Label: ALMAY SMART SHADE SKINTONE MATCHING MAKEUP- 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

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  • Active Ingredients:

    Titanium Dioxide: 4.8%

    Zinc Oxide 2.4%

  • 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

    Aqua ((Water) Eau), Cyclopentasiloxane, Dimethicone, Phenyl Trimethicone, PEG-9 Polydimethylsiloxyethyl Dimethicone, Glycerin, Boron Nitride, Trimethylsiloxysilicate, Dimethicone/PEG-10/15 Crosspolymer, Butylene Glycol, Disteardimonium Hectorite, Alumina, Ginkgo Biloba Leaf Extract, Panax Ginseng Root Extract, Camellia Sinensis Leaf Extract, Centaurea Cyanus Flower Extract, Vitis Vinifera (Grape) Seed Extract, Moringa Oleifera Seed Extract, Tocopheryl Acetate, Niacinamide, Melanin, Sodium Hyaluronate, Aloe Barbadensis Leaf Juice, Polyester-1, Polyglyceryl-3 Diisostearate, Sodium Chloride, Methicone, Triethoxycaprylylsilane, Xanthan Gum, Dimethicone Crosspolymer, Silica Dimethyl Silylate, Tetrasodium EDTA, Maltodextrin, Dipropylene Glycol, Sodium Citrate, Tocopherol, Propylene Glycol, Pentylene Glycol, PVP, Hydrolyzed Glycosaminoglycans, Phenoxyethanol, Methylparaben, Ethylparaben

  • Principal Display Panel

    Almay

    Skintone Matching Makeup 1

  • INGREDIENTS AND APPEARANCE
    ALMAY SMART SHADE SKINTONE MATCHING MAKEUP 
    titanium dioxide zinc oxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0311-0701
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE4.8 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION2.4 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TRIMETHYLSILOXYSILICATE (M/Q 1.0-1.2) (UNII: 78GX033D7I)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    METHICONE (20 CST) (UNII: 6777U11MKT)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    COPOVIDONE K25-31 (UNII: D9C330MD8B)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    HYDROLYZED GLYCOSAMINOGLYCANS (BOVINE; 50000 MW) (UNII: 997385V0VV)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    BORON NITRIDE (UNII: 2U4T60A6YD)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    GINKGO (UNII: 19FUJ2C58T)  
    ASIAN GINSENG (UNII: CUQ3A77YXI)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CENTAUREA CYANUS FLOWER (UNII: QZ239038YC)  
    VITIS VINIFERA SEED (UNII: C34U15ICXA)  
    MORINGA OLEIFERA LEAF (UNII: 4WET1AWO9B)  
    MELANIN SYNTHETIC (TYROSINE, PEROXIDE) (UNII: O0CV1RMR44)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0311-0701-0130 mL in 1 TUBE; Type 0: Not a Combination Product04/16/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35204/16/2016
    Labeler - Almay, Inc. (064988652)
    Establishment
    NameAddressID/FEIBusiness Operations
    REVLON, INC.809725570manufacture(0311-0701)
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