MYCHELLE DERMACEUTICALS SUN SHIELD SPF 28 UNSCENTED  PROTECT- zinc oxide and titanium dioxide 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 Sun Shield SPF 28 Unscented
Protect

DRUG FACTS

Active Ingredients

Zinc Oxide11.6%
PurposeSunscreen
Titanium Dioxide0.67%
PurposeSunscreen

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

1,2-Hexanediol, Allantoin, Aloe Barbadensis Leaf Juice Powder, Alumina, Aqua (Water), Caprylic/Capric Triglyceride, Caprylyl Glycol, Cetearyl Alcohol, Cetearyl Glucoside, Citric Acid, Coco-Caprylate/Caprate, Dicaprylyl Ether, Fructooligosaccharides (D-beta), Gluconolactone, Glycerin, Glyceryl Isostearate, Glycine Soja (Soybean) Oil, Isononyl Isononanoate, Leuconostoc/ Radish Root Ferment Filtrate, Lonicera Caprifolium (Honeysuckle) Flower Extract, Lonicera Japonica (Honeysuckle) Flower Extract, Magnesium Aluminum Silicate, Polyglyceryl-6 Polyricinoleate, Polyhydroxystearic Acid, Polysorbate 60, Populus Tremuloides Bark Extract, Potassium Sorbate, Simethicone, Squalane, Tocopheryl Acetate (D-alpha), Trisodium Ethylenediamine Disuccinate, Tropolone, Xanthan Gum

Other Information

Protect this product from excessive heat and direct sun.

PRINCIPAL DISPLAY PANEL - 68 mL Tube Box

MyCHELLE®
DERMACEUTICALS

PROTECT

Sun Shield SPF 28
Unscented

Broad-spectrum
Protection, Antioxidant-
Rich Vitamin E & Aloe
Soothe & Nourish

REEF
SAFE

clean
label
PROJECT®
CERTIFIED

2.3 fl oz/68 mL

SAME FORMULA
NEW
LOOK

PRINCIPAL DISPLAY PANEL - 68 mL Tube Box
MYCHELLE DERMACEUTICALS SUN SHIELD SPF 28 UNSCENTED   PROTECT
zinc oxide and titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72805-061
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) Zinc Oxide11.6 g  in 100 mL
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide0.67 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
1,2-Hexanediol (UNII: TR046Y3K1G)  
Allantoin (UNII: 344S277G0Z)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
Caprylyl Glycol (UNII: 00YIU5438U)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
Cetearyl Glucoside (UNII: 09FUA47KNA)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H)  
Dicaprylyl Ether (UNII: 77JZM5516Z)  
Dimethicone (UNII: 92RU3N3Y1O)  
Gluconolactone (UNII: WQ29KQ9POT)  
Glycerin (UNII: PDC6A3C0OX)  
Glyceryl Isostearate (UNII: HYE7O27HAO)  
SOYBEAN OIL (UNII: 241ATL177A)  
Isononyl Isononanoate (UNII: S4V5BS6GCX)  
Leuconostoc/Radish Root Ferment Filtrate (UNII: D2QHA03458)  
LONICERA CAPRIFOLIUM FLOWER (UNII: 5N1WD9784U)  
LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)  
Magnesium Aluminum Silicate (UNII: 6M3P64V0NC)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
Polysorbate 60 (UNII: CAL22UVI4M)  
POPULUS TREMULOIDES BARK (UNII: 5543O0CEID)  
Potassium Sorbate (UNII: 1VPU26JZZ4)  
Silicon Dioxide (UNII: ETJ7Z6XBU4)  
Squalane (UNII: GW89575KF9)  
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
Trisodium Ethylenediamine Disuccinate (UNII: YA22H34H9Q)  
Tropolone (UNII: 7L6DL16P1T)  
Xanthan Gum (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72805-061-681 in 1 BOX03/01/2020
168 mL in 1 TUBE; 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: 5cd5c247-10b5-411b-85f0-6f36c5b31795
Set id: 78c14183-deed-46eb-934a-27404686c8da
Version: 3
Effective Time: 20220106
 
French Transit, Ltd.