Sunscreen
FDA Label NDC 75887-003

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 Sunscreen (NDC 75887-003). 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 - Active Ingredient

Drug Facts 30ml/1oz.Active Ingredient PurposeOctinoxate (7.3%) sunscreenOxybenzone (5.2%) sunscreen

Otc - Purpose

UsesProvides moderate protection against sunburnFor skin that burns easily

Warnings

WarningsFor external use only.When using this produceKeep out of eyes, rinse with water to removeDiscontinue use of irritation and redness developKeep out of reach of childrenIf swallowed, get medical help or contact a Poison Control Center right awayIf pregnant or breastfeeding, ask a health care professional before use

Indications & Usage

DirectionsApply generously and evenly before sun exposureReapply as needed or after swimming or perspiring

Inactive Ingredient

Inactive IngredientsAcrylate/C10-30 Alkylacrylate CrosspolymerBHTC12-15 Alkyl BenzoateCarbomer polymersDiazolydinyl UreaDisodium EDTAHexyl LaurateMethylparaben, PropylparabenPEG-8, Sorbitan Oleate, Tocopheryl AcetatePropylene Glycol, Triethanolamine, VP/Eicosene copolymer

Package Label.Principal Display Panel

AZX SPORT30 SPFSunscreen1 oz. / 30 ml.Made in Canada

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