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Elta MD UV SPF46 (Swiss American Products, Inc.)

Available Formats

Dosage Form Package Information Links
SPRAY 4 g in 1 BOTTLE, SPRAY (60232-2585-4) Label Information

Complete Elta MD UV SPF46 Information

  • ACTIVE INGREDIENT

    Active Ingredients        Purpose

    Zinc Oxide 9.3%         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 AND PRECAUTIONS

    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.
    • Top 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.
    • Hard surfaces may become damp when product is sprayed.  Avoid slips or falls.

  • WHEN USING

    Directions

    • Shake Well before use
    • apply liberally 15 minutes before sun exposure.  Gently rub in.
    • reapply
      • after 80 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 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

    Butylene Glycol, Capryloyl Glycine, Cyclopentasiloxane, Dimethicone, Dimethicone/PEG-10/15 Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Lauryl PEG-9 Polymethylsiloxyethyl Dimethicone, Phenoxyethanol, Purified Water, Sodium Chloride, Triethoxycaprylylsilane, Undecylenoyl Glycine


  • INGREDIENTS AND APPEARANCE
    ELTA MD UV SPF46  SPF46
    zinc oxide and octinoxate sunscreen spray
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:60232-2585
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    zinc oxide (UNII: SOI2LOH54Z) (zinc oxide - UNII:SOI2LOH54Z) zinc oxide 93 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)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    capryloyl glycine (UNII: 8TY5YO42NJ)  
    undecylenoyl glycine (UNII: 4D20464K2J)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    water (UNII: 059QF0KO0R)  
    sodium chloride (UNII: 451W47IQ8X)  
    triethoxycaprylylsilane (UNII: LDC331P08E)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:60232-2585-4 4 g in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 06/01/2010
    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(60232-2585)