Label: MARY KAY FOUNDATION PRIMER- avobenzone, homosalate, octisalate, octocrylene gel

  • NDC Code(s): 51531-0850-0, 51531-0850-1
  • Packager: Mary Kay Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 17, 2024

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  • Active Ingredients

    Avobenzone 2.5%

    Homosalate 9%

    Octisalate 5%

    Octocrylene 3%

  • 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
  • Inactive ingredients

    isododecane, dimethicone/bis-isobutyl PPG-20 crosspolymer, polysilicone-11, vp/hexadecene copolymer, silica, C12-15 alkyl benzoate, polyester-7, neopentyl glycol diheptanoate, tribehenin, dipropylene glycol dibenzoate, PPG-15 stearyl ether benzoate

  • Other information

    protect this product from excessive heat and direct sun

  • Questions or comments?

    Call toll free 1-800-627-9529

  • Principal Display Panel - 29 mL carton

    Mary Kay

    foundation primer

    sunscreen

    broad spectrum

    spf 15

    1 FL. OZ. / 29 mL

    image of foundation primer carton

  • INGREDIENTS AND APPEARANCE
    MARY KAY FOUNDATION PRIMER 
    avobenzone, homosalate, octisalate, octocrylene gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51531-0850
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2.5 g  in 100 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE9 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE3 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    ISODODECANE (UNII: A8289P68Y2)  
    DIMETHICONE/BIS-ISOBUTYL PPG-20 CROSSPOLYMER (UNII: O4I3UFO6ZF)  
    VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    POLYESTER-7 (UNII: 0841698D2F)  
    NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
    TRIBEHENIN (UNII: 8OC9U7TQZ0)  
    DIPROPYLENE GLYCOL DIBENZOATE (UNII: 6OA5ZDY41O)  
    PPG-15 STEARYL ETHER BENZOATE (UNII: 80D2J6361M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51531-0850-11 in 1 CARTON03/01/2012
    129 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:51531-0850-00.5 mL in 1 PACKET; Type 0: Not a Combination Product03/01/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02003/01/2012
    Labeler - Mary Kay Inc. (049994452)
    Establishment
    NameAddressID/FEIBusiness Operations
    Mary Kay Inc.103978839manufacture(51531-0850)
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