Label: TOO FACED BB CREME COMPLETE COVERAGE MAKE-UP SPF-20 SNOW GLOW- titanium dioxide 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 December 14, 2012

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

  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS

    TITANIUM DIOXIDE 8.3%

  • 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

    TRIETHYLHEXANOIN, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, ISOTRIDECYL ISONONANOATE, DEXTRIN PALMITATE, MICA, TITANIUM DIOXIDE, IRON OXIDES, SILICA DIMETHYL SILYLATE, ALUMINUM HYDROXIDE, STEARIC ACID, TOCOPHEROL, HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, ALUMINA, BUTYLENE GLYCOL, WATER, SILICA, ROSA MULTIFLORA FRUIT EXTRACT, AVERRHOA CARAMBOLA LEAF EXTRACT, RHODOMYRTUS TOMENTOSA FRUIT EXTRACT.

  • QUESTIONS

    QUESTIONS?

    (949) 553-4431

    MON-FRI 9AM-5PM (PST)

  • PRINCIPAL DISPLAY PANEL

    BB Creme SPF-20 LBL-BTM_Snow Glow

    BB Creme SPF-20 UC-BK_All

    BB Creme SPF-20 UC-FR_All

  • INGREDIENTS AND APPEARANCE
    TOO FACED BB CREME COMPLETE COVERAGE MAKE-UP  SPF-20 SNOW GLOW
    titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79596-096
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE8.3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (UNII: 9E4CO0W6C5)  
    ISOTRIDECYL ISONONANOATE (UNII: WEF51750MT)  
    DECYL PALMITATE (UNII: SDD3SU9U0A)  
    MICA (UNII: V8A1AW0880)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    PIVALIC ACID (UNII: 813RE8BX41)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    WATER (UNII: 059QF0KO0R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ROSA MULTIFLORA FRUIT (UNII: EZ5DSL4T27)  
    AVERRHOA CARAMBOLA LEAF (UNII: HB7UP0QK1T)  
    RHODOMYRTUS TOMENTOSA FRUIT (UNII: Q99511S58K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79596-096-121 in 1 BOX
    1NDC:79596-096-1128 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35212/14/2012
    Labeler - TOO FACED COSMETICS (014131481)