OHUI POWDERY METAL CUSHION COMPACT 02 NATURAL BEIGE- titanium dioxide powder 
LG Household and Health Care Inc

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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ACTIVE INGREDIENTS

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

PURPOSE

Sunscreen

USES

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

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.

OTHER INFORMATION

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)

53208-603-01

OHUI POWDERY METAL CUSHION COMPACT 02 NATURAL BEIGE 
titanium dioxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53208-603
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.077 g  in 15 g
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE0.405 g  in 15 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.05 g  in 15 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.436 g  in 15 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53208-603-012 in 1 CARTON01/25/2016
115 g in 1 CONTAINER; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/25/2016
Labeler - LG Household and Health Care Inc (688276187)
Establishment
NameAddressID/FEIBusiness Operations
LG Household and Health Care Inc688276187manufacture(53208-603)
Establishment
NameAddressID/FEIBusiness Operations
ZENISCE Co.Ltd.690188305manufacture(53208-603)

Revised: 2/2016
Document Id: 2be8e08f-d3de-3083-e054-00144ff88e88
Set id: 2a14c11d-2c04-3267-e054-00144ff88e88
Version: 5
Effective Time: 20160216
 
LG Household and Health Care Inc