KIDS SPF50PLUS MINERAL SUNSCREEN ROLLERBALL TOTALLY TROPICAL- zinc oxide and titanium dioxide spray

Kids SPF50Plus Mineral Sunscreen Rollerball Totally Tropical by

Drug Labeling and Warnings

Kids SPF50Plus Mineral Sunscreen Rollerball Totally Tropical by is a Otc medication manufactured, distributed, or labeled by KAS Direct LLC dba BabyGanics, Fruit of the Earth, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

  • SPL UNCLASSIFIED SECTION

    Dist. by KAS Direct, LLC
    1525 Howe St., Racine, WI 53403

  • PRINCIPAL DISPLAY PANEL - 88 mL Bottle Label

    tear
    free

    roll
    on

    kids
    by babyganics®

    easy rub-in

    SPF 50
    mineral
    sunscreen

    totally tropical

    dermatologist tested

    broad spectrum SPF 50
    water & sweat resistant (80 minutes)

    Discover which of our ingredients are
    Certified Organic on back panel.

    3 FL OZ (88 mL)

    PRINCIPAL DISPLAY PANEL - 88 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    KIDS SPF50PLUS MINERAL SUNSCREEN ROLLERBALL TOTALLY TROPICAL 
    zinc oxide and titanium dioxide spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 59062-2300
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide7.25 g  in 100 mL
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide3.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Isododecane (UNII: A8289P68Y2)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    Isohexadecane (UNII: 918X1OUF1E)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    Neopentyl Glycol Diheptanoate (UNII: 5LKW3C543X)  
    Shea Butter Ethyl Esters (UNII: V2CI786FPG)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B)  
    Butyloctyl Salicylate (UNII: 2EH13UN8D3)  
    COCO-GLUCOSIDE (UNII: ICS790225B)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    Cetearyl Glucoside (UNII: 09FUA47KNA)  
    Cetearyl Olivate (UNII: 58B69Q84JO)  
    Sorbitan Olivate (UNII: MDL271E3GR)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    JOJOBA OIL (UNII: 724GKU717M)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Chlorphenesin (UNII: I670DAL4SZ)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Tocopherol (UNII: R0ZB2556P8)  
    Glycerin (UNII: PDC6A3C0OX)  
    PHYTATE SODIUM (UNII: 88496G1ERL)  
    SUNFLOWER SEED (UNII: R9N3379M4Z)  
    TOMATO SEED OIL (UNII: 7N87T9C06T)  
    CRANBERRY SEED (UNII: 38ZFO1X2U7)  
    NIGELLA SATIVA SEED OIL (UNII: CS4U38E731)  
    RUBUS IDAEUS SEED (UNII: M3CL7US2ZG)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 59062-2300-388 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph drugM02002/01/2022
    Labeler - KAS Direct LLC dba BabyGanics (002764605)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fruit of the Earth, Inc.080086802MANUFACTURE(59062-2300)

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