ULTRASOLSUNSCREEN CLEAR CONTINUOUS SPRAY SPF43 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) AEROSOL, SPRAY [FISCHER PHARMACEUTICALS LTD]

ULTRASOLSUNSCREEN CLEAR CONTINUOUS SPRAY SPF43 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) AEROSOL, SPRAY [FISCHER PHARMACEUTICALS LTD]
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NDC 59886-346-66
Set ID 09121ddb-3504-4da8-9f1b-ac981b29dee0
Category HUMAN OTC DRUG LABEL
Packager Fischer Pharmaceuticals Ltd
Generic Name
Product Class
Product Number
Application Number PART352
  • Drug Facts

    Active Ingredients                                                                                 Purpose
    Avobenzone 3.0%, Homosalate 10.0%, Octinoxate 7.5%,
    Octisalate 5.0%, Octocrylene 6.0%, 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

    Flammable:

    Do not use near heat, flame, or while smoking. Avoid long term
    storage above 40˚C (104˚F)

    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

    Acrylates / Octylacrylamide Copolymer,
    Butylparaben, Ethylparaben, Green Tea (Camellia Sinensis) Leaf Extract,
    Methylparaben, Phenoxyethanol,
    Propylparaben, SD Alcohol 40, Tocopheryl Acetate

  • PRINCIPAL DISPLAY PANEL

    Dr. Fischer

    ULTRASOL

    Sunscreen Clear Spray SPF43

    Clear CONTINUOUS SPRAY

    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

    NO CFCs

    24M

    NO ANIMAL INGREDIENTS - NO ANIMAL TESTING

    Manufactured by:

    Fischer Pharmaceuticals Ltd.

    Bnei Brak, Israel, 51553

    Made in Israel

    www.dr-fischer.com

    Dr. Fischer - Tried and Tested

    PDP and Back

  • INGREDIENTS AND APPEARANCE
    ULTRASOLSUNSCREEN  CLEAR CONTINUOUS SPRAY SPF43
    avobenzone, homosalate, octinoxate, octisalate, octocrylene, oxybenzone aerosol, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59886-346
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone3 g  in 100 g
    Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate10 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) Octocrylene6 g  in 100 g
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    Butylparaben (UNII: 3QPI1U3FV8)  
    Ethylparaben (UNII: 14255EXE39)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    Alcohol (UNII: 3K9958V90M)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59886-346-66200 g in 1 CAN
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35204/10/2010
    Labeler - Fischer Pharmaceuticals Ltd (600158976)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fischer Pharmaceuticals Ltd600158976manufacture

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