Label: ARTISTRY IDEAL RADIANCE ILLUMINATING CC SPF 50 BROAD SPECTRUM SUNSCREEN DEEP- 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 January 8, 2019

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

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  • Uses

    • Helps prevent sunburn
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  • 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.

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  • Other Information

    • Protect this product from excessive heat and direct sun
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  • 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).

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  • 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
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  • Package Labeling:
  • INGREDIENTS AND APPEARANCE
    ARTISTRY IDEAL RADIANCE ILLUMINATING CC SPF 50 BROAD SPECTRUM SUNSCREEN DEEP 
    ensulizole, octinoxate, oxybenzone, titanium dioxide, zinc oxide cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:50390-010
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 84 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 98 mg  in 1 mL
    ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE 20 mg  in 1 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 55 mg  in 1 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 5 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    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 ANHYDROUS (UNII: 8NLQ36F6MM)  
    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)  
    CERAMIDE NP (UNII: 4370DF050B)  
    .BETA.-SITOSTEROL (UNII: S347WMO6M4)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50390-010-00 1 in 1 CARTON 09/23/2017
    1 30 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 09/23/2017
    Labeler - Amway Corp (083416854)
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