Prevage Anti Agining Triple Defense Shield Broad Spectrum Sunscreen Spf 50
FDA Label NDC 67938-0990

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 Prevage Anti Agining Triple Defense Shield Broad Spectrum Sunscreen Spf 50 (NDC 67938-0990). 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 and 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.

Description

PREVAGE Anti-aging Skincare helps protect and correct skin’s appearance from environmental threats, a leading cause of visible aging signs, for younger-looking, more beautiful skin. This daily defense shield for face with advanced Idebenone technology delivers triple environmental protection against the visible effects of free radical damage due to oxidative stress from sun, pollution and Infrared-A exposure. Provides broad spectrum sun protection from UVA and UVB rays. Helps to correct the appearance of existing sun damage like fine lines, wrinkles, age spots and discolorations and helps prevent future aging signs. Leaves a soft, matte finish and works well under makeup.

Indications And Usage

 To Use: Turn brush head to "On" and squeeze gently to dispense product. Brush lightly across face. Turn brush head to "Off" to store. To clean, rinse brush with warm water and towel dry.

Directions For Sunscreen Use:Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours

Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10 a.m. – 2 p.m.. Wear long-sleeve shirts, pants, hats, and sunglasses

Warnings

Warnings:

For external use only

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs

Otc - Active Ingredient

Active Ingredients: Oxtinoxate 7.5%, Oxybenzone 6.0%, Octisalate 5.0%, Oxtocrylene 4.0%, Avobenzone 3.0%

Inactive Ingredient

Inactive Ingredients: Water/Aqua/Eau, Ethylhexyl Methoxycrylene, Nylon-12, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Butylene Glycol, Dimethicone, Propylene Glycol, Methyl Methacrylate Crosspolymer, Caprylic/Capric Triglyceride, Caprylyl Methicone, Isopropyl Isostearate, Ergothioneine, Hydroxydecyl Ubiquinoyl Dipalmitoyl Glycerate, Yeast Extract/Faex/Extrait de Levure, Tocopheryl Acetate, Soy Amino Acids, Isohexadecane, PEG-40 Hydrogenated Castor Oil, BIS-Vinyl Dimethicone/Dimethicone Copolymer, Hydrolyzed Soy Protein, C20-22 Alocohols, C20-22 Alkyl Phosphate, Cetearyl Alcohol, Coco-Glucoside, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Polysorbate 60, Isododecane EDTA, Triethanolamine, BHT, Disodium EDTA, Parfum/Fragrance, Alpha-Isomethyl Ionone, Linalool, Ethylparaben, Methylparaben, Phenoxyethanol, Potassium Sorbate, Propylparaben, Sodium Benzoate, Red 4 (CI 14700), Yellow 5 (CI 19140).

Dosage And Administration

Apply to skin.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Otc - Purpose

Provides SPF 50 Sun Protection.

Otc - When Using

Keep out of eyes.

Package Label.Principal Display Panel

Prevage Triple Defense Carton (Bb0990 Figure 1 Ptdcarton)

Prevage Triple Defense Carton (Bb0990 Figure 1 Ptdcarton)

Prevage Triple Defense Tube (Bb0990 Figure 2 Ptdtube)

Prevage Triple Defense Tube (Bb0990 Figure 2 Ptdtube)

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