ULTRASOL NATURE BABY SUNSCREEN (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [FISCHER PHARMACEUTICALS LTD]

ULTRASOL NATURE BABY SUNSCREEN (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) LOTION [FISCHER PHARMACEUTICALS LTD]
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NDC 59886-336-66
Set ID 15739f81-d01f-4d3e-be5f-bbf04fffb1f9
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, Aloe
    Barbadensis (Aloe Vera) Leaf Extract, Avena Sativa (Oat) Kernel Extract,
    Butylparaben, Calendula officinalis Flower Oil, Chamomilla Recutita (Matricaria)
    Extract, 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

    nature BABY Sunscreen Lotion SPF45

    Broad Spectrum

    UVA and UVB Protection

    Pediatrician Recommended

    With Oatmeal and Aloe Vera

    SCIENCE INSIDETM SUPERIOR SUN TECHNOLOGY

    VERY WATER RESISTANT

    Ophthalmologically Tested

    Non Irritating

    Hypoallergenic

    RECOMMENDED SKIN CANCER FOUNDATION

    200 ML. 6.77 FL. OZ.

    FISCHER PHARMACEUTICALS

    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  NATURE BABY SUNSCREEN
    avobenzone, octinoxate, octisalate, oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59886-336
    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:59886-336-66200 g in 1 BOTTLE
    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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