Label: PREVAGE ANTI AGING MOISTURE BROAD SPECTRUM SUNSCREEN SPF 30- octinoxate, octisalate, oxybenzone, octocrylene, and avobenzone cream

  • 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

If you are a consumer or patient please visit this version.

  • 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.

  • 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

    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: Octinoxate 7.50%, Octisalate 5.00%, Oxybenzone 5.00%, Octocrylene 2.20%, Avobenzone 2.00%

  • 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

    Massage onto face and neck.

  • 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 30 Sun Protection.

  • OTC - WHEN USING

    Keep out of eyes.

  • PRINCIPAL DISPLAY PANEL

    PAAMCCarton

    PAAMCJar

    PAAMCBaseLabel

  • INGREDIENTS AND APPEARANCE
    PREVAGE ANTI AGING MOISTURE BROAD SPECTRUM SUNSCREEN SPF 30 
    octinoxate, octisalate, oxybenzone, octocrylene, and avobenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67938-9144
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.75 g  in 50 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2.5 g  in 50 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE2.5 g  in 50 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1.1 g  in 50 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1 g  in 50 g
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67938-9144-11 in 1 BOX
    1NDC:67938-9144-250 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35206/22/2011
    Labeler - Elizabeth Arden, Inc (849222187)