Label: MINERAL SUNSCREEN BROAD SPECTRUM SPF 40 SUNSCREEN UVA-UVB SUNSCREEN- titanium dioxide and zinc oxide stick

  • 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 October 18, 2018

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  • 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.
    40 Richards Avenue, 3rd Fl., Norwalk, CT 06854

  • PRINCIPAL DISPLAY PANEL - 17 g Tube Carton

    MDSolarSciences™

    40
    MINERAL
    SUNSCREEN STICK

    BROAD SPECTRUM
    SPF 40
    UVA-UVB SUNSCREEN

    +R
    enhanced with
    ProVention-R    ™

    developed & approved
    by Dermatologists

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

    sun care

    Net Wt. 17 g - 0.6 Oz.

    Principal Display Panel - 17 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    MINERAL SUNSCREEN   BROAD SPECTRUM SPF 40 SUNSCREEN UVA-UVB SUNSCREEN
    titanium dioxide and zinc oxide stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49358-553
    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:49358-553-011 in 1 CARTON02/01/2016
    117 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35202/01/2016
    Labeler - MDSolarSciences (013647301)
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