Dosage & Administration
Directions: Apply to the lips prior to sun exposure or as needed.
Sunshades
FDA Label NDC 54473-137
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 Sunshades (NDC 54473-137). 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 dosage & administration, warnings, otc - active ingredient, 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
Warnings
Caution: For external use only. Keep out of reach of children. If irritation or rash develops discontinue use. Avoid contact with the eyes.
Otc - Active Ingredient
Active Ingredients: Octinoxate 7.5% w/w. Oxybenzone 3.0% w/w.
Inactive Ingredient
Other 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 (Berrylabel)
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