KIDSTICK MINERAL BROAD SPECTRUM SPF 40 SUNSCREEN UVA-UVB SUNSCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) STICK [MDSOLARSCIENCES]

KIDSTICK MINERAL BROAD SPECTRUM SPF 40 SUNSCREEN UVA-UVB SUNSCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) STICK [MDSOLARSCIENCES]
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NDC 49358-560-01
Set ID 9a81efaf-9765-4991-81a4-706d204545b3
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 8.1%Sunscreen
    Zinc Oxide 6.6%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

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

    Polyethylene, Dimethicone, Butyrospermum Parkii (Shea) Butter, Petrolatum, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Undecylcrylene Dimethicone, Neopentyl Glycol Diheptanoate, Acrylates/Ethylhexyl Acrylate/Dimethicone Methacrylate Copolymer, Behenyl Olivate, Aluminum Hydroxide, Stearic Acid, Glyceryl Isostearate, Beeswax, Polyhydroxystearic Acid, Cetyl PEG/PPG-10/1 Dimethicone, BHT, Benzylidene Dimethoxydimethylindanone, Tetrahexyldecyl Ascorbate

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    MDSolarSciences Corp.
    Stamford, CT 06902

  • PRINCIPAL DISPLAY PANEL - 12 g Tube Carton

    MDSolarSciences

    40
    KidStick

    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. 12g-0.4Oz

    PRINCIPAL DISPLAY PANEL - 12 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    KIDSTICK   MINERAL BROAD SPECTRUM SPF 40 SUNSCREEN UVA-UVB SUNSCREEN
    titanium dioxide and zinc oxide stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49358-560
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.96 g  in 12 g
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide0.792 g  in 12 g
    Inactive Ingredients
    Ingredient NameStrength
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    BUTYLOCTYL OLEATE (UNII: 2830Y2FNR6)  
    SALICYLIC ACID (UNII: O414PZ4LPZ)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
    BEHENYL OLIVATE (UNII: NGS1GGK4GW)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    BENZYLIDENE DIMETHOXYDIMETHYLINDANONE (UNII: 75HIF3C97L)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49358-560-011 in 1 CARTON06/16/2017
    135 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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