Label: MARY KAY SUNCARE SUNSCREEN SPF 50- avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion

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

Drug Label Information

Updated December 17, 2024

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

  • PURPOSE

    UVA/UVB protection

  • Indications:

    Helps to protect your skin from the damaging effects of the sun.

    Protects from certain harmful UV rays of the sun to help prevent sunburn.

  • Warnings:

    For external use only, not to be swallowed.

    If rash or irritation develops, discontinue use.

    Avoid use in the eye area.

    Keep out of reach of children.

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

    Overexposure to the sun is dangerous.

    Avoid excessive sun exposure at peak hours (between 11 a.m. and 3 p.m.).

    Keep yourself well covered (hat, clothing, sunglasses).

    Contains Benzophenone-3.

  • Directions:

    Apply liberally (about 6 teaspoons or 36 grams of sunscreen for the average adult body) at least 15 minutes before sun exposure.
    Warning: Reducing this quantity will lower the level of protection significantly.
    Re-apply every one to three hours to maintain protection, especially after swimming, toweling, vigorous activities or excessive sweating.

  • Ingredients:

    AQUA, HOMOSALATE, OCTOCRYLENE, BENZOPHENONE-3, ETHYLHEXYL SALICYLATE,

    STYRENE/ACRYLATES COPOLYMER, BUTYLOCTYL SALICYLATE, BUTYL METHOXYDIBENZOYLMETHANE,

    BUTYLENE GLYCOL, CETEARYL ALCOHOL, CETETH-20 PHOSPHATE, METHYL TRIMETHICONE,

    SILICA, ACRYLATES/DIMETHICONE COPOLYMER, ACRYLATES/C12-22 ALKYL METHACRYLATE COPOLYMER,

    ETHYLHEXYL METHOXYCRYLENE, VP/EICOSENE COPOLYMER, BEHENYL ALCOHOL, GLYCERIN,

    DICETYL PHOSPHATE, PENTYLENE GLYCOL, DIMETHICONE, TRIMETHYLSILOXYSILICATE,

    AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER, PHENOXYETHANOL, CAPRYLYL GLYCOL,

    TRIETHANOLAMINE, ETHYLENE BRASSYLATE, XANTHAN GUM, PROPYLENE GLYCOL, DISODIUM EDTA,

    TOCOPHERYL ACETATE, SORBIC ACID, ISOBUTYL METHYL TETRAHYDROPYRANOL,

    EUTERPE OLERACEA FRUIT EXTRACT, ETHYL LINALOOL, METHYLENEDIOXYPHENYL METHYLPROPANAL,

    AMMONIUM HYDROXIDE, PHENYLISOHEXANOL, CYCLAMEN ALDEHYDE.

  • Principal Display Panel - 118 mL carton

    Mary Kay

    suncare

    sunscreen

    spf 50 sunscreen UVA

    high protection

    sonnenpflege lsf 50

    hoher schutz

    118 mL

    image of carton

  • INGREDIENTS AND APPEARANCE
    MARY KAY SUNCARE SUNSCREEN SPF 50 
    avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51531-3275
    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
    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)  
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51531-3275-41 in 1 CARTON03/16/2013
    1118 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Export only03/16/201307/12/2025
    Labeler - Mary Kay Inc. (049994452)
    Establishment
    NameAddressID/FEIBusiness Operations
    Mary Kay Inc.103978839manufacture(51531-3275)