ULTRASOL SUNSCREEN LOTION SPF 45 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYYBENZONE) LOTION [FISCHER PHARMACEUTICALS LTD.]

ULTRASOL SUNSCREEN LOTION SPF 45 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYYBENZONE) LOTION [FISCHER PHARMACEUTICALS LTD.]
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NDC 59886-355-11
Set ID 624ca1a6-2b56-4511-a83e-08b20aa4045d
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

    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

    Section Text
    Dr. Fischer ULTRASOL
    Sunscreen Lotion SPF 45
    Broad Spectrum
    UVA and UVB Protection
    Dermatologist Recommended
    Science InsideTM  Superior Sun Technology
    Very Water Resistant
    Hypoallergenic
    Sensitive Approved
    Recommended - Skin Cancer Foundation
    125 ML. 4.22 FL. OZ.
    FISCHER PHARMACEUTICALS
    (Back of Package):
    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  SUNSCREEN LOTION SPF 45
    avobenzone, octinoxate, octisalate, oxyybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59886-355
    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:59886-355-11125 g in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35209/01/2010
    Labeler - Fischer Pharmaceuticals Ltd. (600158976)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fischer Pharmaceuticals Ltd.600158976manufacture

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