MYCHELLE DERMACEUTICALS REPLENISHING SOLAR DEFENSE BODY SPF 50  PROTECT- zinc oxide lotion 
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 Replenishing Solar Defense Body Lotion SPF 50

DRUG FACTS

Active Ingredient

Zinc Oxide 21%

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

Arachidyl Alcohol, Arachidyl Glucoside, Behenyl Alcohol, Bisabolol, Butyloctyl Salicylate, Butyrospermum Parkii (Shea Butter), Caprylhydroxamic Acid, Caprylic/Capric Triglyceride, Capryloyl Glycerin/ Sebacic Acid Copolymer, Caprylyl Glycol , Cellulose Gum, Cetearyl Alcohol, Cetyl Alcohol, Citric Acid, Coco-Glucoside, Cocos Nucifera (Coconut) Oil, Diheptyl Succinate, Glycerin, Methyl Dihydroabietate, Microcrystalline Cellulose, Polyhydroxystearic Acid, Pongamia Glabra Seed Oil, Sodium Gluconate, Sodium Hyaluronate, Sodium Stearoyl Glutamate, Theobroma Cacao (Cocoa) Seed Butter, Tocopherol, Undaria Pinnatifida Extract, Vanillin, Water

Other Information

PRINCIPAL DISPLAY PANEL - 177 mL Tube Label

MyCHELLE®
DERMACEUTICALS

PROTECT

Replenishing Solar
Defense Body Lotion
SPF 50 Water Resistant

Broad-spectrum Protection,
Coconut Oil & Shea Butter
Moisturize & Soothe

REEF
SAFE

SAME FORMULA
NEW LOOK

clean
label
PROJECT®
CERTIFIED

6.0 fl oz/177 mL

Principal Display Panel - 177 mL Tube Label
MYCHELLE DERMACEUTICALS REPLENISHING SOLAR DEFENSE BODY SPF 50   PROTECT
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72805-021
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide21 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Arachidyl Alcohol (UNII: 1QR1QRA9BU)  
Arachidyl Glucoside (UNII: 6JVW35JOOJ)  
DOCOSANOL (UNII: 9G1OE216XY)  
LEVOMENOL (UNII: 24WE03BX2T)  
Butyloctyl Salicylate (UNII: 2EH13UN8D3)  
SHEA BUTTER (UNII: K49155WL9Y)  
Caprylhydroxamic Acid (UNII: UPY805K99W)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)  
Caprylyl Glycol (UNII: 00YIU5438U)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
Cetyl Alcohol (UNII: 936JST6JCN)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
Coco Glucoside (UNII: ICS790225B)  
COCONUT OIL (UNII: Q9L0O73W7L)  
Diheptyl Succinate (UNII: 057N7SS26Y)  
Glycerin (UNII: PDC6A3C0OX)  
Methyl Dihydroabietate (UNII: 7666FJ0J9F)  
Microcrystalline Cellulose (UNII: OP1R32D61U)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
KARUM SEED OIL (UNII: 62160PU6FJ)  
Sodium Gluconate (UNII: R6Q3791S76)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
Sodium Stearoyl Glutamate (UNII: 65A9F4P024)  
COCOA BUTTER (UNII: 512OYT1CRR)  
Tocopherol (UNII: R0ZB2556P8)  
UNDARIA PINNATIFIDA (UNII: ICV1OK7M1S)  
Vanillin (UNII: CHI530446X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72805-021-68177 mL in 1 TUBE; Type 0: Not a Combination Product03/01/2020
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: 0521af79-26f8-4615-a170-722f4cfddff4
Set id: a4df5ddd-1c69-431e-bd9f-45de5915dc69
Version: 2
Effective Time: 20220106
 
French Transit, Ltd.