How to start a skincare line and have it made for you

Your claims decide which rules apply

Whether a product is a cosmetic or a drug is determined by a product's intended use^[2], and what you say on your label, product page and ads is the part of that intent you control. A cream that promises to increase or decrease the production of melanin (pigment) in the skin, or regenerate cells^[2] is making drug claims, whatever is in the jar.

Some skincare categories are drugs outright. FDA's over the counter monographs cover categories that include acne medications and sunscreens^[2], and moisturizers and makeup marketed with sun-protection claims^[2] are both cosmetics and drugs at once. A drug brings FDA's drug rules into play, not the cosmetics rules alone. For a first line, a range of cleansers, serums, moisturizers and masks without sun, acne or other drug claims, such as fading dark spots or renewing skin cells, keeps you under the cosmetics rules while you learn.

The steps

1. Write the claims before the formula. List what each product will say on the front, the back and your product page. Strike anything that describes treating skin conditions or changing how skin works, or accept that the product is a drug and plan for it.
2. Pick a stock formula or a custom one. A stock base from the range of a private label skincare lab, filled into your packaging with your label, is the fastest start; the distinction between white label and private label decides who else can sell the same formula. A custom formula takes development rounds and its own stability testing, but no other brand has it. Ask for the MOQ per product and per packaging size, since minimums on bottles and jars can be higher than on the fill.
3. Shortlist labs overseas and at home. Under MoCRA, manufacturers and processors must register their facilities with FDA and renew their registration every two years^[3], and a foreign facility's registration names the contact for the United States agent of the facility^[4]. Treat the number as a filing, not a quality mark: its assignment does not indicate FDA approval of the facility or its cosmetic products^[5]. Ask each lab which good manufacturing practice standard it works to, such as ISO 22716, and for its latest audit report against it and the stability and compatibility data it holds on the base you are considering.
4. Build the safety file. Neither the law nor FDA regulations require specific tests^[3] of each product, but as the responsible person you must keep records supporting adequate safety substantiation^[3]. In practice that file holds the ingredient safety data, stability results in your final packaging, preservative efficacy results and any skin testing you ran. Agree in writing which of these come with the product and which you commission.
5. List each product as the responsible person. The responsible person is the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label^[6], so with your brand on the label that is normally you. Unless the small business exemption below covers you, you must list each marketed cosmetic product with FDA, including product ingredients^[3]. A product first marketed now is listed within 120 days of marketing^[4], and the listing includes the facility registration number of each facility where the cosmetic product is manufactured or processed^[4]. Have that number from the lab before launch day, not after.
6. Get the label right. Ingredients are declared in descending order of predominance^[7], and the label must give a domestic address, domestic phone number, or electronic contact information, which may include a website^[8] through which you receive adverse event reports. Serious adverse events go to FDA within 15 business days^[3], and records of adverse event reports are kept for 6 years^[9], or less for the small businesses described below.
7. Approve a production sample, then inspect the run. Sign off one sample from the production setup, in the final packaging, and keep it as the standard. Have the first run checked against it before it ships; a quality inspection at the lab costs far less than a recall.

The small business exemption, and where it stops

Responsible persons and facility owners whose average annual US sales of cosmetics are less than $1,000,000, adjusted for inflation^[10] are exempt from facility registration and product listing. The exemptions do not apply to facilities that manufacture or process, or responsible persons for^[5] a short list of higher risk products, so being the brand behind one is enough to lose them. Products that regularly come into contact with mucus membrane of the eye^[5] are on that list, so check any product used around the eyes against it before you rely on the exemption. The exemption applies to each business on its own: the contract lab's registration duty depends on the lab, not on your size. A small business that is not the brand behind, and does not make or process, any of those higher risk products also keeps its adverse event records for 3 years^[9] rather than 6 years^[9].

What a first run costs, landed

A first run of 3,000 serums from an overseas lab

Line	Amount
Lab price, 3,000 units of a 30 ml serum at $2.10, filled and labeled, FOB the origin port	$6,300
Ocean freight and insurance	$650
Duty at 4% (assumed) of the lab price	$252
Broker and entry fees	$400
Stability and packaging compatibility testing, one time	$1,200
Delivery from the port to your warehouse	$350
Landed cost	$9,152
Landed cost per unit	$3.05

Illustrative figures, not a quote. Real prices depend on the spec, quantity and factory.

The one-time testing line is a large share of a small first run and a small share of a large one, which is why the per unit landed cost falls as you reorder. Price the second run too before you set your retail price.

Getting quotes

We introduce you to skincare manufacturers that fit your request, overseas first, and name each one. It is free for brands, and the labs quote you directly; ask each quote to state its shipping terms, so you can put it straight into the landed cost table above. Request skincare quotes with the formula you want, stock or custom, your packaging and the quantity for your first order.