Bb0904

Bb0904
SPL v6
SPL
SPL Set ID e9cef947-b08b-4fe0-9a65-c8090679608c
Route
TOPICAL
Published
Effective Date 2012-11-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (35 mg) Octisalate (25 mg) Oxybenzone (11 mg) Octocrylene (10 mg) Avobenzone
Inactive Ingredients
Water Glycerin Dimethicone Cetostearyl Alcohol Alkyl (c12-15) Benzoate Propylene Glycol Polyoxyl 40 Hydrogenated Castor Oil Potassium Cetyl Phosphate Glyceryl Monostearate Cyclomethicone 6 Phenoxyethanol Methylparaben Cyclomethicone 5 Mica Sodium Pyrrolidone Carboxylate Urea Chlorphenesin Benzoic Acid Sodium Hydroxide Trehalose Hyaluronate Sodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2009-06-04

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 high performance multi-defense moisturizer with advanced Idebenone technology, a powerful environmental protectant, and broad spectrum UVA/UVB sunscreens, helps protect against the visible signs of aging as it minimizes the appearance of existing sun damage – fine lines, wrinkles and discolorations. Locks in moisture to enhance the benefits of PREVAGE Anti-aging Daily Serum.

Indications and Usage

To Use: Massage onto cleansed face and neck daily after PREVAGE Anti-aging Daily Serum. 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. Children under 6 months: Ask a doctor.

Purpose

Provides SPF 30 Sun Protection.


Medication Information

Indications and Usage

To Use: Massage onto cleansed face and neck daily after PREVAGE Anti-aging Daily Serum.

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. Children under 6 months: Ask a doctor.

Purpose

Provides SPF 30 Sun Protection.

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 high performance multi-defense moisturizer with advanced Idebenone technology, a powerful environmental protectant, and broad spectrum UVA/UVB sunscreens, helps protect against the visible signs of aging as it minimizes the appearance of existing sun damage – fine lines, wrinkles and discolorations. Locks in moisture to enhance the benefits of PREVAGE Anti-aging Daily Serum.

Section 51945-4

 

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 30 Sun Protection.

Otc When Using

Keep out of eyes.

Inactive Ingredient

Other Ingredients: Water/Aqua/Eau, Glycerin, Dimethicone, Cetearyl Alcohol, C12-15 Alkyl Benzoate, Propylene Glycol, PEG-40 Hydrogenated Castor Oil, Potassium Cetyl Phosphate, Glyceryl Polyacrylate, Glyceryl Stearate, Butyrospermum Parkii (Shea Butter), Ergothioneine, Hydroxydecyl Ubiquinoyl Dipalmitoyl Glycerate, Sodium Hyaluronate, Hydrogenated Palm Glycerides, Sodium PCA, Trehalose, Urea, Polyquaternium-51, Carbomer, Sodium Hydroxide, Mica, Cylcohexasiloxane, Cyclopentasiloxane, Parfum/Fragrance, Alpha-Isomethyl Ionone, Linaloo, Benzoic Acid, Methylparaben, Phenoxyethanol, Chlorphenesin, Iron Oxisdes (CI 77492), Red 4 (CI 14700), Titanium Dioxide (CI 77891), Yellow 5 (CI 19140).

Dosage & Administration

Massage on to face and neck.

Otc Active Ingredient

Active Ingredients: Octinoxate, 7.50% , Octisalate, 5.00%, Oxybenzone, 5.00%, Octocrylene, 2.20%, Avobenzone, 2.00%.

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.


Structured Label Content

Section 51945-4 (51945-4)

 

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 high performance multi-defense moisturizer with advanced Idebenone technology, a powerful environmental protectant, and broad spectrum UVA/UVB sunscreens, helps protect against the visible signs of aging as it minimizes the appearance of existing sun damage – fine lines, wrinkles and discolorations. Locks in moisture to enhance the benefits of PREVAGE Anti-aging Daily Serum.

Otc Purpose (OTC - PURPOSE)

Provides SPF 30 Sun Protection.

Otc When Using (OTC - WHEN USING)

Keep out of eyes.

Inactive Ingredient (INACTIVE INGREDIENT)

Other Ingredients: Water/Aqua/Eau, Glycerin, Dimethicone, Cetearyl Alcohol, C12-15 Alkyl Benzoate, Propylene Glycol, PEG-40 Hydrogenated Castor Oil, Potassium Cetyl Phosphate, Glyceryl Polyacrylate, Glyceryl Stearate, Butyrospermum Parkii (Shea Butter), Ergothioneine, Hydroxydecyl Ubiquinoyl Dipalmitoyl Glycerate, Sodium Hyaluronate, Hydrogenated Palm Glycerides, Sodium PCA, Trehalose, Urea, Polyquaternium-51, Carbomer, Sodium Hydroxide, Mica, Cylcohexasiloxane, Cyclopentasiloxane, Parfum/Fragrance, Alpha-Isomethyl Ionone, Linaloo, Benzoic Acid, Methylparaben, Phenoxyethanol, Chlorphenesin, Iron Oxisdes (CI 77492), Red 4 (CI 14700), Titanium Dioxide (CI 77891), Yellow 5 (CI 19140).

Indications and Usage (INDICATIONS AND USAGE)

To Use: Massage onto cleansed face and neck daily after PREVAGE Anti-aging Daily Serum.

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. Children under 6 months: Ask a doctor.

Dosage & Administration (DOSAGE & ADMINISTRATION)

Massage on to face and neck.

Otc Active Ingredient (OTC - ACTIVE INGREDIENT)

Active Ingredients: Octinoxate, 7.50% , Octisalate, 5.00%, Oxybenzone, 5.00%, Octocrylene, 2.20%, Avobenzone, 2.00%.

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.


Advanced Ingredient Data


Raw Label Data

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