§364 Definitions

Summary

Defines key words used in rules about cosmetics. Adverse event: any health problem linked to using a cosmetic. Cosmetic product: a prepared mix of cosmetic ingredients made to a set formula for a finished product. Facility: any place (including importers’ sites) that makes or processes cosmetics sold in the United States, but not places that only do salon services, retail sales, hospitals or clinics, public-health or nonprofit groups giving products directly to consumers, hotels or airlines handing out free toiletries, trade-show sampling, research-only makers, or sites that only label, package, hold, or distribute products; and for that exclusion, “packaging” or “repackaging” does not mean filling a product container. Responsible person: the maker, packer, or distributor whose name is on the product label. Serious adverse event: an adverse event that causes death; a life-threatening experience; inpatient hospitalization; a lasting or major disability; a birth defect; an infection; or major disfigurement (for example, severe long-lasting rashes, 2nd- or 3rd-degree burns, big hair loss, or lasting major change in appearance), or one that needs medical or surgical action to prevent those outcomes.