Label: ALMAY SMART SHADE SKINTONE ANTI- AGING MAKE-UP- titanium dioxide zinc oxide 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 October 22, 2019

If you are a consumer or patient please visit this version.

  • Active Ingredients:

    Titanium Dioxide: 3.9%

    Zinc Oxide 2.0%

  • 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), Dimethicone, Isododecane, Trisiloxane, Butylene Glycol, PEG/PPG-19/19 Dimethicone, C13-16 Isoparaffin, HDI/Trimethylol Hexyllactone Crosspolymer, Cetyl PEG/PPG-10/1 Dimethicone, Nylon-12, Sodium Chloride, Phenyl Trimethicone, Alumina, Glycerin, Melanin, Palmitoyl Tripeptide-5, Oligopeptide-24, Sodium Cocoyl Glutamate, Saccharomyces Magnesium Ferment, Saccharomyces Potassium Ferment, Pisum Sativum (Pea) Extract, Macrocystis Pyrifera Extract, Nereocystis Leutkeana Extract, Laminaria Japonica Extract, Prunus Amygdalus Dulcis (Sweet Almond) Seed Extract, Hydrolyzed Rice Protein, Sodium Hyaluronate, Palmitoyl Hydroxypropyltrimonium Amylopectin/Glycerin Crosspolymer, Hydrogenated Lecithin, Pentylene Glycol, Isodecyl Neopentanoate, Dimethicone/Bis-Isobutyl PPG-20 Crosspolymer, Galactoarabinan, Trimethylsiloxysilicate, Boron Nitride, Disteardimonium Hectorite, Polyisobutene, C10-13 Isoparaffin, Methicone, Triethoxycaprylylsilane, Tribehenin, Tocopheryl Acetate, Tocopherol, Propylene Carbonate, Silica, Sorbitan Sesquioleate, Maltodextrin, Sucrose Dilaurate, Acrylonitrile/Methacrylonitrile/Methyl Methacrylate Copolymer, Phenoxyethanol, Tetrasodium EDTA, Caprylyl Glycol, 1, 2-Hexanediol

  • Principal Display Panel

    Almay

    Skintone Matching Anti Aging  Makeup

    1 oz/ 30mL

    Label

  • INGREDIENTS AND APPEARANCE
    ALMAY SMART SHADE SKINTONE ANTI- AGING MAKE-UP 
    titanium dioxide zinc oxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0311-0702
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION2 mg  in 1 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE3.9 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ISODODECANE (UNII: A8289P68Y2)  
    TRISILOXANE (UNII: 9G1ZW13R0G)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL)  
    C13-16 ISOPARAFFIN (UNII: LED42LZG6O)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 1.5) (UNII: V2W71V8T0X)  
    NYLON-12 (UNII: 446U8J075B)  
    MELANIN SYNTHETIC (TYROSINE, PEROXIDE) (UNII: O0CV1RMR44)  
    PALMITOYL TRIPEPTIDE-5 (UNII: 2A3916MQHO)  
    SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)  
    DIMETHICONE/BIS-ISOBUTYL PPG-20 CROSSPOLYMER (UNII: O4I3UFO6ZF)  
    GALACTOARABINAN (UNII: SL4SX1O487)  
    TRIMETHYLSILOXYSILICATE (M/Q 1.0-1.2) (UNII: 78GX033D7I)  
    BORON NITRIDE (UNII: 2U4T60A6YD)  
    METHICONE (20 CST) (UNII: 6777U11MKT)  
    TRIBEHENIN (UNII: 8OC9U7TQZ0)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    SUCROSE DILAURATE (UNII: 5926LC4S7M)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
    PEA (UNII: W4X7H8GYFM)  
    MACROCYSTIS PYRIFERA (UNII: K31S3OG5C4)  
    NEREOCYSTIS LUETKEANA (UNII: 3PC632V63J)  
    LAMINARIA JAPONICA (UNII: WE98HW412B)  
    ALMOND (UNII: 3Z252A2K9G)  
    POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0311-0702-0130 mL in 1 TUBE; Type 0: Not a Combination Product11/14/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35211/14/2013
    Labeler - Almay, Inc. (064988652)
    Establishment
    NameAddressID/FEIBusiness Operations
    REVLON, INC.809725570manufacture(0311-0702)