Quick answer: Every cosmetic product marketed in the U.S. must be listed with the FDA within 120 days of first being marketed, with updates required annually or whenever a significant change occurs. This is separate from — and on a different schedule than — facility registration, which renews every two years, not every year. Orionex provides MoCRA product listing, facility registration, and U.S. Agent services starting at $650/year.
Two Obligations, Two Different Clocks
MoCRA created two distinct requirements that get conflated constantly, largely because they're both filed through the same portal (Cosmetics Direct) and both feel like "the FDA cosmetic paperwork." They're not the same thing, and they don't run on the same schedule:
- Facility registration — per manufacturing site, renews every two years (biennially)
- Product listing — per product, updates every year (annually), or whenever a significant change occurs
This mismatch causes real problems: a brand that correctly renews its facility registration every two years can still fall out of compliance on individual product listings if it assumes the same two-year clock applies. It doesn't — product listings need annual attention regardless of where you are in the facility renewal cycle.
The 120-Day Listing Deadline
Any new cosmetic product must be listed with the FDA within 120 days of first being marketed in the United States — not 120 days from manufacturing, from formulation, or from when you decided to launch, but from when the product actually reaches the U.S. market. This applies whether you manufacture the product yourself or through a contract manufacturer; the listing obligation sits with the responsible person (typically the brand owner whose name appears on the label), not automatically with the manufacturing facility.
What a Product Listing Actually Requires
- Product name
- Full ingredient list, submitted in Structured Product Labeling (SPL) format
- Applicable product category (skincare, haircare, color cosmetics, etc.)
- Responsible person's contact information
- Facility FEI number — the FDA establishment identifier linking the product to its registered manufacturing facility
Updates are required annually at minimum, and also whenever a significant change occurs — reformulation, a label change, or a change to the manufacturing facility all trigger an update obligation rather than waiting for the next annual cycle.
Facility Registration Renewal — On Its Own Timeline
Facility registration renewal isn't tied to a single industry-wide date — it's tied to your specific facility's initial registration date. If your facility's initial registration was received by FDA on, say, February 20, 2024, your renewal deadline is February 20, 2026, and every two years after that — not a date shared with every other cosmetic facility in the country.
Current as of early 2026: FDA updated its Cosmetics Direct portal on February 11, 2026, adding new "Registration Status" and "Renewal Date" fields specifically to help facilities track their individual biennial renewal deadline — a genuinely useful tool if you've lost track of your original registration date.
Small Business Exemption — Real, But With Real Limits
MoCRA does exempt certain small businesses from facility registration and product listing requirements. But this exemption has specific carve-outs that apply regardless of business size — meaning even a genuinely small business doesn't get the exemption if its product falls into one of these categories:
- Products that regularly contact the mucous membrane of the eye
- Products that are injected
- Products intended for internal use
- Products intended to alter appearance for more than 24 hours, where consumer removal isn't part of normal use
See our MoCRA small business exemption guide for the full exemption criteria. Even when the exemption applies, it does not exempt a company from safety substantiation or adverse event reporting obligations — those apply regardless of registration/listing exemption status.
What Happens If You Don't Comply
A cosmetic product that isn't properly registered and listed is considered misbranded or adulterated under the FD&C Act — the same legal status as a genuinely unsafe product, at least as far as enforcement authority goes. Practical consequences include border holds on imported product, recalls, and FDA's authority to suspend a facility's registration entirely, stopping production.
U.S. Agent Requirement
Foreign cosmetic facilities need a U.S. Agent as their FDA point of contact, in addition to facility registration and product listing — the same requirement covered across our other cosmetic product guides.
Orionex Regulatory Solutions handles MoCRA facility registration, product listing, and U.S. Agent services together, physically based in Casper, Wyoming USA. Learn about our MoCRA cosmetic services →
Product Listing Compliance Checklist
List New Products Within 120 Days
Count from the date the product is actually marketed in the U.S., not manufactured.
Track Your Facility's Individual Renewal Date
Biennial, based on your facility's own initial registration date — not a shared deadline.
Update Product Listings Annually
A separate, more frequent cycle than facility renewal — don't let one lull you into missing the other.
Update Immediately on Reformulation
Don't wait for the annual cycle if you've changed the formula or label significantly.
Check Small Business Exemption Carve-Outs
Eye-contact, injected, internal-use, and long-duration appearance products are never exempt.
What Orionex Provides
- MoCRA Cosmetic Facility Registration + Product Listing + U.S. Agent: $650/year
Note: Orionex handles your facility registration, product listing submissions, and U.S. Agent designation, and tracks your specific renewal dates so you don't have to. Contact us to get started or to check your current compliance status.
Why Cosmetic Brands Choose Orionex
Facility Registration & Product Listing — From $650/Year
Orionex handles MoCRA facility registration, per-product listing, and U.S. Agent designation, tracking both your biennial and annual deadlines.