Label: ULTRASOLSUNSCREEN KIDS SUNSCREEN MOUSSE- avobenzone, octinoxate, octisalate, octocrylene, oxybenzone aerosol, foam

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated March 25, 2010

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  • Drug Facts

    Active Ingredients                                                                                 Purpose
    Avobenzone 2.0%, Octinoxate 7.5%, Octisalate 5.0%,
    Octocrylene 9.0%, 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

    Flammable:

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

    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/C10-30 Alkyl Acrylate Crosspolymer,
    Aminomethyl Propanol, Butylparaben, Camellia Sinensis Leaf Extract, Cetyl Dimethicone,
    Chamomilla Recutita (Matricaria) Extract, Dicaprylyl Ether, Disodium EDTA, Ethylparaben,
    Fragrance, Glycerin, Iodopropynyl Butylcarbamate, Isobutylparaben, Menthyl Lactate,
    Methylparaben, Panthenol, Phenoxyethanol, Potassium Cetyl Phosphate, Propane / Butane /
    Isobutane, Propylparaben, Sorbitane Oleate, Tocopheryl Acetate, VP/Eicosene Copolymer,
    Water.

  • Questions or Comments?

    Call 1-877-212-1985 Mon-Fri

  • PRINCIPAL DISPLAY PANEL

    Dr. Fischer

    ULTRASOL

    KIDS Sunscreen Mousse SPF30

    Broad Spectrum

    UVA and UVB Protection

    Dermatologist Recommended

    Fun Melon Fragrance

    SCIENCE INSIDETM SUPERIOR SUN TECHNOLOGY

    VERY WATER RESISTANT

    Hypoallergenic

    200 ML. 6.77 FL. OZ.

    FISCHER PHARMACEUTICALS

    Manufactured by:

    Fischer Pharmaceuticals Ltd.

    Bnei Brak, Israel, 51553

    Made in Israel

    www.dr-fischer.com

    24m

    NO CFCs

    NO ANIMAL INGREDIENTS NO ANIMAL TESTING

    Dr. Fischer - Tried and Tested

    PDP and Back

  • INGREDIENTS AND APPEARANCE
    ULTRASOLSUNSCREEN  KIDS SUNSCREEN MOUSSE
    avobenzone, octinoxate, octisalate, octocrylene, oxybenzone aerosol, foam
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59886-316
    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
    Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene9 g  in 100 g
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    Butylparaben (UNII: 3QPI1U3FV8)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Ethylparaben (UNII: 14255EXE39)  
    Glycerin (UNII: PDC6A3C0OX)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Panthenol (UNII: WV9CM0O67Z)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Propane (UNII: T75W9911L6)  
    Butane (UNII: 6LV4FOR43R)  
    Isobutane (UNII: BXR49TP611)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59886-316-66200 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 Ltd.600158976manufacture
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