KIDCREME MINERAL BROAD SPECTRUM SPF 40 SUNSCREEN UVA-UVB SUNCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [MDSOLARSCIENCES]

KIDCREME MINERAL BROAD SPECTRUM SPF 40 SUNSCREEN UVA-UVB SUNCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [MDSOLARSCIENCES]
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NDC 49358-559-01
Set ID 4f0bf232-645a-4f69-b386-3a138a5c9964
Category HUMAN OTC DRUG LABEL
Packager MDSolarSciences
Generic Name
Product Class
Product Number
Application Number PART352
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    Titanium Dioxide 2%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

    • 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
  • Inactive Ingredients

    Dimethicone, Dimethicone Crosspolymer, Caprylic/Capric Triglyceride, Glyceryl Isostearate, Polyhydroxystearic Acid, Dimethicone/ Vinyl Dimethicone Crosspolymer, Silica, Butyl Octyl Salicylate Polysilicone-15, Tetrahexyldecyl Ascorbate, Camellia Sinensis (Green Tea) Extract, Vaccinium Macrocarpon (Cranberry) Fruit Extract, Punica Granatum (Pomegranate) Extract, Iron oxide, PEG/PPG-18/18 Dimethicone, Triethoxy-caprylylsilane, Ubiquinone, Tocopheryl Acetate, Squalane

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    MDSolarSciences Corp.
    Stamford, CT 06902

  • PRINCIPAL DISPLAY PANEL - 71 g Tube Carton

    MDSolarSciences

    40
    KidCrème

    MINERAL SUNSCREEN

    BROAD SPECTRUM
    SPF 40
    UVA-UVB SUNSCREEN

    Gentle enough for sensitive skin

    Safe for children
    6 months and older

    Dermatologist developed,
    approved & recommended

    Water resistant (80 minutes)
    Non-Comedogenic–Won't clog pores
    Oil-Free–Fragrance-Free

    sun care

    Net Wt. 71g -2.54Oz

    Principal Display Panel - 71 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    KIDCREME   MINERAL BROAD SPECTRUM SPF 40 SUNSCREEN UVA-UVB SUNCREEN
    titanium dioxide and zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49358-559
    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)  
    DIMETHICONE/DIENE DIMETHICONE CROSSPOLYMER (UNII: RSA9I561OK)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    POLYSILICONE-15 (UNII: F8DRP5BB29)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CRANBERRY (UNII: 0MVO31Q3QS)  
    POMEGRANATE JUICE (UNII: 99S671U9KB)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    UBIDECARENONE (UNII: EJ27X76M46)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SQUALANE (UNII: GW89575KF9)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49358-559-011 in 1 CARTON06/16/2017
    148 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35206/16/2017
    Labeler - MDSolarSciences (013647301)

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