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

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 July 19, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Octisalate 5.0%, Titanium Dioxide 3.0%, Zinc Oxide 6.0%

  • 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 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. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • apply liberally 15 minutes before sun exposure
    • reapply:
      • after 80 minutes of swimming or sweating
      • immediately after towel drying
      • at least every 2 hours
    • children under 6 months of age: ask a doctor
    • Sun Protection Measures. Spending time in the sun increases your risk 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 a.m.-2 p.m.
      • wear long-sleeved shirts, pants, hats, and sunglasses
  • Other information

    protect this product from excessive heat and direct sun

  • Inactive ingredients

    water, butyloctyl salicylate, neopentyl glycol diethylhexanoate, caprylic/capric triglyceride, stearyl/octyldodecyl citrate crosspolymer, polyglyceryl-2 stearate, simmondsia chinensis (jojoba) seed oil1, hydrogenated dimer dilinoleyl/dimethylcarbonate copolymer, glyceryl stearate, cetyl alcohol, cocos nucifera (coconut) oil1, glycerin1, solanum lycopersicum (tomato) seed oil, helianthus annuus (sunflower) seed oil1, vaccinium macrocarpon (cranberry) seed oil, nigella sativa (black cumin) seed oil1, rubus idaeus (red raspberry) seed oil, butyrospermum parkii (shea) butter1, jojoba esters, stearyl alcohol, arachidyl alcohol, arachidyl glucoside, behenyl alcohol, polyhydroxystearic acid, xanthan gum, silica, alumina, ethylhexylglycerin, trisodium ethylenediamine disuccinate, phenoxyethanol

    1
    Certified Organic Ingredient
    Unless otherwise specified, product not labeled as organic
  • 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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