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

  • 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 July 1, 2020

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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.

  • PRINCIPAL DISPLAY PANEL

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  • 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)  
    PALMITOYL TETRAPEPTIDE-10 (UNII: 6Q6H1PKC05)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    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)  
    .ALPHA.-GLUCAN OLIGOSACCHARIDE (UNII: S95658MI3W)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    PEG-20 SORBITAN STEARATE (UNII: HD40WR33LC)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    SMALLANTHUS SONCHIFOLIUS WHOLE (UNII: 4P5T8DTR73)  
    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 finalpart35207/01/2020
    Labeler - Almay (064988652)
    Establishment
    NameAddressID/FEIBusiness Operations
    Revlon, INC.809725570manufacture(0311-0723)
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