FDA.reportPublic FDA data

IOPE UV MEN DEFENSE SUN PROTECTOR EX

Manufacturer
Amorepacific Corporation
Effective date
2022-11-29
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:46:08

Label at a glance#

ProductIOPE UV MEN DEFENSE SUN PROTECTOR EX
Active ingredientAVOBENZONE, OCTISALATE, HOMOSALATE, OCTOCRYLENE
Label structure10 sections

Indications and 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

Dosage and administration

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 measu...

Storage and handling

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.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 2.5%
Homosalate 9%
Octocrylene 9%
Octisalate 4.5%

PURPOSE

OTC - PURPOSE SECTION

Sunscreen

USES

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

  • For external use only

OTC - DO NOT USE SECTION

  • Do not use on damaged or broken skin.

OTC - WHEN USING SECTION

  • When using this product keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

  • Stop use and ask a doctor if rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Keep out of reach of children. If swallowed, call a poison control centre or get medical help right away.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

  • 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

INACTIVE INGREDIENT SECTION

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?

POSTMARKETING EXPERIENCE SECTION

support@us.amorepacific.com

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

IOPE

MEN

UV DEFENSE

SUN PROTECTOR EX

SUNSCREEN

BROAD SPECTRUM SPF39

60 ml / 1.69 FL. OZ.

CARTONCARTON

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 36 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43419-41943419-419-08

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 33 matching rows.

Name, UNII, Kind table
NameUNIIKind
AVOBENZONEG63QQF2NOXACTIB
OCTISALATE4X49Y0596WACTIB
HOMOSALATEV06SV4M95SACTIB
OCTOCRYLENE5A68WGF6WMACTIB
SORBITAN ISOSTEARATE01S2G2C1E4IACT
COCOAD9108TZ9KGIACT
ANHYDROUS DEXTROSE5SL0G7R0OKIACT
C12-20 ALKYL GLUCOSIDEK67N5Z1RUAIACT
CETYL ALCOHOL936JST6JCNIACT
EICOSYL POVIDONEXQQ9MKE2BJIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
CYCLOMETHICONE 50THT5PCI0RIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
DOCOSANOL9G1OE216XYIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PEG-100 STEARATEYD01N1999RIACT
TRISILOXANE9G1ZW13R0GIACT
C14-22 ALCOHOLSB1K89384RJIACT
POLYSORBATE 207T1F30V5YHIACT
DIPHENYLSILOXY PHENYL TRIMETHICONEI445L28B12IACT
DIMETHICONE92RU3N3Y1OIACT
TRIMETHYLSILOXYSILICATE (M/Q 1.0-1.2)78GX033D7IIACT
POTASSIUM CETYL PHOSPHATE03KCY6P7UTIACT
TOCOPHEROLR0ZB2556P8IACT
ICODEXTRIN2NX48Z0A9GIACT
LEVANT COTTON SEED550E4N439VIACT
POLYISOBUTYLENE (45000 MW)YR8AQ94O31IACT
BUTYLENE GLYCOL3XUS85K0RAIACT
EDETATE DISODIUM7FLD91C86KIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
WATER059QF0KO0RIACT
PROPANEDIOL5965N8W85TIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
eea22274-5f09-62df-e053-2a95a90aa857a087ad18-eeda-550a-e053-2a95a90a418d2022-11-29WarningsExact identifier
spl id: eea22274-5f09-62df-e053-2a95a90aa857
spl set id: a087ad18-eeda-550a-e053-2a95a90a418d

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.