MYCHELLE DERMACEUTICALS SUN SHIELD SPF 50 NON-TINTED  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 Liquid SPF 50 Non-Tinted
Protect

DRUG FACTS

Active Ingredient

Zinc Oxide 20.5%

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

Bentonite, Bisabolol, Butyloctyl Salicylate, Caprylhydroxamic Acid, Capryloyl Glycerin/Sebacic Acid Copolymer, Caprylyl Glycol, Carthamus Tinctorius (Safflower) Oleosomes, Cetearyl Alcohol, Citric Acid, Diheptyl Succinate, Galactoarabinan, Glycerin, Glyceryl Caprylate, Glyceryl Stearate Citrate, Jojoba Esters, Polyhydroxystearic Acid, Rubus Idaeus (Raspberry) Seed Oil, Sodium Stearoyl Glutamate, Tocopherol, Water

Other Information

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Box

MyCHELLE®
DERMACEUTICALS

PROTECT

Sun Shield
Liquid SPF 50
Non-Tinted

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

REEF
SAFE

clean
label
PROJECT®
CERTIFIED

1.0 fl oz/30 mL

SAME FORMULA
NEW
LOOK

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Box
MYCHELLE DERMACEUTICALS SUN SHIELD SPF 50 NON-TINTED   PROTECT
zinc oxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72805-081
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide20.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
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)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
Diheptyl Succinate (UNII: 057N7SS26Y)  
Galactoarabinan (UNII: SL4SX1O487)  
Glycerin (UNII: PDC6A3C0OX)  
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)  
Glyceryl Stearate Citrate (UNII: WH8T92A065)  
HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
RASPBERRY SEED OIL (UNII: 9S8867952A)  
Sodium Stearoyl Glutamate (UNII: 65A9F4P024)  
Tocopherol (UNII: R0ZB2556P8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72805-081-311 in 1 BOX03/01/2020
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 FINALpart35203/01/2020
Labeler - French Transit, Ltd. (100044380)

Revised: 1/2022
Document Id: 30640f8f-4284-4daa-b0a9-427ecd3ffbe5
Set id: 4f7a1550-73e1-435c-b481-14cb20cabc51
Version: 2
Effective Time: 20220107
 
French Transit, Ltd.