We register your facility with FDA
Facility registration through FDA’s Cosmetics Direct portal, and renewal every two years.
Registration number
Market · United States
We make your cosmetics MoCRA-ready for the US.
CSL regulatory specialists register your facility, list your products with FDA, act as your US Agent, build your safety substantiation and review your labels, and we tell you early if a claim makes your product an OTC drug.
Guires Cosmetic Science Lab
US FDA and MoCRA compliance from Guires CSL
FDA cosmetic facility registration, MoCRA product listing, a US Agent for cosmetics made outside the US, and the OTC drug route where your claims need it.
Start your project with Guires CSL1–2 wksregistration and listing, once data is ready
US Agentfor facilities outside the US
OTC routefor sunscreens and drug claims
Charlotteour US office
MoCRA · FDA registration & listingthe rules we work to. Timelines are indicative and confirmed in your proposal.
What we do for you
Your US launch, handled end to end.
We do the regulatory work so your team can focus on the launch. Choose the whole service or only the parts you need.
We act as your US Agent
For facilities outside the US, we are the named contact for FDA.
US Agent agreementWe list your products
Each product and its ingredients listed with FDA, and updated every year.
Product listingWe build your safety substantiation
A documented safety record for every product, as MoCRA now requires.
Safety substantiation fileWe review your labels
Ingredient order, warnings, net contents, a US contact for adverse event reports and state rules such as California’s.
Label reportWe set up adverse event handling
A process to record serious adverse events and report them to FDA within 15 business days.
SAE procedureWe check cosmetic vs drug
Sunscreen, anti-dandruff, acne and antiperspirant claims make a product an OTC drug. We classify each product before you launch.
Classification memoWe handle the OTC drug route
Monograph check, drug establishment registration, NDC and drug listing, Drug Facts label and SPF testing for sunscreens.
OTC dossierHow it works
From brief to on-shelf.
Indicative timings once complete data is in hand. We give dates for your products in the proposal.
- Week 1Classification
Cosmetic or OTC drug, product by product
- Week 1–2Safety substantiation
Evidence file for each product
- Week 1–2Label review
Artwork corrected before print
- Week 2Registration and listing
Facility registered and products listed
- +4–12 weeksOTC set-up (if needed)
NDC, drug listing, Drug Facts, testing
What you receive
Your documents.
- Registration numberFrom: register your facility with FDA
- US Agent agreementFrom: act as your US Agent
- Product listingFrom: list your products
- Safety substantiation fileFrom: build your safety substantiation
- Label reportFrom: review your labels
- SAE procedureFrom: set up adverse event handling
- Classification memoFrom: check cosmetic vs drug
- OTC dossierFrom: handle the OTC drug route
What we need from you
To get started.
- Formula with percentages
- Manufacturing and packing site details
- Label artwork
- Existing safety and test data
- Product claims and marketing copy
Missing something? We run the tests or prepare the documents for you.
Special routes
Things to know early.
Sunscreens
OTC drugs under the FDA monograph, with their own UV filter list, SPF testing and drug GMP.
Small businesses
Some small businesses are exempt from registration and listing. We check eligibility first.
Packages
Three ways to enter the US.
Every package is quoted per product after a formula review.
Market entry
For finished products with data in hand.
- Formula review for the market
- Safety file or dossier
- Notification or registration filing
- Local representative role (where we offer it)
Launch ready
For new products that still need testing.
- Everything in Market entry
- Testing the file needs (stability, challenge, safety)
- Label and claims review
- Artwork corrections before print
Compliance partner
For brands selling in several markets.
- Everything in Launch ready
- Regulatory watch for your portfolio
- File updates when formulas or suppliers change
- Renewals, export documents and a named specialist
Questions
Asked before we start.
Do I need to register under MoCRA?
Most manufacturers and processors must register their facilities, and the brand responsible must list each product. Some small businesses are exempt; we check yours.
Can you be our US Agent?
Yes, for facilities outside the US.
Is my sunscreen a cosmetic in the US?
No. Sunscreens are OTC drugs in the US, with a separate route that we can manage.
Does FDA issue a certificate?
No. FDA gives registration and listing numbers, not certificates.
Insights
Related reading.
Recall: hand sanitiser pulled from US shelves over hidden methanol
An alcohol-based hand sanitiser made in Mexico was recalled after testing found undeclared methanol. What happened, and the controls that prevent it.
Read article
MoCRA for brands outside the US: what you need before you ship
Facility registration, product listing, US Agent, safety substantiation and adverse event reporting, in the order to tackle them.
Read article
“Dermatologically tested”: what the claim needs behind it
Patch tests, in-use studies and panel sizes, and how wording differs between markets.
Read articleOther markets
Often on the same launch list.
Start a project
Create your next product with CSL.
Our formulation chemists, testing scientists and regulatory specialists work alongside your team, from the first brief to a market-ready product. Bring a brief, a benchmark or just an idea: a scientist will reply within one working day with next steps and an indicative scope.