Label: PREVAGE ANTI AGINING TRIPLE DEFENSE SHIELD BROAD SPECTRUM SUNSCREEN SPF 50- octinoxate, oxybenzone, octisalate, octocrylene, and avobenzone lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 67938-0990-1, 67938-0990-2 - Packager: Elizabeth Arden, Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated May 1, 2013
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- Official Label (Printer Friendly)
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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.
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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
- OTC - ACTIVE INGREDIENT
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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
- OTC - KEEP OUT OF REACH OF CHILDREN
- OTC - PURPOSE
- OTC - WHEN USING
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PREVAGE ANTI AGINING TRIPLE DEFENSE SHIELD BROAD SPECTRUM SUNSCREEN SPF 50
octinoxate, oxybenzone, octisalate, octocrylene, and avobenzone lotionProduct 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)
