OUTDOOR EXPLORER SET- titanium dioxide, octisalate, and zinc oxide kit

outdoor explorer set by

Drug Labeling and Warnings

outdoor explorer set by is a Otc medication manufactured, distributed, or labeled by KAS Direct LLC dba BabyGanics. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

  • SPL UNCLASSIFIED SECTION

    dist. by KAS direct, LLC
    1600 Stewart Avenue
    Westbury, NY 11590

  • PRINCIPAL DISPLAY PANEL - Kit Package

    bites? burns?
    we've got you
    covered

    babyganics

    outdoor
    explorer
    set

    natural
    insect repellent

    6 FL OZ (177 mL)

    SPF 50+
    sunscreen lotion

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

    2 FL OZ (59 mL)

    Principal Display Panel - Kit Package
  • INGREDIENTS AND APPEARANCE
    OUTDOOR EXPLORER SET 
    titanium dioxide, octisalate, and zinc oxide kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 59062-5300
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 59062-5300-11 in 1 PACKAGE01/01/2018
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 TUBE 59 mL
    Part 21 BOTTLE, SPRAY 177 mL
    Part 1 of 2
    SPF 50 PLUS SUNSCREEN 
    titanium dioxide, octisalate, and zinc oxide lotion
    Product Information
    Item Code (Source)NDC: 59062-1000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide30 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE60 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Butyloctyl Salicylate (UNII: 2EH13UN8D3)  
    Neopentyl Glycol Diethylhexanoate (UNII: U68ZV6W62C)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    Stearyl/Octyldodecyl Citrate Crosspolymer (UNII: PN88NW0KPK)  
    Polyglyceryl-2 Stearate (UNII: 253MC0P0YV)  
    Cetyl Alcohol (UNII: 936JST6JCN)  
    JOJOBA OIL (UNII: 724GKU717M)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    Glycerin (UNII: PDC6A3C0OX)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    TOMATO SEED OIL (UNII: 7N87T9C06T)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    CRANBERRY SEED OIL (UNII: 73KDS3BW5E)  
    Nigella Sativa Seed Oil (UNII: CS4U38E731)  
    RASPBERRY SEED OIL (UNII: 9S8867952A)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)  
    Stearyl Alcohol (UNII: 2KR89I4H1Y)  
    Arachidyl Alcohol (UNII: 1QR1QRA9BU)  
    Arachidyl Glucoside (UNII: 6JVW35JOOJ)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    POLYHYDROXYSTEARIC ACID STEARATE (UNII: 8KQ7I65XZE)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    Trisodium Ethylenediamine Disuccinate (UNII: YA22H34H9Q)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 59062-1000-259 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35207/24/2017
    Part 2 of 2
    NATURAL INSECT REPELLENT 
    lotions, oils, powders, and creams spray
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRsoybean oil (UNII: 241ATL177A)  
    INGRrosemary oil (UNII: 8LGU7VM393)  
    INGRCitronella Oil (UNII: QYO8Q067D0)  
    INGRGERANIUM OIL, ALGERIAN TYPE (UNII: 5Q1I94P4WG)  
    INGRJUNIPERUS VIRGINIANA OIL (UNII: PAD4FN7P2G)  
    INGRPeppermint Oil (UNII: AV092KU4JH)  
    INGRWEST INDIAN LEMONGRASS OIL (UNII: 5BIA40E9ED)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1177 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic01/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/01/2018
    Labeler - KAS Direct LLC dba BabyGanics (002764605)

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