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Elta MD UV Pure (Swiss American Products, Inc.)

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LOTION 4 g in 1 BOTTLE (60232-2582-4) Label Information

Complete Elta MD UV Pure Information

  • ACTIVE INGREDIENT

    Active Ingredients          Purpose

    Zinc Oxide 10.0%          Sunscreen

    Titanium Dioxide 5.5%   Sunscreen


  • INDICATIONS & USAGE

    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

    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 physician if rash occurs
    • Keep out of reach of children.  If product is swallowed, get medical help or contact a Poison Control Center right away.

  • WHEN USING

    Directions

    • Apply liberally 15 minutes before sun exposure
    • Reapply
      • after 80 minutes of swimming or sweating
      • immediately after towel drying
      • at least every 2 hours
    • Sun Protection Measures.  Spending time int he sun increases your risk of skin cancer and early skin aging.  To decrease this risk, egularly use a sunscreen with a broad-spectrum SPF 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-sleeve shirts, pants, hats and sunglasses
    • Children under 6 months: Ask a physician.

  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Ascorbyl Palmitate, Citric Acid, Cycloopentasiloxane, Dimethicone, Dimethicone/PEG-10/15 Crosspolymer, Lauryl PEG-9 Polymethylsiloxyethyl Dimethicone, Octyldodecyl Neopentanoate, Potassium Sorbate, Purified Water, Silica, Sodium Chloride, Triethoxycaprylylsilane


  • INGREDIENTS AND APPEARANCE
    ELTA MD UV PURE  SPF47
    titanium dioxide and zinc oxide lotion lotion
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:60232-2582
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    titanium dioxide (UNII: 15FIX9V2JP) (titanium dioxide - UNII:15FIX9V2JP) titanium dioxide 55 g  in 1000 g
    zinc oxide (UNII: SOI2LOH54Z) (zinc oxide - UNII:SOI2LOH54Z) zinc oxide 100 g  in 1000 g
    Inactive Ingredients
    Ingredient Name Strength
    water (UNII: 059QF0KO0R)  
    potassium sorbate (UNII: 1VPU26JZZ4)  
    sodium chloride (UNII: 451W47IQ8X)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    octyldodecyl neopentanoate (UNII: X8725R883T)  
    ascorbyl palmitate (UNII: QN83US2B0N)  
    dimethicone (UNII: 92RU3N3Y1O)  
    triethoxycaprylylsilane (UNII: LDC331P08E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:60232-2582-4 4 g in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 08/01/2011
    Labeler - Swiss American Products, Inc. (611921669)
    Registrant - Swiss American Products, Inc. (611921669)
    Establishment
    Name Address ID/FEI Business Operations
    Swiss American Products, Inc. 611921669 manufacture(60232-2582)