Label: EEZYSUN SUNSCREEN SPF 50 WITH ALOE VERA, MARINE FRIENDLY- titanium dioxide,zinc oxide cream

  • NDC Code(s): 70116-012-01
  • 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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  • Drug Facts

  • Active ingredients

    Titanium Dioxide 3.5%,   Zinc Oxide 9.5%

  • 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 the eyes, rinse with water to remove.
    Stop using this product 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 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, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Hydrogenated Castor Oil, Hydroxyethyl Cellulose, Phenoxyethanol, Rosehip, Soybean Oil, Tocopheryl Acetate, Water, Xanthan Gum

  • PRINCIPAL DISPLAY PANEL

    image descriptionimage descriptionimage description

  • INGREDIENTS AND APPEARANCE
    EEZYSUN SUNSCREEN SPF 50 WITH ALOE VERA, MARINE FRIENDLY 
    titanium dioxide,zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70116-012
    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)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    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:70116-012-01100 mL in 1 TUBE; Type 0: Not a Combination Product03/30/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02003/30/2021
    Labeler - BIO EARTH MANUFACTURING (PTY) LTD (639768436)
    Establishment
    NameAddressID/FEIBusiness Operations
    BIO EARTH MANUFACTURING (PTY) LTD639768436manufacture(70116-012)
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