Label: MINERAL MOISTURE DEFENSE BROAD SPECTRUM SPF 50 SUNSCREEN UVA-UVB SUNCREEN- titanium dioxide and zinc oxide cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 8, 2018

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    Titanium Dioxide 2%Sunscreen
    Zinc Oxide 17%Sunscreen
  • Uses

    • Helps prevent sunburn
    • If used 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

    • 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

    Shake well. Rub in well.

    • 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
  • Inactives

    Dimethicone, Caprylic/Capric Triglyceride, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Butyloctyl Salicylate, Glyceryl Isostearate, Polyester-8, Polysilicone-15, Behenic Acid, Camelia Sinensis Leaf Extract, Caprooyl Phytosphingosine, Ceramide AP, Ceramide EOP, Ceramide EOS, Ceramide NP, Ceramide NS, Ceteareth-25, Cetyl Alcohol, Cholesterol, Glycerin, Iron Oxides, PEG/PPG-18/18 Dimethicone, Punica Granatum Extract, Silica, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Triethoxycaprylysilane, Vaccinum Macrocarpon (Cranberry) Fruit Extract

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    MDSolarSciences Corp.
    40 Richards Avenue, 3rd Fl., Norwalk, CT 06854

  • PRINCIPAL DISPLAY PANEL - 113 g Tube Carton

    MDSolarSciences™

    50
    MINERAL
    MOISTURE
    DEFENSE

    body

    BROAD SPECTRUM
    SPF 50
    UVA-UVB SUNSCREEN

    +R
    enhanced with
    ProVention-R™

    developed & approved
    by Dermatologists

    Water resistant (80 minutes)
    Non-comedogenic – won't clog pores
    Family Formula

    sun care

    Net Wt. 113 g - 4 Oz.

    Principal Display Panel - 113 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    MINERAL MOISTURE DEFENSE   BROAD SPECTRUM SPF 50 SUNSCREEN UVA-UVB SUNCREEN
    titanium dioxide and zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49358-558
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.7 g  in 35 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE1.3 g  in 35 g
    Inactive Ingredients
    Ingredient NameStrength
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    DIMETHICONE/DIENE DIMETHICONE CROSSPOLYMER (UNII: RSA9I561OK)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
    POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
    POLYSILICONE-15 (UNII: F8DRP5BB29)  
    BEHENIC ACID (UNII: H390488X0A)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CAPROOYL TETRAPEPTIDE-3 (UNII: LZI0HJ3K2R)  
    N-HEXANOYLSPHINGOSINE (UNII: 038753E78J)  
    CERAMIDE AP (UNII: F1X8L2B00J)  
    CERAMIDE 9 (UNII: 88KCS7120E)  
    3-DEHYDROXY CERAMIDE 1 (UNII: CR0J8RN66K)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CERAMIDE NG (UNII: C04977SRJ5)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
    POMEGRANATE JUICE (UNII: 99S671U9KB)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    CRANBERRY (UNII: 0MVO31Q3QS)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49358-558-011 in 1 CARTON01/01/2016
    1113 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35201/01/2016
    Labeler - MDSolarSciences (013647301)
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