Label: MARY KAY CC CREAM SUNSCREEN BROAD SPECTRUM SPF 15 LIGHT TO MEDIUM- homosalate, octinoxate, oxybenzone cream

  • NDC Code(s): 51531-2823-1, 51531-2823-3
  • Packager: Mary Kay Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 July 24, 2023

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  • Active ingredients

    Homosalate 5%

    Octinoxate 6.5%

    Oxybenzone 1.2 %

  • 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
  • Other information

    • Store at 25°C (77°F). Do not freeze or refrigerate.
  • Inactive ingredients

    water, cyclopentasiloxane, butylene glycol, glycerin, PEG-9 polydimethylsiloxyethyl dimethicone, niacinamide, mica, PEG-9 dimethicone, magnesium sulfate, ascorbyl glucoside, silybum marianum fruit extract, tocopheryl acetate, salix nigra (willow) bark extract, salicylic acid, adenosine, dimethicone/PEG-10/15 crosspolymer, disodium stearoyl glutamate, xanthan gum, dipropylene glycol, disodium EDTA, cyclohexasiloxane, sodium citrate, tocopherol, sorbic acid, sodium benzoate, benzyl alcohol, aluminum hydroxide, titanium dioxide, iron oxides

  • Questions or comments?

    Call toll free 1-800-627-9529

  • Principal Display Panel - 29 mL carton

    Mary Kay

    cc cream

    sunscreen broad

    spectrum spf 15

    cream

    1 FL. OZ. / 29 mL

    image of carton

  • INGREDIENTS AND APPEARANCE
    MARY KAY CC CREAM SUNSCREEN BROAD SPECTRUM SPF 15 LIGHT TO MEDIUM 
    homosalate, octinoxate, oxybenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51531-2823
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE5 g  in 100 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE6.5 g  in 100 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE1.2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    MICA (UNII: V8A1AW0880)  
    PEG-9 DIMETHICONE (400 CST) (UNII: 9OZ27X065D)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)  
    MILK THISTLE (UNII: U946SH95EE)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SALIX NIGRA BARK (UNII: QU52J3A5B3)  
    SALICYLIC ACID (UNII: O414PZ4LPZ)  
    ADENOSINE (UNII: K72T3FS567)  
    DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    SORBIC ACID (UNII: X045WJ989B)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51531-2823-11 in 1 CARTON02/16/2014
    129 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:51531-2823-31 mL in 1 PACKET; Type 0: Not a Combination Product02/16/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM02002/16/2014
    Labeler - Mary Kay Inc. (049994452)
    Establishment
    NameAddressID/FEIBusiness Operations
    Englewood Lab Inc.172198223manufacture(51531-2823)
    Establishment
    NameAddressID/FEIBusiness Operations
    Mary Kay Inc.103978839manufacture(51531-2823)
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