Label: TOO FACED TINTED BEAUTY BALM SPF-20- titanium dioxide zinc oxide cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 January 8, 2013

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS

    TITANIUM DIOXIDE 5.0%

    ZINC OXIDE 5.0%

  • PURPOSE

    PURPOSE

    SUNSCREEN

  • INDICATIONS & USAGE

    USE

    • HELPS PREVENT SUNBURN
  • WARNINGS

    WARNINGS

    FOR EXTERNAL USE ONLY

  • DO NOT USE

    DO NOT USE ON DAMAGED OR BROKEN SKIN.

  • STOP USE

    STOP USE AND ASK DOCTOR IF RASH OCCURS.

  • WHEN USING

    WHEN USING THIS PRODUCT KEEP OUT OF EYES. RINSE WITH WATER TO REMOVE.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

  • DOSAGE & ADMINISTRATION

    DIRECTIONS

    • APPLY LIBERALLY AND SMOOTHLY 15 MINUTES BEFORE SUN EXPOSURE.
    • USE A WATER RESISTANT SUNSCREEN IF SWIMMING OR SWEATING.
    • REAPPLY AT LEAST EVERY 2 HOURS.
    • CHILDREN UNDER 6 MONTHS: ASK A DOCTOR.
    • OPTIONAL: APPLY TO ALL SKIN EXPOSED TO THE SUN.
    • 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-SLEEVED SHIRTS, PANTS, HATS AND SUNGLASSES.
  • OTHER SAFETY INFORMATION

    OTHER INFORMATION

    • YOU MAY REPORT A SERIOUS ADVERSE REACTION TO:
      17361 ARMSTRONG AVENUE
      IRVINE, CA 92614
    • PROTECT THE PRODUCT IN THIS CONTAINER FROM EXCESSIVE HEAT AND DIRECT SUNLIGHT.
  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS

    WATER, CYCLOPENTASILOXANE, PROPYLENE GLYCOL, OCTYLDODECYL NEOPENTANOATE, PEG/PPG-18/18 DIMETHICONE, DIMETHICONE, CYCLOHEXASILOXANE, MAGNESIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM CHLORIDE, ZINC CHLORIDE, LYSINE, PANAX GINSENG ROOT EXTRACT, GINKGO BILOBA LEAF EXTRACT, ANTHEMIS NOBILIS FLOWER EXTRACT, CAMELLIA OLEIFERA LEAF EXTRACT, PHYTANTRIOL, MAGNESIUM ASCORBYL PHOSPHATE, RETINYL PALMITATE, TOCOPHERYL ACETATE, TOCOPHEROL, TETRAHEXYDECYL ASCORBATE, ALUMINUM HYDROXIDE, STEARIC ACID, TRIETHOXYCAPRYLYLSILOXANE, BORON NITRIDE, GLYCERIN, SODIUM DEHYDROACETATE, PALMITIC ACID, DEXTRIN PALMITATE, SODIUM HYALURONATE, BUTYLENE GLYCOL, PHENOXYETHANOL, METHYLPARABEN, PROPYLPARABEN, MICA, IRON OXIDES.

  • QUESTIONS

    QUESTIONS?

    (949) 553-4431

    MON-FRI 9AM-5PM (PST)

  • PRINCIPAL DISPLAY PANEL

    TF Beauty Balm SPF-20 Tube Artwork US (12-2012)

    TF Beauty Balm SPF-20 Unit Carton Artwork US (12-2012)

  • INGREDIENTS AND APPEARANCE
    TOO FACED TINTED BEAUTY BALM  SPF-20
    titanium dioxide zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79596-090
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE5 g  in 100 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
    PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ZINC CHLORIDE (UNII: 86Q357L16B)  
    LYSINE (UNII: K3Z4F929H6)  
    PANAX GINSENG ROOT WATER (UNII: P9T4K47OM0)  
    GINKGO BILOBA WHOLE (UNII: 660486U6OI)  
    CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)  
    CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)  
    PHYTANTRIOL (UNII: 8LVI07A72W)  
    MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    BORON NITRIDE (UNII: 2U4T60A6YD)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    ICODEXTRIN (UNII: 2NX48Z0A9G)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    MICA (UNII: V8A1AW0880)  
    BROWN IRON OXIDE (UNII: 1N032N7MFO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79596-090-221 in 1 BOX
    1NDC:79596-090-2145 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35212/14/2012
    Labeler - TOO FACED COSMETICS (014131481)
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