Label: HARMON FACE VALUES BREAK-OUT FREE SPF 55 SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 January 5, 2022

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  • Active Ingredients

    Avobenzone 2.7%,

    Homosalate 4.0%,

    Octisalate 4.5%,

    Octocrylene 6.0%,

    Oxybenzone 4.5%

  • 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 not use

    • 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

    • rash occurs

  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center immediately.

  • Directions

    • apply liberally 15 minutes before sun exposure

    • reapply:

    • after 80 minutes of swimming or sweating

    • immediately after towel drying

    • 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 a.m. - 2 p.m.

    • wear long-sleeved shirts, pants, hats, and sunglasses

  • Other information

    • protect the product in this container from excessive heat and direct sun
    • may stain or damage some fabrics, materials or surfaces
  • Inactive Ingredients

    acrylates/dimethicone copolymer, bisabolol, butylene glycol, C12-15 alkyl benzoate, capryloyl glycine, caprylyl glycol, cedrus atlantica bark extract, cetyl dimethicone, chlorphenesin, cinnamomum zeylanicum bark extract, dimethicone, disodium EDTA, ethylhexyl stearate, ethylhexylglycerin, glycerin, mannan, neopentyl glycol diheptanoate, phenoxyethanol, polyester-7, portulaca oleracea extract, sarcosine, silica, sodium polyacrylate, steareth-100, steareth-2, styrene/acrylates copolymer, tocopherol, trideceth-6, water, xanthan gum

  • PRINCIPAL DISPLAY PANEL

    42344A1

  • INGREDIENTS AND APPEARANCE
    HARMON FACE VALUES BREAK-OUT FREE SPF 55 SUNSCREEN 
    avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63940-081
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE27 mg  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE40 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE45 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE60 mg  in 1 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE45 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    CAPRYLOYL GLYCINE (UNII: 8TY5YO42NJ)  
    CEDRUS ATLANTICA BARK (UNII: ITP1Q41UPF)  
    CETYL DIMETHICONE 45 (UNII: IK315POC44)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    CINNAMON BARK OIL (UNII: XE54U569EC)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    KONJAC MANNAN (UNII: 36W3E5TAMG)  
    NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYESTER-7 (UNII: 0841698D2F)  
    PURSLANE (UNII: M6S840WXG5)  
    SARCOSINE (UNII: Z711V88R5F)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    STEARETH-100 (UNII: 4OH5W9UM87)  
    STEARETH-2 (UNII: V56DFE46J5)  
    TRIDECETH-6 (UNII: 3T5PCR2H0C)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMER (UNII: V5RS026Q0H)  
    .ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    FARNESOL (UNII: EB41QIU6JL)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63940-081-94177 mL in 1 TUBE; Type 0: Not a Combination Product01/11/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/11/2021
    Labeler - Harmon Stores Inc. (804085293)
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