Bc1126

Bc1126
SPL v5
SPL
SPL Set ID ab8039cd-7913-499f-b583-ba607d6530d4
Route
TOPICAL
Published
Effective Date 2012-11-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (0.613 g) Oxybenzone (0.21 g)
Inactive Ingredients
Water Shea Butter Glycerin Butylene Glycol Dimethicone Cetearyl Glucoside Dipentaerythrityl Hexacaprylate/hexacaprate Tridecyl Trimellitate Carnauba Wax Peg-100 Stearate Glyceryl Monostearate Phenoxyethanol Mica Medium-chain Triglycerides Sodium Pyrrolidone Carboxylate Tridecyl Stearate Urea Yellow Wax Polyethylene Glycol 1000 Sorbitan Tristearate Steareth-100 Chlorphenesin Caprylyl Glycol Propylene Glycol Benzoic Acid Cetostearyl Alcohol Xanthan Gum Sodium Hydroxide Diazolidinyl Urea Trehalose Edetate Disodium Hexylene Glycol Sorbic Acid Methylparaben Silicon Dioxide Propylparaben Potassium Sorbate Triacetin Hyaluronate Sodium Cetrimonium Chloride Ethylhexylglycerin Sodium Citrate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2011-03-14

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 multi-defense cream specially designed for the delicate eye area with advanced Idebenone technology provides serious environmental protection, all day intensive moisture and encapsulated sunscreens. Helps smooth the appearance of fine lines, crow’s feet and crepiness and helps prevent future aging signs. Eyes instantly appear smoother and brighter. Ophthalmologist tested.

Indications and Usage

To Use: Gently pat a small amount around eye area after PREVAGE Anti-aging Daily Serum. Directions For Sunscreen Use: Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours. Children under 6 months: Ask a doctor.

Purpose

Provides SPF 15 Sun Protection.


Medication Information

Indications and Usage

To Use: Gently pat a small amount around eye area after PREVAGE Anti-aging Daily Serum.

Directions For Sunscreen Use: Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours. Children under 6 months: Ask a doctor.

Purpose

Provides SPF 15 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 multi-defense cream specially designed for the delicate eye area with advanced Idebenone technology provides serious environmental protection, all day intensive moisture and encapsulated sunscreens. Helps smooth the appearance of fine lines, crow’s feet and crepiness and helps prevent future aging signs. Eyes instantly appear smoother and brighter. Ophthalmologist tested.

Section 51945-4

Warnings

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

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 15 Sun Protection.

Otc When Using

Keep out of eyes.

Inactive Ingredient

Other Ingredients: Water/Aqua/Eau, Butyrospermum Parkii (Shea Butter), Phytosteryl Macadamiate, Glycerin, Butylene Glycol, Dimethicone, Cetearyl Glucoside, Synthetic Beeswax, Theobroma Cacao (Cocoa) Seed Butter, C12-15 Alkyl Benzoate, Stearyl Dimethicone, Dipentaerythrityl Hexacaprylate/Hexacaprate, Tridecyl Trimellitate, Copernicia Cerifera (Canauba) Wax/Cera Carnauba/Cire De Carnauba, Peg-100 Stearate, Hydroxydecyl Ubiquinoyl Dipalmitoyl Glycerate, Beeswax/Cera Alba/Cire D'Abeille, Rabdosia Rubescens Extract, Sigesbeckia Orientalis Extract, Sodium Hyaluronate, Caprylic/Capric Triglyceride, Caprylyl Methicone, BIS-PEG-12 Dimethicone, Caprylyl Glycol, Glyceryl Stearate, Neopentyl Glycol Dicaprylate/Dicaprate, Tridecyl Stearate, Propylene Glycol, Sodium PCA, Trehalose, Urea, Ethylhexylglycerin, Hydrogenated Lecithin, Lecithin, Polyphosphorylcholine Glycol Acrylate, Glycerophosphoinositol Lysine, Acetyl Tetrapeptide-5, Cetearyl Alcohol, PEG-20, Sorbitan Tristearate, Steareth-100, Polyquaternium-51, Sodium Acrylates Copolymer, Hexylene Glycol, Carbomer, PVP, VP/Eicosene Copolymer, Xanthan Gum, Sodium Hydroxide, Disodium EDTA, Mica, Silica, Sodium Citrate, Dimethicone Crosspolymer, Benzoic Acid, Diazolidinyl Urea, Methyparaben, Phenoxyethanol, Potassium Sorbate, Propylparaben, Sorbic Acid, Triacetin, Cetrimonium Chloride, Chlorphenesis, Iron Oxides (CI 77492), Red 40 (CI 16035), Titanium Dioxide (CI 77891).

Dosage & Administration

Pat around eye area.

Otc Active Ingredient

Active Ingredients: Octinoxate, 4.09%, Oxybenzone, 1.40%.

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

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

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 cream specially designed for the delicate eye area with advanced Idebenone technology provides serious environmental protection, all day intensive moisture and encapsulated sunscreens. Helps smooth the appearance of fine lines, crow’s feet and crepiness and helps prevent future aging signs. Eyes instantly appear smoother and brighter. Ophthalmologist tested.

Otc Purpose (OTC - PURPOSE)

Provides SPF 15 Sun Protection.

Otc When Using (OTC - WHEN USING)

Keep out of eyes.

Inactive Ingredient (INACTIVE INGREDIENT)

Other Ingredients: Water/Aqua/Eau, Butyrospermum Parkii (Shea Butter), Phytosteryl Macadamiate, Glycerin, Butylene Glycol, Dimethicone, Cetearyl Glucoside, Synthetic Beeswax, Theobroma Cacao (Cocoa) Seed Butter, C12-15 Alkyl Benzoate, Stearyl Dimethicone, Dipentaerythrityl Hexacaprylate/Hexacaprate, Tridecyl Trimellitate, Copernicia Cerifera (Canauba) Wax/Cera Carnauba/Cire De Carnauba, Peg-100 Stearate, Hydroxydecyl Ubiquinoyl Dipalmitoyl Glycerate, Beeswax/Cera Alba/Cire D'Abeille, Rabdosia Rubescens Extract, Sigesbeckia Orientalis Extract, Sodium Hyaluronate, Caprylic/Capric Triglyceride, Caprylyl Methicone, BIS-PEG-12 Dimethicone, Caprylyl Glycol, Glyceryl Stearate, Neopentyl Glycol Dicaprylate/Dicaprate, Tridecyl Stearate, Propylene Glycol, Sodium PCA, Trehalose, Urea, Ethylhexylglycerin, Hydrogenated Lecithin, Lecithin, Polyphosphorylcholine Glycol Acrylate, Glycerophosphoinositol Lysine, Acetyl Tetrapeptide-5, Cetearyl Alcohol, PEG-20, Sorbitan Tristearate, Steareth-100, Polyquaternium-51, Sodium Acrylates Copolymer, Hexylene Glycol, Carbomer, PVP, VP/Eicosene Copolymer, Xanthan Gum, Sodium Hydroxide, Disodium EDTA, Mica, Silica, Sodium Citrate, Dimethicone Crosspolymer, Benzoic Acid, Diazolidinyl Urea, Methyparaben, Phenoxyethanol, Potassium Sorbate, Propylparaben, Sorbic Acid, Triacetin, Cetrimonium Chloride, Chlorphenesis, Iron Oxides (CI 77492), Red 40 (CI 16035), Titanium Dioxide (CI 77891).

Indications and Usage (INDICATIONS AND USAGE)

To Use: Gently pat a small amount around eye area after PREVAGE Anti-aging Daily Serum.

Directions For Sunscreen Use: Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours. Children under 6 months: Ask a doctor.

Dosage & Administration (DOSAGE & ADMINISTRATION)

Pat around eye area.

Otc Active Ingredient (OTC - ACTIVE INGREDIENT)

Active Ingredients: Octinoxate, 4.09%, Oxybenzone, 1.40%.

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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