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

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 03/13

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  • Active Ingredients

    Avobenzone 2.5%

    Homosalate 9%

    Octisalate 5%

    Octocrylene 3%

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  • Purpose

    Sunscreen

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  • 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
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  • 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.

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  • 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
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  • 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

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  • Other information

    protect this product from excessive heat and direct sun

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  • Questions or comments?

    Call toll free 1-800-627-9529

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  • Principal Display Panel - 29 mL carton

    Mary Kay

    foundation primer

    sunscreen

    broad spectrum

    spf 15

    1 FL. OZ. / 29 mL

    Image of carton

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  • INGREDIENTS AND APPEARANCE
    MARY KAY FOUNDATION PRIMER 
    avobenzone, homosalate, octisalate, octocrylene gel
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:51531-0850
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    AVOBENZONE (AVOBENZONE) AVOBENZONE 2.5 g  in 100 mL
    HOMOSALATE (HOMOSALATE) HOMOSALATE 9 g  in 100 mL
    OCTISALATE (OCTISALATE) OCTISALATE 5 g  in 100 mL
    OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 3 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    ISODODECANE  
    HEXADECYL POVIDONE (4 HEXADECYL BRANCHES/REPEAT)  
    SILICON DIOXIDE  
    ALKYL (C12-15) BENZOATE  
    POLYESTER-7  
    NEOPENTYL GLYCOL DIHEPTANOATE  
    TRIBEHENIN  
    DIPROPYLENE GLYCOL DIBENZOATE  
    PPG-15 STEARYL ETHER BENZOATE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51531-0850-1 1 in 1 CARTON
    1 29 mL in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part352 03/01/2012
    Labeler - Mary Kay Inc. (103978839)
    Establishment
    Name Address ID/FEI Business Operations
    Mary Kay Inc. 103978839 manufacture(51531-0850)
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