Label: IMAN TIME CONTROL OIL FREE MOISTURE COMPLEX SPF 15- octinoxate cream

  • 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 September 5, 2010

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  • ACTIVE INGREDIENT

    Active Ingredients:

    7.5% Ethylhexyl Methoxycinnamate, 3.0% Benzophenone-3

  • PURPOSE

    This advanced hydrating complex conditions the skin with soothing botanics as it controls oil. Provides sun protection with SPF 15, leaves skin soft, supple, and radiant.

  • DOSAGE & ADMINISTRATION


    To Use: Smooth all over face

  • WARNINGS

    Warnings:

    For external use only, not to be swallowed. Avoid contact with eyes. Discontinue use if signs of irritation or rash appear.


  • INACTIVE INGREDIENT

    Inactive Ingredients

    Water, Cetyl Palmitate, Glyceryl Stearate, Myristate Alcohol, Dimethicone, Tocopheryl Acetate (Vitamin E), Retinyl Palmitate, Caprylic/Capric Triglyceride, Pseudoalteromonas Ferment Extract, Hydrolyzed Wheat Protein, Hydrolyzed Soy Protein, Hydrolyzed Silk, Sodium Hyaluronate, Sodium Lactate, Sodium PCA, Sodium Glycotate, Lactic Acid, Glycolic Acid, Malic Acid, Citric Acid, Sodium Citrate, Sodium Malate, Prunus Armeniaca Fruit Extract, Ginkgo Biloba Leaf Extract, Salix Nigra (Willow) Bark Extract, Sodium C8-16 Isoalkylsuccinyl Lactoglobulin Sulfonate, Aloe Barbadensis Leaf Extract, Alcohol Denat, Lecithin, Glycerin, PEG-100 Stearate, Triethanolamine, Phenoxyethanol,  Carbomer, Methylparaben, Propylparaben, Isobutylparaben, Butylparaben, Ethylparaben, Disodium EDTA, Fragrance (Parfum)

  • PRINCIPAL DISPLAY PANEL

    labelabel

  • INGREDIENTS AND APPEARANCE
    IMAN TIME CONTROL OIL FREE MOISTURE COMPLEX SPF 15 
    octinoxate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50950-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 75.5795 g  in 100 g
    ANHYDROUS TRISODIUM CITRATE (UNII: RS7A450LGA) 0.0066 g  in 100 g
    GLYCERIN (UNII: PDC6A3C0OX) 0.71 g  in 100 g
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) 2.5 g  in 100 g
    CETYL PALMITATE (UNII: 5ZA2S6B08X) 2.50 g  in 100 g
    WILLOW BARK (UNII: S883J9JDYX) 0.08 g  in 100 g
    TEA LEAF OIL (UNII: VC855RRT77) 0.02 g  in 100 g
    POLYOXYL 100 STEARATE (UNII: YD01N1999R) 0.8 g  in 100 g
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 0.1 g  in 100 g
    APRICOT JUICE (UNII: YX3B7ZG375) 0.02 g  in 100 g
    HYALURONATE SODIUM (UNII: YSE9PPT4TH) 0.10 g  in 100 g
    GINKGO (UNII: 19FUJ2C58T) 0.02 g  in 100 g
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) 0.0003 g  in 100 g
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.5 g  in 100 g
    MYRISTYL ALCOHOL (UNII: V42034O9PU) 2.0 g  in 100 g
    ALCOHOL (UNII: 3K9958V90M) 0.1 g  in 100 g
    TROLAMINE (UNII: 9O3K93S3TK) 0.512 g  in 100 g
    CARBOMER HOMOPOLYMER TYPE A (UNII: F68VH75CJC) 0.5 g  in 100 g
    PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.798 g  in 100 g
    METHYLPARABEN (UNII: A2I8C7HI9T) 0.17 g  in 100 g
    PROPYLPARABEN (UNII: Z8IX2SC1OH) 0.022 g  in 100 g
    ISOBUTYLPARABEN (UNII: 0QQJ25X58G) 0.022 g  in 100 g
    BUTYLPARABEN (UNII: 3QPI1U3FV8) 0.044 g  in 100 g
    ETHYLPARABEN (UNII: 14255EXE39) 0.044 g  in 100 g
    EDETATE DISODIUM (UNII: 7FLD91C86K) 0.1 g  in 100 g
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62) 0.1 g  in 100 g
    DIMETHICONE (UNII: 92RU3N3Y1O) 1.5 g  in 100 g
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) 0.1 g  in 100 g
    MALIC ACID (UNII: 817L1N4CKP) 0.0003 g  in 100 g
    GLYCOLIC ACID (UNII: 0WT12SX38S) 0.0003 g  in 100 g
    LACTIC ACID (UNII: 33X04XA5AT) 0.0027 g  in 100 g
    SODIUM LACTATE (UNII: TU7HW0W0QT) 0.02 g  in 100 g
    SODIUM GLYCOLATE (UNII: B75E535IMI) 0.0066 g  in 100 g
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) 0.0066 g  in 100 g
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) 0.1 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50950-002-0189 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35209/10/2010
    Labeler - Sheencolor Biotech Co., Ltd. (545285306)
    Registrant - Sheencolor Biotech Co., Ltd. (545285306)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sheencolor Biotech Co., Ltd.545285306manufacture
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