OHUI POWDERY METAL CUSHION COMPACT 02 NATURAL BEIGE- titanium dioxide powder

OHUI Powdery Metal Cushion Compact 02 Natural Beige by

Drug Labeling and Warnings

OHUI Powdery Metal Cushion Compact 02 Natural Beige by is a Otc medication manufactured, distributed, or labeled by LG Household and Health Care Inc, ZENISCE Co.Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

ENSULIZOLE 2.7%, OCTINOXATE 7%, TITANIUM DIOXIDE 7.18%, ZINC OXIDE 2.91%

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: Kepp out of the eyes. Rinse with water to remove.

Stop use and ask doctor, if rash occurs.

Keep out of reach of children. If product is swallowed, get medical help or

contact a Posion Control Center right away.

DIRECTIONS

• 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 value of 15 or higher and other

sun protection measures including:

- Limit time in the sun, especially from 10 a.m. to 2 p.m.

- Wear longsleeved shirts, pants, hats, and sunglasses.

• Children under 6 months: Ask a doctor.

OTHER INFORMATION

• Protect this product from excessive heat and direct sun.

INACTIVE INGREDIENTS

CYCLOPENTASILOXANE, WATER, METHYL TRIMETHICONE, DIPROPYLENE GLYCOL, PEG-10 DIMETHICONE, POLYMETHYL METHACRYLATE, NIACINAMIDE, TROMETHAMINE, 1,2-HEXANEDIOL, DISTEARDIMONIUM HECTORITE, STEARIC ACID, ALUMINUM HYDROXIDE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, SODIUM CHLORIDE, SORBITAN SESQUIOLEATE, SORBITAN SESQUIISOSTEARATE, ZINC STEARATE, DISTEARYLDIMONIUM CHLORIDE, TOCOPHERYL ACETATE, PALMITOYL PROLINE, DIMETHICONE/METHICONE COPOLYMER, ADENOSINE, MAGNESIUM PALMITOYL GLUTAMATE, SODIUM PALMITOYL SARCOSINATE, PHENOXYETHANOL, TRIETHOXYCAPRYLYLSILANE, TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE, BIOSACCHARIDE GUM-1, PALMITIC ACID, BUTYLENE GLYCOL, CETYL PEG/PPG-10/1 DIMETHICONE, HEXYL LAURATE, POLYGLYCERYL-4 ISOSTEARATE, ALBIZIA JULIBRISSIN BARK EXTRACT, FRAGRANCE, TITANIUM DIOXIDE(CI 77891), MICA, IRON OXIDES(CI 77492), IRON OXIDES(CI 77491), IRON OXIDES(CI 77499)

PRINCIPAL DISPLAY PANEL

OHUI Powdery Metal Cushion Compact

Sunscreen Broad Spectrum SPF 50

02 Natural Beige

Net Wt. 1.05 oz / 30 g (15gx2)

INGREDIENTS AND APPEARANCE

OHUI POWDERY METAL CUSHION COMPACT 02 NATURAL BEIGE 
titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53208-603
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.077 g  in 15 g
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42)	ENSULIZOLE	0.405 g  in 15 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.05 g  in 15 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.436 g  in 15 g

Inactive Ingredients
Ingredient Name	Strength
DIPROPYLENE GLYCOL (UNII: E107L85C40)
MAGNESIUM PALMITOYL GLUTAMATE (UNII: DH37YM1F48)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
WATER (UNII: 059QF0KO0R)
ADENOSINE (UNII: K72T3FS567)
SODIUM PALMITOYL SARCOSINATE (UNII: 7297LY09YF)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
PALMITIC ACID (UNII: 2V16EO95H1)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
ALBIZIA JULIBRISSIN BARK (UNII: 0J9G6W44DV)
NIACINAMIDE (UNII: 25X51I8RD4)
BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
MICA (UNII: V8A1AW0880)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
TROMETHAMINE (UNII: 023C2WHX2V)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
PALMITOYL PROLINE (UNII: I49727TDYF)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
STEARIC ACID (UNII: 4ELV7Z65AP)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
ZINC STEARATE (UNII: H92E6QA4FV)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53208-603-01	2 in 1 CARTON	01/25/2016
1		15 g in 1 CONTAINER; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/25/2016

Labeler - LG Household and Health Care Inc (688276187)

Establishment
Name	Address	ID/FEI	Business Operations
LG Household and Health Care Inc		688276187	manufacture(53208-603)

Establishment
Name	Address	ID/FEI	Business Operations
ZENISCE Co.Ltd.		690188305	manufacture(53208-603)