MYCHELLE DERMACEUTICALS SUN SHIELD SPF 50 MEDIUM/DARK  PROTECT- zinc oxide liquid 
French Transit, Ltd.

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.

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MyChelle® Dermaceuticals Sun Shield SPF 50 Medium/Dark
Protect

DRUG FACTS

Active Ingredient

Zinc Oxide 20.0%

Purpose

Sunscreen

Uses

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

Inactive Ingredients

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

Other Information

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Box

MyCHELLE®
DERMACEUTICALS

PROTECT

Sun Shield
Liquid SPF 50
Medium/Dark

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

REEF
SAFE

clean
label
PROJECT®
CERTIFIED

SAME FORMULA
NEW
NAME

1.0 fl oz/30 mL

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Box
MYCHELLE DERMACEUTICALS SUN SHIELD SPF 50 MEDIUM/DARK   PROTECT
zinc oxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72805-200
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide20 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
AGAVE TEQUILANA LEAF (UNII: 05545M0E3M)  
Bentonite (UNII: A3N5ZCN45C)  
LEVOMENOL (UNII: 24WE03BX2T)  
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)  
Ethyl Ferulate (UNII: 5B8915UELW)  
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:72805-200-301 in 1 BOX04/01/2021
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 FINALpart35204/01/2021
Labeler - French Transit, Ltd. (100044380)

Revised: 3/2021
Document Id: 95c39a3b-767e-4835-a449-68af25e566bc
Set id: 964af507-34fd-4967-aab0-3c0e54949fbe
Version: 1
Effective Time: 20210325
 
French Transit, Ltd.