Label: TROPICSURF EXTREME PROTECTION SPF30-ULTRA- titanium dioxide, zinc oxide lotion

  • 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 November 7, 2017

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  • ACTIVE INGREDIENTS

    • TITANIUM DIOXIDE  4.5%
    • ZINC OXIDE            8.7%

  • DIRECTIONS

    • APPLY LIBERALLY 15 MINUTES PRIOR TO SUN EXPOSURE. REAPPLY AFTER
    • 80 MINUTES OF SWIMMING OR SWEATING; IMMEDIATELY AFTER TOWEL
    • DRYING; AND, AT LEAST EVERY 2 HOURS.

    SUN PROTECTION MEASURES:

    • SPENDING TIME IN THE SUN INCREASES YOUR RISKI 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 AM TO 2 PM; WEAR
    • LONG-SLEEVE SHIRTS, PANTS, HATS AND SUNGLASSES; CHILDREN UNDER 6 MOS.
    • OF AGE, ASK A DOCTOR

  • PURPOSE

    • SUNSCREEN
  • USES

    • 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

    WHEN USING THIS PRODUCT

    • KEEP OUT OF THE EYES.
    • RINSE WITH WATER TO REMOVE
  • STOP USE

    STOP USE AND ASK A DOCTOR IF

    • 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.
  • INACTIVE INGREDIENTS

    WATER, CAPRYLIC/CAPRIC TRIGLYCERIDE, GLYCERIN, CETEARYL ALCOHOL, STEARETH-2, VP/HEXADECENE COPOLYMER,

    STEREATH-21, DIMETHICONE, POLYHYDROXYSTEARIC ACID, ALOE BARBADENSIS LEAF EXTRACT, CAMELLIA OLEIFERA

    LEAF EXTRACT, PLEIOGYNIUM TIMORIENSE FRUIT EXTRACT, PODOCARPS ELATUS FRUIT EXTRACT, TERMINALIA FERDINANDIANA

    FRUIT EXTRACT, ADANSONIA DIGITATA SEED OIL, ASTROCARYUM TUCUMA SEED BUTTER, MADACAMIA TERNIFOLIA NUT OIL,

    DIPOTASSIUM GLYCYRRHIZATE, ALUMINA, STEARIC ACID, SODIUM STEAROYL GLUTAMATE, TRIETHOXYCAPRYLYLSILANE,

    PROPANEDIOL, CAPRYLHYDROXAMIC ACID, DISODIUM EDTA, XANTHAN GUM, CAPRYLYL GLYCOL, ALCOHOL DENAT.,

    FRAGRANCE (PARFUM)

  • PRINCIPAL DISPLAY PANEL

    SPF30 ULTRA

  • INGREDIENTS AND APPEARANCE
    TROPICSURF EXTREME PROTECTION SPF30-ULTRA 
    titanium dioxide, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70884-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE4.5 g  in 100 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION8.7 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    STEARETH-2 (UNII: V56DFE46J5)  
    VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)  
    STEARETH-21 (UNII: 53J3F32P58)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)  
    PLUM (UNII: 67M3EQ6BE1)  
    PODOCARPUS ELATUS WHOLE (UNII: H38807Y47G)  
    KAKADU PLUM (UNII: 0ZQ1D2FDLI)  
    ADANSONIA DIGITATA SEED OIL (UNII: 77MKL7AR5I)  
    ASTROCARYUM ACULEATUM SEED OIL (UNII: JUP28JPX3K)  
    MACADAMIA OIL (UNII: 515610SU8C)  
    GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    DISODIUM EDTA-COPPER (UNII: 6V475AX06U)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70884-101-1145 mL in 1 BOTTLE; Type 0: Not a Combination Product08/03/2016
    2NDC:70884-101-0390 mL in 1 BOTTLE; Type 0: Not a Combination Product08/03/2016
    3NDC:70884-101-16195 mL in 1 BOTTLE; Type 0: Not a Combination Product08/03/2016
    4NDC:70884-101-13390 mL in 1 BOTTLE; Type 0: Not a Combination Product08/03/2016
    5NDC:70884-101-32960 mL in 1 BOTTLE; Type 0: Not a Combination Product08/03/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35208/03/2016
    Labeler - PALMER SURF LLC (DBA X3EMBRANDS) (080315280)
    Registrant - PALMER SURF LLC (DBA X3EMBRANDS) (080315280)
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