MYCHELLE DERMACEUTICALS SUN SHIELD UNSCENTED SPF 28 BROAD SPECTRUM (ZINC OXIDE AND TITANIUM DIOXIDE) LOTION [FRENCH TRANSIT, LTD.]

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  • MYCHELLE DERMACEUTICALS SUN SHIELD UNSCENTED SPF 28 BROAD SPECTRUM (ZINC OXIDE AND TITANIUM DIOXIDE) LOTION [FRENCH TRANSIT, LTD.]

MYCHELLE DERMACEUTICALS SUN SHIELD UNSCENTED SPF 28 BROAD SPECTRUM (ZINC OXIDE AND TITANIUM DIOXIDE) LOTION [FRENCH TRANSIT, LTD.]
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NDC 72805-060-68
Set ID 23a9ee35-aad8-4b18-89bf-1ce42e87ab32
Category HUMAN OTC DRUG LABEL
Packager French Transit, Ltd.
Generic Name
Product Class
Product Number
Application Number PART352
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  • SPL UNCLASSIFIED SECTION

    DRUG FACTS

  • Active Ingredients

    Zinc Oxide (ZinClear™)11.6%
    PurposeSunscreen
    Titanium Dioxide0.67%
    PurposeSunscreen
  • 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. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash and irritation develops and lasts.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • For daily use, allow product to absorb completely before applying make-up.
    • Apply liberally 15 minutes before sun exposure.
    • Use a water resistant sunscreen if swimming or sweating.
    • Reapply at least every 2 hours.
    • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a 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-sleeve shirts, pants, hats and sunglasses.
      • Children under 6 months: Ask a doctor.
  • Inactive Ingredients

    1,2-Hexanediol, Allantoin, Aloe Barbadensis Leaf Juice Powder, Alumina, Aqua (Water), Caprylic/Capric Triglyceride, Caprylyl Glycol, Cetearyl Alcohol, Cetearyl Glucoside, Citric Acid, Coco-Caprylate/Caprate, Dicaprylyl Ether, Fructooligosaccharides (D-beta), Gluconolactone, Glycerin, Glyceryl Isostearate, Glycine Soja (Soybean) Oil, Isononyl Isononanoate, Leuconostoc/Radish Root Ferment Filtrate, Lonicera Caprifolium (Honeysuckle) Flower Extract, Lonicera Japonica (Honeysuckle) Flower Extract, Magnesium Aluminum Silicate, Polyglyceryl-6 Polyricinoleate, Polyhydroxystearic Acid, Polysorbate 60, Populus Tremuloides Bark Extract, Potassium Sorbate, Simethicone, Squalane, Tocopheryl Acetate (D-alpha), Trisodium Ethylenediamine Disuccinate, Tropolone, Xanthan Gum

  • Other Information

    Protect this product from excessive heat and direct sun.

  • PRINCIPAL DISPLAY PANEL - 68 mL Tube Box

    SUN
    PROTECTION

    Sun Shield
    Unscented
    SPF 28
    Broad Spectrum

    REEF
    SAFE

    MyChelle®
    dermaceuticals

    2.3 fl oz / 68 mL

    PRINCIPAL DISPLAY PANEL - 68 mL Tube Box
  • INGREDIENTS AND APPEARANCE
    MYCHELLE DERMACEUTICALS SUN SHIELD UNSCENTED   SPF 28 BROAD SPECTRUM
    zinc oxide and titanium dioxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72805-060
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide11.6 g  in 100 mL
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.67 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    Cetearyl Glucoside (UNII: 09FUA47KNA)  
    Coco-Caprylate/Caprate (UNII: 8D9H4QU99H)  
    Polysorbate 60 (UNII: CAL22UVI4M)  
    Glycerin (UNII: PDC6A3C0OX)  
    Squalane (UNII: GW89575KF9)  
    Isononyl Isononanoate (UNII: S4V5BS6GCX)  
    Magnesium Aluminum Silicate (UNII: 6M3P64V0NC)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Glyceryl Isostearate (UNII: HYE7O27HAO)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Allantoin (UNII: 344S277G0Z)  
    Potassium Sorbate (UNII: 1VPU26JZZ4)  
    Trisodium Ethylenediamine Disuccinate (UNII: YA22H34H9Q)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    POPULUS TREMULOIDES BARK (UNII: 5543O0CEID)  
    Leuconostoc/Radish Root Ferment Filtrate (UNII: D2QHA03458)  
    Dicaprylyl Ether (UNII: 77JZM5516Z)  
    1,2-Hexanediol (UNII: TR046Y3K1G)  
    Caprylyl Glycol (UNII: 00YIU5438U)  
    Gluconolactone (UNII: WQ29KQ9POT)  
    LONICERA CAPRIFOLIUM FLOWER (UNII: 5N1WD9784U)  
    LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)  
    Tropolone (UNII: 7L6DL16P1T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72805-060-681 in 1 BOX11/01/2017
    168 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35211/01/2017
    Labeler - French Transit, Ltd. (100044380)
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