IOPE UV DEFENSE SUN PROTECTOR

Product NDC
43419-420
11-digit product format
434190420
Labeler code
43419
Product ID
43419-420_23f91031-feea-4c2e-e063-6294a90a3200
Type
HUMAN OTC DRUG
Nonproprietary name
Homosalate, Octocrylene, Octisalate, Avobenzone
Dosage form
CREAM
Route
TOPICAL
Labeler
AMOREPACIFIC CORPORATION
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-03-01
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength
1.25; 4.5; 2.25; 4.5 g/50mL; g/50mL; g/50mL; g/50mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
IOPE UV DEFENSE SUN PROTECTOR
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE1.25 g/50mL
HOMOSALATE4.5 g/50mL
OCTISALATE2.25 g/50mL
OCTOCRYLENE4.5 g/50mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG63QQF2NOX, V06SV4M95S, 4X49Y0596W, 5A68WGF6WM

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
43419-420-08434190420081 TUBE in 1 BOX (43419-420-08) / 50 mL in 1 TUBE1 tube2024-03-01NoNoHistorical