Label: EEZYSUN BARE SPF 50 TINTED SUNSCREEN TAN- titanium dioxide, zinc oxide cream

  • NDC Code(s): 70116-016-01
  • Packager: BIO EARTH MANUFACTURING (PTY) LTD
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 9, 2024

If you are a consumer or patient please visit this version.

  • Active ingredients 

    Zinc Oxide 10%, Titanium Dioxide 8%

  • Purpose

    Sunscreen

  • Uses

    • Prevents sunburn, Hydrates, Moisturizes and repairs skin with anti-aging properties. Suitable for all skin types.
    • 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 doctor if rash occurs
    Keep out of reach of children

  • Direction

    • Apply every morning or 15 min before sun exposure. For dry skin, apply after a layer of moisturizer. Reapply:
    • after 80 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours
    • Sun protection measures. Use a broad spectrum sunscreen with an SPF value of 50 or higher
    • limit time in the sun, especially from 10 am -2 pm
    • wear long-sleeve shirts, pants, hats and sunglasses
    • Children under 6 months of age: ask a doctor
  • Other information

    Store at or below 77℉. Do not use if seal is broken

  • Inactive ingredients

    Aqua, Cocos Nucifera Oil, Glycine Soja (Soybean) Oil, Baryte, Glyceryl Stearate, Sorbitan Olivate, Ricinus Communis (Castor) Seed Oil (and) Hydrogenated Castor Oil (and) Copernicia Cerifera (Carnauba) Wax,Hydroxyethyl Cellulose, Cetearyl Alcohol, Glycerine, Simmondsia Chinensis (Jojoba)Seed Oil, Citrullus Vulgaris (Kalahari Melon) Oil, Potassium Cetyl Phosphate, Sodium Lactate, Iron Oxides, Potassium Sorbate, Sodium
    Benzoate, Citric Acid, Sodium Hyaluronate (Hyaluronic Acid), Rosa Mosqueta (Rosehip) Fruit Oil, Aloe Barbadensis Leaf Oil, Vanilla Planifolia Fruit Oil, Ascorbic Acid, Tocopherol, Retinol Palmitate

  • KEEP OUT OF REACH OF CHILDREN

  • Product label

    image description

  • INGREDIENTS AND APPEARANCE
    EEZYSUN BARE SPF 50 TINTED SUNSCREEN TAN 
    titanium dioxide, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70116-016
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE8 g  in 100 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION10 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    CITRUS X LIMON FLOWERING TOP OIL (UNII: 4C38SS0J60)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    ROSA MOSCHATA OIL (UNII: J99W255AWF)  
    JOJOBA OIL (UNII: 724GKU717M)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    SODIUM LACTATE (UNII: TU7HW0W0QT)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    VANILLA PLANIFOLIA OIL (UNII: 0A3F415158)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70116-016-0150 mL in 1 TUBE; Type 0: Not a Combination Product03/31/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02003/31/2024
    Labeler - BIO EARTH MANUFACTURING (PTY) LTD (639768436)
    Establishment
    NameAddressID/FEIBusiness Operations
    BIO EARTH MANUFACTURING (PTY) LTD639768436manufacture(70116-016)