ULTRASOL KIDS SUNSCREEN (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [FISCHER PHARMACEUTICALS LTD]

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  • ULTRASOL KIDS SUNSCREEN (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [FISCHER PHARMACEUTICALS LTD]

ULTRASOL KIDS SUNSCREEN (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [FISCHER PHARMACEUTICALS LTD]
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NDC 59886-327-77
Set ID fd5caf43-11ec-4bb4-9f01-bef7471ce358
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 2.0%, 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. Fischer ULTRASOL

    KIDS Sunscreen Face Cream SPF45

    Broad Spectrum UVA and UVB Protection

    Pediatrician Recommended

    FUN MELON FRAGRANCE

    SCIENCE INSIDETM SUPERIOR SUN TECHNOLOGY

    VERY WATER RESISTANT

    Hypoallergenic

    Sensitive Approved

    RECOMMENDED - SKIN CANCER FOUNDATION

    50 ML. 1.69 FL. OZ.

    Manufactured by:

    Fischer Pharmaceuticals Ltd.

    Bnei Brak, Israel, 51553

    Made in Israel

    www.dr-fischer.com

    NO ANIMAL INGREDIENTS - NO ANIMAL TESTING

    24m

    FISCHER PHARMACEUTICALS

    Dr. Fischer - Tried and Tested

    Outdoor Care and Protection

    Extra Skin-Friendly

    Children's Sun Care

    Light Texture

    Rapidly Absorbed

    Soothes and calms the skin with Chamomile

    Vitamin E and Green Tea antioxidant protection against free radicals

    Tested according to the most stringent international sunscreen standards

    This product is recommended by the American Skin Cancer Foundation as an effective UV sunscreen

    PDP and BackImage of box

  • INGREDIENTS AND APPEARANCE
    ULTRASOL  KIDS SUNSCREEN
    avobenzone, octinoxate, octisalate, oxybenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59886-327
    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:59886-327-771 in 1 BOX
    150 g in 1 TUBE
    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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