NDC | 53208-600-02 |
Set ID | 29a1089b-8c62-63a4-e054-00144ff88e88 |
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
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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
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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)
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
OHUI ULTIMATE COVER CC CUSHION COMPACT 01 LIGHT BEIGE
titanium dioxide powderProduct 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:53208-600-02 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 and Health Care Inc (688276187) Establishment Name Address ID/FEI Business Operations LG Household and Health Care Inc 688276187 manufacture(53208-600) Establishment Name Address ID/FEI Business Operations ZENISCE Co.Ltd 690188305 manufacture(53208-600)