Label: REVLON NEW COMPLEXION ONE-STEP PERFECT MAKE-UP- titanium dioxide make-up paste

  • NDC Code(s): 10967-606-35
  • Packager: Revlon Consumer Products Corp
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 12, 2024

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  • Active Ingredients:

    Titanium Dioxide 4%

    Purpose:

    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 notuse 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 a 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
    • Use a water resistant sunscreen if swimming or sweating
    • Reapply at least every 2 hours
    • Children under 6 months: Ask a doctor.

    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 the sun, especially from 10 am - 2 pm
    • Wear long-sleeved shirts, pants, hats and sunglasses.
  • Inactive Ingredients:

    DIMETHICONE,ISOPROPYL,ISOSTEARATE,TALC,SILICA,NEOPENTYL,GLYCOL,DIETHYLHEXANOATE,TRIBEHENIN,ISOSTEARYL,BEHENATE,NYLON-12,BORON,NITRIDE,LAUROYL,LYSINE,TRIDECYL,TRIMELLITATE,MYRISTYL,MYRISTATE,CANDELILLA,CERA,((EUPHORBIA,CERIFERA,(CANDELILLA)WAX),CIRE,DE,CANDELILLA,POLYGLYCERYL-4,ISOSTEARATE,SORBITAN,TRIOLEATE,PENTAHYDROSQUALENE,LAURYL,PEG/PPG-18/18,METHICONE,SACCHAROMYCES,ZINC,FERMENT,SACCHAROMYCES,COPPER,FERMENT,SACCHAROMYCES,MANGANESE,FERMENT,SACCHAROMYCES,IRON,FERMENT,SACCHAROMYCES,SILICON,FERMENT,SACCHAROMYCES,POTASSIUM,FERMENT,CYCLOMETHICONE,SOY,AMINO,ACIDS,CERA,CARNAUBA,((COPERNICIA,CERIFERA,(CARNAUBA),WAX),CIRE,DE,CARNAUBA,TRIMETHYLSILOXYSILICATE,POLYETHYLENE,ETHYLENE/METHACRYLATE,COPOLYMER,LECITHIN,ISOPROPYL,TITANIUM,TRIISOSTEARATE,ALUMINA,BARIUM,SULFATE,DEHYDROACETIC,ACID,METHYLPARABEN,ETHYLPARABEN,PROPYLPARABEN,PHENOXYETHANOL,BHT

    May Contain: Mica, Titanium Dioxide (Ci 77891), Iron Oxides (CI 77491, 77492, 77499)

  • DOSAGE & ADMINISTRATION

    As needed

  • INDICATIONS & USAGE

    Helps prevent sunburn

  • PURPOSE

    Sunscreen

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed seek medical help or contact a Poison Control Center right away.

  • Principal Display Panel:

    ​REVLON

    New Complexion SPF 15 Makeup

    SPF 15

    label

  • INGREDIENTS AND APPEARANCE
    REVLON NEW COMPLEXION ONE-STEP PERFECT MAKE-UP 
    titanium dioxide make-up paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10967-606
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE4 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    TRIBEHENIN (UNII: 8OC9U7TQZ0)  
    NYLON-12 (UNII: 446U8J075B)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    ISOPROPYL ISOSTEARATE (UNII: C67IXB9Y7T)  
    TALC (UNII: 7SEV7J4R1U)  
    NEOPENTYL GLYCOL DIETHYLHEXANOATE (UNII: U68ZV6W62C)  
    ISOSTEARYL BEHENATE (UNII: NA95U012OW)  
    BORON NITRIDE (UNII: 2U4T60A6YD)  
    LAUROYL LYSINE (UNII: 113171Q70B)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    MYRISTYL MYRISTATE (UNII: 4042ZC00DY)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    SORBITAN TRIOLEATE (UNII: QE6F49RPJ1)  
    2,10,15,19,23-PENTAHYDROSQUALENE (UNII: 6IWZ426YD6)  
    LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX)  
    AMINO ACIDS, SOY (UNII: NWB9514AZM)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10967-606-359.9 mL in 1 CONTAINER; Type 0: Not a Combination Product04/01/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02004/01/2014
    Labeler - Revlon Consumer Products Corp (788820165)
    Establishment
    NameAddressID/FEIBusiness Operations
    REVLON, INC.809725570manufacture(10967-606)
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