OHUI ULTIMATE COVER CC CUSHION COMPACT 01 LIGHT BEIGE- titanium dioxide powder 
LG HOUSEHOLD & HEALTH CARE LTD

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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OHUI Ultimate Cover CC Cushion Compact 01 Light Beige

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

CC Cushion 01

OHUI ULTIMATE COVER CC CUSHION COMPACT 01 LIGHT BEIGE 
titanium dioxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53208-600
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE0.405 g  in 15 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.819 g  in 15 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53208-600-023 in 1 CARTON01/25/201612/01/2021
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 finalpart35201/25/201612/01/2021
Labeler - LG HOUSEHOLD & HEALTH CARE LTD (688276187)
Establishment
NameAddressID/FEIBusiness Operations
fmg Co.Ltd690188305manufacture(53208-600)

Revised: 12/2021
 
LG HOUSEHOLD & HEALTH CARE LTD