Label: MDSOLARSCIENCES SPF 50 MINERAL- titanium dioxide and zinc oxide cream

  • 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 January 22, 2013

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Titanium Dioxide 1.5%Sunscreen
    Zinc Oxide 17%Sunscreen
  • Uses

    • Helps prevent sunburn
    • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
  • Warnings

    For external use only

    Do not use on damaged or broken skin

    Stop use and ask a doctor if rash occurs

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

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Shake well. Rub in well.

    • Apply liberally 15 minutes before sun exposure
    • Reapply:
      -
      After 80 minutes of swimming or sweating
      -
      Immediately after towel drying
      -
      At least every 2 hours
    • Children under 6 months: Ask a doctor
    • Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with Broad Spectrum SPF of 15 or higher and other sun protection measures including:
      -
      Limit time in the sun, especially from 10a.m. – 2p.m.
      -
      Wear long-sleeved shirts, pants, hats and sunglasses
  • Other information

    • Protect the product in this container from excessive heat and direct sunlight
    • May stain some fabrics
    • You may report serious adverse reactions to: Report Reaction, LLC. PO Box 22, Plainsboro, NJ 08536-0222
  • Inactive ingredients

    Dimethicone, Dimethicone Crosspolymer, Caprylic/Capric Triglyceride, Glyceryl Isostearate, Polyhydroxystearic Acid, Silica, Butyloctyl Salicylate, Polysilicone-15, Dimethicone/Vinyl Dimethicone Crosspolymer, Iron Oxides, PEG/PPG-18/18 Dimethicone, Triethoxycaprylylsilane, Tetrahexyldecyl Ascorbate, Camellia Sinensis Extract, Vaccinium Macrocarpon (Cranberry) Fruit Extract, Punica Granatum Extract

  • PRINCIPAL DISPLAY PANEL - 48 g Tube Carton

    MDSolarSciences

    50

    MINERAL
    CRÈME

    BROAD SPECTRUM
    SPF 50
    UVA-UVB SUNSCREEN

    +R
    enhanced with
    ProVention-R
    Antioxidant Complex

    Developed & Approved by Dermatologists

    water resistant (80 minutes) / non-comedogenic
    suited for all skin types including acne & rosacea
    formulated without fragrance

    Net Wt. 48 g - 1.7 Oz.

    PRINCIPAL DISPLAY PANEL - 48 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    MDSOLARSCIENCES   SPF 50 MINERAL
    titanium dioxide and zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49358-546
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE15 mg  in 1 g
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide170 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Dimethicone (UNII: 92RU3N3Y1O)  
    Medium-Chain Triglycerides (UNII: C9H2L21V7U)  
    Glyceryl Isostearate (UNII: HYE7O27HAO)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Butyloctyl Salicylate (UNII: 2EH13UN8D3)  
    Polysilicone-15 (UNII: F8DRP5BB29)  
    PEG/PPG-18/18 Dimethicone (UNII: 9H0AO7T794)  
    Triethoxycaprylylsilane (UNII: LDC331P08E)  
    Tetrahexyldecyl Ascorbate (UNII: 9LBV3F07AZ)  
    Green Tea Leaf (UNII: W2ZU1RY8B0)  
    Cranberry (UNII: 0MVO31Q3QS)  
    Punica Granatum Root Bark (UNII: CLV24I3T1D)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49358-546-011 in 1 CARTON
    148 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35202/01/2013
    Labeler - MD Solar Sciences (013647301)