To start a skincare line, you need to define a focused product range, decide whether each product is a cosmetic or a drug under the law, choose how it will be made (by you, with a formulator, or through a contract manufacturer), test formulas for stability and preservation, create compliant labels, and meet the FDA's cosmetics requirements before you sell. In the United States, cosmetics do not need FDA approval before they go on the market, except for color additives, but the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) added real obligations: facility registration, product listing, safety substantiation records, adverse event reporting and contact information on every label. Products that make treatment claims, such as acne or sun protection, are regulated as drugs and have stricter rules. This guide walks through each step in order.
Step 1: Define your brand and a small first range
Consider launching with a handful of products rather than a full regimen. A short range keeps development, testing, packaging and inventory costs manageable and makes it easier to explain what the brand is for. Before you develop anything, write down:
- Who it is for: skin type, age range, concerns and where those customers shop.
- What problem it solves in cosmetic terms (cleansing, moisturizing, improving appearance), keeping in mind the claim limits in Step 2.
- Your price point, which drives ingredient, packaging and manufacturing choices.
- How you will sell: your own website, marketplaces, salons and spas, or retailers. Each channel has different margin and documentation needs.
Step 2: Decide whether each product is a cosmetic or a drug
This decision shapes everything that follows. FDA says a product's legal category is determined by its intended use. Cosmetics are products intended for cleansing, beautifying, promoting attractiveness or altering the appearance. Drugs are products intended to diagnose, cure, mitigate, treat or prevent disease, or to affect the structure or function of the body.
Intended use is judged by what you say on labels, in advertising, online and on social media, by what consumers expect the product to do, and by ingredients with a well-known therapeutic use. FDA gives examples of products that are both a cosmetic and a drug:
- Moisturizers and makeup marketed with sun-protection claims.
- Cleansers that are also intended to treat acne, and antibacterial cleansers.
- Anti-dandruff shampoos.
- Deodorants that are also antiperspirants.
Drug products, including these combination products, generally must either be approved through a new drug application or conform to an OTC monograph for their category; OTC monographs cover acne medications, dandruff and psoriasis treatments, and sunscreens. Drugs must follow the drug manufacturing rules in 21 CFR parts 210 and 211 and carry a "Drug Facts" label. For a first line, many founders stay within cosmetic products and cosmetic claims to keep the regulatory load manageable, then add drug products later with a manufacturer experienced in them.
Step 3: Choose how your products will be made
| Option | How it works | Best suited to | Watch out for |
|---|---|---|---|
| Make it yourself | You formulate and produce in a home or small workspace | Very small batches, testing ideas, local sales | Contamination risk, consistency, scaling, and keeping safety and production records |
| Hire a cosmetic chemist or formulator | A professional develops the formula; you or a manufacturer produce it | Original formulas you want to own | Development fees; confirm in writing that you own the formula |
| Contract manufacturer (custom) | A manufacturer produces your formula, or develops one with you, at scale | Brands ready for larger runs | Minimum order quantities, lead times, quality documentation |
| Private label / white label | You brand an existing stock formula from a manufacturer | Fast launch, testing demand | Little differentiation; others may sell the same formula |
FDA notes that it is not against the law to make cosmetics at home, but it is your responsibility to make them in an environment that will not cause them to become adulterated, for example through microbial contamination, misused color additives, prohibited ingredients or unsafe packaging. FDA also does not license cosmetics firms, although state or local business licenses may apply.
If you work with a manufacturer, ask for the same kind of evidence you would want for any regulated product: its FDA facility registration, quality procedures, batch records, test results for each batch, and how it will notify you of changes to ingredients or processes.
Step 4: Formulate and test
Ingredients
Check every ingredient against FDA's list of prohibited and restricted cosmetic ingredients. Examples on that list include bithionol, chloroform, methylene chloride, halogenated salicylanilides, certain cattle materials, and vinyl chloride and zirconium-containing complexes in aerosol products, with tight limits on hexachlorophene and mercury compounds. Color additives must be approved by FDA for their intended use, and some must come from batches certified by FDA.
Preservation and stability
Products that contain water can become contaminated by microorganisms during use. Preservative efficacy testing, often called challenge testing, checks whether a formula's preservative system works. Common laboratory methods include ISO 11930, which was written specifically for cosmetics, and USP <51>. In an ISO 11930 test, the product is inoculated with five test microorganisms and the surviving counts are measured at 7, 14 and 28 days.
Stability testing checks that the product keeps its appearance, texture, scent and performance over time and under different temperatures, and compatibility testing checks that it does not react with its packaging. Do these tests in the final packaging you plan to sell, since a change of container can change the results.
Safety substantiation
Under MoCRA, the responsible person, meaning the manufacturer, packer or distributor whose name is on the label, must ensure and keep records supporting adequate safety substantiation for each cosmetic product. FDA says animal testing is not a requirement for marketing a cosmetic, and no specific tests are mandated, but the supporting data should come from scientifically sound methods. Keep a file for each product with the formula, ingredient safety information, test results and the reasoning behind your conclusion that the product is safe under normal use.
Step 5: Create compliant labels
Cosmetic labels in the United States are governed by the Federal Food, Drug, and Cosmetic Act, the Fair Packaging and Labeling Act and FDA's regulations in 21 CFR part 701, with additions from MoCRA. Key elements include:
- Principal display panel: the product's name and its nature or use, plus the net quantity of contents, placed in the bottom 30 percent of the panel (with an exception for very small panels). Use fluid measure for liquids and weight for solids, semisolids and viscous products.
- Ingredient declaration: ingredients in descending order of predominance, using the names established by regulation. Ingredients at 1 percent or less may follow in any order, and color additives may be listed in any order after the other ingredients. Fragrance and flavor may be listed as "fragrance" or "flavor."
- Name and place of business of the manufacturer, packer or distributor.
- Adverse event contact: since December 29, 2024, each cosmetic label must include a domestic address, domestic phone number or electronic contact information, such as a website, through which the responsible person can receive adverse event reports.
- Drug labeling if the product is also a drug: active ingredients listed first, in Drug Facts format.
MoCRA also requires fragrance allergens to be identified on labels once FDA finalizes a rule on which substances count. Watch for that rule, since it may require label changes.
Be careful with marketing words
- "Organic." FDA does not define the term for cosmetics. The USDA's National Organic Program regulates organic claims for agricultural ingredients, and a product with an organic claim must meet both USDA rules for the claim and FDA rules for labeling and safety. FDA also notes that an ingredient's source does not determine its safety.
- Treatment language. Words that promise to treat acne, heal skin conditions or change the body's structure can turn a cosmetic into a drug, as described in Step 2.
Step 6: Meet FDA's MoCRA requirements
| Requirement | What it involves |
|---|---|
| Facility registration | Manufacturers and processors register their facilities with FDA and renew every two years. New facilities register within 60 days of starting manufacturing or processing. |
| Product listing | The responsible person lists each marketed cosmetic product, including its ingredients, and updates the listing annually. New products are listed within 120 days of first marketing. |
| Serious adverse event reporting | Report serious adverse events to FDA within 15 business days, with a copy of the label. New medical information received within one year must also be reported within 15 business days. |
| Safety substantiation | Keep records showing each product is adequately substantiated as safe. |
| Records access and recalls | Under certain conditions FDA can access and copy safety records, and it can order a mandatory recall if a company refuses to recall voluntarily. |
Small business exemption
MoCRA exempts certain small businesses from facility registration and product listing, and from the cosmetic GMP requirements FDA is still developing. FDA's guidance defines a small business as one whose average gross annual U.S. sales of cosmetic products over the previous three years are less than $1,000,000, adjusted for inflation. The exemption does not apply, regardless of sales, to businesses that make or process products that:
- regularly come into contact with the mucous membrane of the eye under normal use,
- are injected,
- are intended for internal use, or
- are intended to alter appearance for more than 24 hours where consumers do not normally remove them.
The exemption covers registration and listing, not everything. Small businesses still need safe, properly labeled products, safety substantiation records, and the label contact information described above. FDA does not issue exemption certificates, so document why your business qualifies.
GMP rules
MoCRA directs FDA to issue cosmetic good manufacturing practice regulations. As of FDA's most recent MoCRA update, a final rule had not been issued; FDA has published draft guidance on cosmetic GMPs. Following good manufacturing practices now will make it easier to comply when a final rule arrives.
Step 7: Selling outside the United States
Other markets have their own systems. In the European Union, for example, Regulation (EC) No 1223/2009 requires a designated responsible person within the EU for each product, a product safety report before the product is placed on the market, and notification through the EU Cosmetic Products Notification Portal. Budget for each market's requirements before you expand.
Step 8: Set up the business side
- Business structure and licenses. Register the business and check state and local license requirements where you produce and sell.
- Trademark search. Check that your brand and product names are available before you print packaging.
- Insurance. Ask an insurance broker about product liability coverage, and check whether your retail partners require it.
- Packaging. Choose containers that suit the formula and confirm compatibility through testing.
- Pricing. Include ingredients, packaging, testing, manufacturing minimums, fulfillment, channel fees and marketing in your unit economics.
- Customer contact and records. Set up the label contact channel, a process for logging complaints and adverse events, and a way to trace each product to its batch.
Launch checklist
- Define the audience and a range of three to five products.
- Confirm each product is a cosmetic, or plan for drug requirements if it is not.
- Choose a production route and vet any manufacturer's quality documentation.
- Check ingredients against FDA's prohibited and restricted list and approved color additives.
- Complete preservative efficacy, stability and packaging compatibility testing.
- Build a safety substantiation file for each product.
- Design labels with all required elements, including adverse event contact information.
- Register facilities and list products with FDA, or document your small business exemption.
- Set up adverse event reporting and recordkeeping.
- Review all marketing copy for drug claims before launch.
Before launching, check current FDA and FTC requirements or consult a regulatory attorney; this overview is not legal advice. For the official requirements, see FDA's overview of MoCRA, its explanation of whether a product is a cosmetic, a drug or both, and its fact sheet for small businesses and homemade cosmetics.
