O HUI PERFECT SUN BLACK EX BROAD SPECTRUM SPF 50- ensulizole, octinoxate, octisalate, titanium dioxide, zinc oxide cream

O HUI Perfect Sun Black EX Broad Spectrum SPF 50 by

Drug Labeling and Warnings

O HUI Perfect Sun Black EX Broad Spectrum SPF 50 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 3.5%, OCTINOXATE 7.0%, OCTISALATE 4.5%, TITANIUM DIOXIDE 4.4%, ZINC OXIDE 9.71%

PURPOSE

Sunscreen

USES

• Helps prevent sunburn.
• If used as directed with other sun protection measures (see Directions), may decrease 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: 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

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

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

INGREDIENTS AND APPEARANCE

O HUI PERFECT SUN BLACK EX BROAD SPECTRUM SPF 50 
ensulizole, octinoxate, octisalate, titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53208-604
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.2 g  in 50 g
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42)	ENSULIZOLE	1.75 g  in 50 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.5 g  in 50 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2.25 g  in 50 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	4.86 g  in 50 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53208-604-01	1 in 1 CARTON	06/01/2017
1		50 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	06/01/2017

Labeler - LG Household and Health Care Inc (688276187)

Establishment
Name	Address	ID/FEI	Business Operations
LG Household and Health Care Inc		688276187	manufacture(53208-604)

Establishment
Name	Address	ID/FEI	Business Operations
ZENISCE Co.Ltd.		690188305	manufacture(53208-604)