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

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated October 10, 2022

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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 finalM02003/01/2012
    Labeler - Mary Kay Inc. (049994452)
    Establishment
    NameAddressID/FEIBusiness Operations
    Mary Kay Inc.103978839manufacture(51531-0850)
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