MYCHELLE DERMACEUTICALS SUN SHIELD NON-TINTED SPF 50 BROAD SPECTRUM- zinc oxide liquid

MyChelle Dermaceuticals Sun Shield Non-Tinted by

Drug Labeling and Warnings

MyChelle Dermaceuticals Sun Shield Non-Tinted by is a Otc medication manufactured, distributed, or labeled by French Transit, Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

DRUG FACTS

Active Ingredient

Zinc Oxide 20.5%

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

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 BEFORE USE.
• For daily use, apply to clean, dry skin and allow to absorb completely before applying make-up.
• Apply liberally 15 minutes before sun exposure.
• 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, Bisabolol, Butyloctyl Salicylate, Caprylhydroxamic Acid, Capryloyl Glycerin/Sebacic Acid Copolymer, Caprylyl Glycol, Carthamus Tinctorius (Safflower) Oleosomes, Cetearyl Alcohol, Citric Acid, Diheptyl Succinate, Galactoarabinan, Glycerin, Glyceryl Caprylate, Glyceryl Stearate Citrate, Jojoba Esters, Polyhydroxystearic Acid, Rubus Idaeus (Raspberry) Seed Oil, Sodium Stearoyl Glutamate, Tocopherol, Water

Other Information

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

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Box

SUN
PROTECTION

Sun Shield
Liquid
SPF 50
Broad Spectrum

NON-TINTED

MyChelle®
dermaceuticals

REEF
SAFE

1 fl oz / 30 mL

INGREDIENTS AND APPEARANCE

MYCHELLE DERMACEUTICALS SUN SHIELD NON-TINTED   SPF 50 BROAD SPECTRUM
zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72805-080
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	20.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Bentonite (UNII: A3N5ZCN45C)
Levomenol (UNII: 24WE03BX2T)
Butyloctyl Salicylate (UNII: 2EH13UN8D3)
Caprylhydroxamic Acid (UNII: UPY805K99W)
Capryloyl Glycerin/Sebacic Acid Copolymer (2000 MPA.S) (UNII: N7YC58165T)
Caprylyl Glycol (UNII: 00YIU5438U)
Carthamus Tinctorius Seed Oleosomes (UNII: 9S60Q72309)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
Anhydrous Citric Acid (UNII: XF417D3PSL)
Diheptyl Succinate (UNII: 057N7SS26Y)
Galactoarabinan (UNII: SL4SX1O487)
Glycerin (UNII: PDC6A3C0OX)
Glyceryl Monocaprylate (UNII: TM2TZD4G4A)
Glyceryl Stearate Citrate (UNII: WH8T92A065)
Hydrogenated Jojoba Oil, Randomized (UNII: Q47ST02F58)
Polyhydroxystearic Acid (2300 MW) (UNII: YXH47AOU0F)
Raspberry Seed Oil (UNII: 9S8867952A)
Sodium Stearoyl Glutamate (UNII: 65A9F4P024)
Tocopherol (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72805-080-30	1 in 1 BOX	11/01/2017	09/10/2019
1		30 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
2	NDC: 72805-080-31	1 in 1 BOX	09/10/2019
2		30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

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

Labeler - French Transit, Ltd. (100044380)