Protective Foundation Sunscreen Spf 15
FDA Label NDC 62191-401

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sunrider Manufacturing L.p. for the product Protective Foundation Sunscreen Spf 15 (NDC 62191-401). 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 - purpose, dosage & administration, otc - active ingredient, inactive ingredient, warnings, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Purpose

USES: HELPS PREVENT SUNBURNS.

Dosage & Administration

RECOMMENDATION:  PLACE A SMALL AMOUNT ON A SPONGE, BLEND EVENLY OVER FACE

Otc - Active Ingredient

ACTIVE INGREDIENTS:

OCTINOXATE 6%
AVOBENZONE 2%

Inactive Ingredient

OTHER INGREDIENTS: WATER (DEIONIZED), GLYCERETH-26, CAPRYLIC/CAPRIC/STEARIC TRIGLLYCERIDE, ISOPROPYL PALMITATE, KAOLIN, PROPYLENE GLYCOL, POLYSORBATE 20, GLYCERYL STEARATE, STEARIC ACID, DIMETHICONE, PRUNUS AMYGDALUS DULCIS (SWEEK ALMOND)OIL, SIMMONDSIA CHINENSIS (JOJOBA) OIL, AHNFELTIA CONCINNA EXTRACT, SODIUM HYALURONATE, TOCOPHEROL, SORBITAN STEARATE, SORBITAN PALMITATE, CETYL ALCOHOL, BIS-DIGLYCERYL POLYACYLADIPATE-2, PHENOXYETHANOL, TRIETHANOLAMINE, MAGNESIUM ALUMINUM SILICATE, LECITHIN, OLETH-20, SQUALENE (VEG ORIGIN), CORN STARCH MODIFIED, CELLULOSE GUM, CITRIC ACID, TRISODIUM EDTA, BUTYLENE, BUTYLPARABEN, MAY CONTAIN:TITANIUM DIOXIDE, IRON OXIDE.

Warnings

WARNINGS: FOR EXTERNAL USE ONLY, IF SWALLOWED SEEK MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY, IF CONTACT WITH EYES OCCURS, RINSE THOROUGHLY WITH WATER, DISCONTINUE USE AND CONSULT A DOCTOR IF PERSISTENT SIGNS OF IRRITATION OR RASH APPEAR.

Otc - Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN

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