Label: MAGIS LENE COLLAGEN CHOC EXTRA GOLD BB CREAM- ethylhexyl methoxycinnamate, titanium dioxide, zinc oxide cream

  • NDC Code(s): 43526-113-01, 43526-113-02
  • Packager: Inel Cosmetics Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated January 30, 2018

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Ethylhexyl Methoxycinnamate 3.00%
    Titanium Dioxide 8.61%
    Zinc Oxide 1.92%

  • 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

    CYCLOPENTASILOXANE

    TALC

    GLYCERIN

    ISOEICOSANE

    PEG-10 DIMETHICONE (600 CST)

    MICA

    ARBUTIN

    DIPROPYLENE GLYCOL

    CYCLOMETHICONE

    TRIETHYLHEXANOIN

    DISTEARDIMONIUM HECTORITE

    HEXYL LAURATE

    MAGNESIUM SULFATE

    FERRIC OXIDE YELLOW

    C12-14 PARETH-3

    PHENOXYETHANOL

    FERROSOFERRIC OXIDE

    FERRIC OXIDE RED

    METHICONE (20 CST)

    PALMITIC ACID

    METHYLPARABEN

    TOCOPHERYL ACETATE

    DIMETHICONE

    BETAINE

    PROPYLPARABEN

    ALUMINUM HYDROXIDE

    ADENOSINE

    ALUMINUM STEARATE

    BUTYLPARABEN

    DIMETHICONE

    PORK COLLAGEN

    CERAMIDE 3

    GOLD

    PRUNUS SERRULATA FLOWER EXTRACT

  • PRINCIPAL DISPLAY PANEL

    ML BB Cream - FDA

  • INGREDIENTS AND APPEARANCE
    MAGIS LENE COLLAGEN CHOC EXTRA GOLD BB CREAM 
    ethylhexyl methoxycinnamate, titanium dioxide, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43526-113
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.5 g  in 50 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE4.305 g  in 50 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.96 g  in 50 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    TALC (UNII: 7SEV7J4R1U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOEICOSANE (UNII: AR294KAG3T)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    MICA (UNII: V8A1AW0880)  
    ARBUTIN (UNII: C5INA23HXF)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    C12-14 PARETH-3 (UNII: 93RY22U87E)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    METHICONE (20 CST) (UNII: 6777U11MKT)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    BETAINE (UNII: 3SCV180C9W)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    ADENOSINE (UNII: K72T3FS567)  
    ALUMINUM STEARATE (UNII: U6XF9NP8HM)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    PORK COLLAGEN (UNII: I8442U2G7J)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    GOLD (UNII: 79Y1949PYO)  
    PRUNUS SERRULATA FLOWER (UNII: 60I4615G0K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43526-113-021 in 1 CARTON01/30/2018
    1NDC:43526-113-0150 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(43526-113)