Label: MDSOLARSCIENCES SPF40 ULTRA-SPORT- meradimate and octisalate and octocrylene and titanium dioxide and zinc oxide stick

  • 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 October 15, 2010

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  • Active Igredients

    Meradimate 3.50% .......... Sunscreen

    Octisalate 3.50% .......... Sunscreen

    Octocrylene 10.00% .......... Sunscreen

    Titanium Dioxide 1.35% .......... Sunscreen

    Zinc Oxide 10.25% .......... Sunscreen

  • Uses

    Helps prevent sunburn

    Higher SPF gives more sunburn protection

    Retains SPF after 80 minutes of activity in the water or sweating

  • Warnings

    For external uses only.

    When using this product
    keep out of eyes. Rinse with water to remove.

    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 right away

  • Other Information

    Sun alert: Limiting sun exposure, wearing
    protective clothing, and using sunscreen may
    reduce the risk of skin aging, skin cancer, and
    other harmful effects of the sun.
    May stain
    clothing.You may report serious adverse
    reactions to Report Reactions, LLC,
    PO Box 22, Plainsboro, NJ 08536-0222

  • Inactive Ingredients

    Caprlyl Methicone, Cyclopentasiloxane, Butyrospemum Parkll (Shea Butter), Petrolatum, Beesewax, Polyethylene, C12-15 Alkyl Benzoate, Paraffin Wax, Simmondsia Chinensis (Jojoba) Butter, Copernicia Cerifera (Carnauba) Wax, Polyester-8, Hydrogenated Soybean Oil, Stearic Acid, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Triethoxysilylethyl Polydimethysiloxyethyl Hexyl Dimethicone, Microcrystalline Wax, BHT, Aluminum Hydroxide, Tetrahexyldecyl Ascorbate

  • Directions

    Apply liberally and uniformly to all exposed areas 15-20 minutes before sun exposure. Reapply often (every 2 hours) and after swimming, excessive perspiration and washing. Effective sun protection for children under 2 years of age is strongly recommended.

  • Principle Display Panel

    image of SPF40 Stick PDP

    MDSolarSciences
    SPF 40
    Broad Spectrum
    UVA-UVB Sunscreen
    Ultra-Sport
    Stick
    LIGHT and MOISTURIZING
    Very Water Resistant
    No Fragrance
    For Adults and Children
    10 g - .35 Oz


    image of SPF40 Stick Carton

    image of SPF40 Stick Container

  • Additional Carton Labeling

    MDSolarSciences Corp
    40 Richards Avenue, 3rd Floor, Norwalk, CT 06854

    www.mdsolarsciences.com
    Patent Pending

    UPC 8 55488 00204 2

  • INGREDIENTS AND APPEARANCE
    MDSOLARSCIENCES SPF40 ULTRA-SPORT 
    meradimate and octisalate and octocrylene and titanium dioxide and zinc oxide stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17452-360
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Meradimate (UNII: J9QGD60OUZ) (Meradimate - UNII:J9QGD60OUZ) Meradimate0.35 g  in 10 g
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate0.35 g  in 10 g
    Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene1 g  in 10 g
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.135 g  in 10 g
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide1.025 g  in 10 g
    Inactive Ingredients
    Ingredient NameStrength
    SHEA BUTTER (UNII: K49155WL9Y)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)  
    JOJOBA OIL (UNII: 724GKU717M)  
    Carnauba Wax (UNII: R12CBM0EIZ)  
    POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17452-360-0110 g in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35203/01/2010
    Labeler - Ecometics, Inc (064843923)
    Registrant - Ecometics, Inc (064843923)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ecometics, Inc064843923manufacture
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