Label: IOPE UV MEN DEFENSE SUN PROTECTOR EX- avobenzone, homosalate, octocrylene, octisalate lotion lotion

  • NDC Code(s): 43419-419-08
  • Packager: Amorepacific Corporation
  • 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 November 29, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENTS

    Avobenzone 2.5%
    Homosalate 9%
    Octocrylene 9%
    Octisalate 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, call a poison control centre or get medical help right away.
  • DIRECTIONS

    • Apply liberally 15 minutes before sun exposure
    • Children under 6 months of age : Ask a doctor.
    • Reapply at least every 2 hours.
    • Use a water-resistant sunscreen if swimming or sweating.
    • 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.
    • Sun alert : Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.
  • INACTIVE INGREDIENTS

    Water / Aqua / Eau, Propanediol, Butyloctyl salicylate, Diphenylsiloxy phenyl trimethicone, Dimethicone, VP/Eicosene copolymer, Silica, Trisiloxane, Cyclopentasiloxane, Trimethylsiloxysilicate, 1,2-Hexanediol, Behenyl alcohol, Glyceryl stearate, PEG-100 stearate, C14-22 alcohols, Cetyl alcohol, Potassium cetyl phosphate, Polyacrylate-13, Polyisobutene, Fragrance / Parfum, C12-20 Alkyl glucoside, Butylene glycol, Disodium EDTA, Ethylhexylglycerin, Polysorbate 20, Sorbitan isostearate, Dextrin, Theobroma cacao (cocoa) extract, Gossypium herbaceum (cotton) extract, Glucose, Tocopherol

  • Questions?

    support@us.amorepacific.com

  • PRINCIPAL DISPLAY PANEL

    IOPE

    MEN

    UV DEFENSE

    SUN PROTECTOR EX

    SUNSCREEN

    BROAD SPECTRUM SPF39

    60 ml / 1.69 FL. OZ.

    CARTON

  • INGREDIENTS AND APPEARANCE
    IOPE UV MEN DEFENSE SUN PROTECTOR EX 
    avobenzone, homosalate, octocrylene, octisalate lotion lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43419-419
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.25 mg  in 50 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2.25 mg  in 50 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE4.5 mg  in 50 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE4.5 mg  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    COCOA (UNII: D9108TZ9KG)  
    ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)  
    C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    EICOSYL POVIDONE (UNII: XQQ9MKE2BJ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    TRISILOXANE (UNII: 9G1ZW13R0G)  
    C14-22 ALCOHOLS (UNII: B1K89384RJ)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TRIMETHYLSILOXYSILICATE (M/Q 1.0-1.2) (UNII: 78GX033D7I)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ICODEXTRIN (UNII: 2NX48Z0A9G)  
    LEVANT COTTON SEED (UNII: 550E4N439V)  
    POLYISOBUTYLENE (45000 MW) (UNII: YR8AQ94O31)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    WATER (UNII: 059QF0KO0R)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43419-419-081 in 1 CARTON04/27/202005/31/2024
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35204/27/202005/31/2024
    Labeler - Amorepacific Corporation (631035289)
    Establishment
    NameAddressID/FEIBusiness Operations
    Amorepacific Corporation694894112manufacture(43419-419)
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