Label: DRIVE SUNSCREEN SPF 50- avobenzone, humosalate, octisalate, octocrylene spray

  • 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 December 6, 2018

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  • ACTIVE INGREDIENT

    Avobenzone 3%

    Humosalate 15%

    Octisalate 5%

    Octocrylene 10%

  • WHEN USING

    When using this product:

    • keep out of eyes. Rinse with water to remove.

    • Keep away from face to avoid breathing it.

    • Do not puncture or incinerate, Contents under pressure

    • Do not store at temperature above 120⁰F

    Stop use and ask a doctor if rash occurs.

  • PURPOSE

    Avobenzone 3% ........................Sunscreen

    Humosalate 15% .......................Sunscreen

    Octisalate 5% ............................Sunscreen

    Octocrylene 10% .......................Sunscreen

  • STOP USE

    Stop use and ask a doctor if rash occurs.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • INACTIVE INGREDIENT

    Alcohol Denate, Acrylates/Octylacrylamide Copolymer, Stearoxytrimethylsilane, Aloe Barbadensis Leaf Extract, Retinyl Palmitate, Tocopherol, Glycerin, Caprylic/Capric Triglyceride, Diethylhexyl Syringylidenemalonate, Fragrace.

  • WHEN USING

    When using this product:

    • keep out of eyes. Rinse with water to remove.

    • Keep away from face to avoid breathing it.

    • Do not puncture or incinerate, Contents under pressure

    • Do not store at temperature above 120⁰F

  • PRINCIPAL DISPLAY PANEL

    Drive Sunscreen SPF 50

  • INGREDIENTS AND APPEARANCE
    DRIVE SUNSCREEN SPF 50 
    avobenzone, humosalate, octisalate, octocrylene spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72667-003
    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) HOMOSALATE15 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    RETINYL RETINOATE (UNII: 5AT5X9J439)  
    1,2,3,4,5,6,7,8-OCTAHYDRO-8,8-DIMETHYL-2-NAPHTHALENECARBONITRILE (UNII: EB12VHM8TR)  
    DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    STEAROXYTRIMETHYLSILANE (UNII: 9862TW94B2)  
    BEHENYL BEHENATE (UNII: K8NU647RJ0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)  
    ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72667-003-01177 mL in 1 CAN; Type 0: Not a Combination Product12/06/2018
    2NDC:72667-003-0289 mL in 1 CAN; Type 0: Not a Combination Product12/06/2018
    3NDC:72667-003-0330 mL in 1 CAN; Type 0: Not a Combination Product12/06/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35212/06/2018
    Labeler - Inspec Solutions LLC. (081030372)
    Establishment
    NameAddressID/FEIBusiness Operations
    Inspec Solutions LLC.081030372manufacture(72667-003)