MYCHELLE DERMACEUTICALS SUN SHIELD CLEAR SPF 30 BROAD SPECTRUM- zinc oxide spray 
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 Clear Spray
SPF 30 Broad Spectrum

DRUG FACTS

Active Ingredients

Zinc Oxide 12%

Purpose

Sunscreen

Uses

Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

Do not puncture or incinerate can. Keep away from fire and flames. 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

Shake well. Spray liberally and evenly 15 minutes before sun exposure. Hold container 4 to 6 inches from skin to apply. Do not spray directly on face. Spray on hands and apply to face. Avoid inhaling or exposing others to spray. Reapply: After 80 minutes of swimming or sweating. Immediately after towel drying At least every 2 hours. Children under 6 months: ask a doctor. Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10 a.m. – 2 p.m. Wear long-sleeve shirts, pants, hats and sunglasses.

Inactive Ingredients

Bentonite, Butyloctyl Salicylate, Caprylhydroxamic Acid, Caprylic/Capric Triglyceride, Caprylyl Glycol, Carthamus Tinctorius (Safflower) Seed Oil, Cetearyl Alcohol, Coco-Glucoside, Glycerin, Heptyl Undecylenate, Jojoba Esters, Methyl Dihydroabietate, Vanillin, Water

Other information

Protect this product from excessive heat and direct sun. Store at temperatures below 90°F

PRINCIPAL DISPLAY PANEL - 177 mL Bottle Label

Continuous Spray
Twist-lock Cap

SUN
PROTECTION

Sun Shield
Clear Spray
SPF 30
Broad Spectrum

MyChelle®
dermaceuticals

REEF
SAFE
WATER
RESISTANT

6 fl oz / 177 mL

Principal Display Panel - 177 mL Bottle Label
MYCHELLE DERMACEUTICALS SUN SHIELD CLEAR  SPF 30 BROAD SPECTRUM
zinc oxide spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72805-040
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide12 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Bentonite (UNII: A3N5ZCN45C)  
Butyloctyl Salicylate (UNII: 2EH13UN8D3)  
Caprylhydroxamic Acid (UNII: UPY805K99W)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
Caprylyl Glycol (UNII: 00YIU5438U)  
SAFFLOWER OIL (UNII: 65UEH262IS)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
COCO GLUCOSIDE (UNII: ICS790225B)  
Glycerin (UNII: PDC6A3C0OX)  
Heptyl Undecylenate (UNII: W77QUB6GXO)  
HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58)  
Methyl Dihydroabietate (UNII: 7666FJ0J9F)  
Vanillin (UNII: CHI530446X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72805-040-77177 mL in 1 BOTTLE, SPRAY; 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: 6f871dec-f604-491b-8e2d-09e08ad9ec17
Set id: a5bb1534-c7d7-460d-9314-74dfd2b92487
Version: 1
Effective Time: 20190222
 
French Transit, Ltd.