Otc - Active Ingredient
Active Ingredients: Octinoxate 7.5% w/w, Oxybenzone 3% w/w.
Sun Shades Lip Balm
FDA Label NDC 54473-168
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Melaleuca, Inc. for the product Sun Shades Lip Balm (NDC 54473-168). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, warnings, otc - when using, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Uses: Helps protect against sunburn.
Warnings
Warnings: Keep out of eyes. Stop use if skin rash/irritation occurs. Keep out of reach of children.
Otc - When Using
Directions: Apply to the lips prior to sun exposure or as needed.
Inactive Ingredient
Inactive Ingredients: Petrolatum USP, Jojoba Oil, Beeswax, Cetyl Esters, Ozokerite, Cocoa Butter, Stearyl Dimethicone, Flavor, Tocopheryl Acetate (Vitamin E USP), Monoammonium Glycyrrhizinate, Ethylene/VA Copolymer.
Package Label.Principal Display Panel
image of label
Image Of Label (Pomelabel)
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