MYCHELLE DERMACEUTICALS REPLENISHING SOLAR DEFENSE SPF 30 PROTECT- zinc oxide lotion

MyChelle Dermaceuticals Replenishing Solar Defense SPF 30 by

Drug Labeling and Warnings

MyChelle Dermaceuticals Replenishing Solar Defense SPF 30 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 13.5%

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 makeup.
• Apply liberally 15 minutes before sun exposure.
• Use a water resistant sunscreen if swimming or sweating.
• Reapply 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

Alcohol, Aleurites Moluccanus Seed Oil, Aqua (Water), Behenyl Alcohol, Bisabolol (L-alpha), Candelilla/Jojoba/Rice Bran Polyglyceryl-3 Esters, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Citric Acid, Ergothioneine (L), Ethyl Macadamiate, Glycerin, Glyceryl Isostearate, Glyceryl Stearate, Hamamelis Virginiana (Witch Hazel) Water, Hordeum Distichon (Barley) Extract, Hydrogenated Palm Glycerides, Hydroxypropyl Methylcellulose, Hydroxypropyl Starch Phosphate, Isodecyl Neopentanoate, Lecithin, Lonicera Caprifolium (Honeysuckle) Flower Extract, Lonicera Japonica (Honeysuckle) Flower Extract, Macadamia Ternifolia Seed Oil, Malic Acid (L), Phellodendron Amurense Bark Extract, Phytic Acid, Polyglyceryl-10 Pentastearate, Polyhydroxystearic Acid, Porphyra Umbilicalis (Red Algae) Extract, Potassium Cetyl Phosphate, Santalum Album (Sandalwood) Extract, Sodium Hydroxide, Sodium Lactate, Sodium Stearoyl Lactylate, Tocopherol (D-alpha), Tocopheryl Acetate (D-alpha)

Other Information

Protect this product from excessive heat and direct sun.

PRINCIPAL DISPLAY PANEL - 68 mL Tube Box

MyCHELLE®
DERMACEUTICALS

PROTECT

Replenishing
Solar Defense
SPF 30

Broad-spectrum
Protection, Red Algae
Extract & Kukui Oil
Moisturize & Soothe

REEF
SAFE

clean
label
PROJECT®
CERTIFIED

2.3 fl oz/68 mL

SAME FORMULA
NEW
LOOK

INGREDIENTS AND APPEARANCE

MYCHELLE DERMACEUTICALS REPLENISHING SOLAR DEFENSE SPF 30   PROTECT
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72805-031
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	13.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
Alcohol (UNII: 3K9958V90M)
KUKUI NUT OIL (UNII: TP11QR7B8R)
DOCOSANOL (UNII: 9G1OE216XY)
LEVOMENOL (UNII: 24WE03BX2T)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
ERGOTHIONEINE (UNII: BDZ3DQM98W)
Ethyl Macadamiate (UNII: ANA2NCS6V1)
Glycerin (UNII: PDC6A3C0OX)
Glyceryl Isostearate (UNII: HYE7O27HAO)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
HAMAMELIS VIRGINIANA TOP WATER (UNII: NT00Y05A2V)
BARLEY (UNII: 5PWM7YLI7R)
Hydrogenated Palm Glycerides (UNII: YCZ8EM144Q)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
HYDROXYPROPYL DISTARCH PHOSPHATE, HIGH AMYLOSE CORN (UNII: 9F8ET54T05)
Isodecyl Neopentanoate (UNII: W60VYE24XC)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
LONICERA CAPRIFOLIUM FLOWER (UNII: 5N1WD9784U)
LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)
MACADAMIA OIL (UNII: 515610SU8C)
MALIC ACID, L- (UNII: J3TZF807X5)
PHELLODENDRON AMURENSE BARK (UNII: PBG27B754G)
FYTIC ACID (UNII: 7IGF0S7R8I)
Polyglyceryl-10 Pentastearate (UNII: PMX5872701)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
PORPHYRA UMBILICALIS (UNII: 14AN0J70WO)
Potassium Cetyl Phosphate (UNII: 03KCY6P7UT)
SANDALWOOD (UNII: 3641YW25N2)
Sodium Hydroxide (UNII: 55X04QC32I)
Sodium Lactate (UNII: TU7HW0W0QT)
Sodium Stearoyl Lactylate (UNII: IN99IT31LN)
.ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72805-031-77	1 in 1 BOX	03/01/2020
1		68 mL in 1 TUBE; 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)