Under MoCRA, who is the responsible person for U.S. cosmetic product listing for eye care?

Quick Answer (for busy buyers)

Here’s the buyer-first summary. If your brand name is on the label, you usually act as the responsible person and must ensure the listing is submitted and kept current.

• For U.S. eye-care cosmetics, MoCRA places product listing responsibility on the “Responsible Person” (RP): the U.S. manufacturer, packer, or distributor whose name is on the label.
• In practice, if you are the brand owner/Amazon seller and your U.S. company is listed on the label, you are the RP and you submit the FDA product listing.
• A foreign OEM/ODM factory is typically not the RP unless it is the labeled responsible entity.
• We can support your RP submission by preparing product/ingredient information, product concept positioning, label copy/IFU drafts, and documentation packets.
• We can also arrange third-party testing and track test reports, and provide manufacturing details you may need for your internal compliance files.
• Operationally, we can customize the formula and provide samples after the brief is confirmed; then move into packaging and bulk production.
• Typical bulk production lead time is about 10-20 working days; packaging procurement often takes 10-30 working days (e.g., glass bottles ~15 days, acrylic ~30; unit cartons ~15 days, set boxes ~20).
• If you want a full brand buildout, end-to-end launch is usually planned at 45-60 days depending on packaging and testing.