Label: OHUI POWDERY METAL CUSHION COMPACT 02 NATURAL BEIGE- titanium dioxide powder
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Contains inactivated NDC Code(s)
NDC Code(s): 53208-603-01 - Packager: LG Household and Health Care Inc
- 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 February 16, 2016
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- 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, regularly 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 longsleeved shirts, pants, hats, and sunglasses.
- Children under 6 months: Ask a doctor.
- OTHER INFORMATION
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INACTIVE INGREDIENTS
CYCLOPENTASILOXANE, WATER, METHYL TRIMETHICONE, DIPROPYLENE GLYCOL, PEG-10 DIMETHICONE, POLYMETHYL METHACRYLATE, NIACINAMIDE, TROMETHAMINE, 1,2-HEXANEDIOL, DISTEARDIMONIUM HECTORITE, STEARIC ACID, ALUMINUM HYDROXIDE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, SODIUM CHLORIDE, SORBITAN SESQUIOLEATE, SORBITAN SESQUIISOSTEARATE, ZINC STEARATE, DISTEARYLDIMONIUM CHLORIDE, TOCOPHERYL ACETATE, PALMITOYL PROLINE, DIMETHICONE/METHICONE COPOLYMER, ADENOSINE, MAGNESIUM PALMITOYL GLUTAMATE, SODIUM PALMITOYL SARCOSINATE, PHENOXYETHANOL, TRIETHOXYCAPRYLYLSILANE, TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE, BIOSACCHARIDE GUM-1, PALMITIC ACID, BUTYLENE GLYCOL, CETYL PEG/PPG-10/1 DIMETHICONE, HEXYL LAURATE, POLYGLYCERYL-4 ISOSTEARATE, ALBIZIA JULIBRISSIN BARK EXTRACT, FRAGRANCE, TITANIUM DIOXIDE(CI 77891), MICA, IRON OXIDES(CI 77492), IRON OXIDES(CI 77491), IRON OXIDES(CI 77499)
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
OHUI POWDERY METAL CUSHION COMPACT 02 NATURAL BEIGE
titanium dioxide powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53208-603 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1.077 g in 15 g ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE 0.405 g in 15 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 1.05 g in 15 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 0.436 g in 15 g Inactive Ingredients Ingredient Name Strength DIPROPYLENE GLYCOL (UNII: E107L85C40) MAGNESIUM PALMITOYL GLUTAMATE (UNII: DH37YM1F48) PHENOXYETHANOL (UNII: HIE492ZZ3T) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) WATER (UNII: 059QF0KO0R) ADENOSINE (UNII: K72T3FS567) SODIUM PALMITOYL SARCOSINATE (UNII: 7297LY09YF) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) PALMITIC ACID (UNII: 2V16EO95H1) HEXYL LAURATE (UNII: 4CG9F9W01Q) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) ALBIZIA JULIBRISSIN BARK (UNII: 0J9G6W44DV) NIACINAMIDE (UNII: 25X51I8RD4) BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X) MICA (UNII: V8A1AW0880) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11) TROMETHAMINE (UNII: 023C2WHX2V) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) PALMITOYL PROLINE (UNII: I49727TDYF) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) METHYL TRIMETHICONE (UNII: S73ZQI0GXM) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) STEARIC ACID (UNII: 4ELV7Z65AP) SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A) ZINC STEARATE (UNII: H92E6QA4FV) DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) SODIUM CHLORIDE (UNII: 451W47IQ8X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53208-603-01 2 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 and Health Care Inc (688276187) Establishment Name Address ID/FEI Business Operations LG Household and Health Care Inc 688276187 manufacture(53208-603) Establishment Name Address ID/FEI Business Operations ZENISCE Co.Ltd. 690188305 manufacture(53208-603)
