Label: MDSOLARSCIENCES SPF30 PLUS MINERAL SCREEN- titanium dioxide and zinc oxide gel

  • Category: HUMAN OTC DRUG LABEL

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 November 15, 2010

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  • Active Igredients

    Titanium Dioxide 7.7% .......... Sunscreen

    Zinc Oxide 3.8% ................ 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 ControlCenter right away

  • Directions

    Apply liberally and uniformly to all exposed areas 15-20 minutes before sun exposure.
    Rub in well. Reapply often (every 2 hours) and after swimming, excessive perspiration and washing.
    Children under 6 months of age ask a doctor. Effective sun protection for children under 2 years
    of age is strongly recommended.

  • 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

    Cyclopentasiloxane, Dimethicone Crosspolymer,
    Dimethicone/Vinyl Dimethicone Crosspolymer,
    Dimethicone, Stearoxytrimethylsilane, C30-45 Olefin,
    Phenyl Methicone, Lauryl PEG/PPG-18/18 Methicone,
    Polymethylsilsesquioxane, Dimethiconol, Polyglyceryl-3
    Polydimethylsiloxyethyl Dimethicone, Aluminum Hydroxde,
    Stearic Acid, Triethoxysilylethyl Polymethylsiloxyethyl
    Hexyl Dimethicone.

  • Principle Display Panel

    image of SPF30 Plus Gel PDP

    MDSolarSciences
    SPF 30 Plus
    with
    Broad Spectrum
    UVA-UVB Sunscreen
    Mineral Screen Gel
    Sensitive Skin Formula
    Silky Smooth Application
    Very Water Resistant
    Non-Comedogenic (won't clog pores)
    Non-greasy. No Fragrance
    Suited for Acne/Rosacea Prone Skin
    For Adults and Children
    50g - 1.76 Oz


    image of SPF30 Gel Carton

    image of SPF30 Plus Gel Container

  • Additional Carton Labeling

    MDSolarSciences Corp
    40 Richards Avenue, 3rd Floor, Norwalk, CT 06854
    www.mdsolarsciences.com
    Patent Pending
    UPC 8 55488 00201 1

    MINERAL SCREEN GEL
    Safe, Effective & Elegant
    Suncreen For Sensitive Skin
    Zinc & Titanium based
    Free of chemical actives
    Broad Spectrum Protection
    UVB ("Burning" rays) SPF 30 Plus
    UVA ("Aging" rays) Formulated
    to meet European standards
    Elegant Cosmesis
    Silky smooth
    Clear when rubbed in well

    Also Available from
    MDSolarSciences:
    No Touch Body Spray SPF 40
    Ulta-Sport Stick SPF40
    Mineral Screen Lotion SPF40
    Ulta Mineral
    Screen Gel SPF50 Plus

    A complete sun
    protection routine
    can help to reduce
    photo-aging and the
    incidence of skin cancer

    The use of broad
    spectum (UVA and UVB) sunscreens is
    only one element of safer sun practices.
    It is also important to
    take the following
    sun-safety measures:

    SUN SAFE TIPS:

    Wear Protective Clothing
    A long sleeved shirt, pants,
    a wide-brimmed hat and
    sunglasses should be worn
    where possible

    Seek Shade
    Remember that the sun's
    rays are strongest between
    10am and 4pm. Learn the
    UV Index and be aware of
    the strength of the sun's rays.

    Avoid Tanning Beds
    UV light from the sun and
    tanning beds may cause
    skin cancer and wrinkling

    Get Vitamin D Safely
    Add vitamin supplements
    to a healthy diet in
    consultation with your physician.

  • INGREDIENTS AND APPEARANCE
    MDSOLARSCIENCES SPF30 PLUS MINERAL SCREEN 
    titanium dioxide and zinc oxide gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17452-390
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE7.7 g  in 100 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE3.8 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17452-390-0150 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35203/01/2010
    Labeler - Ecometics, Inc (064843923)