Label: DD TZ FORTE- titanium dioxide, zinc oxide, octinoxate, octisalate lotion

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated December 29, 2022

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  • ACTIVE INGREDIENTS

    TITANIUM DIOXIDE 2%

    ZINC OXIDE 8%

    OCTINOXATE 7.5%

    OCTISALATE 5%

  • PURPOSE

    SUNSCREEN

  • USES

    • HELPS PREVENT SUNBURN.
    • IF USED AS DIRECTED WITH OTHER SUN PROTECTION MEASURES (SEE DIRECTION), 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

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

  • DIRECTIONS

    • APPLY LIBERALLY BEFORE SUN EXPOSURE.
    • REAPPLY -
    • AFTER 40 MINUTES OF SWIMMING
    • AT LEAST EVERY 2 HOURS
    • CHILDREN UNDER 6 MONTHS; ASK A DOCTOR.
  • OTHER INFORMATION

    PROTECT THIS PRODUCT FROM EXCESSIVE HEAT AND DIRECT SUN.

  • INACTIVE INGREDIENTS

    WATER, CYCLOPENTASILOXANE, GLYCERIN, PEG-10 DIMETHICONE, DIMETHICONE, POLYMETHYL METHACRYLATE, CETEARYL ISONONANOATE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, ACRYLATES/DIMETHICONE COPOLYMER, METHYL METHACRYLATE CROSSPOLYMER, SODIUM CHLORIDE, POLYGLYCERYL-3 POLYRICINOLEATE, GINKGO BILOBA LEAF EXTRACT, JOJOBA ESTERS, ALOE BARBADENSIS LEAF JUICE, PHENOXYETHANOL, DISTEARDIMONIUM HECTORITE, GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT, BUTYLENE GLYCOL, SORBITAN SESQUIOLEATE, ALUMINUM HYDROXIDE, STEARIC ACID, CETYL RICINOLEATE, CAPRYLYL GLYCOL, TRIETHOXYCAPRYLYLSILANE, ETHYLHEXYLGLYCERIN, GLYCERYL CAPRATE, MAGNESIUM STEARATE, ALUMINUM TRISTEARATE, SILICA SILYLATE, HEXYLENE GLYCOL, TOCOPHEROL, BEESWAX, VINYL DIMETHICONE/METHICONE SESQUIOXANE CROSSPOLYMER, LYCIUM BARBARUM FRUIT EXTRACT, FRAGRANCE. MAY CONTAIN: MICA, IRON OXIDES (CI 77491, CI 77492, CI 77499)

  • PRINCIPAL DISPLAY PANEL

    DD TZ BOX

  • INGREDIENTS AND APPEARANCE
    DD TZ FORTE 
    titanium dioxide, zinc oxide, octinoxate, octisalate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69769-102
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2 g  in 100 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE8 g  in 100 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    DIMETHICONE 100 (UNII: RO266O364U)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    METHYL METHACRYLATE (UNII: 196OC77688)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)  
    GINKGO BILOBA WHOLE (UNII: 660486U6OI)  
    MICA (UNII: V8A1AW0880)  
    CETEARYL ISONONANOATE (UNII: P5O01U99NI)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    LICORICE (UNII: 61ZBX54883)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CETYL RICINOLEATE (UNII: 1P677500YD)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERYL CAPRATE (UNII: 197M6VFC1W)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    ALUMINUM STEARATES (UNII: O4D7U3B46U)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)  
    POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)  
    LYCIUM BARBARUM FRUIT (UNII: 930626MWDL)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69769-102-511 in 1 BOX04/29/2015
    1NDC:69769-102-1150 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35204/29/2015
    Labeler - LINEX HEALTH & BEAUTY (050219996)
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