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EltaMD UV Shield (Swiss-American Products)

Available Formats

Dosage Form Package Information Links
LOTION 85 g in 1 TUBE (60232-2282-3) Label Information
LOTION 226 g in 1 BOTTLE, PUMP (60232-2282-8) Label Information

Complete EltaMD UV Shield Information

  • ACTIVE INGREDIENT

    Active Ingredients Purpose

    Zinc Oxide 9.0%.................UVA/UVB Sunscreen

    Octinoxate 7.5%.........................UVB Sunscreen


  • INDICATIONS & USAGE

    EltaMD UV Shield SPF 45 is a lightweight, oil-free, daily sunscreen that glides across the skin and is absorbed quickly. The EltaMD UV Shield is non-comedogenic and safe for the most sensitive skin; including oily or acne prone skin. It can be used for rosacea type skin and in conjunction with photosensitizing medications.


    EltaMD UV Shield uses 9% transparent micronized zinc oxide to provide very strong protection from UVA (the aging rays, thought to be a major cause of early wrinkles and melanoma) and it delivers an SPF 45 for UVB (the burning rays) protection.


  • WARNINGS

    Warnings

    For external use only

    - Avoid direct contact with the eyes.
    - Discontinue use if signs of irritation appear.
    - Children under 6 months of age, consult your doctor.


  • WHEN USING

    Directions

    - Apply daily to face, neck and backs of hands, 30 minutes before exposure to the sun.


  • INACTIVE INGREDIENT

    Inactive Ingredients

    Purified Water, Isopropyl Palmitate, Octyl Stearate, Cetearyl Alcohol, Polysorbate 60, Oleth-3 Phosphate, Phenoxyethanol, Cetearyl Glucoside, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Polyisobutene, Polyether-1, Butylene Glycol, PEG-7 Trimethylolpropane Coconut Ether, Tocopheryl Acetate, Citric Acid, Iodopropynyl Butylcarbamate, Triethoxycaprylylsilane


  • PRINCIPAL DISPLAY PANEL

    Image of Pump BottleEnter section text here


  • INGREDIENTS AND APPEARANCE
    ELTAMD UV SHIELD  SPF 45
    zinc oxide, octinoxate lotion
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:60232-2282
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 75 g  in 1000 g
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 90 g  in 1000 g
    Inactive Ingredients
    Ingredient Name Strength
    water (UNII: 059QF0KO0R)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Cetearyl Glucoside (UNII: 09FUA47KNA)  
    Isopropyl Palmitate (UNII: 8CRQ2TH63M)  
    Octyl Stearate (UNII: 772Y4UFC8B)  
    Oleth-3 Phosphate (UNII: 8Q0Z18J1VL)  
    Triethoxycaprylylsilane (UNII: LDC331P08E)  
    2-HYDROXYETHYL ACRYLATE (UNII: 25GT92NY0C)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM ACRYLOYLDIMETHYLTAURATE (UNII: 2T9Q6EKI0G)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    COCONUT ALCOHOL (UNII: 13F4MW8Y9K)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)  
    Iodopropynyl Butylcarbamate (UNII: 603P14DHEB)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:60232-2282-3 85 g in 1 TUBE
    2 NDC:60232-2282-8 226 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 04/30/2002
    Labeler - Swiss-American Products (611921669)
    Registrant - Swiss-American Products (611921669)
    Establishment
    Name Address ID/FEI Business Operations
    Swiss-American Products 611921669 manufacture