MARY KAY SUN PROTECTOR SPF 35 (AVOBENZONE, HOMOSALATE, OCTISALATE, OXYBENZONE) CREAM [MARY KAY INC.]

MARY KAY SUN PROTECTOR SPF 35 (AVOBENZONE, HOMOSALATE, OCTISALATE, OXYBENZONE) CREAM [MARY KAY INC.]
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NDC 51531-8450-2
Set ID 91678a40-ae7a-4ab0-a91e-0456735651d8
Category HUMAN OTC DRUG LABEL
Packager Mary Kay Inc.
Generic Name
Product Class
Product Number
Application Number
  • PURPOSE

    Broad-spectrum UVA/UVB protection.

  • INDICATIONS & USAGE

    • Suitable for sensitive skin.
    • Dermatologist-tested.
    • Tested for Asian skin.
  • Warnings

    Contains Oxybenzone. For external use only. Not to be swallowed. Avoid contact with the eyes. Discontinue use if signs of irritation or rash appear. Do not use on children under 3 years of age. Keep out of the reach of children. Do not stay too long in the sun, even when using a sunscreen product.

  • Directions

    Smooth on liberally after moisturizer. Apply prior to sun exposure and as often as necessary.

  • INGREDIENTS

    WATER, HOMOSALATE, DIMETHICONE, OCTISALATE, OXYBENZONE, STYRENE/ACRYLATES
    COPOLYMER, C12-15 ALKYL BENZOATE, BUTYLENE GLYCOL, DICAPRYLYL
    CARBONATE, OCTOCRYLENE, AVOBENZONE, GLYCERIN, CETEARETH-25, DIMETHICONE CROSSPOLYMER,
    MAGNESIUM ALUMINUM SILICATE, DIPROPYLENE GLYCOL DIBENZOATE,
    ACRYLATES/C12-22 ALKYL METHACRYLATE COPOLYMER, PHENOXYETHANOL, DISODIUM ETHYLENE
    DICOCAMIDE PEG-15 DISULFATE, PENTYLENE GLYCOL, TOCOPHERYL
    ACETATE, CAPRYLYL GLYCOL, HYDROGENATED LECITHIN, XANTHAN GUM, PPG-15 STEARYL ETHER
    BENZOATE, DISODIUM EDTA, ETHYLENE BRASSYLATE, PROPYLENE GLYCOL, PEG-4 LAURATE, SORBIC
    ACID, ISOBUTYL METHYL TETRAHYDROPYRANOL, IODOPROPYNYL BUTYLCARBAMATE, ETHYL LINALOOL,  METHYLENEDIOXYPHENYL METHYLPROPANAL, AMMONIUM HYDROXIDE, PHENYLISOHEXANOL, CYCLAMEN ALDEHYDE.

  • Prinicipal Display Panel - 59 mL carton

    Mary Kay

    sun protector SPF 35 / PA+++

    2.0 FL. OZ. / 59 mL

    image of carton

  • INGREDIENTS AND APPEARANCE
    MARY KAY SUN PROTECTOR SPF 35 
    avobenzone, homosalate, octisalate, oxybenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51531-8450
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2 g  in 100 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE4 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETEARETH-25 (UNII: 8FA93U5T67)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    DIPROPYLENE GLYCOL DIBENZOATE (UNII: 6OA5ZDY41O)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    DISODIUM ETHYLENE DICOCAMIDE PEG-15 DISULFATE (UNII: QI9A6U005W)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    PPG-15 STEARYL ETHER BENZOATE (UNII: 80D2J6361M)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)  
    PEG-4 LAURATE (UNII: AYF4VM3N1Z)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SORBIC ACID (UNII: X045WJ989B)  
    2-ISOBUTYL-4-METHYLTETRAHYDROPYRAN-4-OL (UNII: VK5ZHH2T3F)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    ETHYL LINALOOL (UNII: SF2JS9GF5T)  
    3-(3,4-METHYLENEDIOXYPHENYL)-2-METHYLPROPANAL (UNII: L65EG8H6PA)  
    PHENYLISOHEXANOL (UNII: M56178H183)  
    CYCLAMEN ALDEHYDE (UNII: 4U37UX0E1E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51531-8450-21 in 1 CARTON06/26/2013
    159 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:51531-8450-00.49 mL in 1 PACKET; Type 0: Not a Combination Product06/26/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Export only06/26/2013
    Labeler - Mary Kay Inc. (049994452)
    Establishment
    NameAddressID/FEIBusiness Operations
    Le Papillon, Ltd.040070823pack(51531-8450)
    Establishment
    NameAddressID/FEIBusiness Operations
    Englewood Lab, Inc.080987545pack(51531-8450)
    Establishment
    NameAddressID/FEIBusiness Operations
    Mary Kay Inc.103978839manufacture(51531-8450)

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