Bc1144

Bc1144
SPL v2
SPL
SPL Set ID cf26024a-9873-4d1c-8eea-ed3e9fdc453a
Route
TOPICAL
Published
Effective Date 2012-11-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (3.75 g) Octisalate (2.5 g) Oxybenzone (1.1 g) Octocrylene (1 g) Avobenzone
Inactive Ingredients
Water Dimethicone Butylene Glycol Isostearyl Neopentanoate Propylene Glycol Ppg-2 Isoceteth-20 Acetate Glycerin Ergothioneine Isohexadecane Trehalose Sucrose Polysorbate 60 Trideceth-6 Xanthan Gum Sodium Hydroxide Mica Mineral Oil Phenyl Trimethicone Benzoic Acid Butylparaben Ethylparaben Isobutylparaben Methylparaben Phenoxyethanol Propylparaben Chlorphenesin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2011-06-22

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 multi-defense, concentrated moisturizing cream for dry to very dry skin helps nourish skin’s natural moisture defenses and reverse dryness. Diminishes the appearance of aging signs and existing sun damage – fine lines, wrinkles and discolorations. Advanced Idebenone technology provides powerful environmental protection while broad spectrum UVA/UVB sunscreens help shield from the sun. Skin feels ultra soft and smooth, looks healthy, radiant - younger than ever.

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.

Dosage and Administration

Massage onto face and neck.


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.

Dosage and Administration

Massage onto face and neck.

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 multi-defense, concentrated moisturizing cream for dry to very dry skin helps nourish skin’s natural moisture defenses and reverse dryness. Diminishes the appearance of aging signs and existing sun damage – fine lines, wrinkles and discolorations. Advanced Idebenone technology provides powerful environmental protection while broad spectrum UVA/UVB sunscreens help shield from the sun. Skin feels ultra soft and smooth, looks healthy, radiant - younger than ever.

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

Inactive Ingredients: Water/Aqua/Eau, Dimethicone, C12-15 Alkyl Benzoate, Butylene Glycol, Cyclopentasiloxane, Isostearyl Neopentanoate, Dimethicone/Vinyl Dimethicone Crosspolymer, Butyrospermum Parii (Shea Butter) Extract, Theobroma Cacao (Cocoa) Seed Butter, Propylene Glycol, PPG-2 Isoceteth-20 Acetate, Glycerin, Caprylic/Capric Triglyceride, Ergothioneine, Hydroxydecyl Ubiquinoyl Dipalmitoyl Glycerate, Hibiscus Abelmoschus Seed Extract, Sodium Hyaluronate, Retinyl Linoleate, Cetearyl Dimethicone Crosspolymer, Isohexadecane, Sodium PCA, Trehalose, Urea, Hydrogenated Lecithin, Phospholipids, Polyphosphorylcholine Glycol Acrylate, Sucrose, Cetearyl Alcohol, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Polysorbate 60, Trideceth-6, Acrylamide/Sodium Acrylate Copolymer, Polyquaternium-51, PEG-8, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Xanthan Gum, Sodium Hydroxide, BHT, Mica, Mineral Oil/Paraffinum Liquidum/Huile Minerale, Dimethiconol, Phenyl Trimethicone, Parfum/Fragrance, Alpha-Isomethyl Ionone, Linalool, Benzoic Acid, Butylparaben, Ethylparaben, Isobutylparaben, Methylparaben, Phenoxyethanol, Propylparaben, Chlorphenesin, Iron Oxides (CI 77492), Red 4 (CI 14700), Titanium Dioxide (CI 77891), Yellow 5 (CI 19140).

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 multi-defense, concentrated moisturizing cream for dry to very dry skin helps nourish skin’s natural moisture defenses and reverse dryness. Diminishes the appearance of aging signs and existing sun damage – fine lines, wrinkles and discolorations. Advanced Idebenone technology provides powerful environmental protection while broad spectrum UVA/UVB sunscreens help shield from the sun. Skin feels ultra soft and smooth, looks healthy, radiant - younger than ever.

Otc Purpose (OTC - PURPOSE)

Provides SPF 30 Sun Protection.

Otc When Using (OTC - WHEN USING)

Keep out of eyes.

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive Ingredients: Water/Aqua/Eau, Dimethicone, C12-15 Alkyl Benzoate, Butylene Glycol, Cyclopentasiloxane, Isostearyl Neopentanoate, Dimethicone/Vinyl Dimethicone Crosspolymer, Butyrospermum Parii (Shea Butter) Extract, Theobroma Cacao (Cocoa) Seed Butter, Propylene Glycol, PPG-2 Isoceteth-20 Acetate, Glycerin, Caprylic/Capric Triglyceride, Ergothioneine, Hydroxydecyl Ubiquinoyl Dipalmitoyl Glycerate, Hibiscus Abelmoschus Seed Extract, Sodium Hyaluronate, Retinyl Linoleate, Cetearyl Dimethicone Crosspolymer, Isohexadecane, Sodium PCA, Trehalose, Urea, Hydrogenated Lecithin, Phospholipids, Polyphosphorylcholine Glycol Acrylate, Sucrose, Cetearyl Alcohol, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Polysorbate 60, Trideceth-6, Acrylamide/Sodium Acrylate Copolymer, Polyquaternium-51, PEG-8, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Xanthan Gum, Sodium Hydroxide, BHT, Mica, Mineral Oil/Paraffinum Liquidum/Huile Minerale, Dimethiconol, Phenyl Trimethicone, Parfum/Fragrance, Alpha-Isomethyl Ionone, Linalool, Benzoic Acid, Butylparaben, Ethylparaben, Isobutylparaben, Methylparaben, Phenoxyethanol, Propylparaben, Chlorphenesin, Iron Oxides (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.

Otc Active Ingredient (OTC - ACTIVE INGREDIENT)

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

Dosage and Administration (DOSAGE AND ADMINISTRATION)

Massage onto face and neck.

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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