MAGIS LENE BRILLIANT GOLD CC CREAM XQ (ETHYLHEXYL METHOXYCINNAMATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [INEL COSMETICS CO., LTD]

MAGIS LENE BRILLIANT GOLD CC CREAM XQ (ETHYLHEXYL METHOXYCINNAMATE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [INEL COSMETICS CO., LTD]
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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

    Ethylhexyl Methoxycinnamate 5.00%
    Titanium Dioxide 5.50%
    Zinc Oxide 4.90%

  • PURPOSE

    Sunscreen

    Helps prevent sunburn

  • 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 sunglasses

    Children under 6 months: Ask a doctor.

    For external use only

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • ASK DOCTOR

    Stop use and ask a doctor if rash occurs.

  • WHEN USING

    When using this product keep out of eyes. Rinse with water to remove.

  • DO NOT USE

    Do not use on damaged or broken skin.

  • OTHER SAFETY INFORMATION

    Protect the product in this container from excessive heat and direct sun.

  • 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

    ML CC Cream - FDA

  • INGREDIENTS AND APPEARANCE
    MAGIS LENE BRILLIANT GOLD CC CREAM XQ 
    ethylhexyl methoxycinnamate, titanium dioxide, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43526-114
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.75 g  in 55 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE3.025 g  in 55 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION2.695 g  in 55 g
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43526-114-021 in 1 CARTON01/30/2018
    1NDC:43526-114-0155 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/30/2018
    Labeler - Inel Cosmetics Co., Ltd (688038939)
    Registrant - Inel Cosmetics Co., Ltd (688038939)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kolmar Korea Co., Ltd.689512611manufacture(43526-114)

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