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

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LOTION 1.7 g in 1 BOTTLE, PUMP (60232-2500-1) Label Information

Complete Elta MD UV Clear Information

  • ACTIVE INGREDIENT

    Active Ingredients      Purpose

    Zinc Oxide 9.0%      Sunscreen

    Octinoxate 7.5%      Sunscreen


  • INDICATIONS & USAGE

    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

    Warnings

    • For external use only
    • Do not use on damaged or broken skin
    • When using the 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 to face and neck 15 minutes before sun exposure
    • use a water-resistant sunscreen if swimming or sweating
    • reapply 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 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

    Purified water, Cyclopentasiloxane, Niacinamide, Octyldodecyl Neopentanoate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Polyisobutene, PEG-7 Trimethylolpropane Coconut Ether, Sodium Hyaluronate, Tocopheryl Acetate, Lactic Acid, Oleth-3 Phosphate, Phenoxyethanol, Butylene Glycol, Iodopropynyl Butylcarbamate, Triethoxycaprylylsilane


  • INGREDIENTS AND APPEARANCE
    ELTA MD UV CLEAR   SPF46
    zinc oxide and octinoxate lotion lotion
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:60232-2500
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 90 g  in 1000 g
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 75 g  in 1000 g
    Inactive Ingredients
    Ingredient Name Strength
    butylene glycol (UNII: 3XUS85K0RA)  
    iodopropynyl butylcarbamate (UNII: 603P14DHEB)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    water (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    niacinamide (UNII: 25X51I8RD4)  
    OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
    triethoxycaprylylsilane (UNII: LDC331P08E)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    oleth-3 phosphate (UNII: 8Q0Z18J1VL)  
    lactic acid (UNII: 33X04XA5AT)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:60232-2500-1 1.7 g in 1 BOTTLE, PUMP
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 07/01/2009
    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(60232-2500)