Korean skincare manufacturing for US brands
Private label serums, creams, masks and cleansers, made in an ISO 22716 (GMP) certified, FDA registered factory in Korea. We prepare your FDA MoCRA listing and US label, then ship by air or sea.
Korean cosmetics exports to the US reached $2,184 million in 2025, up 15.0%, more than to any other country (MFDS).
What the US requires
Cosmetics need no FDA approval before sale, but under MoCRA every factory is registered and every product is listed. Here is who does what.
FDA facility registration
Every facility that makes cosmetics for the US registers with FDA and renews every two years. Ours is registered.
MoCRA product listing
Each product is listed with its ingredients by the responsible person, the brand named on the label, with updates every year. We prepare the listing for your products.
Safety records and adverse events
As the responsible person you keep records that support each product's safety and report serious adverse events to FDA within 15 business days. The full INCI list and the tests planned into your project support that file.
A US label
English, ingredients in descending order, net quantity in fl oz or oz, your name and place of business, a US address, phone number or website for adverse event reports, and Made in Korea.
Sunscreen is a drug
SPF products are over-the-counter drugs in the US: FDA-permitted UV filters, US testing and a Drug Facts label. We quote US sunscreen case by case.
Customs entry and duty
Your customs broker files the entry. Most skincare (HTS 3304.99.50, normally duty free) pays a combined 12.5% on goods of Korea under a Section 301 action in force since July 24, 2026.
What we prepare and ship
We sell our own skincare in the US, so we have been through US import and MoCRA listing ourselves. Our US office is in Atlanta, Georgia.
Documents
- FDA MoCRA product listing
- Full INCI list
- Stability, challenge and patch tests, planned in
- Your custom formula stays yours
Your US label
- Ingredients in descending order
- Net quantity in fl oz or oz
- Your name and place of business
- US contact for adverse event reports
- Made in Korea
Shipping
- Air: about 5 to 10 days
- Sea: about 4 to 6 weeks
- We quote freight with your order
- Deposit at order, balance before shipment
Products to start with
Starting prices per unit with a library formula, a stock container and a one-color label. Larger runs cost less.
Serum$2.96 at 1,000 · $3.70 at 500
Toner$1.68 at 1,000 · $2.10 at 500
Cream$2.48 at 1,000 · $3.10 at 500
Sheet mask$0.55 at 1,000 units
Planning an SPF for the US?
A Korean sunscreen usually needs its own US formula, testing and Drug Facts label, because several filters common in Korea are not permitted in US sunscreens. Tell us early and we quote it case by case. See why Korean sunscreen is rare in the US.
US questions, answered
Straight answers for brands selling in the United States.
Does Korean skincare need FDA approval?
Who is the responsible person under MoCRA?
Can you make a sunscreen for the US market?
What duty do I pay on skincare from Korea?
How long does shipping to the US take?
Read more
Official sources
- FDA: Modernization of Cosmetics Regulation Act of 2022 (MoCRA)
- FDA: Registration and listing of cosmetic product facilities and products
- FDA: Authority over cosmetics
- FDA: Cosmetics labeling guide
- US Code: 21 U.S.C. 364e, labeling
- FDA: Sunscreen
- USTR: Notice of actions in Section 301 investigations (July 2026)
- USITC: Harmonized Tariff Schedule, 3304.99.50
Rules as of September 2026. Check the official pages before you launch.
Other markets
Plan your US launch
No commitment until you approve a sample.