Label: ALMAY LINE SMOOTHING LIQUID MAKE-UP FOR DRY SKIN- 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 December 21, 2016

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  • Active Ingredients:

    Titanium Dioxide: 4.7%

    Zinc Oxide 2.1%

  • 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), Cyclomethicone, Dimethicone, Butylene Glycol, Cetyl PEG/PPG-10/1 Dimethicone, Polyglyceryl-4 Isostearate, Nylon-12, Trimethylsiloxysilicate, Boron Nitride, Magnesium Sulfate, Polyglyceryl-6 Polyricinoleate, Glycerin, PEG/PPG-20/15 Dimethicone, PEG-10 Dimethicone, Methicone, Laureth-7, Tribehenin, Ginkgo Biloba Leaf Extract, Panax Ginseng Root Extract, Sodium Hyaluronate, Camellia Sinensis Leaf Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Punica Granatum Extract, Riboflavin, Centaurea Cyanus Flower Extract, Erythrulose, Algae Extract, Vitis Vinifera (Grape) Seed Extract, Cucumis Sativus (Cucumber) Fruit Extract, Hydrolyzed Glycosaminoglycans, Saccharide Isomerate, Silica, Triethoxycaprylylsilane, Sodium Ascorbyl Phosphate, Aluminum Hydroxide, Caffeine, Stearic Acid, Hydrogenated Lecithin, Tocopheryl Acetate, Acrylonitrile/Methacrylonitrile/Methyl Methacrylate Copolymer, Trihydroxystearin, Aloe Barbadensis Leaf Juice, Anthemis Nobilis Flower Oil, Aspalathus Linearis Leaf Extract, Dimethiconol, HDI/Trimethylol Hexyllactone Crosspolymer, Palmitoyl Hydroxypropyl Trimonium Amylopectin/Glycerin Crosspolymer, PEG/PPG-18/18 Dimethicone, Sorbitol, Talc, Tetrasodium EDTA, Phenoxyethanol, Methylparaben, Ethylparaben, Propylparaben

  • Principal Display Panel

    Almay Line Smoothing Liquid Make-Up for Dry Skin

    1

  • INGREDIENTS AND APPEARANCE
    ALMAY LINE SMOOTHING LIQUID MAKE-UP FOR DRY SKIN 
    titanium dioxide zinc oxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0311-0700
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE4.7 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION2.1 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 1.5) (UNII: V2W71V8T0X)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    NYLON-12 (UNII: 446U8J075B)  
    TRIMETHYLSILOXYSILICATE (M/Q 1.0-1.2) (UNII: 78GX033D7I)  
    BORON NITRIDE (UNII: 2U4T60A6YD)  
    MAGNESIUM SULFATE (UNII: DE08037SAB)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEG/PPG-20/15 DIMETHICONE (UNII: 06R6X77P9C)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    METHICONE (20 CST) (UNII: 6777U11MKT)  
    LAURETH-7 (UNII: Z95S6G8201)  
    TRIBEHENIN (UNII: 8OC9U7TQZ0)  
    GINKGO (UNII: 19FUJ2C58T)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    LICORICE (UNII: 61ZBX54883)  
    PUNICA GRANATUM LEAF (UNII: O9486I5JXI)  
    RIBOFLAVIN (UNII: TLM2976OFR)  
    ERYTHRULOSE, D- (UNII: 09058VOU0Z)  
    GRAPE (UNII: 6X543N684K)  
    CUCUMBER (UNII: YY7C30VXJT)  
    SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYDROLYZED GLYCOSAMINOGLYCANS (BOVINE; 50000 MW) (UNII: 997385V0VV)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    CAFFEINE (UNII: 3G6A5W338E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ASIAN GINSENG (UNII: CUQ3A77YXI)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    CENTAUREA CYANUS FLOWER (UNII: QZ239038YC)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TRIHYDROXYSTEARIN (UNII: 06YD7896S3)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    DIMETHICONOL (100000 CST) (UNII: OSA9UP217S)  
    PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
    SORBITOL (UNII: 506T60A25R)  
    TALC (UNII: 7SEV7J4R1U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0311-0700-0130 mL in 1 TUBE; Type 0: Not a Combination Product07/09/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35207/09/2009
    Labeler - Almay, Inc. (064988652)
    Establishment
    NameAddressID/FEIBusiness Operations
    REVLON, INC.809725570manufacture(0311-0700)