Label: ALMAY AGE ESSENTIALS CONCEALER SPF 20- octinoxate 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 12, 2016

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

  • Active Ingredients:

    Octinoxate: 7.5%

    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

    Dimethicone, Polyethylene, Neopentyl Glycol Diheptanoate, Trimethylsiloxysilicate, Polyisobutene, Caprylyl Methicone, Phenyl Trimethicone, Boron Nitride, Ozokerite, Sorbitan Trioleate, Kaolin, Isodecyl Neopentanoate, Tocopheryl Acetate, Hyaluronic Acid, Atelocollagen, Tocopherol, Soluble Collagen, Tripeptide-29, Sodium Hyaluronate, Trisiloxane, Isostearyl Behenate, Triethoxycaprylylsilane, Cetyl PEG/PPG-10/1 Dimethicone, Hexyl Laurate, Polyglyceryl-4 Isostearate, Disteardimonium Hectorite, Dimethicone/Bis-Isobutyl PPG-20 Crosspolymer, Isopropyl Titanium Triisostearate, Triethyl Citrate, Phospholipids, Ethylhexyl Palmitate, Sodium Chondroitin Sulfate, Silica Dimethyl Silylate, Sorbic Acid

  • Principal Display Panel

    Almay 

    Age Essentials Concealer

    SPF 20

    0.13 oz/ 3.7g

    image description

  • INGREDIENTS AND APPEARANCE
    ALMAY AGE ESSENTIALS CONCEALER SPF 20 
    octinoxate zinc oxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0311-0708
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION2.4 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
    BORON NITRIDE (UNII: 2U4T60A6YD)  
    SORBITAN TRIOLEATE (UNII: QE6F49RPJ1)  
    KAOLIN (UNII: 24H4NWX5CO)  
    ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    HYALURONIC ACID (UNII: S270N0TRQY)  
    TRISILOXANE (UNII: 9G1ZW13R0G)  
    ISOSTEARYL BEHENATE (UNII: NA95U012OW)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 1.5) (UNII: V2W71V8T0X)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    DIMETHICONE/BIS-ISOBUTYL PPG-20 CROSSPOLYMER (UNII: O4I3UFO6ZF)  
    ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    SODIUM CHONDROITIN SULFATE (PORCINE; 5500 MW) (UNII: H5BJH23Z9A)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    SORBIC ACID (UNII: X045WJ989B)  
    POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    CERESIN (UNII: Q1LS2UJO3A)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0311-0708-133.8 mL in 1 CONTAINER; 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(0311-0708)