MoCRA Product Listing: The Step-by-Step Checklist for Indie Beauty Brands

Do you have to list your cosmetic products with the FDA under MoCRA? Here's the exact checklist — exemption check, FEI number, facility registration, product listing, and the updates you owe every year.

Published August 26, 2026 · By Formulate 360 Team· Topics: mocra product listing, fda cosmetic product listing, how to list cosmetic products with fda

Do you even have to list? (Check this first — it decides everything)

Under MoCRA, a responsible person (the manufacturer, packer, or distributor whose name appears on the label) must list each marketed cosmetic product with the FDA, including its ingredients, and update that listing annually. CONFIRMED FDA registration & listing page [1].

But most indie beauty brands are exempt. The small-business exemption: a responsible person (or facility owner/operator) whose average gross annual sales of cosmetics in the US over the previous 3 years is under $1,000,000 (inflation-adjusted) is exempt from registration, listing, and GMP. CONFIRMED FDA guidance [4].

The exemption does NOT apply if your products:

  • Regularly come into contact with the mucus membrane of the eye under customary use,
  • Are injected,
  • Are intended for internal use, or
  • Are intended to alter appearance for more than 24 hours under customary use (and consumer removal isn't part of the conditions of use).

CONFIRMED FDA [1][4].

So the fork is simple: under $1M in cosmetics sales over 3 years and none of the carve-out categories? You're exempt — file voluntarily or not at all. Above the threshold (or in a carve-out category)? The checklist below is for you. And remember from our MoCRA explainer: exemption from registration/listing does not exempt you from safety substantiation or adverse event reporting. Those apply to everyone. CONFIRMED FDA MoCRA page [2].

The checklist

Step 1 — Get your FEI number

FDA uses its FDA Establishment Identifier (FEI)as the required facility registration number. You'll need an FEI before you can submit a facility registration. CONFIRMED FDA [1].

  • Search the FEI Search Portal to see if your firm already has one.
  • If you don't have one, FDA's portal explains how to request an FEI.

Time: one session. Do this before anything else.

Step 2 — Register the facility (if you're a manufacturer or processor)

Manufacturers and processors must register their facilities with the FDA. CONFIRMED FDA [1].

  • Where: Cosmetics Direct — the FDA's free electronic submission portal. It's a structured (SPL) authoring tool with user-friendly data entry forms, built-in validation, and direct submission — you don't need the heavier Electronic Submissions Gateway (ESG NextGen). CONFIRMED FDA [1].
  • Alternatives: any SPL authoring software (including SPL Xforms) submitted through ESG NextGen, or paper forms — Form FDA 5066 for facility registration, Form FDA 5067 for product listing. FDA strongly encourages electronic submission. CONFIRMED FDA [1].
  • Renewal: renew every two yearsfrom your initial registration date. Renewal dates are based on the initial registration date — e.g., an initial registration received February 20, 2024 renews by February 20, 2026. There's an abbreviated renewal option when nothing changed since your last submission, and Cosmetics Direct now shows REGISTRATION STATUS and RENEWAL DATE fields on the facility homepage, with automated email reminders before your renewal date (portal update February 2026). CONFIRMED FDA [1].
  • Changes: update registration content within 60 days of any change. CONFIRMED FDA compliance policy [5].

The teeth:FDA can suspend a facility's registration if a product from the facility has a reasonable probability of causing serious adverse health consequences or death — and once suspended, distributing or selling products from that facility in the US is a prohibited act. CONFIRMED FDA [1].

Step 3 — List each product (the responsible person's job)

The responsible person lists each marketed cosmetic product, including product ingredients, and provides updates annually. CONFIRMED FDA [1].

Data you'll want in front of you before you sit down DIRECTIONAL — assembled from FDA's SPL/Cosmetics Direct submission fields [1][3]; field set can change, check the current user guide:

DataWhat it isWhere it comes from
Responsible person name + contactThe manufacturer/packer/distributor whose name is on the labelYour label — the same name in the FPLA "responsible person" line
Facility FEIYour FDA Establishment IdentifierStep 1
Product category codeFDA's cosmetic product category/code for your product typeFDA Cosmetic Product Categories and Codes page [3]
Ingredient listFull INCI declaration, in orderYour formula sheet and label — see our INCI primer
Product label / labelingThe label as marketedYour design files
Intended use + formHow the product is meant to be usedYour claim and marketing copy — keep it cosmetic, not drug
Baby product flag + related fieldsWhether it's intended for children under 3Product definition

Step 4 — Keep it current (this is where brands actually trip)

Three clocks run after your first submission CONFIRMED all — FDA [1][5]:

  1. Facility registration changes → update within 60 days.
  2. Product listing → update annually (and update the listing when the product changes — new ingredients, new label, discontinued status; Cosmetics Direct has discontinuation/relisting features, added July 2024).
  3. Facility registration → renew biennially from the initial registration date (abbreviated renewal if nothing changed).

Put all three on a calendar with owners. The failure mode is registering once, celebrating, and letting the renewal date slide — that's exactly the kind of drift FDA's new reminders and portal fields are built to catch.

Step 5 — Know what this is and isn't

  • It is not approval. “Cosmetic product facility registration and product listing is neither a cosmetic approval program nor a promotional tool. FDA does not issue ‘certificates’.” CONFIRMED FDA [1].If anyone tries to sell you “FDA approval” or an “FDA certificate” for your lotion, walk away.
  • It is scaled and live. As of June 30, 2026: 16,398 active facility registrations and 1,298,361 active product listingsin the FDA's cosmetics program. CONFIRMED FDA [1]. The program is real, the portal is mature, and the reminders are automated.
  • Voluntary filing exists for the exempt.FDA welcomes voluntary registration/listing for facilities and products that aren't required to file (you'll fill all mandatory fields either way). CONFIRMED FDA [1].Some brands file voluntarily anyway to be squeaky-clean for retailers; that's a business call, not a legal requirement.
  • Enforcement posture (our read, not a legal opinion): the visible enforcement focus so far has been registration/listing compliance, SAE reporting, and mandatory recall. ESTIMATE expect the data-quality questions (correct category codes, complete ingredient lists, timely updates) to tighten as the program matures — sloppy listings are the cheapest thing for the FDA to audit.

Common mistakes (and the honest versions)

  1. “My contract manufacturer handles it.”If your brand name is on the label, you're the responsible person. The facility registers itself; the product listing is yours. CONFIRMED FD&C Act § 609(a) / FPLA § 4(a), via FDA [1][5].
  2. “We're under $1M, we're safe.”For registration/listing: probably yes — but the exemption doesn't cover eye-area, injectable, internal-use, or 24h+ appearance-altering products, and it never covers safety substantiation or adverse event reporting. CONFIRMED FDA [1][4].
  3. “I registered once, I'm done.” Biennial renewal, 60-day change updates, annual listing updates. Three calendars.
  4. “FDA approved my product.” No. Registration and listing are not approval and FDA issues no certificates. CONFIRMED FDA [1].
  5. “The portal is too complicated, I'll pay someone.” Cosmetics Direct is a guided form tool with a user guide and tutorials — most indie brands can file directly for free. FDA does not charge a fee for registration or listing. CONFIRMED FDA [1].

Quick answers

I'm a solo founder selling 200 jars a month. Do I need to list products?

Only if you're over the $1M/3-year cosmetics-sales threshold or make carve-out product types. Under it, you're exempt from listing (but not from safety substantiation and adverse event reporting — those apply to everyone).

How much does it cost to register and list?

Nothing. FDA does not charge for facility registration or product listing. (CONFIRMED — FDA [1].)

How often do I update?

Facility registration changes within 60 days; facility registration renews every 2 years; product listings update annually.

What happens if I don't comply?

Registration/listing is a legal requirement for non-exempt businesses. FDA can suspend a facility's registration (which makes distribution a prohibited act) and has mandatory recall authority for products that could cause serious adverse health consequences or death. (CONFIRMED — FDA [1].)

Can I file voluntarily if I'm exempt?

Yes — FDA welcomes voluntary registration and listing.

The tool-shaped answer

Formulate360 can't file your listing for you — filing happens in Cosmetics Direct with your FEI and your label facts. What the tool cando is keep the ingredient data the listing wants: INCI declarations, formula records, batch records, and the documentation trail MoCRA expects (safety substantiation, adverse event logs). That's the record-keeping wedge — you still own the submission, and every output is formulation assistance, not a substitute for a qualified formulator or regulatory professional.

How this connects to the rest of the knowledge base

Formulation assistance only. This article is general information compiled from FDA sources, not legal advice. For your specific product, work with a regulatory professional.

Citations

  • FDA — Registration & Listing of Cosmetic Product Facilities and Products: https://www.fda.gov/cosmetics/registration-listing-cosmetic-product-facilities-and-products (verified 2026-08-26)
  • FDA — MoCRA (Modernization of Cosmetics Regulation Act of 2022): https://www.fda.gov/cosmetics/cosmetics-laws-regulations/modernization-cosmetics-regulation-act-2022-mocra
  • FDA — Cosmetic Product Categories and Codes: https://www.fda.gov/cosmetics/registration-listing-cosmetic-product-facilities-and-products/cosmetic-product-categories-and-codes
  • FDA Guidance — Registration and Listing of Cosmetic Product Facilities and Products: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-registration-and-listing-cosmetic-product-facilities-and-products
  • FDA — Compliance Policy for Cosmetic Product Facility Registration and Cosmetic Product Listing (Nov 8, 2023): https://www.fda.gov/cosmetics/cosmetics-news-events/fda-issues-compliance-policy-cosmetic-product-facility-registration-and-cosmetic-product-listing

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