MENAJI POWER HYDRATOR PLUS SUNSCREEN BROAD SPECTRUM SPF 30 PLUS TINTED MOISTURIZE MEDIUM- octinoxate and zinc oxide cream

Menaji Power Hydrator Plus Sunscreen Broad Spectrum SPF 30 Plus Tinted Moisturize Medium by

Drug Labeling and Warnings

Menaji Power Hydrator Plus Sunscreen Broad Spectrum SPF 30 Plus Tinted Moisturize Medium by is a Otc medication manufactured, distributed, or labeled by Cosmetic Solutions LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

DRUG FACTS:

ACTIVE INGREDIENTS

Octyl Methoxycinnamate 7.5%

Zinc Oxide 7.0%

PURPOSE

Sunscreen

USES

Helps prevent sunburn.

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 occurs.

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

Apply generously until desired coverage is achieved. If exposed to sun, reapply every 2 hours. If swimming or sweating, use water resistant sunscreen. 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 value 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-sleeved shirts, pants, hats, and sunglasses.

INACTIVE INGREDIENTS

Water (Aqua), Stearyl Alcohol, Glycerin, Glyceryl Stearate, PEG-100 Stearate, Glyceryl Dilaurate, Cetearyl Alcohol, Beeswax, Dimethicone, Cyclomethicone, Diisopropyl Adipate, Hexylene Glycol, PEG-40 Stearate, C12-15 Alkyl Benzoate, Aluminum Starch Octenylsuccinate, PEG-20, Carnauba Wax, Dimethicone Copolyol, VP/ Eicosene Copolymer, Sorbitan Tristearate, Stearoxytrimethylsilane, Steareth-100, Laureth-7, C13-14 Isoparaffin, Phenoxyethanol, Ethylhexylglycerin, Polyacrylamide, Iron Oxides (CI77491), (CI77492) (CI77499).

OTHER INFORMATION

Protect the product in this container from excessive heat and direct sun.

SPL UNCLASSIFIED SECTION

Distr. by Manaji Worldwide, LLC. Southport, CT 06890 USA

PRINCIPAL DISPLAY PANEL - 60 mL Bottle Label

MËNAJI™
ADVANCED MEN'S SKINCARE

Power
Hydrator
PLUS

Sunscreen
Broad Spectrum SPF 30
+ Tinted Moisturizer

MEDIUM

2 FL. OZ. / 60 mL e

INGREDIENTS AND APPEARANCE

MENAJI POWER HYDRATOR PLUS SUNSCREEN BROAD SPECTRUM SPF 30 PLUS TINTED MOISTURIZE MEDIUM 
octinoxate and zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66163-7621
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	75 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	70 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Stearyl Alcohol (UNII: 2KR89I4H1Y)
Glycerin (UNII: PDC6A3C0OX)
Glyceryl Monostearate (UNII: 230OU9XXE4)
PEG-100 Stearate (UNII: YD01N1999R)
Glyceryl Dilaurate (UNII: MFL3ZIE8SK)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
Yellow Wax (UNII: 2ZA36H0S2V)
Dimethicone (UNII: 92RU3N3Y1O)
Cyclomethicone (UNII: NMQ347994Z)
Diisopropyl Adipate (UNII: P7E6YFV72X)
Hexylene Glycol (UNII: KEH0A3F75J)
PEG-40 Stearate (UNII: ECU18C66Q7)
Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)
Aluminum Starch Octenylsuccinate (UNII: I9PJ0O6294)
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)
Carnauba Wax (UNII: R12CBM0EIZ)
PEG/PPG-18/18 Dimethicone (UNII: 9H0AO7T794)
Sorbitan Tristearate (UNII: 6LUM696811)
Stearoxytrimethylsilane (UNII: 9862TW94B2)
Steareth-100 (UNII: 4OH5W9UM87)
Laureth-7 (UNII: Z95S6G8201)
C13-14 Isoparaffin (UNII: E4F12ROE70)
Phenoxyethanol (UNII: HIE492ZZ3T)
Ethylhexylglycerin (UNII: 147D247K3P)
Ferric Oxide Red (UNII: 1K09F3G675)
Ferric Oxide Yellow (UNII: EX438O2MRT)
Ferrosoferric Oxide (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66163-7621-2	60 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	01/01/2019

Labeler - Cosmetic Solutions LLC (807907928)