PREVAGE ANTI AGING EYE SUNSCREEN SPF 15- octinoxate and oxybenzone cream

Prevage Anti Aging Eye Sunscreen SPF 15 by

Drug Labeling and Warnings

Prevage Anti Aging Eye Sunscreen SPF 15 by is a Otc medication manufactured, distributed, or labeled by Elizabeth Arden, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

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 - ACTIVE INGREDIENT

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

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 - 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 15 Sun Protection.

OTC - WHEN USING

Keep out of eyes.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PREVAGE ANTI AGING EYE SUNSCREEN SPF 15 
octinoxate and oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67938-1126
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.613 g  in 15 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.21 g  in 15 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SHEA BUTTER (UNII: K49155WL9Y)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIMETHICONE (UNII: 92RU3N3Y1O)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
CARNAUBA WAX (UNII: R12CBM0EIZ)
PEG-100 STEARATE (UNII: YD01N1999R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
MICA (UNII: V8A1AW0880)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
TRIDECYL STEARATE (UNII: A8OE252M6L)
UREA (UNII: 8W8T17847W)
YELLOW WAX (UNII: 2ZA36H0S2V)
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)
SORBITAN TRISTEARATE (UNII: 6LUM696811)
STEARETH-100 (UNII: 4OH5W9UM87)
CHLORPHENESIN (UNII: I670DAL4SZ)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
BENZOIC ACID (UNII: 8SKN0B0MIM)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
TREHALOSE (UNII: B8WCK70T7I)
EDETATE DISODIUM (UNII: 7FLD91C86K)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
SORBIC ACID (UNII: X045WJ989B)
METHYLPARABEN (UNII: A2I8C7HI9T)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
TRIACETIN (UNII: XHX3C3X673)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SODIUM CITRATE (UNII: 1Q73Q2JULR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67938-1126-1	1 in 1 BOX
1	NDC: 67938-1126-2	15 g in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	03/14/2011

Labeler - Elizabeth Arden, Inc (849222187)