MYCHELLE DERMACEUTICALS SUN SHIELD SPF 50 NON-TINTED PROTECT- zinc oxide stick

MyChelle Dermaceuticals Sun Shield SPF 50 Non-Tinted by

Drug Labeling and Warnings

MyChelle Dermaceuticals Sun Shield SPF 50 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 17%

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

• Apply liberally and evenly 15 minutes before sun exposure.
• Reapply:
  • After 80 minutes of swimming or sweating.
  • Immediately after towel drying
  • At least every 2 hours
• 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.
  • Children under 6 months: Ask a doctor.

Inactive Ingredients

Beeswax, Bisabolol, Butyrospermum Parkii (Shea Butter), Calophyllum Tacamahaca Seed Oil, Cannabis Sativa Seed Oil, Euphorbia Cerifera (Candelilla) Wax, Jojoba Esters, Octyldodecyl Olivate, Oryza Sativa (Rice) Bran Oil, Oryzanol, Persea Gratissima (Avocado) Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Theobroma Cacao (Cocoa) Seed Butter, Tocopherol

Other Information

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

PRINCIPAL DISPLAY PANEL - 15 g Container Box

MyCHELLE®
DERMACEUTICALS

PROTECT

Sun Shield
Stick SPF 50
Non-Tinted

Water Resistant

Broad-spectrum
Protection, Avocado
& Vitamin E
Moisturize & Restore

REEF
SAFE

clean
label
PROJECT®
CERTIFIED

.52 oz/15 g

SAME FORMULA
NEW
LOOK

INGREDIENTS AND APPEARANCE

MYCHELLE DERMACEUTICALS SUN SHIELD SPF 50 NON-TINTED   PROTECT
zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72805-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	17 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
YELLOW WAX (UNII: 2ZA36H0S2V)
LEVOMENOL (UNII: 24WE03BX2T)
SHEA BUTTER (UNII: K49155WL9Y)
Calophyllum Tacamahaca Seed Oil (UNII: 05G85L61OE)
Cannabis Sativa Seed Oil (UNII: 69VJ1LPN1S)
CANDELILLA WAX (UNII: WL0328HX19)
HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58)
RICE BRAN OIL (UNII: LZO6K1506A)
Oryzanol (UNII: SST9XCL51M)
AVOCADO OIL (UNII: 6VNO72PFC1)
JOJOBA OIL (UNII: 724GKU717M)
COCOA BUTTER (UNII: 512OYT1CRR)
Tocopherol (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72805-101-15	1 in 1 BOX	03/01/2020
1		15 g in 1 CONTAINER; 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	03/01/2020

Labeler - French Transit, Ltd. (100044380)