Label: TAKE COVER ANTI-AGING FOUNDATION MEDIUM DEEP- octinoxate 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 June 8, 2012

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  • Active Ingredients


    Octinoxate 7.0%
    Titanium Dioxide 3.50%
    Zinc Oxide 1.95%

  • Purpose

    Sunscreen

  • Use

    • 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

    • Apply generously 15 minutes before sun exposure.
    • Reapply:
      • after 40 minutes of swimming or sweating
      • immediately after towel drying
      • 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 value 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-sleeved shirts, pants, hats and sunglasses
    • Children under 6 months of age: Ask a doctor.
  • Other Information

    • Protect the product in this container from excessive heat and direct sun.
  • Inactive Ingredients

    Cyclopentasiloxane,Water (Aqua), Trimethylolpropan, Triisostearate, Dimethicone, Isododecane, PEG/PPG-18/ 18 Dimethicone, Butylene Glycol, Hexyl Laurate, Disteardimonium Hectorite, C12-C15 Alkyl Benzoate, Polyglyceryl-4 Isostearate, Dimethiconol, Dipalmitoyl Hydroxyproline, Dimethicone/Divinyldimethicone/Silses-quioxane Crosspolymer, Polysilicone-11, Phenoxyethanol, Sodium Chloride, Magnesium Aluminium Silicate, PEG-10 Dimethicone, Coco-Caprylate/Caprate, Lecithin, Theobroma Grandiflorum Seed Butter, Cetyl PEG/PPG-10 Dimethicone, Tribehenin, Stearic Acid, Propylene Carbonate, Alumina, Methylparaben, Tocopheryl Acetate, Ceramide-2, PEG-10 Rapeseed Sterol, Triethoxycaprylysilane, Butylparaben, Ethylparaben, Dimethylacrylamide/Acrylic Acid/Polystyrene Ethyl Methacrylate Copolymer, Propylparaben, Decyl Glucoside, Isobutylparaben, Retinyl Palmitate, Tetrahexyldecyl Ascorbate, Caprylyl Glycol, Hexylene Glycol,Laureth-12, Plamitoyl Oligopeptide May Contain:Titanium Dioxide(CI 77891),Mica(CI 77019), Iron Oxides(CI 77492,CI 77491, CI 77499)

  • Questions or comments?

    Call Laura Geller Make-up, Inc., 1(800) MAKE UP4

  • Principal Display Panel

    LAURA GELLER
    BEAUTY INGENUITY
    take cover
    anti-aging
    foundation
    broad spectrum
    SPF 20
    with
    Skin Self-Defense
    ComplexTM
    MEDIUM DEEP
    Net Wt.
    1 fl. oz./30 ml
    Untitled.jpg
  • INGREDIENTS AND APPEARANCE
    TAKE COVER ANTI-AGING FOUNDATION  MEDIUM DEEP
    octinoxate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51389-117
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7 g  in 100 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE3.5 g  in 100 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE1.95 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    WATER (UNII: 059QF0KO0R)  
    TRIMETHYLOLPROPANE (UNII: 090GDF4HBD)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ISODODECANE (UNII: A8289P68Y2)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    DIMETHICONOL (250000 MW) (UNII: RKI3S914RT)  
    DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    THEOBROMA GRANDIFLORUM SEED BUTTER (UNII: I711F13FXM)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 1.5) (UNII: V2W71V8T0X)  
    TRIBEHENIN (UNII: 8OC9U7TQZ0)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CERAMIDE 2 (UNII: C04977SRJ5)  
    PEG-10 RAPESEED STEROL (UNII: 258O76T85M)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    LAURETH-12 (UNII: OAH19558U1)  
    PALMITOYL OLIGOPEPTIDE (UNII: HO4ZT5S86C)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    MICA (UNII: V8A1AW0880)  
    EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
    PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51389-117-0329.57 g in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35206/08/2012
    Labeler - LAURA GELLER MAKE UP INC. (199474524)
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