PREVAGE ANTI AGINING TRIPLE DEFENSE SHIELD BROAD SPECTRUM SUNSCREEN SPF 50- octinoxate, oxybenzone, octisalate, octocrylene, and avobenzone lotion

Prevage Anti Agining Triple Defense Shield Broad Spectrum Sunscreen SPF 50 by

Drug Labeling and Warnings

Prevage Anti Agining Triple Defense Shield Broad Spectrum Sunscreen SPF 50 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 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

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 - ACTIVE INGREDIENT

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

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).

DOSAGE AND ADMINISTRATION

Apply to skin.

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 50 Sun Protection.

OTC - WHEN USING

Keep out of eyes.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PREVAGE ANTI AGINING TRIPLE DEFENSE SHIELD BROAD SPECTRUM SUNSCREEN SPF 50 
octinoxate, oxybenzone, octisalate, octocrylene, and avobenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67938-0990
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 50 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	60 mg  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	40 mg  in 50 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
NYLON-12 (UNII: 446U8J075B)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIMETHICONE (UNII: 92RU3N3Y1O)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
ISOPROPYL ISOSTEARATE (UNII: C67IXB9Y7T)
ERGOTHIONEINE (UNII: BDZ3DQM98W)
YEAST (UNII: 3NY3SM6B8U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ISOHEXADECANE (UNII: 918X1OUF1E)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
C20-22 ALCOHOLS (UNII: O4M0347C6A)
C20-22 ALKYL PHOSPHATE (UNII: L4VKP0Y7RP)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
COCO GLUCOSIDE (UNII: ICS790225B)
POLYSORBATE 60 (UNII: CAL22UVI4M)
ISODODECANE (UNII: A8289P68Y2)
EDETIC ACID (UNII: 9G34HU7RV0)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
ETHYLPARABEN (UNII: 14255EXE39)
METHYLPARABEN (UNII: A2I8C7HI9T)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67938-0990-1	1 in 1 BOX
1	NDC: 67938-0990-2	50 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	12/14/2011

Labeler - Elizabeth Arden, Inc (849222187)