Eight Hour Cream Sun Defense For Face Spf 50 Sunscreen
FDA Label NDC 67938-1094

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Elizabeth Arden, Inc for the product Eight Hour Cream Sun Defense For Face Spf 50 Sunscreen (NDC 67938-1094). 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 description, indications and usage, warnings, otc - active ingredient, inactive ingredient, dosage & administration, otc - keep out of reach of children, otc - purpose, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Description

Provides powerful SPF 50 PA+++ protection to shield against UVA/UVB rays that can cause sunburn, surface skin cell damage and premature signs of aging. Lightweight, oil-free lotion helps protect your skin from sun exposure while hydrating for up to 8 hours. PABA free.

Uses: Helps prevent sunburn. Higher SPF gives more sunburn protection.

Sun Alert: Limiting sun exposure, wearing protective clothing and using sunscreens may reduce the risk of skin cancer and other harmful effects of the sun.

Indications And Usage

Directions: Apply liberally and evenly to face 30 minutes before sun exposure. Reapply as needed or after towel drying, swimming, or perspiring. Children under 6 months of age: ask a doctor.

Warnings

Warnings: For external use only. When using this product, keep out of eyes. Rinse with water to remove. Stop use and ask a doctor is rash or irritation develops and lasts. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Otc - Active Ingredient

Active Ingredients: Zinc Oxide 11.62% w/w, Octinoxate 7.40% w/w, Octisalate 5.00% w/w.

Inactive Ingredient

Water/Aqua/Eau, C12-25 Alkyl Benzoate, Isodecyl Neopentanoate, Neopentyl Glycol Diheptanoate, Magnesium Aluminum Silicate, Glyceryl Stearate, PEG-100 Stearate, Caprlyl Glycol, Arachidyl Alcohol, Polyhydroxystearic Acid, Arachidyl Glucoside, Triethoxycaprylylsilane, Behenyl Alcohol, Xanthan Gum, BHT, Disodium EDTA, Parfum/Fragrance, Citral, Citronellol, Geraniol, Limonene, Linalool, Methylparaben, Phenoxyethanol, Sorbic Acid.

Dosage & Administration

Apply liberally and evenly to face.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Otc - Purpose

Helps prevent sunburn. Higher SPF gives more sunburn protection.

Otc - When Using

Keep out of eyes.

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