Label: AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE spray

  • 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 March 15, 2022

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  • Active Ingredients

    Avobenzone 3%

    Homosalate 10%

    Octisalate 5%

    Octocrylene 10%

  • Purpose

    Sunscreen

  • Uses

    • helps prevent sunburn
    • if used as directed with other sun protections 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 right away

  • Directions

    • apply liberally 15 minutes before sun exposure
    • children under 6 months: ask a doctor
    • Hold container 6 to 8 inches from the skin to apply
    • reapply:
    • after 80 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours
    • ​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 from excessive heat and direct sun
    • May Stain Fabrics
  • Inactive ingredients

    Acrylates/octylacrylamide copolymer, Alcohol Denat., Aloe Barbadensis Leaf Extract, Tocopherol, caprylic/capric triglyceride, diethylhexyl syringylidene malonate, glycerin, Retinyl palmitate, stearoxytrimethylsilane

  • disclaimer

    May stain or damage some fabrics or surfaces

    Oxybenzone & Octinoxate free

    Reef Safe

    Non- Comedogenic

  • Adverse Reactions

    Questions? 1-800-661-5804

  • principal display panel

    LabelUnscented Sunscreen

    SPF 50

    water resistant 80 minutes

    Facemist

    BROAD

    SPECTRUM

    SPF 50

    3.38 FL OZ (100 ML)

  • INGREDIENTS AND APPEARANCE
    AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE 
    avobenzone, homosalate, octisalate, octocrylene spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82603-000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10 g  in 100 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE5 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    STEAROXYTRIMETHYLSILANE (UNII: 9862TW94B2)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK)  
    ALCOHOL (UNII: 3K9958V90M)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82603-000-01100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/15/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35203/15/2022
    Labeler - Avert Skincare Inc (243258452)
    Registrant - Avert Skincare Inc (243258452)
    Establishment
    NameAddressID/FEIBusiness Operations
    Inspec solutions LLC081030372manufacture(82603-000)
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