Label: ELIZABETH ARDEN PREVAGE ANTI-AGING FOUNDATION BROAD SPECTRUM SUNSCREEN SPF 30- octinoxate, titanium dioxide lotion

  • 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 August 1, 2017

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  • Active Ingredients

    OCTINOXATE 6.0%

    TITANIUM DIOXIDE 6.0%

  • Purpose

    Sunscreen

    Sunscreen

  • Uses

    • Helps prevent sunburn
    • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
  • 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

    • Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
  • Directions For Sunscreen Use:

    • Apply liberally 15 minutes before sun exposure
    • Reapply:
      • at least every 2 hours
      • use a water resistant sunscreen if swimming or sweating
    • 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.
  • Inactive Ingredients

    WATER/AQUA/EAU, CYCLOPENTASILOXANE, DICAPRYLYL CARBONATE, MYRISTYL TRISILOXANE, POLYMETHYLSILSESQUIOXANE, CYCLOHEXASILOXANE, SORBITAN ISOSTEARATE, ALUMINA, ALUMINUM/MAGNESIUM HYDROXIDE STEARATE, GLYCERIN, TETRAHEXYLDECYL ASCORBATE, TRIMETHYLSILOXYSILICATE, MICA, CAPRYLYL DIMETHICONE ETHOXY GLUCOSIDE, CAMELLIA SINENSIS LEAF EXTRACT, CARNOSINE, DIMETHICONE, DIMETHICONOL, DISODIUM COCOYL GLUTAMATE, ERGOTHIONEINE, FERULIC ACID, HYDROXYDECYL UBIQUINOYL DIPALMITOYL GLYCERATE, PARFUM/FRAGRANCE, PCA DIMETHICONE, POLYHYDROXYSTEARIC ACID, SILICA, SILICA SILYLATE, SODIUM CHLORIDE, SODIUM COCOYL GLUTAMATE, STEARIC ACID, TOCOPHEROL, CHLORPHENESIN, PHENOXYETHANOL, POTASSIUM SORBATE, SODIUM DEHYDROACETATE, IRON OXIDES (CI 77491, CI 77492, CI 77499), TITANIUM DIOXIDE (CI 77891).

  • Other Information

    • Protect this product from excessive heat and direct sun
  • Questions or comments?

    • Call toll free 1-800 326-7337
  • Principal Display Panel - Prevage Anti-Aging Foundation Carton Label

    prevage®

    anti-aging foundation

    broad spectrum sunscreen

    SPF 30

    1 FL. OZ. 30 ml

    Principal Display Panel - Prevage Anti-Aging Foundation Carton Label
  • INGREDIENTS AND APPEARANCE
    ELIZABETH ARDEN PREVAGE ANTI-AGING FOUNDATION BROAD SPECTRUM SUNSCREEN SPF 30 
    octinoxate, titanium dioxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67938-3051
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE.06 g  in 1 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE.06 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    MYRISTYL TRISILOXANE (UNII: J7960S4R1T)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    MICA (UNII: V8A1AW0880)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CARNOSINE (UNII: 8HO6PVN24W)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DISODIUM COCOYL GLUTAMATE (UNII: MBK0CP8F5A)  
    ERGOTHIONEINE (UNII: BDZ3DQM98W)  
    FERULIC ACID (UNII: AVM951ZWST)  
    HYDROXYDECYL UBIQUINOYL DIPALMITOYL GLYCERATE (UNII: OV1BT2N8RC)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67938-3051-11 in 1 CARTON08/01/2017
    130 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35208/01/2017
    Labeler - ELIZABETH ARDEN, INC (849222187)
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