Label: MARY KAY TIMEWISE MIRACLE SET 3D SAMPLER (NORMAL TO DRY SKIN)- avobenzone, homosalate, octisalate, octocrylene, and oxybenzone kit

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

Drug Label Information

Updated December 17, 2024

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

  • Age Minimize 4-in-1 Cleanser

  • Age Minimize 3D Day Cream SPF 30 Broad-Spectrum Sunscreen

    Drug Facts

  • Active ingredients

    Avobenzone 3%

    Homosalate 9%

    Octisalate 4.5%

    Octocrylene 3%

    Oxybenzone 4.5%

    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

    • apply liberally 15 minutes before sun exposure
    • use a water resistant sunscreen if swimming or sweating
    • reapply at least every 2 hours
    • 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 10 a.m. - 2 p.m.
    • wear long-sleeve shirts, pants, hats, and sunglasses
    • children under 6 months: Ask a doctor
  • Other information

    • protect this product from excessive heat and direct sun
    • store above 32° F / 0° C
  • Inactive ingredients

    water, glycerin, dicaprylyl  carbonate, cetearyl alcohol, dimethicone, ammonium acryloyldimethyltaurate/VP copolymer, ceteareth-25, niacinamide, saccharomyces cerevisiae extract, opuntia ficus-indica fruit extract, tocopheryl acetate, bisabolol, oligopeptide-1, resveratrol,  behenyl alcohol, jojoba esters, sucrose palmitate, disodium ethylene dicocamide PEG-15 disulfate, silica, hydroxypropyl cyclodextrin, glyceryl linoleate, ethoxydiglycol, methyldihydrojasmonate, ethylene brassylate, tetramethyl acetyloctahydronaphthalenes, ethyl linalool, isobutyl methyl  tetrahydropyranol, methylenedioxyphenyl methylpropanal, phenylisohexanol, trimethylbenzenepropanol, methyl benzodioxepinone, triethanolamine, disodium EDTA, sodium benzoate, ethylhexylglycerin, caprylhydroxamic acid, caprylyl glycol, propanediol, phenoxyethanol, iodopropynyl butylcarbamate.

  • Questions?

    Call toll-free 1-800-627-9529

  • Age Minimize 3D Night Cream

  • Age Minimize 3D Eye Cream

  • Principal Display Panel - Normal/Dry sample packettes

    Mary Kay TimeWise Age Minimize 3D 4-in-1 Cleanser .1 OZ. NET WT. / 3 g

    Mary Kay TimeWise Age Minimize 3D Day Cream SPF 30 Broad-Spectrum Sunscreen .06 OZ. NET WT. / 1.7 g / 1,7 g

    Mary Kay TimeWise Age Minimize 3D Night Cream .06 OZ. NET WT. / 1.7 g / 1,7 g

    Mary Kay TimeWise Age Minimize 3D Eye Cream .01 OZ. NET WT. / 0.5 g / 0,5 g

    image of N/D sample packettes

  • INGREDIENTS AND APPEARANCE
    MARY KAY TIMEWISE MIRACLE SET 3D SAMPLER (NORMAL TO DRY SKIN) 
    avobenzone, homosalate, octisalate, octocrylene, and oxybenzone kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51531-5604
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51531-5604-01 in 1 CARTON05/16/2018
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 PACKET 1.7 g
    Part 21 PACKET 3 g
    Part 31 PACKET 1.7 g
    Part 41 PACKET 0.5 g
    Part 1 of 4
    TIMEWISE AGE MINIMIZE 3D DAY CREAM SPF 30  BROAD SPECTRUM SUNSCREEN (NORMAL TO DRY SKIN)
    avobenzone, homosalate, octisalate, octocrylene, oxybenzone cream
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE9 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.5 g  in 100 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE3 g  in 100 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE4.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
    CETEARETH-25 (UNII: 8FA93U5T67)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    SACCHAROMYCES CEREVISIAE (UNII: 978D8U419H)  
    PRICKLY PEAR FRUIT (UNII: 18V8PAQ629)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    RESVERATROL (UNII: Q369O8926L)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)  
    SUCROSE PALMITATE (UNII: 3OSQ643ZK5)  
    DISODIUM ETHYLENE DICOCAMIDE PEG-15 DISULFATE (UNII: QI9A6U005W)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYDROXYPROPYL .ALPHA.-CYCLODEXTRIN (UNII: ZFR0T80O4Y)  
    GLYCERYL MONOLINOLEATE (UNII: 4763AXI84L)  
    DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    METHYL DIHYDROJASMONATE (SYNTHETIC) (UNII: 3GW44CIE3Y)  
    ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)  
    TETRAMETHYL ACETYLOCTAHYDRONAPHTHALENES (UNII: 2JU6ZH6GRE)  
    ETHYL LINALOOL (UNII: SF2JS9GF5T)  
    2-ISOBUTYL-4-METHYLTETRAHYDROPYRAN-4-OL (UNII: VK5ZHH2T3F)  
    3-(3,4-METHYLENEDIOXYPHENYL)-2-METHYLPROPANAL (UNII: L65EG8H6PA)  
    PHENYLISOHEXANOL (UNII: M56178H183)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    TRIMETHYLBENZENEPROPANOL (UNII: 7S411YY2VY)  
    METHYL BENZODIOXEPINONE (UNII: 0NQ136C313)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    11.7 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM020
    Part 2 of 4
    TIMEWISE AGE MINIMIZE 3D 4-IN-1 CLEANSER (NORMAL TO DRY SKIN) 
    cleansing (cold creams, cleansing lotions, liquids, and pads) [skin care preparations (creams, lotions, powder, and sprays)]
    Product Information
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWATER (UNII: 059QF0KO0R)  
    INGRCETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    INGRSODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
    INGRSODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)  
    INGRCOCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    INGRBUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)  
    INGRPROPANEDIOL (UNII: 5965N8W85T)  
    INGRPPG-2 HYDROXYETHYL COCO/ISOSTEARAMIDE (UNII: EK4J71ZKEQ)  
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGRSTARCH, CORN (UNII: O8232NY3SJ)  
    INGRSODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    INGRPOTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    INGRMAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    INGRCOCO GLUCOSIDE (UNII: ICS790225B)  
    INGRCARNAUBA WAX (UNII: R12CBM0EIZ)  
    INGRRESVERATROL (UNII: Q369O8926L)  
    INGRJOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)  
    INGRNIACINAMIDE (UNII: 25X51I8RD4)  
    INGRSUCROSE PALMITATE (UNII: 3OSQ643ZK5)  
    INGR.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    INGRHYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    INGRPOWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    INGRHYDROXYPROPYL .ALPHA.-CYCLODEXTRIN (UNII: ZFR0T80O4Y)  
    INGRLACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    INGRCITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    INGRSODIUM CHLORIDE (UNII: 451W47IQ8X)  
    INGRGLYCERYL MONOLINOLEATE (UNII: 4763AXI84L)  
    INGRDIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    INGRMETHYL DIHYDROJASMONATE (SYNTHETIC) (UNII: 3GW44CIE3Y)  
    INGRETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)  
    INGRTETRAMETHYL ACETYLOCTAHYDRONAPHTHALENES (UNII: 2JU6ZH6GRE)  
    INGRETHYL LINALOOL (UNII: SF2JS9GF5T)  
    INGR2-ISOBUTYL-4-METHYLTETRAHYDROPYRAN-4-OL (UNII: VK5ZHH2T3F)  
    INGR3-(3,4-METHYLENEDIOXYPHENYL)-2-METHYLPROPANAL (UNII: L65EG8H6PA)  
    INGRPHENYLISOHEXANOL (UNII: M56178H183)  
    INGRTRIMETHYLBENZENEPROPANOL (UNII: 7S411YY2VY)  
    INGRMETHYL BENZODIOXEPINONE (UNII: 0NQ136C313)  
    INGREDETATE DISODIUM (UNII: 7FLD91C86K)  
    INGRIODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    INGRMAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    INGRMAGNESIUM NITRATE (UNII: 77CBG3UN78)  
    INGRMETHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    INGRMETHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    INGRTALC (UNII: 7SEV7J4R1U)  
    INGRD&C RED NO. 7 (UNII: ECW0LZ41X8)  
    INGRD&C RED NO. 30 (UNII: 2S42T2808B)  
    INGRULTRAMARINE BLUE (UNII: I39WR998BI)  
    INGRTITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    13 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic
    Part 3 of 4
    TIMEWISE AGE MINIMIZE 3D NIGHT CREAM (NORMAL TO DRY SKIN) 
    night [skin care preparations (creams, lotions, powder, and sprays)]
    Product Information
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWATER (UNII: 059QF0KO0R)  
    INGRDIMETHICONE (UNII: 92RU3N3Y1O)  
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGRALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    INGRMEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    INGRCETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    INGRGLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    INGRCETEARETH-33 (UNII: R42C2O714B)  
    INGRNIACINAMIDE (UNII: 25X51I8RD4)  
    INGRAMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
    INGRRESVERATROL (UNII: Q369O8926L)  
    INGRSODIUM ACRYLOYLDIMETHYLTAURATE-ACRYLAMIDE COPOLYMER (1:1; 90000-150000 MPA.S) (UNII: 5F4963KLHS)  
    INGRISOHEXADECANE (UNII: 918X1OUF1E)  
    INGRBUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    INGRGLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    INGRJOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)  
    INGR.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    INGRISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    INGRSUCROSE PALMITATE (UNII: 3OSQ643ZK5)  
    INGRDIMETHICONOL (100000 CST) (UNII: OSA9UP217S)  
    INGRPOLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    INGRHYDROXYPROPYL .ALPHA.-CYCLODEXTRIN (UNII: ZFR0T80O4Y)  
    INGRGLYCERYL MONOLINOLEATE (UNII: 4763AXI84L)  
    INGRDIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    INGRMETHYL DIHYDROJASMONATE (SYNTHETIC) (UNII: 3GW44CIE3Y)  
    INGRETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)  
    INGRTETRAMETHYL ACETYLOCTAHYDRONAPHTHALENES (UNII: 2JU6ZH6GRE)  
    INGRETHYL LINALOOL (UNII: SF2JS9GF5T)  
    INGR2-ISOBUTYL-4-METHYLTETRAHYDROPYRAN-4-OL (UNII: VK5ZHH2T3F)  
    INGR3-(3,4-METHYLENEDIOXYPHENYL)-2-METHYLPROPANAL (UNII: L65EG8H6PA)  
    INGRPHENYLISOHEXANOL (UNII: M56178H183)  
    INGRTRIMETHYLBENZENEPROPANOL (UNII: 7S411YY2VY)  
    INGRMETHYL BENZODIOXEPINONE (UNII: 0NQ136C313)  
    INGRTROLAMINE (UNII: 9O3K93S3TK)  
    INGREDETATE DISODIUM (UNII: 7FLD91C86K)  
    INGRHYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    INGRETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
    INGRIODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    11.7 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic
    Part 4 of 4
    TIMEWISE AGE MINIMIZE 3D EYE CREAM 
    moisturizing [skin care preparations (creams, lotions, powder, and sprays)]
    Product Information
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWATER (UNII: 059QF0KO0R)  
    INGRCETYL ALCOHOL (UNII: 936JST6JCN)  
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGRALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    INGRSTEARIC ACID (UNII: 4ELV7Z65AP)  
    INGRGLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    INGRPEG-100 STEARATE (UNII: YD01N1999R)  
    INGR1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    INGRNIACINAMIDE (UNII: 25X51I8RD4)  
    INGRFUCUS VESICULOSUS (UNII: 535G2ABX9M)  
    INGRPANTHENOL (UNII: WV9CM0O67Z)  
    INGRRESVERATROL (UNII: Q369O8926L)  
    INGR.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    INGRGLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    INGRXANTHAN GUM (UNII: TTV12P4NEE)  
    INGRHEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    INGRDIMETHICONE (UNII: 92RU3N3Y1O)  
    INGRPOLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    INGRTRICAPRYLIN (UNII: 6P92858988)  
    INGRETHYLHEXYL PALMITATE (UNII: 2865993309)  
    INGRSILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    INGRHYDROXYPROPYL .ALPHA.-CYCLODEXTRIN (UNII: ZFR0T80O4Y)  
    INGRTROLAMINE (UNII: 9O3K93S3TK)  
    INGREDETATE DISODIUM (UNII: 7FLD91C86K)  
    INGRBENZYL ALCOHOL (UNII: LKG8494WBH)  
    INGRCAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    INGRIODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    INGRMICA (UNII: V8A1AW0880)  
    INGRTITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    10.5 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02005/16/201802/19/2025
    Labeler - Mary Kay Inc. (049994452)
    Establishment
    NameAddressID/FEIBusiness Operations
    Mary Kay Inc.103978839manufacture(51531-5604)