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

  • NDC Code(s): 59062-2300-3
  • Packager: KAS Direct LLC dba BabyGanics
  • 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 March 23, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Titanium dioxide 3.5%, Zinc oxide 7.25%

  • 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 and spread evenly by hand 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, isododecane, caprylic/capric triglyceride, isohexadecane, C12-15 alkyl benzoate, neopentyl glycol diheptanoate, shea butter ethyl esters, carthamus tinctorius (safflower) seed oil, C30-38 olefin/isopropyl maleate/MA copolymer, butyloctyl salicylate, coco-glucoside, cetearyl alcohol, cetearyl glucoside, cetearyl olivate, sorbitan olivate, ethylhexylglycerin, simmondsia chinensis (jojoba) seed oil1, sodium hydroxide, chlorphenesin, xanthan gum, tocopherol, glycerin1, sodium phytate, helianthus annuus (sunflower) seed oil1, solanum lycopersicum (tomato) seed oil, vaccinium macrocarpon (cranberry) seed oil, nigella sativa (black cumin) seed oil1, rubus idaeus (raspberry) seed oil, citric acid, fragrance2

    1
    Certified Organic Ingredient • Unless otherwise specified, product not labeled as organic.
    2
    Product formulated with plant-derived fragrance and ingredients chosen with kids in mind. Learn about these and all our ingredients and the choices we make at babyganics.com/products
  • 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 NOT FINALpart35202/01/2022
    Labeler - KAS Direct LLC dba BabyGanics (002764605)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fruit of the Earth, Inc.080086802MANUFACTURE(59062-2300)
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