ULTRASOL SUNSCREEN SPF45 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) AEROSOL, SPRAY [FISCHER PHARMACEUTICALS LTD]

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  • ULTRASOL SUNSCREEN SPF45 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) AEROSOL, SPRAY [FISCHER PHARMACEUTICALS LTD]

ULTRASOL SUNSCREEN SPF45 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) AEROSOL, SPRAY [FISCHER PHARMACEUTICALS LTD]
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NDC 59886-352-66
Set ID a33c156d-0904-42b9-bc04-157559c7fe00
Category HUMAN OTC DRUG LABEL
Packager Fischer Pharmaceuticals Ltd
Generic Name
Product Class
Product Number
Application Number PART352
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  • Drug Facts

    Active Ingredients                                                                                 Purpose
    Avobenzone 2.5%, Homosalate 5.0%, Octinoxate 7.5%,
    Octisalate 5.0%, Octocrylene 9.0%, Oxybenzone 5.0% .................... Sunscreen

  • Uses

    • helps prevent sunburn • higher SPF gives more sunburn protection
    • helps protect the skin against the harmful effects of UVA and UVB rays
    • retains SPF after 80 minutes of activity in the water or sweating

  • Warnings

    For external use only

    When using this product

    • avoid contact with the eyes. If contact occurs
    rinse thoroughly with water
    • do not puncture or incinerate. Contents under pressure. Do not store at
    temperatures above 120°F

    Stop use and ask a doctor if

    rash or irritation develops and lasts.

    Keep out of reach of children.

    If swallowed, get medical help or contact a
    Poison Control Center immediately.

  • Directions

    • apply generously and evenly to all exposed areas before sun exposure
    • reapply as needed or after towel drying, swimming, perspiring or vigorous
    activity • children under 6 months of age: ask a doctor
    • do not spray directly on face. Spray into hands and apply to face
    • use in well-ventilated areas

  • Other Information

    • may stain some fabrics
    • Sun alert: Limiting sun exposure, wearing protective clothing, and using
    sunscreens may reduce the risks of skin aging, skin cancer, and other harmful
    effects of the sun.

  • Inactive Ingredients

    Acrylate/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, Butylparaben,
    Camellia Sinensis Leaf Extract, Cetyl Dimethicone, Chamomilla Recutita (Matricaria)
    Extract, Chlorphenesin, Dicaprylyl Ether, Disodium EDTA, Ethylparaben, Fragrance,
    Glycerin, Menthyl Lactate, Methylparaben, Panthenol, Phenoxyethanol, Potassium
    Cetyl Phosphate, Propylparaben, Sorbitan Oleate, Tocopheryl Acetate, VP/Eicosene
    Copolymer, Water.

  • Questions or Comments?

    Call 1-877-212-1985 Mon-Fri

  • PRINCIPAL DISPLAY PANEL

    Dr. Fischer ULTRASOL

    Lotion CONTINUOUS SPRAY

    Sunscreen Spray Lotion SPF45

    Broad Spectrum UVA and UVB Protection

    Dermatologist Recommended

    SCIENCE INSIDETM SUPERIOR SUN TECHNOLOGY

    VERY WATER RESISTANT

    Hypoallergenic

    Non-irritating

    RECOMMENDED SKIN CANCER FOUNDATION

    200 ML. 6.77 FL. OZ.

    FISCHER PHARMACEUTICALS

    CONTAINS NO CFCs WHICH DEPLETE THE OZONE LAYER

    24m

    NO ANIMAL TESTING NO ANIMAL INGREDIENTS

    Manufactured by:

    Fischer Pharmaceuticals Ltd.

    Bnei Brak, Israel, 51553

    Made in Israel

    www.dr-fischer.com

    FISCHER PHARMACEUTICALS

    Dr. Fischer - Tried and Tested


    PDP and Back


  • INGREDIENTS AND APPEARANCE
    ULTRASOL  SUNSCREEN SPF45
    avobenzone, homosalate, octinoxate, octisalate, octocrylene, oxybenzone aerosol, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59886-352
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone2.5 g  in 100 g
    Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate5 g  in 100 g
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate7.5 g  in 100 g
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate5 g  in 100 g
    Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene9 g  in 100 g
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    Butylparaben (UNII: 3QPI1U3FV8)  
    Chlorphenesin (UNII: I670DAL4SZ)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Ethylparaben (UNII: 14255EXE39)  
    Glycerin (UNII: PDC6A3C0OX)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Panthenol (UNII: WV9CM0O67Z)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59886-352-66200 g in 1 CAN
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35206/10/2010
    Labeler - Fischer Pharmaceuticals Ltd (600158976)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fischer Pharmaceuticals Ltd600158976manufacture
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