Label: ALMAY AGE ESSENTIALS MAKEUP SPF 15- octinoxate, titanium dioxide make-up 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 2, 2016

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

  • Active Ingredients:

    Octinoxate: 3.5%

    Titanium Dioxide 4.3%

  • 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, — Glycerin, — PEG-9 Polydimethylsiloxyethyl Dimethicone, — Boron Nitride, — Trimethylsiloxysilicate, — Disteardimonium Hectorite, — Atelocollagen, — Soluble Collagen, Tripeptide-29, — Hyaluronic Acid, — Tocopherol, — Palmitoyl Tripeptide-5, — Acetyl Hexapeptide-8, — Sodium Hyaluronate, — Hydrolyzed Glycosaminoglycans, — Methyl Acetylglycyrrhetinoyl Hydroxyprolinate, — Glycyrrhetinic Acid, — Niacinamide, — Sodium Ascorbyl Phosphate, — Acetyl Hydroxyproline, — Pullulan, — Sorbitol, — Trehalose, — Dimethicone/PEG-10/15 Crosspolymer, — Alumina, — Laureth-7, — Polyglyceryl-3 Diisostearate, — Silica, — Sodium Chloride, — Methicone, — Dimethicone Crosspolymer, — Triethoxycaprylylsilane, — Xanthan Gum, — Phospholipids, — Calcium Aluminum Borosilicate, — Tetrasodium EDTA, — Tocopheryl Acetate, — C12-15 Alkyl Benzoate, — Sodium Chondroitin Sulfate, — Acacia Senegal Gum, — Dipropylene Glycol, — Sodium Citrate, — Propylene Glycol, — Linoleic Acid, — Lecithin, — Phytosteryl Canola Glycerides, — Oleic Acid, — Palmitic Acid, — Stearic Acid, — Triolein, Phenoxyethanol, — Caprylyl Glycol, — Potassium Sorbate

    May Contain, — Mica, — Titanium Dioxide (CI 77891), — Iron Oxides (CI 77491, 77492, 77499),

  • Principal Display Panel

    Almay 

    Age Essentials Makeup

    Broad Spectrum

    SPF 15

    1.0 fL. OZ/30 mL

    image description

  • INGREDIENTS AND APPEARANCE
    ALMAY AGE ESSENTIALS MAKEUP SPF 15 
    octinoxate, titanium dioxide make-up liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0311-0707
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.5 mg  in 1 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE4.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    METHICONE (20 CST) (UNII: 6777U11MKT)  
    LAURETH-7 (UNII: Z95S6G8201)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)  
    BORON NITRIDE (UNII: 2U4T60A6YD)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    LINOLEIC ACID (UNII: 9KJL21T0QJ)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    OLEIC ACID (UNII: 2UMI9U37CP)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    PULLULAN (UNII: 8ZQ0AYU1TT)  
    SORBITOL (UNII: 506T60A25R)  
    TREHALOSE (UNII: B8WCK70T7I)  
    CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
    ENOXOLONE (UNII: P540XA09DR)  
    OXACEPROL (UNII: Q0XV76B96L)  
    ACACIA (UNII: 5C5403N26O)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    HYDROLYZED GLYCOSAMINOGLYCANS (BOVINE; 50000 MW) (UNII: 997385V0VV)  
    PALMITOYL TRIPEPTIDE-5 (UNII: 2A3916MQHO)  
    ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL)  
    GLYCYLHYDROXYPROLYLPROLINE (UNII: 2Y6E8387T3)  
    HYALURONIC ACID (UNII: S270N0TRQY)  
    SODIUM CHONDROITIN SULFATE (PORCINE; 5500 MW) (UNII: H5BJH23Z9A)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    GLYCERYL TRIOLEATE (UNII: O05EC62663)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0311-0707-0130 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/18/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35204/18/2016
    Labeler - Almay, Inc. (064988652)
    Establishment
    NameAddressID/FEIBusiness Operations
    REVLON, INC.809725570manufacture(0311-0707)