![O HUI PERFECT SUN BLACK EX BROAD SPECTRUM SPF 50 (ENSULIZOLE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LG HOUSEHOLD AND HEALTH CARE INC]](https://medic.hrt.org//dailymed/images/52ff4754-d5ee-3297-e054-00144ff88e88/O-HUI-Perfect-Sun-Black-EX-outbox.jpg)
| NDC | 53208-604-01 |
| Set ID | 52ff4754-d5ee-3297-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
- Helps prevent sunburn.
- If used as directed with other sun protection measures (see Directions), may decrease the risk of skin cancer and early skin aging caused by the sun.
- 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 doctor, if rash occurs.
Keep out of reach of children. If product is swallowed, get medical help or
contact a Posion Control Center right away.
Close - 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 othersun 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
- Protect the product in this container from excessive heat and direct sun.
CloseINACTIVE INGREDIENTS
WATER, CYCLOPENTASILOXANE, DIPROPYLENE GLYCOL, GLYCERIN, DICAPRYLYL CARBONATE, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, TROMETHAMINE, DIMETHICONE, PANTHENOL, CHRYSIN, GALANTHUS NIVALIS SEED EXTRACT, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, DISTEARDIMONIUM HECTORITE, ALUMINUM HYDROXIDE, STEARIC ACID, ZINC STEARATE, SORBITAN SESQUIOLEATE, DIMETHICONE/PEG-10/15 CROSSPOLYMER, GLYCERYL CAPRYLATE, HYDROGEN DIMETHICONE, DISTEARYLDIMONIUM CHLORIDE, ETHYLHEXYLGLYCERIN, TRISODIUM EDTA, TRIETHOXYCAPRYLYLSILANE, DIPHENYLSILOXY PHENYL TRIMETHICONE, TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE, MICA, TITANIUM DIOXIDE (CI 77891), IRON OXIDES (CI 77491, CI 77492, CI 77499), FRAGRANCE
- PRINCIPAL DISPLAY PANEL
- INGREDIENTS AND APPEARANCE
O HUI PERFECT SUN BLACK EX BROAD SPECTRUM SPF 50
ensulizole, octinoxate, octisalate, titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53208-604 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2.2 g in 50 g ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE 1.75 g in 50 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 3.5 g in 50 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 2.25 g in 50 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 4.86 g in 50 g Inactive Ingredients Ingredient Name Strength DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) WATER (UNII: 059QF0KO0R) DIPROPYLENE GLYCOL (UNII: E107L85C40) TROMETHAMINE (UNII: 023C2WHX2V) STEARIC ACID (UNII: 4ELV7Z65AP) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K) PHENOXYETHANOL (UNII: HIE492ZZ3T) LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA) CHRYSIN (UNII: 3CN01F5ZJ5) HYDROGEN DIMETHICONE (20 CST) (UNII: 12Z59IF64N) DIMETHICONE (UNII: 92RU3N3Y1O) GLYCERIN (UNII: PDC6A3C0OX) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) PANTHENOL (UNII: WV9CM0O67Z) GALANTHUS NIVALIS SEED (UNII: SJ1FOL985M) GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A) DISTEARYLDIMONIUM (UNII: 251IW5I21C) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) MICA (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53208-604-01 1 in 1 CARTON 06/01/2017 1 50 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 06/01/2017 Labeler - LG Household and Health Care Inc (688276187) Establishment Name Address ID/FEI Business Operations LG Household and Health Care Inc 688276187 manufacture(53208-604) CloseEstablishment Name Address ID/FEI Business Operations ZENISCE Co.Ltd. 690188305 manufacture(53208-604)
