Label: ARTISTRY BEAUTY BALM PERFECTING PRIMER SPF 35 BROAD SPECTRUM SUNSCREEN- ensulizole, octinoxate, 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.

  • Active Ingredients

    Ensulizole 2.0% (W/W P/P)
    Octinoxate 5.0% (W/W P/P)
    Zinc Oxide 5.49% (W/W P/P)......

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  • 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, DIMETHICONE, CYCLOPENTASILOXANE, BUTYLENE GLYCOL, GLYCERIN, TALC, METHYL TRIMETHICONE, TRIMETHYLOLPROPANE TRICAPRYLATE/ TRICAPRATE, LAURYL PEG-9, POLYDIMETHYLSILOXYETHYL DIMETHICONE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, DIMETHICONE/PEG-10/15 CROSSPOLYMER, TRIETHANOLAMINE, POLYGLYCERYL-6 POLYRICINOLEATE, POLYSILICONE-11, LECITHIN, PHENOXYETHANOL, SODIUM CHLORIDE, SODIUM CITRATE, POLYMETHYL
    METHACRYLATE, ALUMINA, POLYSORBATE-20, PEG/ PPG-18/18 DIMETHICONE, TRISILOXANE, HYDROGEN DIMETHICONE, METHYLPARABEN, DISODIUM EDTA, SILICA, PROPYLPARABEN, TRIETHOXYCAPRYLYLSILANE, ETHYLPARABEN, LAURETH-12, METHYLDIHYDROJASMONATE,
    IODOPROPYNYL BUTYLCARBAMATE, PEARL POWDER,ETHYLENE BRASSYLATE, ETHYL 2,2-DIMETHYLHYDROCINNAMAL, YEAST EXTRACT, CERAMIDE 3, BETA-SITOSTEROL, SODIUM HYALURONATE, GLUCOSAMINE HCL, UREA, ALGAE EXTRACT, TOCOPHEROL. MAY CONTAIN/PEUT CONTEINIR: IRON OXIDES (CI 77491, 77492, 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 BEAUTY BALM PERFECTING PRIMER SPF 35 BROAD SPECTRUM SUNSCREEN 
    ensulizole, octinoxate, zinc oxide cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:50390-004
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE 20 mg  in 1 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 50 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 54.9 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TALC (UNII: 7SEV7J4R1U)  
    METHYL TRIMETHICONE (UNII: S73ZQI0GXM)  
    TRIMETHYLOLPROPANE TRICAPRYLATE/TRICAPRATE (UNII: N1TRQ06KVJ)  
    LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
    DIMETHICONE/DIENE DIMETHICONE CROSSPOLYMER (UNII: RSA9I561OK)  
    HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
    TRISILOXANE (UNII: 9G1ZW13R0G)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    LAURETH-12 (UNII: OAH19558U1)  
    METHYL DIHYDROJASMONATE (SYNTHETIC) (UNII: 3GW44CIE3Y)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    PEARL (HYRIOPSIS CUMINGII) (UNII: A75L5FZ40U)  
    ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)  
    ETHYL 2,2-DIMETHYLHYDROCINNAMAL (UNII: 5V2FN5AA3W)  
    YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    .BETA.-SITOSTEROL (UNII: S347WMO6M4)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    GLUCOSAMINE HYDROCHLORIDE (UNII: 750W5330FY)  
    UREA (UNII: 8W8T17847W)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    MICA (UNII: V8A1AW0880)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50390-004-30 30 mL in 1 TUBE; Type 0: Not a Combination Product 05/05/2015
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 05/05/2015
    Labeler - Amway Corp (083416854)
    Establishment
    Name Address ID/FEI Business Operations
    Access Business Group LLC 839830713 manufacture(50390-004)
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