MYCHELLE DERMACEUTICALS SUN SHIELD UNSCENTED  SPF 28 BROAD SPECTRUM- 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 Unscented
SPF 28 Broad Spectrum

DRUG FACTS

Active Ingredients

Zinc Oxide (ZinClear™)11.6%
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

SUN
PROTECTION

Sun Shield
Unscented
SPF 28
Broad Spectrum

REEF
SAFE

MyChelle®
dermaceuticals

2.3 fl oz / 68 mL

PRINCIPAL DISPLAY PANEL - 68 mL Tube Box
MYCHELLE DERMACEUTICALS SUN SHIELD UNSCENTED   SPF 28 BROAD SPECTRUM
zinc oxide and titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72805-060
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)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
Cetearyl Glucoside (UNII: 09FUA47KNA)  
Coco-Caprylate/Caprate (UNII: 8D9H4QU99H)  
Polysorbate 60 (UNII: CAL22UVI4M)  
Glycerin (UNII: PDC6A3C0OX)  
Squalane (UNII: GW89575KF9)  
Isononyl Isononanoate (UNII: S4V5BS6GCX)  
Magnesium Aluminum Silicate (UNII: 6M3P64V0NC)  
Xanthan Gum (UNII: TTV12P4NEE)  
Glyceryl Isostearate (UNII: HYE7O27HAO)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
SOYBEAN OIL (UNII: 241ATL177A)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
Allantoin (UNII: 344S277G0Z)  
Potassium Sorbate (UNII: 1VPU26JZZ4)  
Trisodium Ethylenediamine Disuccinate (UNII: YA22H34H9Q)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
POPULUS TREMULOIDES BARK (UNII: 5543O0CEID)  
Leuconostoc/Radish Root Ferment Filtrate (UNII: D2QHA03458)  
Dicaprylyl Ether (UNII: 77JZM5516Z)  
1,2-Hexanediol (UNII: TR046Y3K1G)  
Caprylyl Glycol (UNII: 00YIU5438U)  
Gluconolactone (UNII: WQ29KQ9POT)  
LONICERA CAPRIFOLIUM FLOWER (UNII: 5N1WD9784U)  
LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)  
Tropolone (UNII: 7L6DL16P1T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72805-060-681 in 1 BOX11/01/2017
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 FINALpart35211/01/2017
Labeler - French Transit, Ltd. (100044380)

Revised: 2/2019
Document Id: 4856d7aa-4c94-4521-ba9e-a098855eaa09
Set id: 23a9ee35-aad8-4b18-89bf-1ce42e87ab32
Version: 1
Effective Time: 20190225
 
French Transit, Ltd.