ULTRASOL SPORT (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [FISCHER PHARMACEUTICALS LTD]

ULTRASOL SPORT (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [FISCHER PHARMACEUTICALS LTD]
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NDC 59886-339-55
Set ID 3059ffac-c12e-49c7-b0e6-2af35217f3e5
Category HUMAN OTC DRUG LABEL
Packager Fischer Pharmaceuticals Ltd
Generic Name
Product Class
Product Number
Application Number PART352
  • Drug Facts

    Active Ingredients                                                 Purpose
    Avobenzone 2.0%, Octinoxate 7.5%,
    Octisalate 5.0%, Oxybenzone 4.0% .................. 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.

    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

  • 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 / C10-30 Alkyl
    Acrylate Crosspolymer, Butylparaben, Chlorophenesin,
    Disodium EDTA, Ethylparaben, Fragrance, Glyceryl
    Stearate, Green Tea (Camellia Sinensis) Leaf Extract,
    Iodopropynyl Butylcarbamate, Isopropyl Myristate,
    Methylparaben, Phenoxyethanol, Polyethylene,
    Potassium Cetyl Phosphate, Propylene Glycol,
    Propylparaben, Sodium Hydroxide, Stearic Acid, Stearyl
    Alcohol, Tocopheryl Acetate, Water.

  • Questions or Comments?

    Call 1-877-212-1985 Mon-Fri

  • PRINCIPAL DISPLAY PANEL

    Dr. Fisscher

    ULTRASOL

    Sunscreen Lotion SPF45

    Broad UVA and UVB protection

    Dermatologist Recommended

    SCIENCE INSIDETM SUPERIOR SUN TECHNOLOGY

    VERY WATER RESISTANT

    VERY SWEAT RESISTANT

    NON GREASY

    250 ML. 8.45 FL. OZ.

    RECOMMENDED - SKIN CANCER FOUNDATION

    FISCHER PHARMACEUTICALS LTD.

    Manufactured by:

    Fischer Pharmaceuticals Ltd.

    Bnei Brak, Israel, 51553

    Made in Israel

    www.dr-fischer.com

    NO ANIMAL INGREDIENTS - NO ANIMAL TESTING

    24m

    Dr. Fischer - Tried and Tested

    PDP and Back



  • INGREDIENTS AND APPEARANCE
    ULTRASOL  SPORT
    avobenzone, octinoxate, octisalate, oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59886-339
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone2 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
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    Butylparaben (UNII: 3QPI1U3FV8)  
    Chlorphenesin (UNII: I670DAL4SZ)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Ethylparaben (UNII: 14255EXE39)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    Isopropyl Myristate (UNII: 0RE8K4LNJS)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Stearyl Alcohol (UNII: 2KR89I4H1Y)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59886-339-55250 g in 1 BOTTLE, PLASTIC
    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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