Label: ULTRASOLSUNSCREEN SUNSCREEN SPRAY LOTION SPF 15- avobenzone, octinoxate, oxybenzone spray

  • 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 January 27, 2010

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  • Drug Facts

    Active Ingredients                                                               Purpose
    Avobenzone 2.0%, Octinoxate 7.5%,
    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/C 10-30 Alkyl Acrylate
    Crosspolymer, Aminomethyl Propanol, Butylparaben, Cetyl
    Dimethicone, Chamomilla Recutita (Matricaria) Extract,
    Dicaprylyl Ether, Disodium EDTA, Ethylparaben, Fragrance,
    Glycerin, Iodopropynyl Butylcarbamate, Menthyl Lactate,
    Methylparaben, Panthenol, Phenoxyethanol, Potassium Cetyl
    Phosphate, Propylparaben, Sorbitan Oleate, Tocopheryl Acetate,
    VP/Eicosene Copolymer, Water

  • Questions or Comments?

    Call 1-877-212-1985 Mon-Fri

  • PRINCIPAL DISPLAY PANEL

    PDP and Back

    Dr. Fischer ULTRASOL

    Sunscreen Spray Lotion

    SPF 15

    Broad Spectrum UVA and UVB Protection

    Dermatologist Recommended

    SCIENCE INSIDETM - SUPERIOR SUN TECHNOLOGY

    VERY WATER RESISTANT

    Hypoallergenic

    200 ML. 6.77 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

  • INGREDIENTS AND APPEARANCE
    ULTRASOLSUNSCREEN  SUNSCREEN SPRAY LOTION SPF 15
    avobenzone, octinoxate, oxybenzone spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59886-330
    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
    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)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59886-330-66200 g in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35203/01/2010
    Labeler - Fischer pharmaceuticals Ltd. (600158976)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fischer pharmaceuticals Ltd.600158976manufacture
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