IOPE UV DEFENSE SUN PROTECTOR SPF 50PLUS- avobenzone, octisalate, homosalate, and octocrylene cream 
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 UV Defense Sun Protector SPF 50+

Drug Facts

ACTIVE INGREDIENTS

BUTYL METHOXYDIBENZOYLMETHANE 3% / ETHYLHEXYL SALICYLATE 4.5% / HOMOSALATE 9% / OCTOCRYLENE 9%

PURPOSE

Sunscreen

USE

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.

INACTIVE INGREDIENTS

WATER, BUTYLENE GLYCOL, BUTYLOCTYL SALICYLATE, CYCLOPENTASILOXANE, CYCLOHEXASILOXANE, BEHENYL ALCOHOL, SILICA, C14-22 ALCOHOLS, GLYCERYL STEARATE, PEG-100 STEARATE, POLYACRYLATE-13, CICHORIUM INTYBUS (CHICORY) ROOT EXTRACT, FRAGRANCE, POLYISOBUTENE, C12-20 ALKYL GLUCOSIDE, GLYCERYL CAPRYLATE, ETHYLHEXYLGLYCERIN, DISODIUM EDTA, POLYSORBATE 20, GLYCOPROTEINS

OTHER INFORMATION

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

PRINCIPAL DISPLAY PANEL - 60 mL Tube Carton

IOPE

UV DEFENSE
SUN
PROTECTOR

SUNSCREEN
BROAD SPECTRUM
SPF50+

Advanced sun screen care with
high UVA/UVB protection.

BIOSCIENCE FORMULA

60 ml/2.02 FL.OZ.

PRINCIPAL DISPLAY PANEL - 60 mL Tube Carton
IOPE UV DEFENSE SUN PROTECTOR SPF 50PLUS 
avobenzone, octisalate, homosalate, and octocrylene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43419-350
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.8 g  in 60 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2.7 g  in 60 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE5.4 g  in 60 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE5.4 g  in 60 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
DOCOSANOL (UNII: 9G1OE216XY)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
C14-22 ALCOHOLS (UNII: B1K89384RJ)  
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)  
PEG-100 STEARATE (UNII: YD01N1999R)  
CHICORY ROOT (UNII: 090CTY533N)  
C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA)  
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43419-350-181 in 1 CARTON10/13/201410/01/2018
160 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 FINALpart35210/13/201410/01/2018
Labeler - Amorepacific Corporation (631035289)

Revised: 10/2018
Document Id: cee6edb9-3dc8-4a92-b427-58fd5d02d56c
Set id: 92c5a3de-e80e-4b7a-a757-a3a5777fe782
Version: 3
Effective Time: 20181024
 
Amorepacific Corporation