Label: SPF 50 MINERAL SUNSCREEN BKIDS- zinc oxide stick

  • NDC Code(s): 59062-2201-4
  • 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 February 22, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Zinc oxide 21.6%

  • 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 evenly 15 minutes before sun exposure
    • reapply:
      • after 80 minutes of swimming or sweating
      • immediately after towel drying
      • at least every 2 hours
    • this product is meant for targeted protection and small areas of exposed skin
    • for full protection use in conjunction with another sunscreen lotion or spray
    • 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

    isopropyl palmitate, ozokerite, cetyl alcohol, neopentyl glycol diethylhexanoate, caprylic/capric triglyceride, butyloctyl salicylate, silica, beeswax, isostearic acid, 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, caprylyl glycol, centella asiatica (gotu kola) extract, daucus carota stavia (carrot) seed oil, euphorbia cerifera (candelilla) wax, polyhydroxystearic acid, rubus idaeus (raspberry) seed oil

    1
    Certified Organic Ingredient • Unless otherwise specified, product not labeled as organic. • *Learn about these and all our ingredients and the choices we make at babyganics.com/products
  • SPL UNCLASSIFIED SECTION

    dist. by KAS
    Direct, LLC
    san francisco, ca
    94111

  • PRINCIPAL DISPLAY PANEL - 45 g Container Label

    tear
    free

    kids
    by babyganics®

    easy rub-in

    SPF 50
    mineral sunscreen

    dermatologist tested

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

    Discover which of our ingredients are certified
    organic inside the back label.

    1118956
    NET WT 1.6 OZ (45 g)

    PRINCIPAL DISPLAY PANEL - 45 g Container Label
  • INGREDIENTS AND APPEARANCE
    SPF 50 MINERAL SUNSCREEN   BKIDS
    zinc oxide stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59062-2201
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide216 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CENTELLA ASIATICA WHOLE (UNII: 7M867G6T1U)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CARROT SEED OIL (UNII: 595AO13F11)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    NEOPENTYL GLYCOL DIETHYLHEXANOATE (UNII: U68ZV6W62C)  
    CERESIN (UNII: Q1LS2UJO3A)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    NIGELLA SATIVA SEED OIL (UNII: CS4U38E731)  
    RASPBERRY SEED OIL (UNII: 9S8867952A)  
    CRANBERRY SEED OIL (UNII: 73KDS3BW5E)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    Water (UNII: 059QF0KO0R)  
    TOMATO SEED OIL (UNII: 7N87T9C06T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59062-2201-445 g in 1 CONTAINER; Type 0: Not a Combination Product03/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35203/01/2021
    Labeler - KAS Direct LLC dba BabyGanics (002764605)
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