Mychelle Dermaceuticals Sun Shield Tinted Spf 50 Broad Spectrum (Zinc Oxide) Stick [French Transit, Ltd.] -

MYCHELLE DERMACEUTICALS SUN SHIELD TINTED SPF 50 BROAD SPECTRUM (ZINC OXIDE) STICK [FRENCH TRANSIT, LTD.]
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NDC	72805-110-15
Set ID	9b980690-a10d-4469-b914-58e66d1fc361
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 Ingredient

Zinc Oxide 21.8%
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.
- 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

Beeswax, Bisabolol, Butyrospermum Parkii (Shea Butter), Cannabis Sativa Seed Oil, Euphorbia Cerifera (Candelilla) Wax, Helianthus Annuus (Sunflower) Seed Oil, Iron Oxides, Jojoba Esters, Lonicera Japonica (Honeysuckle) Flower Extract, Octyldodecanol, Octyldodecyl Oleate, Oryzanol, Oryza Sativa (Rice) Bran Oil, Persea Gratissima (Avocado) Oil, Salvia Hispanica (Chia) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Theobroma Cacao (Cocoa) Seed Butter, Tocopherol, Trihydroxystearin
Other Information
- Protect this product from excessive heat and direct sun.
- May stain some fabrics
PRINCIPAL DISPLAY PANEL - 15 g Container Box

SUN
PROTECTION

Sun Shield
Stick
SPF 50
Broad Spectrum

TINTED

REEF
SAFE
WATER
RESISTANT

MyChelle®
dermaceuticals

.52 oz / 15 g

INGREDIENTS AND APPEARANCE

MYCHELLE DERMACEUTICALS SUN SHIELD TINTED SPF 50 BROAD SPECTRUM
zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72805-110
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	21.8 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
YELLOW WAX (UNII: 2ZA36H0S2V)
LEVOMENOL (UNII: 24WE03BX2T)
SHEA BUTTER (UNII: K49155WL9Y)
Cannabis Sativa Seed Oil (UNII: 69VJ1LPN1S)
CANDELILLA WAX (UNII: WL0328HX19)
SUNFLOWER OIL (UNII: 3W1JG795YI)
FERRIC OXIDE RED (UNII: 1K09F3G675)
HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58)
LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)
Octyldodecanol (UNII: 461N1O614Y)
Octyldodecyl Oleate (UNII: MCA43PK7MH)
GAMMA ORYZANOL (UNII: SST9XCL51M)
AVOCADO OIL (UNII: 6VNO72PFC1)
CHIA SEED OIL (UNII: MC2LH51BO7)
JOJOBA OIL (UNII: 724GKU717M)
Tocopherol (UNII: R0ZB2556P8)
Trihydroxystearin (UNII: 06YD7896S3)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:72805-110-15	1 in 1 BOX	11/01/2017
1		15 g in 1 CONTAINER; Type 0: Not a Combination Product

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 TINTED SPF 50 BROAD SPECTRUM (ZINC OXIDE) STICK [FRENCH TRANSIT, LTD.]

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