Label: VIRTUAL MATTE OIL CONTROL MAKEUP BROAD SPECTRUM SPF 15- octinoxate and titanium dioxide liquid

  • 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 18, 2013

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Octinoxate 2.50%
    Titanium Dioxide 0.97%

  • Purpose

    Sunscreen

  • Use

    helps prevent sunburn

  • 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.

    For sunscreen use:

    • apply liberally 15 minutes before sun exposure
    • reapply at least every two 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 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
  • Inactive ingredients

    water\aqua\eau • cyclopentasiloxane • butylene glycol • peg-10 dimethicone • trimethylsiloxysilicate • dimethicone • magnesium sulfate • dimethicone/peg-10/15 crosspolymer • laminaria saccharina extract • algae extract • acetyl hexapeptide-8 • sodium hyaluronate • cholesterol • ceramide 2 • linoleic acid • tocopheryl • acetate • hydrogenated lecithin • sorbitan sesquioleate • polysilicone-11 • phenyl trimethicone • lecithin • peg/ppg-18/ 18 dimethicone • disteardimonium hectorite • triethoxycaprylylsilane • propylene carbonate • silica • dimethicone/peg-10 crosspolymer • xanthan gum • laureth-7 • methyl methacrylate crosspolymer • methoxy amodimethicone/ silsesquioxane copolymer • dipropylene glycol • bht • chloroxylenol • phenoxyethanol • methylparaben • propylparaben • [+/- mica • iron oxides (ci 77491, ci 77492, ci 77499) • titanium dioxide (ci 77891)] <ILN37462>

  • Other information

    protect the product in this container from excessive heat and direct sun

  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton

    PRESCRIPTIVES

    Virtual Matte

    Oil-Control Makeup

    Broad Spectrum SPF 15

    1 FL. OZ./OZ. LIQ./30 ml e

    Principal Display Panel - 30 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    VIRTUAL MATTE   OIL CONTROL MAKEUP BROAD SPECTRUM SPF 15
    octinoxate and titanium dioxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59158-915
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.02775 g  in 1 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.010767 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    cyclomethicone 5 (UNII: 0THT5PCI0R)  
    butylene glycol (UNII: 3XUS85K0RA)  
    dimethicone (UNII: 92RU3N3Y1O)  
    magnesium sulfate (UNII: DE08037SAB)  
    saccharina latissima (UNII: 68CMP2MB55)  
    acetyl hexapeptide-8 (UNII: L4EL31FWIL)  
    hyaluronate sodium (UNII: YSE9PPT4TH)  
    cholesterol (UNII: 97C5T2UQ7J)  
    ceramide 2 (UNII: C04977SRJ5)  
    linoleic acid (UNII: 9KJL21T0QJ)  
    .alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
    sorbitan sesquioleate (UNII: 0W8RRI5W5A)  
    phenyl trimethicone (UNII: DR0K5NOJ4R)  
    peg/ppg-18/18 dimethicone (UNII: 9H0AO7T794)  
    disteardimonium hectorite (UNII: X687XDK09L)  
    triethoxycaprylylsilane (UNII: LDC331P08E)  
    propylene carbonate (UNII: 8D08K3S51E)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    xanthan gum (UNII: TTV12P4NEE)  
    laureth-7 (UNII: Z95S6G8201)  
    dipropylene glycol (UNII: E107L85C40)  
    butylated hydroxytoluene (UNII: 1P9D0Z171K)  
    chloroxylenol (UNII: 0F32U78V2Q)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    methylparaben (UNII: A2I8C7HI9T)  
    propylparaben (UNII: Z8IX2SC1OH)  
    mica (UNII: V8A1AW0880)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59158-915-011 in 1 CARTON
    130 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35209/01/2003
    Labeler - PRESCRIPTIVES INC (151701588)
    Establishment
    NameAddressID/FEIBusiness Operations
    ELGC K.K.712808195RELABEL(59158-915) , REPACK(59158-915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Pennsylvania Distribution Center 2 (PADC 2)828534516MANUFACTURE(59158-915) , RELABEL(59158-915) , REPACK(59158-915)
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER COSMETICS DISTRIBUTION CENTER208579636REPACK(59158-915) , RELABEL(59158-915)
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER COSMETICS, LTD244669714MANUFACTURE(59158-915)
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER COSMETICS, LTD.205952385MANUFACTURE(59158-915)
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER N.V.370151326MANUFACTURE(59158-915)
    Establishment
    NameAddressID/FEIBusiness Operations
    LEN-RON MANUFACTURING DIVISION OF ARAMIS INC809771152MANUFACTURE(59158-915)
    Establishment
    NameAddressID/FEIBusiness Operations
    NORTEC KEYSTONE943871157MANUFACTURE(59158-915) , RELABEL(59158-915) , REPACK(59158-915)
    Establishment
    NameAddressID/FEIBusiness Operations
    NORTHTEC BRISTOL959338336MANUFACTURE(59158-915) , RELABEL(59158-915) , REPACK(59158-915)
    Establishment
    NameAddressID/FEIBusiness Operations
    NORTHTEC KEYSTONE949264774MANUFACTURE(59158-915) , RELABEL(59158-915) , REPACK(59158-915)
    Establishment
    NameAddressID/FEIBusiness Operations
    WHITMAN LABORATORIES, LTD.216866277MANUFACTURE(59158-915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aveda Corporation071352058MANUFACTURE(59158-915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pennsylvania Logistics Center078364654RELABEL(59158-915) , REPACK(59158-915)
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