TROPICSURF EXTREME PROTECTION SPF50 (OCTOCRYLENE, ZINC OXIDE) LOTION [PALMER SURF LLC (DBA X3EMBRANDS)]

TROPICSURF EXTREME PROTECTION SPF50 (OCTOCRYLENE, ZINC OXIDE) LOTION [PALMER SURF LLC (DBA X3EMBRANDS)]
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NDC 70884-102-03, 70884-102-11, 70884-102-13, 70884-102-16, 70884-102-30
Set ID 5f91b1c1-26be-45fc-90e9-d258f8326666
Category HUMAN OTC DRUG LABEL
Packager PALMER SURF LLC (DBA X3EMBRANDS)
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    ACTIVE INGREDIENT

    • OCTOCRYLENE  7.5%
    • ZINC OXIDE      10.5%

  • DOSAGE & ADMINISTRATION

    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

    PURPOSE:

    • SUNSCREEN
  • INDICATIONS & USAGE

    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

    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 INGREDIENT

    INACTIVE INGREDIENTS:

    WATER/AQUA/EAU, OCTYLDODECYL NEOPENTANOATE, DIMETHICONE, CETEARYL ALCOHOL, ACRYLATES COPOLYMER,

    PEG-100 STEARATE, GLYCERYL STEARATE, PENTYLENE GLYCOL, PHENYL TRIMETHICONE, GLYCERIN, CYCLOPENTASILOXANE,

    TRIMETHYLSILOXYSILICATE, PEG-40 STEARATE, ALOE BARBADENSIS LEAF JUICE, CAMELLIA OLEIFERA LEAF JUICE,

    ASTROCARYUM TUCUMA SEED BUTTER, MACADAMIA TERNIFOLIA SEED OIL, ADANSONIA DIGITATA SEED OIL, MANGIFERA

    INDICA (MANGO) SEED BUTTER, COCO GLUCOSIDE, TOCOPHERYL ACETATE, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL

    TAURATE COPOLYMER, SQUALANE, POLYSORBATE 60, POLYSILICONE-11, SODIUM POLYACRYLATE, XANTHAN GUM,

    DICETYL PHOSPHATE, CETTH-10 PHOSPHATE, AMINOMETHYLPROPANOL, DISODIUM EDTA, CAPRYLYL GLYCOL, PHENOXYETHANOL,

    CHLOPHENESIN, BENXYL CINNAMATE, COUMARIN, LIMONENE, HEXYL CINNAMAL, FRAGRANCE (PARFUM)

  • PRINCIPAL DISPLAY PANEL

    SPF50

  • INGREDIENTS AND APPEARANCE
    TROPICSURF EXTREME PROTECTION SPF50 
    octocrylene, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70884-102
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE7.5 g  in 100 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION10.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    PEG-40 STEARATE (UNII: ECU18C66Q7)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)  
    ASTROCARYUM ACULEATUM SEED OIL (UNII: JUP28JPX3K)  
    MACADAMIA OIL (UNII: 515610SU8C)  
    ADANSONIA DIGITATA SEED OIL (UNII: 77MKL7AR5I)  
    MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
    SQUALANE (UNII: GW89575KF9)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
    CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    DISODIUM EDTA-COPPER (UNII: 6V475AX06U)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    BENZYL CINNAMATE (UNII: V67O3RO97U)  
    COUMARIN (UNII: A4VZ22K1WT)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70884-102-1145 mL in 1 BOTTLE; Type 0: Not a Combination Product08/04/2016
    2NDC:70884-102-0390 mL in 1 BOTTLE; Type 0: Not a Combination Product08/04/2016
    3NDC:70884-102-16195 mL in 1 BOTTLE; Type 0: Not a Combination Product08/04/2016
    4NDC:70884-102-13390 mL in 1 BOTTLE; Type 0: Not a Combination Product08/04/2016
    5NDC:70884-102-30960 mL in 1 BOTTLE; Type 0: Not a Combination Product08/04/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35208/04/2016
    Labeler - PALMER SURF LLC (DBA X3EMBRANDS) (080315280)
    Registrant - PALMER SURF LLC (DBA X3EMBRANDS) (080315280)

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