7 US Label and MoCRA Checks Before You Approve a Final Formula

Final approval is the written sign-off that freezes your formula and packaging artwork so the ODM can order materials and book production. It is the last cheap moment to change anything. After it, one changed word on a carton means new printed stock, and a changed formula can mean new stability testing.

By this point the sample rounds have settled texture, scent and performance (see our guide to evaluating Korean ODM samples). This list covers the other half: the US rules that decide whether the approved product can be imported and sold as printed.

What Should You Check Before Approving a Final Formula?

Check seven things before you sign: the ingredient declaration, color additive uses, state ingredient bans, the Prop 65 warning call, country of origin marking, MoCRA listing data and drug status. Your ODM can supply a document for each one before approval.

Every check depends on the final formula or artwork, so approval is the moment to run them. Earlier, the next revision undoes the work. Later, each fix costs a reprint or a retest. For the full FDA rules behind them, see our FDA requirements guide for Korean skincare.

Seven Checks, Before and After Approval

The table sets each check against the two moments: one request to the ODM before approval, or a reprint, a retest or an updated FDA filing after it.

Sources: FDA on color additives in cosmetics and on registration and listing; 19 CFR 134.51 on goods found not legally marked.

Are Your Ingredient List and Colors Final?

They are final when the US list matches the approved formula in FDA order and every color is approved for where the product is used. Both sit on the same panel, so check them together.

The ingredient declaration is the list of every ingredient on the label in descending order of predominance. Under 21 CFR 701.3 you may instead list ingredients above 1 percent in order, then those at 1 percent or less in any order, then the color additives. Our US label guide for Korean skincare covers naming, type size and the other required panels.

Ask the ODM for: the approved formula's list in that format, with the 1 percent line marked. Then check each name against the US label name, not a translation of the Korean list.

Color additives are approved by intended use, so a color approved for externally applied cosmetics is not approved for the lips or other mucous membranes. No color may be used in the area of the eye unless its regulation allows it. Our lip treatment development guide walks through the lip rules.

Ask the ODM for: the FDA name, the permitted use area and, for colors that need batch certification, the FDA lot certification number from the supplier's label. FDA states that a Colour Index number does not show certification, and Korean and EU-style ingredient lists often show colors that way.

If it changes after approval: a shade tweak usually brings new colors, so the ingredient panel and the listing change with it. FDA also names color additive violations as a common reason for detaining imported cosmetics.

State Bans and Prop 65 Sit Outside Federal Law

Meeting federal rules does not settle state law. Before approval, confirm the formula contains no ingredient banned in the states you sell into, and decide whether California's Proposition 65 calls for a warning on the pack.

California's Toxic-Free Cosmetics Act bans a list of intentionally added ingredients, including formaldehyde, mercury and certain PFAS, and several other states have passed PFAS bans of their own. Our state PFAS ban guide tracks which states and dates apply.

Proposition 65 requires a warning for exposure to a listed chemical unless the exposure falls below the law's risk thresholds (OEHHA). Our Prop 65 guide for Korean skincare covers when a warning is needed and how it must read.

Ask the ODM for: a signed statement that no banned substance is intentionally added, backed by raw material specifications, and a screen of the formula and packaging parts against the Prop 65 list. Make the warning call before the artwork freezes.

If it changes after approval: a banned ingredient found late means a reformulation, new stability testing and new artwork. A warning added late means new artwork and updated online product pages.

Where Does "Made in Korea" Go on the Pack?

It goes right next to any US place name on the pack. The rule applies when a label shows "USA" or a US city or address that could mislead buyers about origin. The country of origin must then appear in close proximity, in at least comparable size, after "Made in," "Product of" or similar words (19 CFR 134.46).

A "Distributed by" line with your New York address is the usual trigger. The rule also asks for legible and permanent marking, so print the origin line rather than relying on a sticker that peels off.

Ask the ODM for: final proofs of both the container and the outer carton, with the origin line placed beside the address in matching type size.

If it changes after approval: fixing a missing line before shipment means reprints. Finding it at the port is worse, because CBP can require the goods to be marked, exported or destroyed under its supervision at the importer's expense.

MoCRA Data Comes Straight From the Approved Formula

Your MoCRA product listing repeats facts fixed at approval. It lists the registration number of each facility that makes the product, the product name as printed, its category and every ingredient, including fragrances, flavors and colors (21 U.S.C. 364c). The responsible person, the company named on the label, files the listing within 120 days of first marketing and submits updates every year.

The label itself needs a MoCRA line too. It must carry a domestic address, a domestic phone number or electronic contact information, such as a website, where the responsible person can receive adverse event reports (21 U.S.C. 364e). Settle that line before the artwork freezes.

Ask the ODM for: the facility registration number and renewal date from its registration record. The facility owner or operator registers, renews every two years from the first registration date and reports changes within 60 days, with no FDA fee. Registration is not FDA approval, and FDA issues no registration certificates, so a "certificate" is not proof.

If it changes after approval: a new plant changes the facility number in the listing, and a reformulation changes the ingredient list. Shade, scent and size variants of one formula can share one listing, as long as the data stays accurate.

Could One Claim Make Your Product an OTC Drug?

Yes. Intended use decides whether a product is a cosmetic or a drug, and claims on the label, in ads and online establish it (FDA). Sunscreen, acne, dandruff and antiperspirant claims put a product under OTC drug rules, with drug registration and listing instead of the MoCRA cosmetic listing (21 U.S.C. 364i).

Our acne product guide walks through the drug steps, from the monograph to the Drug Facts label.

Ask the ODM for: a claims review of the label, the carton and your launch copy. If any claim is a drug claim, ask for proof that the plant is registered as a drug establishment and makes the product under drug GMP.

If it changes after approval: a drug claim added late is the most expensive change here. It brings a new label format, the testing the monograph requires (SPF testing for a sunscreen, for example) and possibly a different plant.

A Sign-Off File That Closes All Seven

Approve only when your file holds one document per check. Name each document in the approval email, so the ODM, your label designer and whoever files your listing all work from the same version.

• The ingredient list in FDA order, matching the formula version you approve
• A color sheet with FDA names, use areas and certification lot numbers
• A signed non-use statement for state-banned substances
• The Prop 65 screen and your written warning decision
• Artwork proofs showing the origin line and the adverse event contact line
• A MoCRA data sheet with the facility registration number, product category and label name
• A claims review with the cosmetic or drug call in writing

Write the formula version number into the approval. If the formula or artwork changes later, the version changes and all seven checks run again. A formula change can also restart stability work; see our guide on reading Korean ODM stability reports before production.

Frequently Asked Questions

Does FDA approve my label or formula before I sell?
No. FDA does not approve cosmetic products or their labels before sale, except that color additives need FDA approval for their intended use. A facility registration number or product listing number is not FDA approval either.

Can my Korean ODM's English ingredient list go straight onto the US label?
Only after a line-by-line check. It has to follow the order rules in 21 CFR 701.3 and use US label names, and colors shown only as Colour Index numbers need their US names.

Do I need a separate MoCRA listing for each shade or scent?
Not always. One listing can cover products with identical formulas, or formulas that differ only in colors, fragrances or flavors, or quantity of contents. Any change to the listed data goes in with the annual update.

Who owns the Prop 65 and state-ban call, the ODM or my brand?
Your brand does, because it sells into those states and its name is on the label. The ODM supplies the facts behind the call: a non-use statement for banned substances and a screen against the Prop 65 list.

By Liz Song, K-beauty sourcing consultant.