If you decant bulk product into your own bottles and put your salon name on the label, you are not just reselling anymore. In the eyes of the FDA you have become the responsible person for that cosmetic. Two obligations follow: labelling, and registration.
Before you close this tab: both filings are free, and both are done online.
Take a breath first
I regularly watch technicians back away from buying bulk because of this step. The word regulation makes people think of lawyers, inspections and fines. So let us put it in proportion right away.
- It is not an approval. The FDA does not approve cosmetics. Nobody evaluates your formula and nobody can turn you down. You are telling the agency that a product exists, what is in it, and who to contact.
- No lab testing is required for a standard cosmetic. You have nothing to send away for analysis.
- Nobody comes to your salon. There is no inspection attached to filing.
- It is not set in stone. Change supplier, size or name and you update the listing.
- The paperwork is small. One facility registration, one product listing, and a label that carries five things.
An organised technician clears the whole thing in one afternoon. The longest part is waiting for your supplier's email.
1. Does this actually apply to me?
Yes, if any of these are true:
- You buy a bulk cleanser, serum or primer and fill your own bottles
- You put your own brand name, logo or salon name on a product you sell
- You sell any cosmetic to a client, in person or online
It does not apply if you only use a product on clients during a service and never sell a container of it. The moment money changes hands for a bottle, you are in scope.
2. What has to be on your label
US cosmetic labelling is governed by the Fair Packaging and Labeling Act and 21 CFR 701. Five things are mandatory.
- Identity statement. What the product is, on the front panel, in reasonably bold type. "Foaming lash cleanser" works. "Lash Magic" alone does not.
- Net quantity of contents. Also on the front panel, bottom third, in both US customary and metric units. For example: 2 fl oz (60 mL).
- Name and place of business. If you did not manufacture the product yourself, your name has to be qualified by a phrase revealing your connection to it, such as Manufactured for or Distributed by. This is the line most private labels get wrong.
- Ingredient declaration. INCI names, in descending order of concentration down to 1 percent. Anything at 1 percent or less can appear in any order after that, and colour additives go last.
- Warnings and directions where the product needs them.
You may not have to print your full street address
This is the question that comes up most often. Under 21 CFR 701.12, the street address may be omitted if it is shown in a current city directory or telephone directory. City, state and ZIP still have to appear.
If your business is not listed in a directory, the address has to be complete. If you work from home and would rather keep that private, a mailbox at a UPS Store or an equivalent gives you a business address that works. It is an annual cost, and it is the one genuinely unavoidable expense in this process if privacy matters to you.
Which document to ask your supplier for
Ask for an ingredient disclosure sheet, or an INCI statement with concentration ranges. That is the document that contains what you need.
You may instead be offered a Safety Data Sheet. Keep it, it is useful for storage and handling, but it usually will not be enough on its own: an SDS only declares components considered hazardous. For a mild lash cleanser, the ingredient section can be nearly empty. If that is all you receive, ask again for the full list. It is a routine request and nobody will find you difficult.
If a supplier will not give you an ingredient list at all, you cannot properly label the product, and you should change suppliers.
3. FDA registration under MoCRA
The Modernization of Cosmetics Regulation Act changed the rules for everyone selling cosmetics in the United States. Two filings matter:
- Facility registration, renewed every two years, for the place where the product is manufactured or processed. Filling bottles counts as processing.
- Product listing, renewed annually, submitted by the responsible person, which is whoever's name is on the label. That is you.
Both are submitted free of charge through the FDA's Cosmetics Direct portal.
The small business exemption, and why it probably does not save you
MoCRA exempts businesses with average annual gross US cosmetic sales under one million dollars, averaged over the previous three years, from facility registration and product listing.
Here is the part that catches lash technicians. The statute excludes cosmetic products that regularly come into contact with mucus membrane of the eye under conditions of use that are customary or usual. A lash cleanser applied at the lash line and rinsed off falls squarely into that category.
Note the wording: regularly come into contact, not intended to. The test is about how the product is actually used, so adding a warning telling people to avoid eye contact does not move a lash product out of the excluded category. It just creates a label that contradicts how the product works.
In practice, assume you need to register and list. The upside: it is free and it takes under an hour, so there is very little to gain from trying to argue your way out of it.
What you still owe even if you are exempt
Regardless of size, you must:
- Meet all labelling requirements, including contact information
- Hold adequate safety substantiation for the product
- Report serious adverse events to the FDA within 15 business days and keep the records
- Comply with any FDA recall order
4. Claims: the fastest way to turn a cosmetic into a drug
A cosmetic changes appearance. A drug changes the structure or function of the body. Cross that line on your label or in your Instagram caption and the product becomes an unapproved drug.
Safe territory: moisturising, conditioning, nourishing, helps improve the appearance of lashes.
Problem territory: grows lashes, regrows, treats blepharitis, eliminates bacteria, heals, cures, prevents.
The FDA looks at your marketing, not just your bottle. A compliant label with a non-compliant caption is still a non-compliant product.
5. The real time and the real cost
- Ask your supplier for the INCI list: one email
- Design the label: varies, depending on whether you build it yourself from an editable template or hire a designer
- Facility registration and product listing: under an hour once your ingredient list and product details are in front of you
The costs: both filings are free. Budget for a mailbox if you would rather not display your home address, and for a designer if you do not want to touch the template yourself. Nothing else costs anything but your afternoon.
6. The mistakes I see most often
- Saying "FDA approved" on a label or a post. The FDA does not approve cosmetics. Registering and listing is not approval, and claiming otherwise is its own violation.
- Omitting Distributed by when the product was made by someone else.
- Dropping the street address without being listed in a current directory.
- Copying and pasting the supplier's marketing copy instead of the real INCI. Very common with imported products.
- Net quantity in millilitres only, with no US customary unit.
- Assuming the small business exemption applies without checking the eye-contact exclusion.
- A compliant label paired with a growth claim in the caption.
What if nobody ever asks?
Honestly? In over ten years, very few clients have ever asked me for my INCI list or my documents. That does not make the exercise pointless.
The day a client reacts to a product, or an esthetician wants to carry your line, or a salon wants to buy your brand, or someone asks a pointed question in front of other people, you are the one who answers in thirty seconds instead of the one who goes looking. That difference is what your afternoon buys you.
And in reverse: when you are shopping for a supplier and they cannot produce these documents, you have just learned something important about them.
Need a hand?
I have been on the manufacturing side of this industry for over a decade and I have filled out these forms more times than I can count. If you get stuck, write to me at contact@secretsid.com and I will help. No charge, no catch. I would rather you do it properly than not at all.
This article is general information, not legal or regulatory advice. Requirements change. Confirm the current rules with the FDA before you rely on anything here.