NDC | 43526-114-01, 43526-114-02 |
Set ID | a51183b2-d117-408d-9aff-7817914e9f4a |
Category | HUMAN OTC DRUG LABEL |
Packager | Inel Cosmetics Co., Ltd |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- ACTIVE INGREDIENT
- PURPOSE
-
INSTRUCTIONS FOR USE
Apply liberally 15 minutes before sun exposure
Reapply at least every two hours
Use a water resistant sunscreen if swimming or sweating
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 of 15 or higher and other sun protection measures including:
Limit time in the sun, especially from 10a.m. - 2p.m.
Wear long-sleeve shirts, pants, hats, and sunglassesChildren under 6 months: Ask a doctor.
For external use only
- KEEP OUT OF REACH OF CHILDREN
- ASK DOCTOR
- WHEN USING
- DO NOT USE
- OTHER SAFETY INFORMATION
-
INACTIVE INGREDIENT
WATER
CYCLOMETHICONE 5
PHENYL TRIMETHICONE
CYCLOMETHICONE 6
CAPRYLYL TRISILOXANE
NIACINAMIDE
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE
METHYLPROPANEDIOL
SODIUM CHLORIDE
GLYCERIN
SUNFLOWER OIL
HONEY
ROYAL JELLY
PRUNUS SERRULATA FLOWER
NYMPHAEA ALBA FLOWER
NELUMBO NUCIFERA FLOWER
CENTELLA ASIATICA
PURSLANE
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE
SORBITAN ISOSTEARATE
PENTYLENE GLYCOL
DISTEARDIMONIUM HECTORITE
TRIBEHENIN
PEG-10 DIMETHICONE (600 CST)
GLYCERYL TRIBEHENATE/ISOSTEARATE/EICOSANDIOATE
DIMETHICONE
ALUMINUM HYDROXIDE
STEARIC ACID
DIMETHICONE
SILICA DIMETHYL SILYLATE
ETHYLHEXYLGLYCERIN
TRIETHOXYCAPRYLYLSILANE
ADENOSINE
BUTYLENE GLYCOL
ETHYLHEXYL PALMITATE
CAPRYLYL GLYCOL
SODIUM HYALURONATE
HEXYLENE GLYCOL
DISODIUM EDTA
PHENOXYETHANOL
MICA (CI 77019)
FERRIC OXIDE YELLOW
FERRIC OXIDE RED
FERROSOFERRIC OXIDE
GOLD - PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
MAGIS LENE BRILLIANT GOLD CC CREAM XQ
ethylhexyl methoxycinnamate, titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43526-114 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.75 g in 55 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 3.025 g in 55 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 2.695 g in 55 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) CYCLOMETHICONE 6 (UNII: XHK3U310BA) CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL) NIACINAMIDE (UNII: 25X51I8RD4) LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA) METHYLPROPANEDIOL (UNII: N8F53B3R4R) SODIUM CHLORIDE (UNII: 451W47IQ8X) GLYCERIN (UNII: PDC6A3C0OX) SUNFLOWER OIL (UNII: 3W1JG795YI) HONEY (UNII: Y9H1V576FH) ROYAL JELLY (UNII: L497I37F0C) PRUNUS SERRULATA FLOWER (UNII: 60I4615G0K) NYMPHAEA ALBA FLOWER (UNII: 40KQ7Q535O) NELUMBO NUCIFERA FLOWER (UNII: 61W322NLDV) CENTELLA ASIATICA (UNII: 7M867G6T1U) PURSLANE (UNII: M6S840WXG5) BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI) SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4) PENTYLENE GLYCOL (UNII: 50C1307PZG) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) TRIBEHENIN (UNII: 8OC9U7TQZ0) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) GLYCERYL TRIBEHENATE/ISOSTEARATE/EICOSANDIOATE (UNII: 3Y9NJ5Z7E5) DIMETHICONE (UNII: 92RU3N3Y1O) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) STEARIC ACID (UNII: 4ELV7Z65AP) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) ADENOSINE (UNII: K72T3FS567) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) ETHYLHEXYL PALMITATE (UNII: 2865993309) CAPRYLYL GLYCOL (UNII: 00YIU5438U) HYALURONATE SODIUM (UNII: YSE9PPT4TH) HEXYLENE GLYCOL (UNII: KEH0A3F75J) EDETATE DISODIUM (UNII: 7FLD91C86K) PHENOXYETHANOL (UNII: HIE492ZZ3T) MICA (UNII: V8A1AW0880) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERRIC OXIDE RED (UNII: 1K09F3G675) FERROSOFERRIC OXIDE (UNII: XM0M87F357) GOLD (UNII: 79Y1949PYO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43526-114-02 1 in 1 CARTON 01/30/2018 1 NDC:43526-114-01 55 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 01/30/2018 Labeler - Inel Cosmetics Co., Ltd (688038939) Registrant - Inel Cosmetics Co., Ltd (688038939) Establishment Name Address ID/FEI Business Operations Kolmar Korea Co., Ltd. 689512611 manufacture(43526-114)