Label: EEZY PRO SPF 30- meradimate, octinoxate, octocrylene, titanium dioxide, zinc oxide cream

  • NDC Code(s): 70116-004-01
  • Packager: BIO EARTH MANUFACTURING (PTY) LTD
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated October 30, 2024

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  • Actives

     Meradimate, Octinoxate, Octocrylene, Titanium Dioxide, Zinc Oxide

  • Purpose

    Sunsreen

  • Uses

    • Helps prevent sunburn
    • If used as directed with other sun protection measures decreases the risk of skin cancer and early skin aging caused by sun(see Directions)
  • Warnings

    For external use only

    Do not useon damaged or broken skin

    When using this productkeep out of eyes. Rinse with water to remove.

    Stop use and ask a doctorif rash occurs

  • KEEP OUT OF REACH OF CHILDREN

    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.
    • 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:
    • Limited time in the sun, espesially from 10 a.m - 2 p.m
    • Wear long-sleeved shirts, pants, hats and sunglasses
    • Children under 6 months of age: ask a doctor

  • Inactive ingredients

    Aloe barbadensis leaf juice, Cellulose gum, Cetearyl alcohol, Glycerin, Glycerol Stearate, Methylparaben, Phenoxyethanol, Propylparaben,

    Vitamin A & E, Water, White petrolatum, Xanthan gum 

  • Other information

    Protect the product in this container from excessive heat and direct sun

  • Product label

    image description

  • INGREDIENTS AND APPEARANCE
    EEZY PRO SPF 30 
    meradimate, octinoxate, octocrylene, titanium dioxide, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70116-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MERADIMATE (UNII: J9QGD60OUZ) (MERADIMATE - UNII:J9QGD60OUZ) MERADIMATE3 g  in 100 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE4 g  in 100 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE5 g  in 100 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION9 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BULBINE FRUTESCENS WHOLE (UNII: M2U1C7UW6Y)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    VITAMIN A (UNII: 81G40H8B0T)  
    WATER (UNII: 059QF0KO0R)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70116-004-0110 in 1 PACKET03/17/2020
    18 mL in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02003/17/2020
    Labeler - BIO EARTH MANUFACTURING (PTY) LTD (639768436)
    Establishment
    NameAddressID/FEIBusiness Operations
    BIO EARTH MANUFACTURING (PTY) LTD639768436manufacture(70116-004)
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