Otc - Active Ingredient
SPF 15 SUNSCREEN LIPBALM 4.2gDrug FactsActive Ingredient PurposeOctinoxate (7.3%) sunscreenOctisalate (2%) sunscreenOxybenzone (3%) sunscreen
Lip Balm
FDA Label NDC 75887-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Aztex Enterprises for the product Lip Balm (NDC 75887-002). 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, indications & usage, 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
UsesHelps protect against sunburn and chapped lips.
Warnings
Warnings:Stop use if skin rash occurs.
Indications & Usage
Directions+Apply to lips prior to sun exposure+Apply to lips when dry or chapped
Inactive Ingredient
Inactive IngredientsAloe Barbadensis Leaf ExtractBeeswaxCaprylic/Capric TriglycerideCastor OilEuphorbia Cerifera(Candelilla Wax)Glycine Soja (soybean) OilPropylparabenMethylparabenSaccharin
Package Label.Principal Display Panel
AZX SPORTLip Balm - Unlfavored l SPF 15
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