Label: BABYGANICS KIDS SHEER BLEND SPF50 MINERAL SUNSCREEN- zinc oxide lotion

  • NDC Code(s): 59062-2203-3
  • Packager: KAS Direct LLC dba BabyGanics
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 30, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Zinc oxide 20%

  • 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

    butyloctyl salicylate, butyrospermum parkii (shea) butter1, caprylic/capric triglyceride, capryloyl glycine, caprylyl glycol, coco-caprylate, cocos nucifera (coconut) oil1, ethylhexylglycerin, fragrance2, glycerin1, helianthus annuus (sunflower) seed oil1, isoamyl laurate, magnesium stearate, magnesium sulfate, nigella sativa seed oil1, polyglyceryl-2 oleate, polyglyceryl-2 stearate, polyhydroxystearic acid, propanediol, rubus ldaeus (raspberry) seed oil, sodium phytate, solanum lycopersicum (tomato) seed oil, stearyl/octyldodecyl citrate crosspolymer, undecylenoyl glycine, vaccinium macrocarpon (cranberry) seed oil, water

    1
    Certified Organic Ingredient Unless otherwise specified, product not labeled as organic.
    2
    Product formulated with plantderived fragrance and ingredients chosen with kids in mind.
  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 89 mL Tube Label

    non
    allergenic

    blends in
    & blocks
    out

    kids
    by babyganics®

    SHEER BLEND

    SPF 50 mineral
    sunscreen

    totally tropical

    tear free • dermatologist tested

    broad spectrum SPF 50
    water resistant (80 minutes)

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

    3 FL OZ (89 mL)

    PRINCIPAL DISPLAY PANEL - 89 mL Tube Label
  • INGREDIENTS AND APPEARANCE
    BABYGANICS KIDS SHEER BLEND SPF50 MINERAL SUNSCREEN 
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59062-2203
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide20 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Coco-Caprylate (UNII: 4828G836N6)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    Isoamyl laurate (UNII: M1SLX00M3M)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Shea Butter Ethyl Esters (UNII: V2CI786FPG)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    Butyloctyl Salicylate (UNII: 2EH13UN8D3)  
    Polyglyceryl-2 oleate (UNII: 5759J47SAM)  
    Polyglyceryl-2 stearate (UNII: 253MC0P0YV)  
    Propanediol (UNII: 5965N8W85T)  
    Stearyl/Octyldodecyl Citrate Crosspolymer (UNII: PN88NW0KPK)  
    Undecylenoyl Glycine (UNII: 4D20464K2J)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    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)  
    Capryloyl Glycine (UNII: 8TY5YO42NJ)  
    Caprylyl Glycol (UNII: 00YIU5438U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59062-2203-389 mL in 1 TUBE; Type 0: Not a Combination Product12/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph drugM02012/01/2023
    Labeler - KAS Direct LLC dba BabyGanics (002764605)
    Establishment
    NameAddressID/FEIBusiness Operations
    APEX International MFG., LLC079110793MANUFACTURE(59062-2203)
    Establishment
    NameAddressID/FEIBusiness Operations
    Voyant Beauty, Inc.253610042MANUFACTURE(59062-2203)
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