reports.
State and local licenses and permits
The licenses you are likely to need in the US come from states, counties and cities, not FDA:
| Permit | Who issues it | When you need it |
|---|---|---|
| General business license | Many cities and counties | Often for any business operating there, including online and home-based ones; rules vary by city |
| Fictitious business name (DBA) | County or state | When you sell under a name different from your legal name or company name |
| Sales tax permit (seller's permit) | Each state's revenue department | Before you collect sales tax in a state where you have nexus: a physical presence (including inventory in a warehouse) or economic nexus from remote sales over the state's threshold |
| Home occupation permit or zoning approval | City or county planning department | If you run the business from home, especially with storage, deliveries or visitors |
| State cosmetic program reporting | Some states | For example California's Safe Cosmetics Program: companies with USD 1 million or more in annual cosmetic sales report products containing listed ingredients |
Cottage food laws do not cover cosmetics. Cottage food laws are state food laws that let you sell certain home-made foods, such as baked goods and jams, with simple rules. Lotions, serums, balms and scrubs are not food, so a cottage food permit does not authorize them; cosmetics fall under the federal Food, Drug, and Cosmetic Act and MoCRA, plus any state cosmetic laws such as ingredient bans (see our Prop 65 and state bans guide).
United Kingdom
Do you need a licence to sell skincare in the UK? No. GOV.UK guidance does not require a licence or permit to sell cosmetics in Great Britain. What it requires:
- A UK Responsible Person with a UK-established address (not a mail forwarding address or PO box). It can be your company, if it is in the UK, or a service provider.
- A safety assessment by a qualified safety assessor, before the product is made available.
- A product information file kept for 10 years after the last batch is made available.
- A notification through the Submit Cosmetic Product Notifications service before the product reaches consumers.
- Good manufacturing practice, which can be shown through ISO 22716 (see our ISO 22716 guide), and a compliant label.
These apply whether you sell, give away or make the product at home. For the business side (sole trader or Ltd company, VAT), see the business setup guide. If you sell at a market stall, your local council may require a street trading licence for the pitch; that is about trading in public places, not about cosmetics. Full details are in our UK cosmetics regulation guide.
European Union
Do you need a license to sell skincare in the EU? No. The Cosmetics Regulation (EC) No 1223/2009 works through a Responsible Person instead of a license:
- An EU Responsible Person established in the EU, named with an EU address on the label.
- A CPSR (Cosmetic Product Safety Report) signed by a qualified safety assessor.
- A PIF (Product Information File) kept at the Responsible Person's address for 10 years after the last batch.
- A CPNP notification before the first unit is placed on the market; one notification covers every member state.
- Manufacturing under good manufacturing practice (Article 8).
If you make cosmetics yourself inside the EU, some member states also require the manufacturing or packing site to be declared to the national authority, for example France's declaration to ANSM; check the rule in your country. See our EU cosmetics regulation guide and, for packaging and online selling duties, the EU GPSR and packaging rules guide.
Canada
Do you need a license to sell cosmetics in Canada? No, as long as the product is a cosmetic. What applies:
- Every manufacturer and importer files a free Cosmetic Notification Form (CNF) with Health Canada at the latest 10 days after first selling the product in Canada, and a revised one within 10 days of a change.
- No ingredient on the Cosmetic Ingredient Hotlist above its limit.
- Bilingual labels in English and French.
Licenses do apply to drugs and natural health products: a product that is a drug needs a Drug Identification Number, and a natural health product needs a product license and a site license. Many sunscreens, acne products and anti-dandruff shampoos fall into those groups. Business registration and GST/HST registration follow normal Canadian rules. See our Canada cosmetics regulation guide.
Australia
Do you need a license to sell skincare in Australia? No, but a registration comes close to one:
- A business that imports or manufactures cosmetics must register with AICIS (the Australian Industrial Chemicals Introduction Scheme) before it starts, with no minimum value, categorize the ingredients, and file an annual declaration. Even finished, branded products bought overseas trigger registration for the importer.
- The ingredient labeling standard enforced by the ACCC applies to cosmetics sold to consumers.
- Products with therapeutic claims, and primary sunscreens, are therapeutic goods regulated by the TGA and must be in the ARTG before sale.
A retailer that buys from a local importer does not register with AICIS; the importer does. See our Australia cosmetics regulation guide.
Selling from home and at markets
Selling skincare from home is legal in all five markets, under the same product rules as any other seller. The differences are local:
- Check zoning and home business rules
Your city or council may limit storage, deliveries or customer visits for home businesses.
- Register the business and taxes
Sole trader or company, tax ID, and sales tax, VAT or GST when you reach the thresholds; see the business setup guide.
- Meet the product rules
Listing or notification, a responsible person, a safety assessment where required, a compliant label.
- Get insurance
Product liability insurance is not a license, but marketplaces, markets and retailers often require it. See our liability insurance guide.
- Selling at markets and pop-ups
The organizer or council may ask for a trading permit, insurance certificate and product labels that meet the rules.
Making it yourself vs using a manufacturer
The license answer is the same either way. The work behind it is not.
| Task | You make it at home or in your own workshop | A manufacturer makes it |
|---|---|---|
| US facility registration | You register your facility, unless exempt as a small business | The factory registers its own facility |
| Good manufacturing practice | You set up hygiene, batch records, testing and storage yourself | The factory's GMP system (for example ISO 22716) covers it |
| Stability and preservative testing | You arrange and pay for tests per formula | Often existing data for ready formulas; tests arranged by the factory |
| Batch testing (COA, microbiology) | You send samples to a lab for each batch | Done by the factory's QC for each batch |
| EU or UK safety assessment | You hire an assessor and supply the quantitative formula | The factory or its partner provides the formula data to the assessor |
| Minimum batch size | As small as you like | A minimum order per product |
| Your legal role | Manufacturer and responsible person | Responsible person (brand); the factory is the manufacturer |
Many founders start at home with small batches for friends and local markets, then move to a manufacturer once they want consistent quality, documents for marketplaces and lower unit costs. Our guide to starting a brand with a Korean OEM and OEM vs ODM vs private label explain the manufacturer route.
A worked example
- Searching for an "FDA cosmetic license" or buying a third-party "FDA certificate"; neither exists for cosmetics.
- Making drug claims (acne, SPF, "heals") on a product sold as a cosmetic, which turns it into an unapproved drug.
- Assuming a cottage food permit covers lotions or serums.
- Collecting sales tax without a permit, or ignoring nexus created by inventory in a marketplace warehouse.
- Treating the US small business exemption as an exemption from safety, labeling and adverse event duties.
- Selling in the UK or EU with no Responsible Person or notification because "no licence is needed".
- Importing into Australia before the business is registered with AICIS.
- Every claim checked: the product is a cosmetic, not a drug, in each market
- Business registered and tax ID in place (see the business setup guide)
- US: city and county business license and home occupation rules checked
- US: sales tax permits in states with nexus
- US: MoCRA listing filed, or small business exemption confirmed in writing
- US: facility registration by whoever manufactures
- UK: UK Responsible Person, safety assessment, PIF and notification before sale
- EU: EU Responsible Person, CPSR, PIF and CPNP before sale
- Canada: CNF within 10 days of first sale, bilingual label
- Australia: importer or maker registered with AICIS before the first import
- Label compliant for each market
- Product liability insurance in place for the channels that require it
How KoreanOEM helps
KoreanOEM is a Korean skincare OEM and private label manufacturer: we develop your formula and produce it in Korea at an ISO 22716 facility that is FDA registered under MoCRA, so the manufacturing side of the rules is covered and you focus on your business registrations.
- Registrations: US MoCRA product listing filed by our team, USD 150 per SKU; EU and UK through our partner (CPSR and PIF USD 1,250 per formula with UK notification included, CPNP USD 420 per product, Responsible Person USD 240 per product per year for the UK or USD 335 for the UK and EU); Canada CNF filed for about USD 450 per product. For Australia we prepare the documents your AICIS-registered importer needs.
- Documents: COA and microbiology for every batch, MSDS (SDS), specification and the full INCI list after the NDA, for marketplaces, insurers and importers.
- Label proof check: free on orders where we print the labels, against the rules of your market.
- Low minimums: ready library formulas from 500 units for serums, creams and ampoules. First orders below 500 units are possible when you share your growth plan (expected volumes for the next orders), reviewed case by case. Start with a sample box from USD 129, credited in full against the first production order when it is placed within 3 months of your sample order.
Best price, best cost and the lowest minimum order you cannot find anywhere else. We believe in our customers' vision rather than our own profit, so even if we lose money at the beginning, we still support you.
Frequently asked questions
Do I need a license or permit to sell skincare?
Do I need a state business license or sales tax permit to sell skincare in the US?
Do I need FDA approval to sell skincare?
Can I sell homemade skincare legally?
Do cottage food laws cover lotions, balms or serums?
Am I exempt from MoCRA registration as a small business?
Do I need a company before contacting a manufacturer?
Do I need a licence to sell cosmetics in the UK?
Is soap regulated like skincare?
Sources
- FDA: Small businesses and homemade cosmetics fact sheet
- FDA: Modernization of Cosmetics Regulation Act of 2022 (MoCRA)
- FDA: Registration and listing of cosmetic product facilities and products
- 21 U.S.C. 364h: Small businesses (MoCRA)
- FDA: Is it a cosmetic, a drug, or both? (Or is it soap?)
- U.S. Small Business Administration: Apply for licenses and permits
- California CDTFA: Remote sellers and economic nexus (Wayfair)
- California Department of Public Health: Safe Cosmetics Program, who needs to submit
- GOV.UK: Making cosmetic products available to consumers in Great Britain
- EUR-Lex: Regulation (EC) No 1223/2009 on cosmetic products
- Health Canada: Cosmetic notification
- AICIS: Personal care, skincare, make-up and other cosmetic products
- TGA: Determining if your product is a cosmetic or therapeutic good
Checked against these sources in October 2026. Rules and fees change; check with the authority or your importer before you sell.