GUCCI FACE LUSTROUS GLOW FOUNDATION BROADSPECTRUM SPF 25 (ALL SHADES) (OCTINOXATE AND TITANIUM DIOXIDE) LOTION [NOXELL CORPORATION]

GUCCI FACE LUSTROUS GLOW FOUNDATION BROADSPECTRUM SPF 25 (ALL SHADES) (OCTINOXATE AND TITANIUM DIOXIDE) LOTION [NOXELL CORPORATION]
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NDC 22700-002-08, 22700-002-13, 22700-002-30
Set ID 44180653-baa1-4178-b6d6-693d484c9b5d
Category HUMAN OTC DRUG LABEL
Packager Noxell Corporation
Generic Name
Product Class
Product Number
Application Number PART352
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    OCTINOXATE 3.49%Sunscreen
    TITANIUM DIOXIDE 2.52%Sunscreen
  • Uses

    • helps prevent sunburn
    • if used as directed with other sun protection measures (see Directions) , decreases the risk of skin cancer and early skin aging caused by the sun
  • Warnings

    For external use only

    Do not use on damaged or broken 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

    • apply liberally 15 minutes before sun exposure
    • reapply at least every 2 hours
    • use water resistant sunscreen if swimming or sweating
    • 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 value of 15 or higher and other sun protection measures including:

      • limit time in sun, especially from 10 a.m. – 2 p.m.
      • wear long-sleeved 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, cyclopentasiloxane, diphenylsiloxy phenyl trimethicone, butylene glycol, PEG-9 polydimethylsiloxyethyl dimethicone, triethylhexanoin, talc, disteardimonium hectorite, cetyl PEG/PPG-10/1 dimethicone, sodium chloride, tocopherol, tribehenin, vinyl dimethicone/methicone silsesquioxane crosspolymer, phytosteryl/behenyl/octyldodecyl lauroyl glutamate, phytosteryl/octyldodecyl lauroyl glutamate, synthetic fluorphlogopite, aluminum hydroxide, dimethicone, trimethylsiloxysilicate, hydrated silica, hydrogen dimethicone, dimethicone/vinyl dimethicone crosspolymer, phenoxyethanol, methylparaben, sodium benzoate, propylparaben, fragrance, titanium dioxide, iron oxides

  • Questions or comments?

    1-866-607-0858

  • PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton

    GUCCI

    GUCCI FACE

    LUSTROUS
    GLOW FOUNDATION
    WITH SUNSCREEN

    SPF 25
    BROAD SPECTRUM

    30 ml / 1.0 FL. OZ.

    PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton
  • INGREDIENTS AND APPEARANCE
    GUCCI FACE LUSTROUS GLOW FOUNDATION   BROADSPECTRUM SPF 25 (ALL SHADES)
    octinoxate and titanium dioxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:22700-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.49 g  in 100 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.52 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)  
    TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
    TALC (UNII: 7SEV7J4R1U)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    TRIBEHENIN (UNII: 8OC9U7TQZ0)  
    PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE (UNII: 65954KGO9Q)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:22700-002-301 in 1 CARTON06/01/2016
    130 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    2NDC:22700-002-131 in 1 CARTON06/01/201603/31/2018
    213 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    3NDC:22700-002-081 in 1 PACKAGE06/01/201603/31/2018
    30.8 mL in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35206/01/2016
    Labeler - Noxell Corporation (003082997)
    Registrant - Coty US LLC (039056361)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nihon Kolmar Co., Ltd717820687manufacture(22700-002)

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