Label: MDSOLARSCIENCES SPF40 MINERAL SCREEN- titanium dioxide and zinc oxide lotion

  • 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 November 15, 2010

If you are a consumer or patient please visit this version.

  • 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 Control Center right away

  • Directions

    Apply liberally and uniformly to all exposed areas 15-20 minutes before sun exposure.
    Shake well. 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, Caprylyl Methicone, Dimethicone
    Crosspolymer, Dimethicone/Vinyl Dimethicone,
    Crosspolymer, Dimethiconol, Dimethicone, C30-45 Olefin,
    Phenyl Methicone, Stearoxytrimethylsilane, Polyglyceryl-3
    Polydimethylsiloxyethyl Dimethicone, Aluminum Hydroxde,
    Stearic Acid, Thriethoxysilylethyl Polydimethylsiloxyethyl
    Hexyl Dimethicone

  • Principle Display Panel

    image of SPF40 Plus Lotion PDP

    MDSolarSciences
    SPF 40
    Broad Spectrum
    UVA-UVB Sunscreen
    Mineral Screen Lotion
    Sensitive Skin Formula
    Light and Moisturizing
    Silky Smooth Application
    Very Water Resistant
    No Fragrance
    For Adults and Children
    80g - 1.2.82 Oz


    image of SPF40 LotionCarton

    image of SPF40 LotionContainer

  • Additional Carton Labeling

    MDSolarSciences Corp
    40 Richards Avenue, 3rd Floor, Norwalk, CT 06854
    www.mdsolarsciences.com
    Patent Pending
    UPC 8 55488 00203 5

    MINERAL SCREEN
    LOTION
    Safe, Effective & Elegant
    Suncreen For Sensitive Skin
    Zinc & Titanium based
    Free of chemical actives
    Broad Spectrum Protection
    UVB ("Burning" rays) SPF 40
    UVA ("Aging" rays) Formulated
    to meet European standards
    Elegant Cosmesis
    Silky smooth
    Clear when rubbed in well
    Emolient, mosturizing
    light formula

    Also Available from
    MDSolarSciences:
    No Touch Body Spray SPF 40
    Ulta-Sport Stick SPF40
    Ulta Mineral
    Screen Gel SPF50 Plus
    Mineral Screen Gel SPF30 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 SPF40 MINERAL SCREEN 
    titanium dioxide and zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17452-400
    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
    CAPRYL METHICONE (UNII: J7960S4R1T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17452-400-0180 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)