Eye Make-Up Preparations

FDA maintains a separate, more restrictive approval list for color additives used in the area of the eye, because the eye's mucous membranes are particularly vulnerable to irritation and injury. Many colorants approved for general cosmetic use are not permitted in eye-area products. Importers must confirm that every colorant in their eye make-up formulations is on FDA's approved list specifically for eye-area use.

Dual-use products can present classification challenges. If the product is specifically formulated and marketed for use in the eye area, 330420 is generally appropriate. If it is primarily a general skin preparation that may incidentally be used near the eyes, heading 330499 may be more applicable. The product's primary function, labeling, and marketing materials are the key factors; consulting a licensed customs broker is advisable for borderline cases.