MoCRA Compliance Checklist for Importing Korean Cica Serum into the USA: Documents, Deadlines, and Roles

Private-label brands and US buyers sourcing a Korean centella (cica) facial serum face a specific set of FDA filings under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). These are not future obligations — facility registration and product listing have been enforceable since July 1, 2024. This checklist walks you through who is responsible for what, which six documents you need before filing, and how to submit through the Cosmetics Direct portal or paper forms.

Step One: Decide Who Fills Which MoCRA Role

Two distinct roles exist under MoCRA for an imported serum. Mixing them up causes delays and incorrect filings, so resolve this question before anything else.

The US agent is linked to the Korean manufacturing facility. According to the U.S. Food and Drug Administration (FDA), a foreign cosmetic facility must name a US agent for its FDA registration. That agent must reside in the US or maintain a US place of business, must be physically present in the US, and cannot be a mailbox, answering machine, or answering service. The US agent handles FDA communications on behalf of the Korean factory — this role does not appear on your product label.

The responsible person is linked to the product. Per the FDA, the responsible person is the manufacturer, packer, or distributor of the cosmetic whose name appears on the label under section 609(a) of the FD&C Act or section 4(a) of the Fair Packaging and Labeling Act. As the US distributor or private-label buyer, if your brand name goes on the label, you are likely the responsible person. The responsible person files the product listing, maintains safety substantiation records, and reports serious adverse events to FDA.

One company or person can serve as both the US agent and the responsible person if they meet both sets of requirements. Confirm this arrangement with your legal or regulatory advisor before filing.

The Six Documents to Assemble Before Filing

MoCRA compliance for a Korean centella (cica) facial serum is a document-assembly exercise before it is a filing exercise. These six items must exist before you open Cosmetics Direct:

Six documents to have ready before opening Cosmetics Direct

• ✓ Korean facility's FDA registrationThe Korean OEM/ODM that manufactures or processes the serum must register via Cosmetics Direct or Form 5066, naming a US agent who is physically present in the US.
• ✓ Facility registration numberIssued after the facility completes registration; the product listing must generally include this number — so the facility registers first.
• ✓ Full INCI ingredient listAll ingredients in descending order by weight, using INCI names. For your cica serum: centella asiatica extract, niacinamide, and hyaluronic acid in their correct sequence.
• ✓ Safety substantiation recordsDocuments supporting adequate safety of the product. No specific tests are required by law; existing ingredient safety data from scientifically sound methods is acceptable.
• ✓ US-compliant label draftINCI ingredient declaration, English-language text, net quantity (1 fl oz / 30 mL), responsible person name and US address, and country of origin (Made in Korea).
• ✓ Responsible person's US name and business addressThe marketing firm's name and place of business that will appear on the label's information panel, as required under 21 CFR 701.12.

On safety substantiation: the FDA requires the responsible person to ensure there is adequate substantiation of the product's safety and to keep supporting records. The law does not require specific tests, and animal testing is not required by FDA regulations. Existing safety data from scientifically sound methods is acceptable. For a fragrance-free serum built on centella asiatica extract, niacinamide, and hyaluronic acid — all well-documented cosmetic ingredients — the substantiation file typically draws on supplier safety data and existing literature rather than new testing.

How to Submit: Cosmetics Direct, ESG NextGen, and Paper Forms

The FDA provides Cosmetics Direct as its Structured Product Labeling (SPL) authoring tool for facility registration and product listing. You can also use the Electronic Submissions Gateway NextGen or other SPL-compatible software. For paper filers, Form 5066 covers facility registration and Form 5067 covers product listing.

The order of filing is fixed. Per the FDA, a product listing must generally include the facility registration number of each facility where the product is manufactured or processed. That means the Korean factory's facility registration must come first, because the listing references its number.

Filing sequence for MoCRA facility registration and product listing

1. 1

   Coordinate with your Korean OEM

   Confirm the factory has a Cosmetics Direct account or SPL authoring software, and agree on who will serve as the US agent named in the registration.

2. 2

   Korean factory files Form 5066 (facility registration)

   The facility submits via Cosmetics Direct, ESG NextGen, or the paper Form 5066. The named US agent must be physically present in the US — not a mailbox or answering service.

3. 3

   Collect the facility registration number

   Once registration is complete, the facility has an FDA-issued registration number. Obtain this number before starting the product listing.

4. 4

   Responsible person files Form 5067 (product listing)

   Submit the product listing via Cosmetics Direct, ESG NextGen, or Form 5067. Include the full INCI ingredient list and the Korean facility's registration number.

5. 5

   Set a recurring compliance calendar

   Facility registration renews every two years; update within 60 days of any change. The product listing requires annual updates by the responsible person.

One important clarification: according to the FDA, facility registration and product listing is neither a cosmetic approval program nor a promotional tool, and FDA does not issue certificates for facility registrations or product listings. You cannot market a serum as "FDA approved" or imply that a certificate confirms the product's safety.

Critical Dates: When These Requirements Became Enforceable

Three MoCRA enforcement dates

These requirements are already in force — not upcoming deadlines

December 29, 2023: Serious adverse event reporting became enforceable. July 1, 2024: Facility registration and product listing requirements became enforceable (after a six-month delay FDA granted to give industry time to submit). Every two years: Biennial renewal of facility registration. If your Korean OEM's facility is not yet registered or your product is not yet listed, both filings are overdue.

Biennial renewal applies to facility registrations. Per the FDA, registrations must be updated within 60 days of any change and renewed every two years. An abbreviated renewal is available when nothing has changed since the last submission. Product listings require annual updates from the responsible person.

For adverse event reporting, the FDA sets a 15-business-day window. A responsible person must report serious adverse events tied to a cosmetic used in the US within 15 business days, include a copy of the label on or within the retail packaging, and submit follow-up medical information received within one year within another 15 business days. FDA recommends MedWatch Form 3500A, emailed to CosmeticAERS@fda.hhs.gov.

Five Label Elements FDA Requires on Your US Serum

US cosmetics labeling is governed by the FD&C Act and the Fair Packaging and Labeling Act (codified at 21 CFR 701 and 740). A label that falls short may be treated as misbranded and subject to regulatory action. For a 30 ml airless pump bottle of fragrance-free cica serum, five required items must be present:

1. INCI ingredient declaration (21 CFR 701.3). List all ingredients in descending order by weight, using INCI names — the internationally standardized cosmetic ingredient names. Ingredients at one percent or less and color additives may be listed without weight order. Centella asiatica extract, niacinamide, and hyaluronic acid all have established INCI names and must appear in the correct sequence.

2. English language and conspicuous text (21 CFR 701.2). All required label statements must appear in English and be easy to see and read. A Korean-only label does not satisfy this requirement.

3. Net quantity on the principal display panel (21 CFR 701.10). The principal display panel must state the net fill — for a 30 ml bottle, that appears as "1 fl oz (30 mL)" in the required format.

4. Responsible person's name and US address (21 CFR 701.12). The name and place of business of the firm marketing the cosmetic must appear on the information panel. If you are the distributor, the label must include wording like "Distributed by [Company Name], [City, State, USA]." This is where your US business address appears.

5. Country of origin (Tariff Act of 1930). Imported cosmetics must state the English name of the country of origin. "Made in Korea" or "Product of Korea" belongs on the label — this is a US customs requirement, not optional.

ISO 22716 and FDA GMP: What Your Supplier's Certificate Actually Covers

Korean OEMs holding ISO 22716 certification — the international standard for cosmetics Good Manufacturing Practice — are working to a framework that closely aligns with FDA's direction on cosmetic GMP requirements.

FDA cosmetic GMP is still draft guidance as of 2026

MoCRA mandates GMP rules, but the formal FDA regulation has not been finalized

MoCRA requires FDA to establish Good Manufacturing Practice regulations for cosmetic manufacturing facilities. FDA has published Draft Guidance for Industry on cosmetic GMP to support that mandate. Because it is draft guidance and not yet a final binding rule, confirm its current status before treating it as mandatory. A Korean OEM already certified to ISO 22716 — the international cosmetics GMP standard — is well positioned to align with FDA's expectations as the rule is finalized.

When evaluating a Korean cica serum supplier, ask for their current ISO 22716 certificate and most recent internal audit summary. These documents support your safety substantiation file and demonstrate manufacturing credibility to US retail buyers and regulatory reviewers.

Sourcing a MoCRA-Ready Korean Cica Serum

A Korean centella (cica) facial serum that ships ready for US import needs three things aligned from the start: a manufacturer with an active FDA facility registration and a documented ISO 22716 record, a complete INCI ingredient specification that maps directly to a product listing, and a label built to 21 CFR 701 standards before the first purchase order. Getting these right from the outset prevents compliance gaps from becoming shipment delays.

Need MoCRA-ready documentation for a Korean centella (cica) facial serum — including facility registration data, product-listing inputs, and US-compliant label information? Submit your sourcing request at exportservice.cloud/inquiry.

Frequently Asked Questions

If I am the private-label buyer, am I automatically the responsible person?

You likely are, if your brand name appears on the label. Per the FDA, the responsible person is the manufacturer, packer, or distributor of the cosmetic whose name is on the product label under section 609(a) of the FD&C Act or section 4(a) of the Fair Packaging and Labeling Act. A private-label buyer who puts their brand on the serum box and distributes it in the US is typically the responsible person. The Korean factory is the registered facility and needs a separate US agent for that registration.

Can the product listing be filed before the Korean factory registers?

No. According to the FDA, a cosmetic product listing must generally include the facility registration number of each facility where the product is manufactured or processed. That number only exists after the facility completes registration. The correct sequence is: facility registers and receives its registration number, then the responsible person completes the product listing that references it.

What triggers the 15-business-day adverse event report, and how does it get submitted?

A serious adverse event connected to a cosmetic used in the US triggers the report. Per the FDA, the responsible person must file within 15 business days and include a copy of the label on or within the retail packaging. If new medical or other information about the same event arrives within one year of the initial report, that follow-up must also be submitted within 15 business days. FDA recommends MedWatch Form 3500A, emailed to CosmeticAERS@fda.hhs.gov. This requirement became enforceable on December 29, 2023.

Can FDA refuse entry of a Korean cosmetic at the US port?

Yes. According to the FDA, the agency may refuse entry of adulterated or misbranded foreign cosmetic products into the US, and may inspect establishments, seize violative products, and pursue legal action. Additionally, if FDA suspends a facility's registration because a product made there poses a serious health risk, distributing or selling that facility's cosmetics in US interstate commerce becomes a prohibited act under MoCRA. Keeping registrations current and labels compliant is the practical way to keep shipments moving.

References

• Modernization of Cosmetics Regulation Act of 2022 (MoCRA) — U.S. Food and Drug Administration
• Registration & Listing of Cosmetic Product Facilities and Products — U.S. Food and Drug Administration
• Guidance for Industry: Registration and Listing of Cosmetic Product Facilities and Products (December 2024) — U.S. Food and Drug Administration
• Deadline for Registration and Listing — U.S. Food and Drug Administration
• Serious Adverse Event Reporting for Cosmetic Products — U.S. Food and Drug Administration
• Summary of Cosmetics Labeling Requirements (21 CFR 701 & 740) — U.S. Food and Drug Administration
• Cosmetics & U.S. Law (FD&C Act) — U.S. Food and Drug Administration
• Draft Guidance for Industry: Cosmetic Good Manufacturing Practices — U.S. Food and Drug Administration