IOPE MEN UV DEFENSE SUN PROTECTOR- avobenzone, homosalate, octisalate, and octocrylene lotion 
AMOREPACIFIC CORPORATION

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.

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IOPE MEN UV DEFENSE SUN PROTECTOR

Drug Facts

ACTIVE INGREDIENTS W/W

AVOBENZONE 2.5% / HOMOSALATE 9% / OCTISALATE 4.5% / OCTOCRYLENE 9%

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 product is swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

Apply liberally 15 minutes before sun exposure. 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. Children under 6 months of age: Ask a doctor.

OTHER INFORMATION

protect the product in this container from excessive heat and direct sun.

INACTIVE INGREDIENTS

WATER, PROPANEDIOL, BUTYLOCTYL SALICYLATE, CYCLOPENTASILOXANE, PHENYL TRIMETHICONE, SILICA, VP/EICOSENE COPOLYMER, CYCLOHEXASILOXANE, TRIMETHYLSILOXYSILICATE, BEHENYL ALCOHOL, GLYCERYL STEARATE , PEG-100 STEARATE, C14-22 ALCOHOLS, POTASSIUM CETYL PHOSPHATE, CICHORIUM INTYBUS (CHICORY) ROOT EXTRACT, POLYACRYLATE-13, POLYISOBUTENE, FRAGRANCE/PARFUM, C12-20 ALKYL GLUCOSIDE, GLYCERYL CAPRYLATE, ETHYLHEXYLGLYCERIN, DISODIUM EDTA, POLYSORBATE 20, MANNITOL, AMMONIUM GLYCYRRHIZATE, CAFFEINE, ZINC GLUCONATE, AESCULUS HIPPOCASTANUM (HORSE CHESTNUT) SEED EXTRACT.

PRINCIPAL DISPLAY PANEL - 50 ml Tube Carton

IOPE
MEN

UV DEFENSE
SUN

PROTECTOR

SUNSCREEN
BROAD SPECTRUM
SPF 50+

Sunscreen care with
high UVA/UVB protection.

BIOSCIENCE FORMULA

50 ml/1.69 FL.OZ.

PRINCIPAL DISPLAY PANEL - 50 ml Tube Carton
IOPE MEN UV DEFENSE SUN PROTECTOR 
avobenzone, homosalate, octisalate, and octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43419-365
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.25 g  in 50 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE4.5 g  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2.25 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE4.5 g  in 50 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PROPANEDIOL (UNII: 5965N8W85T)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
DOCOSANOL (UNII: 9G1OE216XY)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
C14-22 ALCOHOLS (UNII: B1K89384RJ)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
CHICORY ROOT (UNII: 090CTY533N)  
C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA)  
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
MANNITOL (UNII: 3OWL53L36A)  
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
CAFFEINE (UNII: 3G6A5W338E)  
ZINC GLUCONATE (UNII: U6WSN5SQ1Z)  
HORSE CHESTNUT (UNII: 3C18L6RJAZ)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43419-365-011 in 1 CARTON11/14/201610/01/2018
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 FINALpart35211/14/201610/01/2018
Labeler - AMOREPACIFIC CORPORATION (631035289)

Revised: 10/2018
 
AMOREPACIFIC CORPORATION