Label: REVLON AGE DEFYING FIRMING LIFTING MAKEUP SPF 15- octinoxate, titanium dioxide make-up liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 June 25, 2018

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  • Active Ingredients:

    Octinoxate: 3.5%

    Titanium Dioxide 4.3%

  • 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

    AQUA ((WATER) EAU), CYCLOPENTASILOXANE, DIMETHICONE, PHENYL TRIMETHICONE, GLYCERIN, PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, BORON NITRIDE, TRIMETHYLSILOXYSILICATE, DISTEARDIMONIUM HECTORITE, DIMETHICONE/PEG-10/15 CROSSPOLYMER, ALUMINA, CAPRYLYL GLYCOL, PHENOXYETHANOL, SILICA, NIACINAMIDE, LAURETH-7, SODIUM CHLORIDE, POLYGLYCERYL-3 DIISOSTEARATE, PULLULAN, DIMETHICONE CROSSPOLYMER, METHICONE, XANTHAN GUM, POTASSIUM SORBATE, TRIETHOXYCAPRYLYLSILANE, SORBITOL, TREHALOSE, SODIUM ASCORBYL PHOSPHATE, TOCOPHERYL ACETATE, CALCIUM ALUMINUM BOROSILICATE, C12-15 ALKYL BENZOATE, TETRASODIUM EDTA, GLYCYRRHETINIC ACID, ACETYL HYDROXYPROLINE, ACACIA SENEGAL GUM, TOCOPHEROL, SODIUM CITRATE, DIPROPYLENE GLYCOL, METHYL ACETYLGLYCYRRHETINOYL HYDROXYPROLINATE, LINOLEIC ACID, LECITHIN, SODIUM HYALURONATE, PHYTOSTERYL CANOLA GLYCERIDES, HYDROLYZED GLYCOSAMINOGLYCANS, PALMITIC ACID, OLEIC ACID, TRIOLEIN, STEARIC ACID, PALMITOYL TRIPEPTIDE-5, ACETYL HEXAPEPTIDE-8

  • Principal Display Panel

    REVLON

    Age Defying Firming + Lifting Makeup

    Broad Spectrum

    SPF 15

    1.0 fL. OZ/30 mL

    image description

  • INGREDIENTS AND APPEARANCE
    REVLON AGE DEFYING FIRMING LIFTING MAKEUP SPF 15 
    octinoxate, titanium dioxide make-up liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10967-621
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.5 mg  in 1 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE4.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    METHICONE (20 CST) (UNII: 6777U11MKT)  
    LAURETH-7 (UNII: Z95S6G8201)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)  
    BORON NITRIDE (UNII: 2U4T60A6YD)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    LINOLEIC ACID (UNII: 9KJL21T0QJ)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    OLEIC ACID (UNII: 2UMI9U37CP)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    PULLULAN (UNII: 8ZQ0AYU1TT)  
    SORBITOL (UNII: 506T60A25R)  
    TREHALOSE (UNII: B8WCK70T7I)  
    CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
    ENOXOLONE (UNII: P540XA09DR)  
    OXACEPROL (UNII: Q0XV76B96L)  
    ACACIA (UNII: 5C5403N26O)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    HYDROLYZED GLYCOSAMINOGLYCANS (BOVINE; 50000 MW) (UNII: 997385V0VV)  
    PALMITOYL TRIPEPTIDE-5 (UNII: 2A3916MQHO)  
    ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10967-621-0130 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product09/30/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35209/30/2013
    Labeler - Revlon Consumer Products Corp (788820165)
    Establishment
    NameAddressID/FEIBusiness Operations
    REVLON, INC.809725570manufacture(10967-621)