OHUI ULTIMATE COVER CC CUSHION COMPACT 01 LIGHT BEIGE- titanium dioxide powder

OHUI Ultimate Cover CC Cushion Compact 01 Light Beige by

Drug Labeling and Warnings

OHUI Ultimate Cover CC Cushion Compact 01 Light Beige by is a Otc medication manufactured, distributed, or labeled by LG HOUSEHOLD & HEALTH CARE LTD, fmg Co.Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

ENSULIZOLE 2.7%, TITANIUM DIOXIDE 5.46%

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 exposure.

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 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 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, regulary 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 long-sleeved 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

WATER, TRIETHYLHEXANOIN, DIMETHICONE, PHENYL TRIMETHICONE, BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE, CYCLOPENTASILOXANE, DIPENTAERYTHRITYL HEXA C5-9 ACID ESTERS, CETYL PEG/PPG-10/1 DIMETHICONE, NIACINAMIDE, TROMETHAMINE, 1,2-HEXANEDIOL, SORBITAN SESQUIOLEATE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, SODIUM CHLORIDE, ZINC STEARATE, PEG-30 DIPOLYHYDROXYSTEARATE, DIMETHICONE/POLYGLYCERIN-3 CROSSPOLYMER, DISTEARDIMONIUM HECTORITE, ALUMINUM HYDROXIDE, STEARIC ACID, DISTEARYLDIMONIUM CHLORIDE, DIMETHICONE/PEG-10/15 CROSSPOLYMER, TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE, PALMITOYL PROLINE, PHENOXY ETHANOL, ADENOSINE, BIOSACCHARIDE GUM-1, TRIETHOXYCAPRYLYLSILANE, MAGNESIUM PALMITOYL GLUTAMATE, SODIUM PALMITOYL SARCOSINATE, PALMITIC ACID, DIPROPYLENE GLYCOL, LUFFA CYLINDRICA FRUIT EXTRACT, HEXYL LAURATE, SODIUM CITRATE, POLYGLYCERYL-4 ISOSTEARATE, TOCOPHEROL, FRAGRANCE, TITANIUM DIOXIDE(CI 77891), MICA, IRON OXIDES(CI 77492), IRON OXIDES(CI 77491), IRON OXIDES(CI 77499)

Principal Display Panel

O HUI

ULTIMATE COVER

CC CUSHION COMPACT

Sunscreen

Broad Spectrum SPF 50

Net Wt. 1.58 oz / 45 g (15g x 3)

INGREDIENTS AND APPEARANCE

OHUI ULTIMATE COVER CC CUSHION COMPACT 01 LIGHT BEIGE 
titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53208-600
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42)	ENSULIZOLE	0.405 g  in 15 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.819 g  in 15 g

Inactive Ingredients
Ingredient Name	Strength
TOCOPHEROL (UNII: R0ZB2556P8)
NIACINAMIDE (UNII: 25X51I8RD4)
WATER (UNII: 059QF0KO0R)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
DIMETHICONE (UNII: 92RU3N3Y1O)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)
DIPENTAERYTHRITYL HEXA C5-9 ACID ESTERS (UNII: D818OLQ51Z)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
ZINC STEARATE (UNII: H92E6QA4FV)
PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)
ADENOSINE (UNII: K72T3FS567)
SODIUM PALMITOYL SARCOSINATE (UNII: 7297LY09YF)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
LUFFA AEGYPTIACA FRUIT (UNII: QKL9NEO1F9)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
MAGNESIUM PALMITOYL GLUTAMATE (UNII: DH37YM1F48)
PALMITIC ACID (UNII: 2V16EO95H1)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
TROMETHAMINE (UNII: 023C2WHX2V)
PALMITOYL PROLINE (UNII: I49727TDYF)
BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53208-600-03	3 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 & HEALTH CARE LTD (688276187)

Establishment
Name	Address	ID/FEI	Business Operations
fmg Co.Ltd		690188305	manufacture(53208-600)