Label: ARTISTRY IDEAL RADIANCE ILLUMINATING CC SPF 50 BROAD SPECTRUM SUNSCREEN LIGHT/MEDIUM- ensulizole,octinoxate, oxybenzone, titanium dioxide, zinc oxide cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 December 6, 2018

If you are a consumer or patient please visit this version.

  • Drug Facts

  • Active Ingredients

    Ensulizole 2.0% (W/W P/P)
    Octinoxate 5.5% (W/W P/P)
    Oxybenzone 0.5% (WW P/P)
    Titanium Dioxide 0.84% (W/W P/P)
    Zinc Oxide 9.8% (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.

    Keep out of reach of children.

    If product is swallowed, get medical help or contact a Poison Control Center right away.

  • Other Information

    ■ Protect this product from excessive heat and direct sun

  • Inactive Ingredients

    WATER/EAU/AQUA, DIMETHICONE, CYCLOPENTASILOXANE, METHYL TRIMETHICONE, BUTYLENE GLYCOL, GLYCERIN, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, TALC, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, TRIMETHYLOLPROPANE TRICAPRYLATE/TRICAPRATE, TRIETHANOLAMINE, HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, POLYGLYCERYL-6 POLYRICINOLEATE, DIMETHICONE/PEG-10/15 CROSSPOLYMER, PHENOXYETHANOL, SODIUM CHLORIDE, SODIUM CITRATE, PEG/PPG-18/18 DIMETHICONE, ALUMINA, POLYGLYCERYL-3, POLYDIMETHYLSILOXYETHYL DIMETHICONE, TRISILOXANE, HYDROGEN DIMETHICONE, ALUMINUM HYDROXIDE, STEARIC ACID, TRIETHOXYCAPRYLYLSILANE, METHYLPARABEN, DISODIUM EDTA, FRAGRANCE/PARFUM, SILICA, PROPYLPARABEN, BELLIS PERENNIS (DAISY) FLOWER EXTRACT, MALTODEXTRIN, ETHYLPARABEN,, IODOPROPYNYL BUTYLCARBAMATE, JASMINUM OFFICINALE (JASMINE) FLOWER EXTRACT, LECITHIN, SOPHORA JAPONICA FLOWER POWDER, GERANIUM ROBERTIANUM EXTRACT, OENOTHERA BIENNIS (EVENING PRIMROSE) SEED EXTRACT, LACTOBACILLUS/ACEROLA CHERRY FERMENT, GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT, HYDROLYZED CONCHIOLIN PROTEIN, TOCOPHERYL ACETATE, CERAMIDE-3, BETA-SITOSTEROL, TETRAHEXYLDECYL ASCORBATE, MAY CONTAIN/PEUT CONTEINIR: IRON OXIDES (CI 77491, CI 77492, CI 77499), MICA (CI 77019), TITANIUM DIOXIDE (CI 77891).

  • 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
    ■ 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

  • Product Label

    Carton

  • INGREDIENTS AND APPEARANCE
    ARTISTRY IDEAL RADIANCE ILLUMINATING CC SPF 50 BROAD SPECTRUM SUNSCREEN LIGHT/MEDIUM 
    ensulizole,octinoxate, oxybenzone, titanium dioxide, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50390-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE20 mg  in 1 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE55 mg  in 1 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE5 mg  in 1 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE8.8 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION98 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    METHYL TRIMETHICONE (UNII: S73ZQI0GXM)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
    TALC (UNII: 7SEV7J4R1U)  
    TRIMETHYLOLPROPANE TRICAPRYLATE/TRICAPRATE (UNII: N1TRQ06KVJ)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    TRISILOXANE (UNII: 9G1ZW13R0G)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    BELLIS PERENNIS FLOWER (UNII: 26I94X9A1K)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    JASMINUM OFFICINALE FLOWER (UNII: 0Q8K841432)  
    GERANIUM ROBERTIANUM (UNII: R5I1HK0UBL)  
    EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    .BETA.-SITOSTEROL (UNII: S347WMO6M4)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50390-001-301 in 1 CARTON05/01/2015
    130 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35205/01/2015
    Labeler - Amway Corp (083416854)
    Establishment
    NameAddressID/FEIBusiness Operations
    Access Business Group LLC839830713manufacture(50390-001)