Label: MK MEN ADVANCED FACIAL HYDRATOR SUNSCREEN SPF 30- avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Export only

Drug Label Information

Updated August 24, 2020

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  • ACTIVE INGREDIENTS:

    AVOBENZONE (2% W/W)

    HOMOSALATE (5% W/W)

    OCTISALATE (5% W/W)

    OCTOCRYLENE (2% W/W)

    OXYBENZONE (4% W/W)

  • Indications:

    Broad spectrum UVA/UVB protection.

    Filters certain of the sun's harmful UV rays to help prevent sunburn.

  • Warnings:

    For external use only, not to be swallowed.

    Avoid contact with the eyes.

    If contact occurs, rinse thoroughly with water.

    Discontinue use if skin irritation develops or increases.

    If irritation persists, consult a doctor.

    Contains Oxybenzone.

    Keep out of the reach of children.

    Do not stay too long in the sun, even while using a sunscreen product.

  • Directions:

    Apply liberally after using cleanser and prior to sun exposure.

    For SPF protection, reapply frequently and as necessary.

  • Principal Display Panel - 88 mL carton

    MK Men

    ADVANCED FACIAL HYDRATOR
    SUNSCREEN SPF 30
    HYDRATANT VISAGE
    FPS 30 INTENSIF
    LOCIÓN FACIAL HIDRATANTE
    INTENSIVA FPS 30
    LOTION / LOCIÓN
    DIN 02395630

    3 FL. OZ. / 88 mL

    image of carton

  • INGREDIENTS AND APPEARANCE
    MK MEN ADVANCED FACIAL HYDRATOR SUNSCREEN SPF 30 
    avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51531-0291
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2 g  in 100 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE5 g  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE4 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERETH-26 (UNII: NNE56F2N14)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    PHENETHYL BENZOATE (UNII: 0C143929GK)  
    TRISILOXANE (UNII: 9G1ZW13R0G)  
    POLYESTER-7 (UNII: 0841698D2F)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    BETAINE (UNII: 3SCV180C9W)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ACRYLIC ACID/ETHYLENE COPOLYMER (600 MPA.S) (UNII: 1PEZ3NLY6I)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    DIPROPYLENE GLYCOL DIBENZOATE (UNII: 6OA5ZDY41O)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
    METHYL TRIMETHICONE (UNII: S73ZQI0GXM)  
    DIMETHYL CAPRAMIDE (UNII: O29Y6X2JEZ)  
    SQUALANE (UNII: GW89575KF9)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
    PPG-15 STEARYL ETHER BENZOATE (UNII: 80D2J6361M)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SORBIC ACID (UNII: X045WJ989B)  
    ALLANTOIN (UNII: 344S277G0Z)  
    METHYL DIHYDROJASMONATE (SYNTHETIC) (UNII: 3GW44CIE3Y)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)  
    ETHYL LINALOOL (UNII: SF2JS9GF5T)  
    TRIMETHYLBENZENEPROPANOL (UNII: 7S411YY2VY)  
    2-ISOBUTYL-4-METHYLTETRAHYDROPYRAN-4-OL (UNII: VK5ZHH2T3F)  
    AMMONIA (UNII: 5138Q19F1X)  
    .GAMMA.-UNDECALACTONE (UNII: QB1T0AG2YL)  
    PHENYLISOHEXANOL (UNII: M56178H183)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51531-0291-31 in 1 CARTON12/05/2012
    188 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Export only12/05/2012
    Labeler - Mary Kay Inc. (049994452)
    Establishment
    NameAddressID/FEIBusiness Operations
    Mary Kay Inc.103978839manufacture(51531-0291)
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