IOPE UV DEFENSE SUN PROTECTOR

Manufacturer
AMOREPACIFIC CORPORATION
Effective date
2024-10-08
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:23:11

Label at a glance#

ProductIOPE UV DEFENSE SUN PROTECTOR
Active ingredientOCTISALATE, OCTOCRYLENE, AVOBENZONE, HOMOSALATE
Label structure9 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#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 2.5%

Homosalate 9%

Octisalate 4.5%

Octocrylene 9%

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 externel 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, get medical help or contact a Poison Control Center 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, BUTYLENE GLYCOL,GLYCERIN, BUTYLOCTYL SALICYLATE, CETEARYL ALCOHOL, PHENYL TRIMETHICONE, CAPRYLYL METHICONE, POTASSIUM CETYL PHOSPHATE, CETEARYL GLUCOSIDE, 1,2-HEXANEDIOL, SODIUM POLYACRYLOYLDIMETHYL, TAURATE, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER,
FRAGRANCE / PARFUM, TOCOPHEROL, GLYCERYL CAPRYLATE, DISODIUM EDTA, ETHYLHEXYLGLYCERIN, LIMONENE, SORBITAN ISOSTEARATE, LINALOOL, GLUCOSE, CITRONELLOL, HEXYL CINNAMAL, FERULIC ACID

Questions?

TROUBLESHOOTING

support@us.amorepacific.com

IOPE UV Defense Sun Protector Sunscreen

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

IOPE

UV DEFENSE

SUN PROTECTOR

SUNSCREEN

BROAD SPECTRUM SPF45

50 mL / 1.69 fl. oz.

pdppdp

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43419-420-08IOPE UV DEFENSE SUN PROTECTOR50 mL in 1 TUBECREAM502
43419-420-08IOPE UV DEFENSE SUN PROTECTOR1 in 1 BOXCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43419-420IOPE UV DEFENSE SUN PROTECTOR (HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE) CREAM [AMOREPACIFIC CORPORATION]2Current NDC, 2 package rows20241010_0f2a87f7-2185-16a5-e063-6294a90a92a3.zip

Products#

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

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43419-42043419-420-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

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
IOPE UV DEFENSE SUN PROTECTORHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEAMOREPACIFIC CORPORATION0f2a87f7-2185-16a5-e063-6294a90a92a32024-10-08WarningsExact identifier
ndc (package): 43419-420-08
ndc (product): 43419-420
ndc11 (package): 43419042008
spl id: 23f91031-feea-4c2e-e063-6294a90a3200
spl set id: 0f2a87f7-2185-16a5-e063-6294a90a92a3

Reported adverse events (FAERS/openFDA)#

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