Label: ALMAY HEALTHY BIOME MAKEUP- homosalate, octisalate, octocrylene, titanium dioxide, zinc oxide emulsion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 30, 2024

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  • Active Ingredient Section

    Homosalate 5.0%

    Octisalate 5.0%

    Octocrylene 5.0%

    Titanium Dioxide 5.8%

    Zinc Oxide 3.94%

  • Uses

    Helps prevent sunburn. if used as directed with other sun protection measures descreases the risk of skin cancer and early skin aging caused by the sun.

  • Warnings

    For external use only

    Do not use on danaged skin or broken skin

    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 10am- 2pm. Wear long-sleeved shrirts, pants, hats and sunglasses.

  • When using this product

    Keep out of the eyes, Rinse with water to remove.

    Stop use and ask a doctor if rash occurs.

  • Keep out of reach of children

    If product is swalled get medical help or contact a Poison Control Center right away.

  • Directions

    Apply liberally 15 minutes before sun exposure. Use water resistant sunscreen is swimming or sweating. Repply at least ever 2 hours. Children under 6 months; Ask a doctor.

  • INACTIVE INGREDIENT

    Other Ingredients: Aqua/Water/Eau, Cyclopentasiloxane, Butyloctyl Salicylate, Cetyl PEG/PPG-10/1 Dimethicone, Trimethylsiloxysilicate, Glycerin, Isododecane, Alumina, Magnesium Sulfate, Silica, Alpha-Glucan Oligosaccharide, Caprylic/Capric Triglyceride, Caprylyl Glycol, Cetyl Palmitate, Disteardimonium Hectorite, Hydrogen Dimethicone, Hydrogenated Lecithin, Lactobacillus, Maltodextrin, Ophiopogon Japonicus Root Extract, Palmitoyl Tetrapeptide-10, Polyglyceryl-3 Diisostearate, Polymnia Sonchifolia Root Juice, Polysorbate 80, Propylene Carbonate, Simethicone, Sorbitan Stearate, Tetrasodium EDTA, Tocopheryl Acetate, Triethoxycaprylylsilane, Phenoxyethanol.

    MAY CONTAIN/PEUT CONTENIR/PUEDE CONTENER (+/-):
    [Iron Oxides (CI 77491),Iron Oxides (CI 77492),Iron Oxides (CI 77499),Titanium Dioxide (CI 77891).]

  • INDICATIONS & USAGE

    Helps prevent sunbunrs. 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.

  • PRINCIPAL DISPLAY PANEL

    back labelfront label

  • INGREDIENTS AND APPEARANCE
    ALMAY HEALTHY BIOME MAKEUP 
    homosalate, octisalate, octocrylene, titanium dioxide, zinc oxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0311-0723
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE5 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE3.94 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE5 mg  in 1 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE5.8 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    TRIMETHYLSILOXYSILICATE (M/Q 0.66) (UNII: 5041RX63GN)  
    MAGNESIUM SULFATE ANHYDROUS (UNII: ML30MJ2U7I)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CETYL PALMITATE (UNII: 5ZA2S6B08X)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    PALMITOYL TETRAPEPTIDE-10 (UNII: 6Q6H1PKC05)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .ALPHA.-GLUCAN OLIGOSACCHARIDE (UNII: S95658MI3W)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    OPHIOPOGON JAPONICUS ROOT (UNII: 90PS6JV9GZ)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    ISODODECANE (UNII: A8289P68Y2)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    PEG-20 SORBITAN STEARATE (UNII: HD40WR33LC)  
    SMALLANTHUS SONCHIFOLIUS WHOLE (UNII: 4P5T8DTR73)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0311-0723-011 mL in 1 TUBE; Type 0: Not a Combination Product08/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02007/01/2020
    Labeler - Almay (064988652)
    Establishment
    NameAddressID/FEIBusiness Operations
    Revlon, INC.809725570manufacture(0311-0723)
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