MYCHELLE DERMACEUTICALS SUN SHIELD NUDE SPF 50 BROAD SPECTRUM (ZINC OXIDE) LIQUID [FRENCH TRANSIT, LTD.]

MYCHELLE DERMACEUTICALS SUN SHIELD NUDE SPF 50 BROAD SPECTRUM (ZINC OXIDE) LIQUID [FRENCH TRANSIT, LTD.]
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NDC 72805-090-30
Set ID 18b29ebd-3030-446a-b02f-400355104b99
Category HUMAN OTC DRUG LABEL
Packager French Transit, Ltd.
Generic Name
Product Class
Product Number
Application Number PART352
  • SPL UNCLASSIFIED SECTION

    DRUG FACTS

  • Active Ingredient

    Zinc Oxide 16.1%

  • Purpose

    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. 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

    • SHAKE WELL BEFORE USE
    • For daily use, apply to clean, dry skin and allow to absorb completely before applying make-up.
    • Apply liberally and evenly 15 minutes before sun exposure.
    • Reapply:
      • After 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 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.
  • Inactive Ingredients

    Agave Tequilana Leaf Extract, Bentonite, Butyloctyl Salicylate, Caprylhydroxamic Acid, Capryloyl Glycerin/Sebacic Acid Copolymer, Caprylyl Glycol, Carthamus Tinctorius (Safflower) Oleosomes, Cetearyl Alcohol, Coco-Glucoside, Diheptyl Succinate, Glycerin, Hydrolyzed Wheat Protein / PVP Crosspolymer, Iron Oxides, Jojoba Esters, Maltose, Octyldodecanol, Sodium Gluconate, Tocopherol,Trihydroxystearin, Water

  • Other Information

    • Protect this product from excessive heat and direct sun.
    • May stain some fabrics
  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Box

    SUN
    PROTECTION

    Sun Shield
    Liquid

    SPF 50

    Broad Spectrum

    NUDE
    (LIGHT / MEDIUM)

    REEF
    SAFE

    MyChelle®
    dermaceuticals

    1 fl oz / 30 mL

    PRINCIPAL DISPLAY PANEL - 30 mL Bottle Box
  • INGREDIENTS AND APPEARANCE
    MYCHELLE DERMACEUTICALS SUN SHIELD NUDE   SPF 50 BROAD SPECTRUM
    zinc oxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72805-090
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide16.1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    AGAVE TEQUILANA LEAF (UNII: 05545M0E3M)  
    Bentonite (UNII: A3N5ZCN45C)  
    Butyloctyl Salicylate (UNII: 2EH13UN8D3)  
    Caprylhydroxamic Acid (UNII: UPY805K99W)  
    CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)  
    Caprylyl Glycol (UNII: 00YIU5438U)  
    CARTHAMUS TINCTORIUS SEED OLEOSOMES (UNII: 9S60Q72309)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    Diheptyl Succinate (UNII: 057N7SS26Y)  
    Glycerin (UNII: PDC6A3C0OX)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58)  
    MALTOSE, UNSPECIFIED FORM (UNII: XJ6S9RV06F)  
    Octyldodecanol (UNII: 461N1O614Y)  
    Sodium Gluconate (UNII: R6Q3791S76)  
    Tocopherol (UNII: R0ZB2556P8)  
    Trihydroxystearin (UNII: 06YD7896S3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72805-090-301 in 1 BOX11/01/201709/10/2019
    130 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    2NDC:72805-090-311 in 1 BOX09/10/2019
    230 mL in 1 BOTTLE, DROPPER; 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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