Label: PREVAGE CITY SMART- titanium dioxide, zinc oxide emulsion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 12, 2024

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  • ACTIVE INGREDIENTS

    TITANIUM DIOXIDE 6.2% W/W.................Sunscreen
    ZINC OXIDE 5.6% W/W ............................Sunscreen

  • INACTIVE INGREDIENTS

    CYCLOPENTASILOXANE, WATER/AQUA/EAU, ISODODECANE, DIMETHICONE, C12-15 ALKYL BENZOATE, ISOPROPYL MYRISTATE, PENTYLENE GLYCOL, BUTYLENE GLYCOL, SILICA DIMETHYL SILYLATE, CAPRYLYL METHICONE,
    POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE, ACRYLATES/POLYTRIMETHYLSILOXYMETHACRYLATE COPOLYMER, GLYCERIN, ALUMINUM HYDROXIDE, STEARIC ACID, PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, CARNOSINE, ACRYLATES/ETHYLHEXYL ACRYLATE/DIMETHICONE METHACRYLATE COPOLYMER, ARABIDOPSIS THALIANA EXTRACT, CAMELLIA SINENSIS LEAF EXTRACT, CAPRYLYL GLYCOL, DISODIUM EDTA, ERGOTHIONEINE, FERULIC ACID, HYDROGEN DIMETHICONE, HYDROXYDECYL UBIQUINOYL DIPALMITOYL GLYCERATE, LECITHIN, MICA, MICROCOCCUS LYSATE, PARFUM/FRAGRANCE, PEG/PPG-18/18 DIMETHICONE, PLANKTON EXTRACT, SODIUM PCA, TIN OXIDE, TOCOPHERYL ACETATE, TRIETHOXYCAPRYLYLSILANE, ALPHA-ISOMETHYL IONONE, LINALOOL, CHLORPHENESIN, PHENOXYETHANOL, IRON OXIDES (CI 77491, CI 77492, CI 77499), TITANIUM DIOXIDE (CI 77891).

  • 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

    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 FOR SUNSCREEN USE

    Directions For Sunscreen Use:
    ■ Apply liberally 15 minutes before sun exposure
    ■ Reapply:

    • at least every 2 hours
    • use a 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 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

  • OTHER INFORMATION

    ■ Protect this product from excessive heat and direct
    ■ Store at room temperature

  • DOSAGE & ADMINISTRATION

    As needed

  • INDICATIONS & USAGE

    • Helps prevent sunburn
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

  • PURPOSE

    Sunscreen

  • CARTON ART

    prvg city art

  • INGREDIENTS AND APPEARANCE
    PREVAGE CITY SMART 
    titanium dioxide, zinc oxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10967-670
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE5.6 mg  in 1 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE6.2 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ARABIDOPSIS THALIANA WHOLE (UNII: AI3L60HQ81)  
    PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    MICA (UNII: V8A1AW0880)  
    PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    WATER (UNII: 059QF0KO0R)  
    HYDROGEN DIMETHICONE (20 CST) (UNII: 12Z59IF64N)  
    HYDROXYDECYL UBIQUINOYL DIPALMITOYL GLYCERATE (UNII: OV1BT2N8RC)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    ERGOTHIONEINE (UNII: BDZ3DQM98W)  
    CARNOSINE (UNII: 8HO6PVN24W)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    FERULIC ACID (UNII: AVM951ZWST)  
    STANNIC OXIDE (UNII: KM7N50LOS6)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    ISODODECANE (UNII: A8289P68Y2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10967-670-6240 g in 1 TUBE; Type 0: Not a Combination Product03/14/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02003/14/2019
    Labeler - REVLON (788820165)
    Registrant - REVLON (788820165)
    Establishment
    NameAddressID/FEIBusiness Operations
    Revlon809725570manufacture(10967-670)
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