Label: MYCHELLE DERMACEUTICALS SUN SHIELD SPF 30 LIGHT/MEDIUM PROTECT- zinc oxide liquid
MYCHELLE DERMACEUTICALS SUN SHIELD SPF 30 MEDIUM/DARK PROTECT- zinc oxide liquid
MYCHELLE DERMACEUTICALS SUN SHIELD SPF 30 LIGHT PROTECT- 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 December 15, 2022

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  • 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 makeup.
    • Apply liberally and evenly 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

    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 - Light/Medium

    MyCHELLE®
    DERMACEUTICALS

    PROTECT

    Sun Shield
    Liquid SPF 30
    Light/Medium

    Broad-spectrum
    Protection, Bentonite
    Clay & Safflower
    Smooth & Balance

    REEF
    SAFE

    clean
    label
    PROJECT®
    CERTIFIED

    1.0 fl oz/30 mL

    PRINCIPAL DISPLAY PANEL - 30 mL Bottle Box - Light/Medium
  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Box - Medium/Dark

    MyCHELLE®
    DERMACEUTICALS

    PROTECT

    Sun Shield
    Liquid SPF 30
    Medium/Dark

    Broad-spectrum
    Protection, Bentonite
    Clay & Safflower
    Smooth & Balance

    REEF
    SAFE

    clean
    label
    PROJECT®
    CERTIFIED

    1.0 fl oz/30 mL

    PRINCIPAL DISPLAY PANEL - 30 mL Bottle Box - Medium/Dark
  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Box - Light

    SPF 30

    MyCHELLE®
    DERMACEUTICALS

    PROTECT

    Sun Shield
    Liquid SPF 30
    Light

    Broad-spectrum
    Protection, Bentonite
    Clay & Safflower
    Smooth & Balance

    REEF
    SAFE

    clean
    label
    PROJECT®
    CERTIFIED

    1.0 fl oz/30 mL

    PRINCIPAL DISPLAY PANEL - 30 mL Bottle Box - Light
  • INGREDIENTS AND APPEARANCE
    MYCHELLE DERMACEUTICALS SUN SHIELD SPF 30 LIGHT/MEDIUM   PROTECT
    zinc oxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72805-669
    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)  
    Hydrolyzed Wheat Protein (Enzymatic; 3000 MW) (UNII: J2S07SB0YL)  
    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:72805-669-011 in 1 BOX09/01/2022
    130 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 finalpart35209/01/2022
    MYCHELLE DERMACEUTICALS SUN SHIELD SPF 30 MEDIUM/DARK   PROTECT
    zinc oxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72805-670
    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)  
    Hydrolyzed Wheat Protein (Enzymatic; 3000 MW) (UNII: J2S07SB0YL)  
    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:72805-670-011 in 1 BOX09/01/2022
    130 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 finalpart35209/01/2022
    MYCHELLE DERMACEUTICALS SUN SHIELD SPF 30 LIGHT   PROTECT
    zinc oxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72805-671
    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)  
    Hydrolyzed Wheat Protein (Enzymatic; 3000 MW) (UNII: J2S07SB0YL)  
    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:72805-671-011 in 1 BOX09/01/2022
    130 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 finalpart35209/01/2022
    Labeler - French Transit, Ltd. (100044380)
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