BABYGANICS SUNSCREEN 50 SPF (OCTINOXATE, OCTISALATE, AND ZINC OXIDE) SPRAY [KAS DIRECT LLC DBA BABYGANICS]

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BABYGANICS SUNSCREEN 50 SPF (OCTINOXATE, OCTISALATE, AND ZINC OXIDE) SPRAY [KAS DIRECT LLC DBA BABYGANICS]
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NDC 59062-1207-1
Set ID 1d6b1153-f59d-4812-ac73-2681e11d51e4
Category HUMAN OTC DRUG LABEL
Packager KAS Direct LLC dba BabyGanics
Generic Name
Product Class
Product Number
Application Number PART352
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Octinoxate 7.5%, Octisalate 5.0%, Zinc oxide 11.2%

  • 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, caprylic/capric triglyceride, glycerin, aloe barbadensis leaf juice, vp/hexadecene copolymer, glyceryl stearate, hexaglyceryl polyricinoleate, polysorbate 80, phenethyl alcohol, glyceryl caprylate, sodium magnesium silicate, xanthan gum, hydroxyethyl acrylate/sodium acryloyldimethyltaurate copolymer, citric acid, squalane, lecithin, polysorbate 60, sorbitan isostearate.

  • SPL UNCLASSIFIED SECTION

    Dist. by:
    KAS Direct, LLC.
    Hicksville, NY 11801

  • PRINCIPAL DISPLAY PANEL - 177 mL Bottle Label

    50+
    SPF

    tear
    free

    water
    resistant

    babyganics®

    mineral-based
    sunscreen spray

    broad spectrum SPF 50+
    UVA + UVB protection
    water resistant (80 minutes)
    non-allergenic

    no: PABA, phthalates, parabens,
    fragrances or nano-particles

    6 FL OZ (177mL)

    040-12078-01

    PRINCIPAL DISPLAY PANEL - 177 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    BABYGANICS SUNSCREEN   50 SPF
    octinoxate, octisalate, and zinc oxide spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59062-1207
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE112 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    HEXADECYL POVIDONE (UNII: AG75W62QYU)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
    GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)  
    SODIUM MAGNESIUM FLUOROSILICATE (UNII: U1QJ22MC8E)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SQUALANE (UNII: GW89575KF9)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59062-1207-1177 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product06/21/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35206/21/2013
    Labeler - KAS Direct LLC dba BabyGanics (002764605)
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