Mychelle Dermaceuticals Sun Shield Clear Spf 30 Broad Spectrum (Zinc Oxide) Spray [French Transit, Ltd.] -

MYCHELLE DERMACEUTICALS SUN SHIELD CLEAR SPF 30 BROAD SPECTRUM (ZINC OXIDE) SPRAY [FRENCH TRANSIT, LTD.]
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NDC	72805-040-77
Set ID	a5bb1534-c7d7-460d-9314-74dfd2b92487
Category	HUMAN OTC DRUG LABEL
Packager	French Transit, Ltd.
Generic Name
Product Class
Product Number
Application Number	PART352

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SPL UNCLASSIFIED SECTION

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
- May stain some fabrics
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

INGREDIENTS AND APPEARANCE

MYCHELLE DERMACEUTICALS SUN SHIELD CLEAR SPF 30 BROAD SPECTRUM
zinc oxide spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72805-040
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	12 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:72805-040-77	177 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	11/01/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	11/01/2017

Labeler - French Transit, Ltd. (100044380)

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Medic

MYCHELLE DERMACEUTICALS SUN SHIELD CLEAR SPF 30 BROAD SPECTRUM (ZINC OXIDE) SPRAY [FRENCH TRANSIT, LTD.]

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