Label: OHUI ULTIMATE COVER CC CUSHION COMPACT 02 NATURAL BEIGE- titanium dioxide powder
- NDC Code(s): 72330-601-03
- Packager: fmg Co.Ltd
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated December 13, 2021
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENTS
- Purpose
- Uses
- Warnings
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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
- Inactive Ingredients
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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)
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INGREDIENTS AND APPEARANCE
OHUI ULTIMATE COVER CC CUSHION COMPACT 02 NATURAL BEIGE
titanium dioxide powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72330-601 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.819 g in 15 g ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE 0.405 g in 15 g Inactive Ingredients Ingredient Name Strength DIMETHICONE (UNII: 92RU3N3Y1O) ZINC STEARATE (UNII: H92E6QA4FV) TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) PALMITIC ACID (UNII: 2V16EO95H1) NIACINAMIDE (UNII: 25X51I8RD4) TROMETHAMINE (UNII: 023C2WHX2V) SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) SODIUM CHLORIDE (UNII: 451W47IQ8X) PALMITOYL PROLINE (UNII: I49727TDYF) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) WATER (UNII: 059QF0KO0R) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) STEARIC ACID (UNII: 4ELV7Z65AP) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) DIPENTAERYTHRITYL HEXA C5-9 ACID ESTERS (UNII: D818OLQ51Z) PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X) PHENOXYETHANOL (UNII: HIE492ZZ3T) ADENOSINE (UNII: K72T3FS567) BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) MAGNESIUM PALMITOYL GLUTAMATE (UNII: DH37YM1F48) SODIUM PALMITOYL SARCOSINATE (UNII: 7297LY09YF) DIPROPYLENE GLYCOL (UNII: E107L85C40) LUFFA AEGYPTIACA FRUIT (UNII: QKL9NEO1F9) HEXYL LAURATE (UNII: 4CG9F9W01Q) SODIUM CITRATE (UNII: 1Q73Q2JULR) TOCOPHEROL (UNII: R0ZB2556P8) MICA (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72330-601-03 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 - fmg Co.Ltd (690188305) Establishment Name Address ID/FEI Business Operations fmg Co.Ltd 690188305 manufacture(72330-601)
