Do I need FDA registration to sell skincare?
Under the Modernization of Cosmetics Regulation Act (MoCRA), the facility that manufactures or processes a cosmetic must register with the U.S. Food and Drug Administration, and each cosmetic product must be listed with FDA by its responsible person. The brand whose name appears on the label is normally the responsible person, so the brand carries the product listing, the safety substantiation and the adverse event reporting duty, while the manufacturer carries the facility registration. SkinCore Labs is operated by TV Manufacturing, LLC, FDA Establishment Identifier (FEI) 3048933157, and our Pompano Beach, Florida facility holds an accepted MoCRA cosmetic facility registration — so brands manufacturing with us inherit a registered facility and need to handle their own product listings and safety files.
Who is responsible for what
MoCRA splits the obligations between the facility and the brand.
- —Facility registration with FDA — the manufacturer
- —Cosmetic product listing — the responsible person, usually the brand on the label
- —Safety substantiation records — the responsible person
- —Serious adverse event reporting within 15 business days — the responsible person
- —Good manufacturing practice compliance — the manufacturer
- —Label content, including a contact for adverse events — the responsible person
Sunscreen and other OTC drugs are different
A sunscreen sold in the United States is regulated as an over-the-counter drug, not a cosmetic. That brings a separate set of requirements: an OTC monograph-compliant formula, a National Drug Code, drug facts labeling, drug establishment registration and drug listing, and in most cases SPF and broad-spectrum testing at an accredited lab. The same applies to anti-acne, anti-dandruff and antiperspirant products.
This is why our sunscreen minimums and lead times are meaningfully higher than our cosmetic ones.
Our registrations
Legal entity: TV Manufacturing, LLC, doing business as SkinCore Labs. FDA Establishment Identifier (FEI): 3048933157. MoCRA cosmetic facility registration: submission accepted. Facility: 3400 NW 27th Ave, C2, Pompano Beach, FL 33069, USA.