MYCHELLE DERMACEUTICALS SUN SHIELD NUDE  SPF 50 BROAD SPECTRUM- 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 Nude
SPF 50 Broad Spectrum

DRUG FACTS

Active Ingredient

Zinc Oxide 16.1%

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, 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

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
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)

Revised: 8/2019
Document Id: 027f1233-710d-4776-a808-b4134145f63b
Set id: 18b29ebd-3030-446a-b02f-400355104b99
Version: 2
Effective Time: 20190830
 
French Transit, Ltd.