MYCHELLE DERMACEUTICALS REPLENISHING SOLAR DEFENSE  SPF 30 BROAD SPECTRUM- zinc oxide lotion 
French Transit, Ltd.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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MyChelle® Dermaceuticals Replenishing Solar Defense
SPF 30 Broad Spectrum

DRUG FACTS

Active Ingredient

Zinc Oxide (ZinClear™) 13.5%

Purpose

Sunscreen

Uses

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

Inactive Ingredients

Alcohol, Aleurites Moluccana Seed Oil, Aqua (Water), Behenyl Alcohol, 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

SUN
PROTECTION

Replenishing
Solar Defense
SPF 30
Broad Spectrum

Age Defense

REEF
SAFE

MyChelle®
dermaceuticals

2.3 fl oz / 68 mL

PRINCIPAL DISPLAY PANEL - 68 mL Tube Box
MYCHELLE DERMACEUTICALS REPLENISHING SOLAR DEFENSE   SPF 30 BROAD SPECTRUM
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72805-030
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide13.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
Glycerin (UNII: PDC6A3C0OX)  
Isodecyl Neopentanoate (UNII: W60VYE24XC)  
Ethyl Macadamiate (UNII: ANA2NCS6V1)  
KUKUI NUT OIL (UNII: TP11QR7B8R)  
HYDROXYPROPYL DISTARCH PHOSPHATE, HIGH AMYLOSE CORN (UNII: 9F8ET54T05)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
ERGOTHIONEINE (UNII: BDZ3DQM98W)  
BARLEY (UNII: 5PWM7YLI7R)  
MACADAMIA OIL (UNII: 515610SU8C)  
PORPHYRA UMBILICALIS (UNII: 14AN0J70WO)  
SANDALWOOD (UNII: 3641YW25N2)  
PHELLODENDRON AMURENSE BARK (UNII: PBG27B754G)  
Glyceryl Isostearate (UNII: HYE7O27HAO)  
Sodium Stearoyl Lactylate (UNII: IN99IT31LN)  
Polyglyceryl-10 Pentastearate (UNII: PMX5872701)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
.ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
MALIC ACID, L- (UNII: J3TZF807X5)  
LONICERA CAPRIFOLIUM FLOWER (UNII: 5N1WD9784U)  
LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)  
Potassium Cetyl Phosphate (UNII: 03KCY6P7UT)  
Hydrogenated Palm Glycerides (UNII: YCZ8EM144Q)  
Alcohol (UNII: 3K9958V90M)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
DOCOSANOL (UNII: 9G1OE216XY)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
Sodium Lactate (UNII: TU7HW0W0QT)  
FYTIC ACID (UNII: 7IGF0S7R8I)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
Sodium Hydroxide (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72805-030-771 in 1 BOX11/01/2017
168 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35211/01/2017
Labeler - French Transit, Ltd. (100044380)

Revised: 2/2019
Document Id: fc093be6-d401-411b-a337-410897509991
Set id: 0b53c2a2-04e5-4e23-8cc6-34673a0d3216
Version: 1
Effective Time: 20190222
 
French Transit, Ltd.