Label: PREVAGE ANTI AGING MOISTURE BROAD SPECTRUM SUNSCREEN SPF 30- octinoxate, octisalate, oxybenzone, octocrylene, and avobenzone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 67938-9144-1, 67938-9144-2 - Packager: Elizabeth Arden, Inc
- Category: HUMAN OTC DRUG LABEL
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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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.
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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.
- WARNINGS
- OTC - ACTIVE INGREDIENT
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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).
- DOSAGE AND ADMINISTRATION
- OTC - KEEP OUT OF REACH OF CHILDREN
- OTC - PURPOSE
- OTC - WHEN USING
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PREVAGE ANTI AGING MOISTURE BROAD SPECTRUM SUNSCREEN SPF 30
octinoxate, octisalate, oxybenzone, octocrylene, and avobenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67938-9144 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 3.75 g in 50 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 2.5 g in 50 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 2.5 g in 50 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 1.1 g in 50 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 1 g in 50 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PPG-2 ISOCETETH-20 ACETATE (UNII: BI6C7YO419) GLYCERIN (UNII: PDC6A3C0OX) ERGOTHIONEINE (UNII: BDZ3DQM98W) ISOHEXADECANE (UNII: 918X1OUF1E) TREHALOSE (UNII: B8WCK70T7I) SUCROSE (UNII: C151H8M554) POLYSORBATE 60 (UNII: CAL22UVI4M) TRIDECETH-6 (UNII: 3T5PCR2H0C) XANTHAN GUM (UNII: TTV12P4NEE) SODIUM HYDROXIDE (UNII: 55X04QC32I) MICA (UNII: V8A1AW0880) MINERAL OIL (UNII: T5L8T28FGP) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) BENZOIC ACID (UNII: 8SKN0B0MIM) BUTYLPARABEN (UNII: 3QPI1U3FV8) ETHYLPARABEN (UNII: 14255EXE39) ISOBUTYLPARABEN (UNII: 0QQJ25X58G) METHYLPARABEN (UNII: A2I8C7HI9T) PHENOXYETHANOL (UNII: HIE492ZZ3T) PROPYLPARABEN (UNII: Z8IX2SC1OH) CHLORPHENESIN (UNII: I670DAL4SZ) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67938-9144-1 1 in 1 BOX 1 NDC:67938-9144-2 50 g in 1 JAR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 06/22/2011 Labeler - Elizabeth Arden, Inc (849222187)