MARY KAY SUNCARE SUNSCREEN BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [MARY KAY INC.]

MARY KAY SUNCARE SUNSCREEN BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [MARY KAY INC.]
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NDC 51531-3276-4
Set ID 91d16ee2-aefe-44f8-a58a-3cfd19a543f9
Category HUMAN OTC DRUG LABEL
Packager Mary Kay Inc.
Generic Name
Product Class
Product Number
Application Number PART352
  • Active Ingredients

    Avobenzone 3%

    Homosalate 10%

    Octisalate 4.5%

    Octocrylene 5.5%

    Oxybenzone 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
    •reapply:
    •    after 80 munutes of swimming or sweating
    •    immediately after towel drying
    •    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

  • Inactive ingredients

    acrylates/C12-22 alkyl methacrylate copolymer, acrylates/dimethicone copolymer,

    ammonium acryloyldimethyltaurate/vp copolymer, ammonium hydroxide, behenyl alcohol,

    butylene glycol, butyloctyl salicylate, caprylyl glycol,

    cetearyl alcohol, ceteth-20 phosphate, cyclamen

    aldehyde, dicetyl phosphate, dimethicone, disodium

    EDTA, ethyl linalool, ethylene brassylate, ethylhexyl

    methoxycrylene, euterpe oleracea

    fruit extract, glycerin, isobutyl methyl

    tetrahydropyranol, methyl trimethicone, methylenedioxyphenyl

    methylpropanal,  pentylene glycol, phenoxyethanol, phenylisohexanol,

    propylene glycol, silica, sorbic acid,

    styrene/acrylates copolymer, tocopheryl acetate,

    triethanolamine, trimethylsiloxysilicate, vp/eicosene

    copolymer, water, xanthan gum

  • Other information

    •protect this product from excessive heat and direct sun

  • Questions or comments?

    Call toll free 1-800-627-9529

  • Principal Display Panel - 118 mL carton

    Mary Kay

    suncare

    sunscreen

    broad spectrum spf 50

    protector solar

    con amplia proteccion solar fps 50

    water resistant

    (80 minutes)

    a prueba de agua

    (80 minutos)

    4 FL. OZ. / 118 mL

    image of carton

  • INGREDIENTS AND APPEARANCE
    MARY KAY SUNCARE SUNSCREEN BROAD SPECTRUM SPF 50 
    avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51531-3276
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.5 g  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE5.5 g  in 100 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SORBIC ACID (UNII: X045WJ989B)  
    2-ISOBUTYL-4-METHYLTETRAHYDROPYRAN-4-OL (UNII: VK5ZHH2T3F)  
    3-(3,4-METHYLENEDIOXYPHENYL)-2-METHYLPROPANAL (UNII: L65EG8H6PA)  
    ACAI (UNII: 46AM2VJ0AW)  
    ETHYL LINALOOL (UNII: SF2JS9GF5T)  
    AMMONIA (UNII: 5138Q19F1X)  
    PHENYLISOHEXANOL (UNII: M56178H183)  
    CYCLAMEN ALDEHYDE (UNII: 4U37UX0E1E)  
    WATER (UNII: 059QF0KO0R)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETETH-20 PHOSPHATE (UNII: 921FTA1500)  
    METHYL TRIMETHICONE (UNII: S73ZQI0GXM)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)  
    ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51531-3276-41 in 1 CARTON03/16/2014
    1118 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35203/16/201408/19/2023
    Labeler - Mary Kay Inc. (049994452)
    Establishment
    NameAddressID/FEIBusiness Operations
    Mary Kay Inc.103978839manufacture(51531-3276)

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