MYCHELLE DERMACEUTICALS REPLENISHING SOLAR DEFENSE BODY  SPF 50 BROAD SPECTRUM- 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 Broad Spectrum

DRUG FACTS

Active Ingredients

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

Protect this product from excessive heat and direct sun. May stain some fabrics.

PRINCIPAL DISPLAY PANEL - 177 mL Tube Label

SUN
PROTECTION

Replenishing
Solar Defense
Body Lotion

SPF 50

Broad Spectrum

ANTI-AGING

MyChelle®
dermaceuticals

REEF
SAFE
WATER
RESISTANT

6 fl oz / 177 mL

PRINCIPAL DISPLAY PANEL - 177 mL Tube Label
MYCHELLE DERMACEUTICALS REPLENISHING SOLAR DEFENSE BODY   SPF 50 BROAD SPECTRUM
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72805-020
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)  
Microcrystalline Cellulose (UNII: OP1R32D61U)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
Caprylhydroxamic Acid (UNII: UPY805K99W)  
Caprylyl Glycol (UNII: 00YIU5438U)  
Glycerin (UNII: PDC6A3C0OX)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
Sodium Gluconate (UNII: R6Q3791S76)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
Sodium Stearoyl Glutamate (UNII: 65A9F4P024)  
COCONUT OIL (UNII: Q9L0O73W7L)  
Diheptyl Succinate (UNII: 057N7SS26Y)  
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)  
Methyl Dihydroabietate (UNII: 7666FJ0J9F)  
SHEA BUTTER (UNII: K49155WL9Y)  
COCOA BUTTER (UNII: 512OYT1CRR)  
KARUM SEED OIL (UNII: 62160PU6FJ)  
Butyloctyl Salicylate (UNII: 2EH13UN8D3)  
LEVOMENOL (UNII: 24WE03BX2T)  
Tocopherol (UNII: R0ZB2556P8)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
Cetyl Alcohol (UNII: 936JST6JCN)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
Coco Glucoside (UNII: ICS790225B)  
Arachidyl Alcohol (UNII: 1QR1QRA9BU)  
DOCOSANOL (UNII: 9G1OE216XY)  
Arachidyl Glucoside (UNII: 6JVW35JOOJ)  
UNDARIA PINNATIFIDA (UNII: ICV1OK7M1S)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
Vanillin (UNII: CHI530446X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72805-020-68177 mL in 1 TUBE; Type 0: Not a Combination Product11/01/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35211/01/2017
Labeler - French Transit, Ltd. (100044380)

Revised: 2/2019
Document Id: eb1c7cec-2203-4d85-a8a8-6b6ddfa3c631
Set id: 0fb25f5d-a3af-46fb-906a-a5ccc62a4b22
Version: 1
Effective Time: 20190222
 
French Transit, Ltd.