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

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 01/13

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • ACTIVE INGREDIENT

    Active ingredients: Purpose:
    Titanium Dioxide 3% Sunscreen
    Zinc Oxide 15% Sunscreen
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  • 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.
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  • 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.

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  • 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 10 a.m. - 2 p.m.
      -
      Wear long-sleeved shirts, pants, hats and sunglasses
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  • 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
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  • Inactive ingredients

    Water, Dimethicone, Dimethicone Crosspolymer, Dimethicone/PEG-10/15 Crosspolymer, Octyldodecanol, Quaternium-90 Bentonite, Propylene Carbonate, Butyloctyl Salicylate, Cetyl PEG/PPG-10/1 Dimethicone, Polysilicone-15, PEG-10 Dimethicone, Camellia Sinensis (Green Tea) Extract, Vaccinium Macrocarpon (Cranberry) Fruit Extract, Punica Granatum Extract, Tetrahexyldecyl Ascorbate, Magnesium Aluminum Silicate, Sodium Chloride, Sodium Citrate, Sodium Hyaluronate, Aloe Barbadensis Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Caprylhydroxamic acid, Caprylyl Glycol, Glycerin

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  • PRINCIPAL DISPLAY PANEL - 78 g Tube Carton

    MDSolarSciences

    MINERAL
    LOTION

    for Face & Body

    BROAD SPECTRUM
    SPF 50
    UVA-UVB SUNSCREEN

    +R
    enhanced with
    ProVention-R™
    Antioxidant Complex

    Developed & Approved by Dermatologists

    water resistant (80 minutes) / non-comedogenic
    silky smooth and moisturizing
    suited for all ages & skin types
    formulated without fragrance

    Net Wt. 78 g - 2.75 Oz.

    PRINCIPAL DISPLAY PANEL - 78 g Tube Carton
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  • INGREDIENTS AND APPEARANCE
    MDSOLARSCIENCES   SPF 50 MINERAL
    titanium dioxide and zinc oxide lotion
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:49358-548
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 30 mg  in 1 g
    Zinc Oxide (Zinc Oxide) Zinc Oxide 150 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    Water  
    Dimethicone  
    Octyldodecanol  
    Propylene Carbonate  
    Butyloctyl Salicylate  
    Polysilicone-15  
    Green Tea Leaf  
    Cranberry  
    Punica Granatum Root Bark  
    Tetrahexyldecyl Ascorbate  
    Magnesium Aluminum Silicate  
    Sodium Chloride  
    Sodium Citrate  
    Hyaluronate Sodium  
    Aloe Vera Leaf  
    Chamomile  
    Caprylhydroxamic acid  
    Caprylyl Glycol  
    Glycerin  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49358-548-01 1 in 1 CARTON
    1 78 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part352 02/01/2013
    Labeler - MD Solar Sciences (013647301)
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