Label: MARY KAY SUNCARE SPF 50 SUNSCREEN- 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.

  • ACTIVE INGREDIENTS:

    HOMOSALATE (10% W/W)

    OCTOCRYLENE (5.50% W/W)

    OXYBENZONE (5% W/W)

    OCTISALATE (4.50% W/W)

    AVOBENZONE (3% W/W)

  • Indications:

    Protects from certain harmful UVA and UVB rays of the sun to help prevent sunburn.

    Provides high sunburn protection but not 100% protection.

    Retains its sun protection for 80 minutes in water.

  • Warnings:

    For external use only.

    Stop use and ask a doctor if rash occurs .

    Do not use on damaged or broken skin.

    If swallowed, get medical help or contact a poison control center immediately.

    For use on children under 6 months of age, consult your doctor.

    Avoid contact with eyes.

    If contact occurs, rinse thoroughly with water.

    Keep out of reach of children.

    Sun Alert: The sun may cause sunburn, premature aging of the skin and skin cancer.

    Avoiding the sun, wearing protective clothing, sunglasses, and regular use of sunscreens over the years may reduce the chance of these harmful effects.

    Keep babies and children out of direct sunlight.

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

    Limit time in the sun, especially from  10 a.m. - 4 p.m.).

    Wear long-sleeved shirts, pants, hats and sunglasses.

    This product contains Oxybenzone.

  • Directions:

    Adults and children older than 6 months of age: Apply a generous amount sufficiently at least 15 minutes before sun exposure.

    Reapply at least every 2 hours.

    Reapply after 80 minutes of swimming or sweating, and reapply immediately after towel drying.

  • Ingredients:

    WATER/EAU,  STYRENE/ACRYLATES COPOLYMER, BUTYLOCTYL SALICYLATE, 

    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

    spf 50 sunscreen

    écran solaire fps 50

    protector solar fps 50

    lotion/loción

    DIN 02410915

    4 FL. OZ. / 118 mL

    image of carton

  • INGREDIENTS AND APPEARANCE
    MARY KAY SUNCARE SPF 50 SUNSCREEN 
    avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51531-3274
    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
    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)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    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)  
    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)  
    VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51531-3274-41 in 1 CARTON12/16/2013
    1118 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Export only12/16/201311/07/2025
    Labeler - Mary Kay Inc. (049994452)
    Establishment
    NameAddressID/FEIBusiness Operations
    Mary Kay Inc.103978839manufacture(51531-3274)