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

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AEROSOL, SPRAY 6 g in 1 CAN (60232-2587-6) Label Information

Complete Elta MD UV Aero 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

    Warnings

    • For external use only; not to be swallowed
    • do not use on damaged or broken skin
    • Do not spray directly on face
    • When using this product keep out of eyes.  Avoid inhaling.  Avoid spraying into eyes or onto other mucous membranes.  Rinse with water to remove.
    • Stop use and ask a physician if signs of irritation or rash appear.
    • Keep out of reach of children.  If product is swallowed, get medical help or contact a Poison Control Center right away.
    • Flammable. Contents under pressure. Do not use near fire, heat or while smoking.  Do not puncture or incinerate.  Store at temperature below 120F (49C).  Use only as directed.  Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.  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
      • do not apply in windy conditions
      • hold can (upright or inverted) 4 to 6 inches away from body and apply liberally, spraying slowly and evenly until product is visible on skin.  Gently rub in.  Do not spray in face.  Spray into hand and apply to the face.
    • Use in well ventilated areas.
    • 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, 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, Isobutane, Lauryl PEG-9 Polymethylsiloxyethyl Diemthicone, Phenoxyethanol, Propane, Purified Water, Sodium Chloride, Triethoxycaprylylsilane, Undecylenoyl Glycine


  • INGREDIENTS AND APPEARANCE
    ELTA MD UV AERO  SPF45
    zinc oxide and octinoxate aerosol aerosol, spray
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:60232-2587
    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
    isobutane (UNII: BXR49TP611)  
    propane (UNII: T75W9911L6)  
    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:60232-2587-6 6 g in 1 CAN
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 05/01/2012
    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(60232-2587)