Expensive to get wrongUnited StatesSkincare

The small business exemption excludes eye products

MoCRA’s small business exemption from facility registration and product listing does not apply to products that regularly come into contact with the mucus membrane of the eye, products that are injected, products intended for internal use, or products intended to alter appearance for more than 24 hours without consumer removal.

An eye cream or eye patch cancels the small-business exemption that the rest of your range would qualify for.

95

95 of a possible 97Tier A, primary document or measured outcome. Nothing at this tier is allowed past 97, however good it looks.

Verified August 4, 2026Rechecked every 180 days, next by January 31, 2027.

Constraint

Held since August 4, 2026A rule, law or policy that limits what you may do or say. The earliest date we are willing to say this held. It may well have been true before that; we do not backdate a record past the evidence we have read. Supported, version 1.

This entry is wrong if

FDA removes eye-area products from the carve-out list, or extends the small business exemption to cover them.

Written before the record was published, not after. If you can show this, send it to hello@tryorbt.com and the correction goes on the record with the entry.

Evidence

  1. Tier Aregulation

    U.S. Food and Drug Administration: Registration & Listing of Cosmetic Product Facilities and Products

    MoCRA exempts certain small businesses from facility registration and product listing requirements. However, such exemptions do not apply to facilities that manufacture or process, or responsible persons for, the following cosmetic products: Products that regularly come into contact with mucus membrane of the eye under customary or usual conditions of use. Products that are injected. Products that are intended for internal use. Products that are intended to alter appearance for more than 24 hours under customary or usual conditions of use and removal by the consumer is not part of such conditions of use.

    Read 2026-08-04 · Public domain · page hash 68fc8dd94651

History

  1. v1created

    Initial entry from primary regulator text, read 2026-08-04.

Append-only. Nothing in this list is edited or removed once written, including the entries that record our own mistakes. Every change to every record is on the corrections page, and the same log is in entries.json under revisions.

  • mocra
  • exemption
  • eye-care
  • small-business
  • edge-case

Cite this entry

“The small business exemption excludes eye products”, The Orbt Market Index 0.1.0, entry omr:us:mocra-small-business-exemption-excludes-eye-products, retrieved September 9, 2026, https://tryorbt.com/markets/entry/us--mocra-small-business-exemption-excludes-eye-products. Dataset: https://doi.org/10.5281/zenodo.22679129

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