Label: LAB SERIES SKINCARE FOR MEN BB TINTED MOISTURIZER BROAD SPECTRUM SPF 35- octinoxate, octisalate, oxybenzone, titanium dioxide, and zinc oxide liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 11, 2024

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Octinoxate 7.5%
    Octisalate 4.0%
    Oxybenzone 2.5%
    Titanium Dioxide 2.2%
    Zinc Oxide 2.0%

  • Purpose

    Sunscreen

  • Uses

    • helps prevent sunburn
    • if used as directed with other sun protection measures (see Directions) decreases the risk of skin cancer and early skin aging caused by the sun
  • Warnings

    For external use only

    Do not use on damaged or broken skin

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

    Stop use and ask a doctor if rash occurs

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

  • Directions

    For sunscreen use:

    • apply liberally and evenly 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 value of 15 or higher and other sun protection measures including:
      • limit time in the sun, especially from 10 a.m. – 2 p.m.
      • wear long-sleeved shirts, pants, hats and sunglasses
    • children under 6 months of age: ask a doctor
  • Inactive ingredients

    water\aqua\eau•trioctyldodecyl citrate•methyl trimethicone•dimethicone•octyldodecyl stearoyl stearate•butylene glycol•phenyl trimethicone•pentylene glycol•glyceryl stearate•behenyl alcohol•polymethylsilsesquioxane•peg-40 stearate•polyglyceryl-10 pentastearate•acetyl glucosamine•tocopheryl acetate•sodium hyaluronate•lecithin•squalane•sigesbeckia orientalis (st. paul's wort) extract•hordeum vulgare (barley) extract\extrait d'orge• triticum vulgare (wheat) germ extract•laminaria saccharina extract•cucumis sativus (cucumber) fruit extract•pyrus malus (apple) fruit extract•scutellaria baicalensis root extract•caffeine•cholesterol•glycerin•sodium pca•polyglyceryl-6 polyricinoleate•oryzanol•trehalose•octyldodecyl neopentanoate•acetyl hexapeptide-8•propylene glycol stearate•propylene glycol laurate•isopropyl myristate•aluminum hydroxide•sodium stearoyl lactylate•xanthan gum•sucrose•urea•acrylates/ammonium methacrylate copolymer•disodium edta•ammonium acryloyldimethyltaurate/vp copolymer•silica•isopropyl titanium triisostearate•sorbitan laurate•polysorbate 20•polyquaternium-51•stearic acid•linoleic acid•glycyrrhetinic acid•triethyl citrate•triacetin•bht•sodium sulfite•sodium metabisulfite•potassium sorbate•pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate•phenoxyethanol•chlorphenesin•sodium dehydroacetate•[+/- iron oxides (ci 77491)•iron oxides (ci 77492)•iron oxides (ci 77499)•titanium dioxide (ci 77891)] <iln48883>

  • Other information

    protect the product in this container from excessive heat and direct sun

  • PRINCIPAL DISPLAY PANEL - 50 ml Bottle Carton

    LAB

    SERIES

    INSTANT FIX

    BB TINTED

    MOISTURIZER

    BROAD

    SPECTRUM

    SPF 35

    SOLUTIONS FOR MEN

    1.7 FL. OZ./OZ. LIQ./50 ml ℮

    PDP

  • INGREDIENTS AND APPEARANCE
    LAB SERIES SKINCARE FOR MEN  BB TINTED MOISTURIZER BROAD SPECTRUM SPF 35
    octinoxate, octisalate, oxybenzone, titanium dioxide, and zinc oxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42472-011
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE40 mg  in 1 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE25 mg  in 1 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE22 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    PEG-40 STEARATE (UNII: ECU18C66Q7)  
    N-ACETYLGLUCOSAMINE (UNII: V956696549)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    SQUALANE (UNII: GW89575KF9)  
    WHEAT GERM (UNII: YR3G369F5A)  
    SACCHARINA LATISSIMA (UNII: 68CMP2MB55)  
    CUCUMBER (UNII: YY7C30VXJT)  
    APPLE (UNII: B423VGH5S9)  
    SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)  
    CAFFEINE (UNII: 3G6A5W338E)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    ORYZANOL (UNII: SST9XCL51M)  
    TREHALOSE (UNII: B8WCK70T7I)  
    OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
    ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL)  
    PROPYLENE GLYCOL MONOSTEARATE (UNII: MZM1I680W0)  
    PROPYLENE GLYCOL MONOLAURATE (UNII: 668Z5835Z3)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SUCROSE (UNII: C151H8M554)  
    UREA (UNII: 8W8T17847W)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)  
    SORBITAN MONOLAURATE (UNII: 6W9PS8B71J)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    LINOLEIC ACID (UNII: 9KJL21T0QJ)  
    ENOXOLONE (UNII: P540XA09DR)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    WATER (UNII: 059QF0KO0R)  
    TRIOCTYLDODECYL CITRATE (UNII: 35X8CT063R)  
    METHYL TRIMETHICONE (UNII: S73ZQI0GXM)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    OCTYLDODECYL STEAROYL STEARATE (UNII: 3D47Q6D93C)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42472-011-011 in 1 CARTON11/19/2020
    150 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02004/24/2011
    Labeler - Aramis Inc. (042918826)
    Registrant - Estee Lauder Companies Inc. (790802086)
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder N.V.370151326pack(42472-011) , manufacture(42472-011) , label(42472-011)