Label: BABYGANICS SUNSCREEN 30SPF- titanium dioxide and zinc oxide lotion

  • NDC Code(s): 59062-1227-1
  • 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 4, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Titanium dioxide 3.0%, Zinc oxide 3.0%

  • 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 40 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, cetearyl olivate, cocos nucifera (coconut) oil, sorbitan olivate, caprylic/capric triglyceride, carthamus tinctorius (safflower) seed oil, cetyl alcohol, stearyl/octadodecyl citrate crosspolymer, glycerin, ozokerite, simmondsia chinensis (jojoba) seed oil, butyrospermum parkii (shea) butter, theobroma cacao (cocoa) seed butter, jojoba esters, squalane, glyceryl caprylate, arachidyl alcohol, behenyl alcohol, arachidyl glucoside, sucrose stearate, stearic acid, polyglyceryl-2 caprate, xanthan gum, polyhydroxystearic acid, silica, alumina, trisodium ethylenediamine disuccinate, ethylhexylglycerin, phenoxyethanol

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 118 mL Tube Label

    30
    SPF

    tear
    free

    water
    resistant

    babyganics®

    pure mineral
    sunscreen

    broad spectrum SPF 30
    UVA + UVB protection
    water resistant
    (40 minutes)
    non-allergenic

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

    4 FL OZ (118mL)

    Principal Display Panel - 118 mL Tube Label
  • INGREDIENTS AND APPEARANCE
    BABYGANICS SUNSCREEN   30SPF
    titanium dioxide and zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59062-1227
    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
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE30 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    MONOSTEARYL CITRATE (UNII: YWW937R1QR)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CERESIN (UNII: Q1LS2UJO3A)  
    JOJOBA OIL (UNII: 724GKU717M)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    DECYL JOJOBATE (UNII: ZL61O8TFZU)  
    SQUALANE (UNII: GW89575KF9)  
    GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)  
    ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
    SUCROSE STEARATE (UNII: 274KW0O50M)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59062-1227-1118 mL in 1 TUBE; 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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