MYCHELLE DERMACEUTICALS SUN SHIELD NON-TINTED  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 Non-Tinted SPF 50 Broad Spectrum

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

SUN
PROTECTION

Sun Shield
Liquid
SPF 50
Broad Spectrum

NON-TINTED

MyChelle®
dermaceuticals

REEF
SAFE

1 fl oz / 30 mL

Principal Display Panel - 30 mL Bottle Box
MYCHELLE DERMACEUTICALS SUN SHIELD NON-TINTED   SPF 50 BROAD SPECTRUM
zinc oxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72805-080
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:72805-080-301 in 1 BOX11/01/201709/10/2019
130 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
2NDC:72805-080-311 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: 9/2019
Document Id: 2389b220-ff07-487c-88f3-84a4ea1e024c
Set id: d52ecb43-01f2-437e-be10-b7681ea81687
Version: 3
Effective Time: 20190909
 
French Transit, Ltd.