Label: ALMAY SMART SHADE ANTI-AGING SKINTONE MATCHING MAKEUP SPF 20- titanium dioxide, zinc oxide liquid

  • Category: HUMAN OTC DRUG LABEL

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: 5.5%

    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

    CYCLOPENTASILOXANE, AQUA ((WATER) EAU), DIMETHICONE, PHENYL TRIMETHICONE, PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, TRIMETHYLSILOXYSILICATE, BUTYLENE GLYCOL, METHYL METHACRYLATE CROSSPOLYMER, SILICA, NYLON-12, TRIBEHENIN, DIMETHICONE/PEG-10/15 CROSSPOLYMER, ALUMINA, TOCOPHERYL ACETATE, NIACINAMIDE, PISUM SATIVUM (PEA) EXTRACT, GLYCINE SOJA (SOYBEAN) OIL, HYDROLYZED RICE PROTEIN, PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) SEED EXTRACT, LAMINARIA JAPONICA EXTRACT, NEREOCYSTIS LUETKEANA EXTRACT, MACROCYSTIS PYRIFERA (KELP) EXTRACT, SACCHAROMYCES/MAGNESIUM FERMENT, SACCHAROMYCES/POTASSIUM FERMENT, PALMITOYL HYDROXYPROPYLTRIMONIUM AMYLOPECTIN/GLYCERIN CROSSPOLYMER, SODIUM HYALURONATE, OLIGOPEPTIDE-24, GLYCERIN, PALMITOYL TRIPEPTIDE-5, MELANIN, POLYESTER-1, LAURETH-7, MAGNESIUM SULFATE, POLYGLYCERYL-3 DIISOSTEARATE, METHICONE, TRIETHOXYCAPRYLYLSILANE, POLYSILICONE-11, DISTEARDIMONIUM HECTORITE, ETHYLENE BRASSYLATE, SILICA DIMETHYL SILYLATE, TRIETHYL CITRATE, TETRASODIUM EDTA, DIPROPYLENE GLYCOL, SODIUM CITRATE, TOCOPHEROL, PENTYLENE GLYCOL, MALTODEXTRIN, SUCROSE DILAURATE, SODIUM COCOYL GLUTAMATE, PHENOXYETHANOL, ETHYLPARABEN, METHYLPARABEN

  • Principal Display Panel

    Almay

    ALMAY SMART SHADE ANTI-AGING SKINTONE MATCHING MAKEUP SPF 20

    1 oz/ 30mL

    Label

  • INGREDIENTS AND APPEARANCE
    ALMAY SMART SHADE ANTI-AGING SKINTONE MATCHING MAKEUP SPF 20 
    titanium dioxide, zinc oxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0311-0710
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION2.4 mg  in 1 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE5.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    NYLON-12 (UNII: 446U8J075B)  
    PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TRIBEHENIN (UNII: 8OC9U7TQZ0)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    PEA (UNII: W4X7H8GYFM)  
    SOYBEAN (UNII: L7HT8F1ZOD)  
    ALMOND (UNII: 3Z252A2K9G)  
    PALMITOYL TRIPEPTIDE-5 (UNII: 2A3916MQHO)  
    MELANIN SYNTHETIC (TYROSINE, PEROXIDE) (UNII: O0CV1RMR44)  
    LAURETH-7 (UNII: Z95S6G8201)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    POLYSILICONE-15 (UNII: F8DRP5BB29)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    SUCROSE DILAURATE (UNII: 5926LC4S7M)  
    SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    LAMINARIA JAPONICA (UNII: WE98HW412B)  
    NEREOCYSTIS LUETKEANA (UNII: 3PC632V63J)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0311-0710-0130 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(0311-0710)