Label: MYCHELLE DERMACEUTICALS SUN SHIELD NATURAL TAN SPF 50 BROAD SPECTRUM- zinc oxide liquid

  • 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 August 30, 2019

If you are a consumer or patient please visit this version.

  • 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

    NATURAL TAN
    (MEDIUM / DARK)

    MyChelle®
    dermaceuticals

    REEF
    SAFE

    1 fl oz / 30 mL

    Principal Display Panel - 30 mL Bottle Box
  • INGREDIENTS AND APPEARANCE
    MYCHELLE DERMACEUTICALS SUN SHIELD NATURAL TAN   SPF 50 BROAD SPECTRUM
    zinc oxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72805-070
    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:72805-070-301 in 1 BOX11/01/201709/10/2019
    130 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    2NDC:72805-070-311 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)