Label: ARTISTRY EXACT FIT LONGWEARING FOUNDATION SHADE CARAMEL L5N1- titanium dioxide cream

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated October 22, 2023

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  • Drug Facts

  • Active Ingredients

    Titanium Dioxide 4.025% (W/W P/P)

    Purpose

    Sunscreen

  • Uses

    • Helps prevent sunburn
  • Warnings

    For external use only

    Do not use

    on broken or damaged 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

    For suncreen use

    • Apply liberally 15 minutes before sun exposure
    • Use a water resistant sunscreen if swimming or sweating or washing
    • Reapply at least every 2 hours
    • Spending time in the sun increases your risk of skin cancer and early skin aging. Sun Protection Measures.
    • 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

    • Protect this product from excessive heat and direct sun
  • Inactive ingredients

    WATER/AQUA/EAU, CYCLOPENTASILOXANE, TRIMETHYLSILOXYSILICATE, GLYCERIN, PEG-10 DIMETHICONE, BUTYLENE GLYCOL, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, TRIMETHYLSILOXYPHENYL DIMETHICONE, TALC, SILICA, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, POLYSILICONE-11, PHENOXYETHANOL, DISTEARDIMONIUM HECTORITE, ALUMINA, POLYSORBATE-20, SODIUM CHLORIDE, SODIUM CITRATE, STEAROYL GLUTAMIC ACID, TRIETHOXYCAPRYLYLSILANE, METHYLPARABEN, DISODIUM EDTA, TOCOPHERYL ACETATE, PROPYLPARABEN, ETHYLPARABEN, IODOPROPYNYL BUTYLCARBAMATE, PEARL POWDER, LAURETH-12, LECITHIN, CERAMIDE NP, BETA-SITOSTEROL, SODIUM HYALURONATE, GLUCOSAMINE HCL, UREA, YEAST EXTRACT, ALGAE EXTRACT, TOCOPHEROL CITRIC ACID, SODIUM HYDROXIDE MAY CONTAIN / PEUT CONTIENIR: IRON OXIDES (CI 77491, 77492, 77499), BISMUTH OXYCHLORIDE (CI 77163), TITANIUM DIOXIDE (CI 77891).

  • Package Labeling:

    Label0Shade12

  • INGREDIENTS AND APPEARANCE
    ARTISTRY EXACT FIT LONGWEARING FOUNDATION SHADE CARAMEL   L5N1
    titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50390-212
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE40.25 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
    TALC (UNII: 7SEV7J4R1U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    STEAROYL GLUTAMIC ACID (UNII: 4R4O71786G)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    PEARL (HYRIOPSIS CUMINGII) (UNII: A75L5FZ40U)  
    LAURETH-12 (UNII: OAH19558U1)  
    CERAMIDE NP (UNII: 4370DF050B)  
    .BETA.-SITOSTEROL (UNII: S347WMO6M4)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    GLUCOSAMINE HYDROCHLORIDE (UNII: 750W5330FY)  
    UREA (UNII: 8W8T17847W)  
    YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50390-212-301 in 1 CARTON05/01/2015
    130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02005/01/2015
    Labeler - Amway Corp (083416854)