Review cosmetic labels, including MoCRA contact information

Cosmetic label review is coming soon to ArcheSync. It will check supported label elements on skincare, color cosmetics and fragrance: ingredients, identity, net contents, the business line, and the US contact information MoCRA requires. Label review will not establish facility registration, product listing, or safety substantiation.

Status: coming soon. Cosmetic labels cannot be uploaded yet.

Join the waitlist MoCRA contact guide

Demonstration render of a fictional hydrating serum in a dropper bottle. — Demonstration artwork. Fictional brand, not a customer label.

What cosmetic review will cover.

The planned checks, each with the provision it cites.

Statement of identity
What the product is, on the principal display panel.
21 CFR 701.11(a)
Ingredients
Descending order of predominance; items at 1% or less and color additives may follow in any order; "Fragrance" may be declared as such.
21 CFR 701.3
Net contents
US fluid ounces for liquids or ounces for solids, on the principal display panel in the bottom 30%; metric may be added.
21 CFR 701.13
Name and place of business
Manufacturer, packer or distributor with a qualifying phrase such as "Distributed by".
21 CFR 701.12
US contact for adverse events
A domestic address, domestic phone number or electronic contact information, such as a website.
FD&C Act §609(a)

A preview of the report format.

The demonstration lipstick carton names a distributor in Seoul and a Korean phone number, with no US contact route. This is demonstration artwork; cosmetic labels cannot be reviewed yet.

Flat carton artwork for a fictional satin lipstick with a Seoul distributor address and a Korean phone number. — Demonstration artwork. Fictional brand, not a customer label.

Evidence: The only contact on the carton is a distributor in Seoul and a +82 phone number. There is no US address, US phone number, website or other electronic contact.
Why: FD&C Act §609(a) requires a domestic address, domestic phone number, or electronic contact information (which may include a website) through which the responsible person can receive adverse event reports. 21 CFR 701.12 is still met, because the name and place of business may be outside the United States.
Next step: Add a US contact route, for example a US phone number and a website or email address that reaches the responsible person.

lipstick_carton.pdf

Cosmetics, color cosmetics. Coming soon. Illustrative sample

Uploaded5 elements extractedFindings with clauses

No issueStatement of identity on the front panel21 CFR 701.11(a)
No issueNet weight in ounces with grams, bottom 30% of the panel21 CFR 701.13(f), (j)(1), (r)
No issueIngredients with color additives last21 CFR 701.3(a), (f)(3)
No issueDistributor name and place of business (Seoul)21 CFR 701.12
FlagNo U.S. address, phone or electronic contact for adverse-event reportsFD&C Act §609(a)

5 elements checked: 1 flagged, 4 with no issue foundIn the sample report

Label review is one part of MoCRA.

A label review can show

Whether a US address, US phone number or electronic contact appears on the label.
Ingredient order and how fragrance and color additives are declared.
Net contents units and placement.
The name and place of business.

Separate obligations

Whether the contact route actually receives adverse event reports.
Facility registration and product listing.
Safety substantiation.
OTC drug labeling, when claims make a product a drug.

Join the cosmetics waitlist.

Leave your email and we will tell you when cosmetic label review opens. Food, supplement and beverage review is available now.

Questions

Which MoCRA-related label elements will be reviewed?

The planned review checks whether the label carries a domestic address, domestic phone number or electronic contact information for adverse event reports, under FD&C Act §609(a). It also covers the name and place of business, ingredients and net contents.

Does label review include registration or listing?

No. Facility registration, product listing and safety substantiation are separate obligations. A label review can only speak to what the artwork shows.

What happens if the label makes drug claims?

A claim to treat or prevent disease, or to affect the structure or function of the body, can make a product a drug. Cosmetic review will not check OTC drug requirements; those labels need specialist review.