O HUI PERFECT SUN BLACK EX BROAD SPECTRUM SPF 50- ensulizole, octinoxate, octisalate, titanium dioxide, zinc oxide cream 
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 3.5%, OCTINOXATE 7.0%, OCTISALATE 4.5%, TITANIUM DIOXIDE 4.4%, ZINC OXIDE 9.71%

PURPOSE

Sunscreen

USES

WARNINGS

For external use only

Do not use on damaged or broken skin.

When using this product: Keep 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

- 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

WATER, CYCLOPENTASILOXANE, DIPROPYLENE GLYCOL, GLYCERIN, DICAPRYLYL CARBONATE, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, TROMETHAMINE, DIMETHICONE, PANTHENOL, CHRYSIN, GALANTHUS NIVALIS SEED EXTRACT, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, DISTEARDIMONIUM HECTORITE, ALUMINUM HYDROXIDE, STEARIC ACID, ZINC STEARATE, SORBITAN SESQUIOLEATE, DIMETHICONE/PEG-10/15 CROSSPOLYMER, GLYCERYL CAPRYLATE, HYDROGEN DIMETHICONE, DISTEARYLDIMONIUM CHLORIDE, ETHYLHEXYLGLYCERIN, TRISODIUM EDTA, TRIETHOXYCAPRYLYLSILANE, DIPHENYLSILOXY PHENYL TRIMETHICONE, TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE, MICA, TITANIUM DIOXIDE (CI 77891), IRON OXIDES (CI 77491, CI 77492, CI 77499), FRAGRANCE

PRINCIPAL DISPLAY PANEL

O HUI Perfect Sun Black EX

Sunscreen Broad Spectrum SPF 50+

1.69 fl oz / 50 ml

box

O HUI PERFECT SUN BLACK EX BROAD SPECTRUM SPF 50 
ensulizole, octinoxate, octisalate, titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53208-604
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.2 g  in 50 g
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE1.75 g  in 50 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.5 g  in 50 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2.25 g  in 50 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE4.86 g  in 50 g
Inactive Ingredients
Ingredient NameStrength
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
WATER (UNII: 059QF0KO0R)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
TROMETHAMINE (UNII: 023C2WHX2V)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
CHRYSIN (UNII: 3CN01F5ZJ5)  
HYDROGEN DIMETHICONE (20 CST) (UNII: 12Z59IF64N)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
GLYCERIN (UNII: PDC6A3C0OX)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
PANTHENOL (UNII: WV9CM0O67Z)  
GALANTHUS NIVALIS SEED (UNII: SJ1FOL985M)  
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
DISTEARYLDIMONIUM (UNII: 251IW5I21C)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)  
MICA (UNII: V8A1AW0880)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53208-604-011 in 1 CARTON06/01/2017
150 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 finalpart35206/01/2017
Labeler - LG Household and Health Care Inc (688276187)
Establishment
NameAddressID/FEIBusiness Operations
LG Household and Health Care Inc688276187manufacture(53208-604)
Establishment
NameAddressID/FEIBusiness Operations
ZENISCE Co.Ltd.690188305manufacture(53208-604)

Revised: 6/2017
Document Id: 52ff4754-d5ef-3297-e054-00144ff88e88
Set id: 52ff4754-d5ee-3297-e054-00144ff88e88
Version: 1
Effective Time: 20170601
 
LG Household and Health Care Inc