ULTRASOL NATURE BABY SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [FISCHER PHARMACEUTICALS LTD]

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  • ULTRASOL NATURE BABY SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [FISCHER PHARMACEUTICALS LTD]

ULTRASOL NATURE BABY SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [FISCHER PHARMACEUTICALS LTD]
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NDC 59886-304-77
Set ID 723e8d14-f981-4aee-a3cf-62f0c97f5e12
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
    Titanium Dioxide 15.0%, Zinc Oxide 8.0%.......................................... 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

    Aloe Barbadensis (Aloe Vera) Leaf Extract, Alumina,
    Aluminum Stearate, Avena Satina (Oat) Kernel Oil, C20-40 Acid, Calendula
    Officinalis Flower Oil, Camellia Sinensis Leaf Extract, Caprylic / Capric Triglyceride,
    Cetyl Dimethicone, Cetyl PEG/PPG 10/1 Dimethicone, Chamomile Oil, Coco
    Nucifera (Coconut) Oil, Cyclomethicone, Diazolidinyl Urea, Dimethicone, Ethylhexyl
    Palmitate, Fragrance, Hydrogenated Castor Oil, Isododecane, Methylparaben,
    Mineral Oil, Panthenol, Polyethylene, Polyhydroxystearic Acid, Propylene Glycol,
    Propylparaben, Sodium Chloride, Tocopheryl Acetate, Water.

  • Questions or Comments?

    Call 1-877-212-1985 Mon-Fri

  • PRINCIPAL DISPLAY PANEL

    Dr. Fischer ULTRASOL

    nature BABY Sunscreen Face Cream SPF50

    Broad Spectrum UVA and UVB Protection

    Pediatrician Recommended

    SCIENCE INSIDETM SUPERIOR SUN TECHNOLOGY

    VERY WATER RESISTANT

    Non-Irritating

    Ophthalmologically Tested

    RECOMMENDED SKIN CANCER FOUNDATION

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

    Extra gentle for baby's delicate skin

    Gentle Baby Sun Care and Protection

    Hypoallergenic

    Sensitive-Tested

    Light Texture

    Rapidly Absorbed

    Natural Herbal Complex to Care for Baby's Skin: Oatmeal, Aloe Vera,

    Chamomile and Calendula

    Vitamin E and Green Tea antioxidant protection against free radicals

    50 ML. 1.69 FL. OZ.

    100% NATURAL SUNSCREENS

    Manufactured by:

    Fischer Pharmaceuticals Ltd.

    Bnei Brak, Israel, 51553

    Made in Israel

    www.dr-fischer.com

    Fischer Pharmaceuticals

    Dr. Fischer - Tried and Tested

    24m

    NO ANIMAL TESTING NO ANIMAL INGREDIENTS


    PDP and Back

    Image of box

  • INGREDIENTS AND APPEARANCE
    ULTRASOL  NATURE BABY SUNSCREEN
    titanium dioxide, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59886-304
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide15 g  in 100 g
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide8 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    Aluminum Stearate (UNII: U6XF9NP8HM)  
    Coconut Oil (UNII: Q9L0O73W7L)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Panthenol (UNII: WV9CM0O67Z)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59886-304-771 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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