Label: EEZYSUN SPF50 BABIES AND KIDS- titanium dioxide, zinc oxide cream

  • NDC Code(s): 70116-013-01
  • Packager: BIO EARTH MANUFACTURING (PTY) LTD
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 18, 2023

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  • Active ingredients 

    Titanium Dioxide 3.5%, Zinc Oxide 9.5%

  • Purpose

    Topical SPF50 Sun Cream for the prevention of sun burn

  • Uses

    Helps prevents 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 ondamaged or broken skin
    When using this productkeep out of eyes.
    rinse with water to remove
    Stop use and ask doctor ifrash occurs
    Keep out of reach of children

  • Direction

    Apply liberally 15 minutes before sun exposure
    Reapply after 40 minutes if swimming or sweating
    immediately after towel drying
    at least every two hours
    Sun protection measuresuse a broad-spectrum sunscreen with an SPF value of 50 or higher
    limit time in the sun, especially from 10am - 2pm
    wear long-sleeve shirts, pants, hats, sunglasses
    Children under 6 months of age: ask a doctor

  • Other information

    Store at or below 77℉. Do not use if seal is broken
    Protect the product in this container from excessive heat and direct sun

  • Inactive ingredients

    Aloe Vera, Ascorbic Acid, Barium Sulphate, Bulbinella, Carnauba, Castor Seed Oil, Cetearyl Alcohol, Chamomile Oil, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Hydrogenated Castor Oil, Hydroxyethyl Cellulose, Phenoxyethanol, Rosehip, Soybean Oil, Tocopheryl Acetate, Water, Xanthan Gum

  • KEEP OUT OF REACH OF CHILDREN

  • Product label

    image description

  • INGREDIENTS AND APPEARANCE
    EEZYSUN SPF50 BABIES AND KIDS 
    titanium dioxide, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70116-013
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE3.5 g  in 100 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION9.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF POLYSACCHARIDES (UNII: W21O437517)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    BULBINE FRUTESCENS WHOLE (UNII: M2U1C7UW6Y)  
    CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ROSA MOSCHATA OIL (UNII: J99W255AWF)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70116-013-0170 in 1 CARTON08/31/2022
    1100 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02008/31/2022
    Labeler - BIO EARTH MANUFACTURING (PTY) LTD (639768436)
    Establishment
    NameAddressID/FEIBusiness Operations
    BIO EARTH MANUFACTURING (PTY) LTD639768436manufacture(70116-013)
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