Label: ARTISTRY TIME DEFIANCE UV DEFENSE SPF 50 ULTRA FACIAL SUNSCREEN- octinoxate, zinc oxide, octisalate,titanium dioxide 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 May 17, 2012

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  • ARTISTRY Time Defiance UV Defense SPF 50 Ultra Facial Sunscreen


  • Active Ingredients

    OCTINOXATE 7.5%, ZINC OXIDE 6.528%, OCTISALATE 5.0%, TITANIUM DIOXIDE 2.49%

  • Other Ingredients

    WATER , CYCLOPENTASILOXANE , ALCOHOL DENAT., BUTYLENE GLYCOL, DIPROPYLENE GLYCOL, ISODECYL NEOPENTANOATE, METHYL METHACRYLATE CROSSPOLYMER, PEG-10 DIMETHICONE, MAGNESIUM SULFATE, VINYL DIMETHICONE / METHI CONE SILSESQUIOXANE CROSSPOLYMER, CALCIUM ALUMINUM BOROSILI CATE , PHENOXYETHANOL , METHICONE , ALUMINUM HYDROXIDE , ALUMINUM STEARATE, FRAGRANCE, METHYLPARABEN, POLYGLY CERYL -6 POLYRI CINOLEATE , PROPLYPARABEN, MICROCRYSTALLINE CELLULOSE, BUTYLPARABEN, GLYCERIN, CELLULOSE GUM, HYDROLYZED OATS, ARCTOSTAPHYLOS UVA
    URSI LEAF EXTRA CT, CAMELLIA SINENSIS LEAF EXTRA CT, DIPOTASSIUM GLY CYRRHI ZATE, MAGNESIUM ASCORBYL PHOSPHATE, LACTOBACILLUS/ ACEROLA CHERRY FERMENT, HYDROLYZED POTATO PROTEIN, CITRUS AURANTIUM AMARA (BITTER ORANGE ) PEEL EXTRACT, CHAMOMILLA RECUTITA (MATRICARIA), FLOWER EXTRACT, ERGOTHIONEINE
  • To Use:

    SHAKE BOTTLE WELL. AFTER APPLYING MOISTURIZER, SMOOTH A LIBERAL AMOUNT OVER FACE AND NECK WITH YOUR FINGERTIPS. USE EVERY MORNING.

  • Use:

    Helps prevent sunburn

  • Warnings:

    • For external use only.
    • Keep out of eyes.
    • Stop use if rash or irritation develops
    • Keep out reach of children. If swallowed, get medical help or contact a Poison Control Center right away .
  • Directions:

    For use as a sunscreen:
    • Apply liberally before sun exposure and as needed
    • Children under 6 months of age: Ask a doctor

  • MADE IN KOREA 1029785 DIST. BY AMWAY CORP., ADA, MI 49355 WWW.AMWAY.COM/SHOPARTISTRY


  • ARTISTRY® TIME DEFIANCE® UV DEFENSE SPF 50 ULTRA FACIAL SUNSCREEN

    Help keep your skin looking younger longer by protecting it with this high-level sunscreen. Moisturizing and fast absorbing, it works during the highest levels of sun exposure to deflect damaging rays and environmental assaults.

    Shields skin against dark spots and discoloration. An exclusive Balanced Brightening Complex of 10 extracts, including white tea extract, helps give your skin a luminous glow. This lightweight, water-resistant formula creates the perfect base for makeup to glide on.

    To use: Shake bottle well. After applying moisturizer, smooth a liberal amount over face and neck with your fingertips. Use every morning.

    Smooth on as the final step in your ARTISTRY TIME DEFIANCE skincare regimen and before applying foundation.

    Dermatologist- and allergy-tested. Suitable for use on sensitive skin. Non-acnegenic.

  • ARTISTRY Time Defiance UV Defense SPF 50 Ultra Facial Sunscreen 30ml/1oz (50390-110-30)

    ARTISTRYCarton

    ARTISTRYBottle

  • INGREDIENTS AND APPEARANCE
    ARTISTRY TIME DEFIANCE UV DEFENSE SPF 50 ULTRA FACIAL SUNSCREEN 
    octinoxate, zinc oxide, octisalate,titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50390-110
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 mL  in 100 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE6.528 mL  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 mL  in 100 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.49 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)  
    METHYL METHACRYLATE (UNII: 196OC77688)  
    MAGNESIUM SULFATE (UNII: DE08037SAB)  
    CALCIUM ALUMINOSILICATE (UNII: 3L00JH8411)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    METHICONE (20 CST) (UNII: 6777U11MKT)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    ALUMINUM STEARATE (UNII: U6XF9NP8HM)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    OAT (UNII: Z6J799EAJK)  
    ARCTOSTAPHYLOS UVA-URSI LEAF (UNII: 3M5V3D1X36)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)  
    ACEROLA (UNII: XDD2WEC9L5)  
    POTATO (UNII: CFE1S8DYWD)  
    CITRUS AURANTIUM FRUIT RIND (UNII: 055456JHI7)  
    CHAMOMILE (UNII: FGL3685T2X)  
    ERGOTHIONEINE (UNII: BDZ3DQM98W)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50390-110-3030 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35205/10/2012
    Labeler - Amway Corp (083416854)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kolmar Korea Co. Ltd.687846360manufacture
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