Bb0990

Bb0990
SPL v1
SPL
SPL Set ID dcd18b73-beda-48dd-9cb0-59630685e247
Route
TOPICAL
Published
Effective Date 2012-10-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (75 mg) Oxybenzone (60 mg) Octisalate (50 mg) Octocrylene (40 mg) Avobenzone (30 mg)
Inactive Ingredients
Water Nylon-12 Butyloctyl Salicylate Alkyl (c12-15) Benzoate Butylene Glycol Dimethicone Propylene Glycol Medium-chain Triglycerides Caprylyl Trisiloxane Isopropyl Isostearate Ergothioneine Yeast .alpha.-tocopherol Acetate Isohexadecane Polyoxyl 40 Hydrogenated Castor Oil C20-22 Alcohols C20-22 Alkyl Phosphate Cetostearyl Alcohol Coco Glucoside Polysorbate 60 Isododecane Edetic Acid Butylated Hydroxytoluene Edetate Disodium Isomethyl-.alpha.-ionone Ethylparaben Methylparaben Phenoxyethanol Potassium Sorbate Propylparaben Sodium Benzoate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2011-12-14

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

Purpose

Provides SPF 50 Sun Protection.

Dosage and Administration

Apply to skin.


Medication Information

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

Purpose

Provides SPF 50 Sun Protection.

Dosage and Administration

Apply to skin.

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.

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 Purpose

Provides SPF 50 Sun Protection.

Otc When Using

Keep out of eyes.

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).

Otc Active Ingredient

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

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.

Package Label.principal Display Panel


Structured Label Content

Warnings (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

Description (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.

Otc Purpose (OTC - PURPOSE)

Provides SPF 50 Sun Protection.

Otc When Using (OTC - WHEN USING)

Keep out of eyes.

Inactive Ingredient (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).

Indications and Usage (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

Otc Active Ingredient (OTC - ACTIVE INGREDIENT)

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

Dosage and Administration (DOSAGE AND ADMINISTRATION)

Apply to skin.

Otc Keep Out of Reach of Children (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.

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)


Advanced Ingredient Data


Raw Label Data

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