![OHUI POWDERY METAL CUSHION COMPACT 01 LIGHT BEIGE (TITANIUM DIOXIDE) POWDER [LG HOUSEHOLD AND HEALTH CARE INC]](https://medic.hrt.org//dailymed/images/2ab771d0-25ae-1256-e054-00144ff8d46c/53208-602-01-OHUI-Powdery-Metal-Cushion-Compact-01-Light-Beige.jpg)
| NDC | 53208-602-01 |
| Set ID | 2ab771d0-25ae-1256-e054-00144ff8d46c |
| Category | HUMAN OTC DRUG LABEL |
| Packager | LG Household and Health Care Inc |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART352 |
- ACTIVE INGREDIENTS
- PURPOSE
- USES
- WARNINGS
-
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
-
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 - 15 g Container 01 Light Beige
-
INGREDIENTS AND APPEARANCE
OHUI POWDERY METAL CUSHION COMPACT 01 LIGHT BEIGE
titanium dioxide powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53208-602 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 METHYL TRIMETHICONE (UNII: S73ZQI0GXM) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) SODIUM CHLORIDE (UNII: 451W47IQ8X) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) WATER (UNII: 059QF0KO0R) DIPROPYLENE GLYCOL (UNII: E107L85C40) NIACINAMIDE (UNII: 25X51I8RD4) TROMETHAMINE (UNII: 023C2WHX2V) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) STEARIC ACID (UNII: 4ELV7Z65AP) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A) POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53208-602-01 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(53208-602) Establishment Name Address ID/FEI Business Operations ZENISCE Co.Ltd. 690188305 manufacture(53208-602)
