FDA.reportPublic FDA data

MEDIFORDEAR CICA CALMING SUNSCREEN

Product NDC
72169-550
11-digit product format
721690550
Labeler code
72169
Product ID
72169-550_2bc94923-b222-5159-e063-6394a90ab8ff
Type
HUMAN OTC DRUG
Nonproprietary name
Homosalate, Octocrylene, Ethylhexyl Salicylate, Avobenzone
Dosage form
CREAM
Route
TOPICAL
Labeler
Youngwon Costech Co.,ltd.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-01-02
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength
3; 10; 5; 10 g/100mL; g/100mL; g/100mL; g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
MEDIFORDEAR CICA CALMING SUNSCREEN
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE3 g/100mL
HOMOSALATE10 g/100mL
OCTISALATE5 g/100mL
OCTOCRYLENE10 g/100mL

Harmonized Identifiers#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72169-550-01MEDIFORDEAR CICA CALMING SUNSCREEN50 mL in 1 TUBECREAM501
72169-550-02MEDIFORDEAR CICA CALMING SUNSCREEN1 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72169-550MEDIFORDEAR CICA CALMING SUNSCREEN (HOMOSALATE, OCTOCRYLENE, ETHYLHEXYL SALICYLATE, AVOBENZONE) CREAM [YOUNGWON COSTECH CO.,LTD.]1Current NDC, 2 package rows20250117_2bc94923-b221-5159-e063-6394a90ab8ff.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72169-550-017216905500150 mL in 1 TUBE50 mlHistorical
72169-550-02721690550021 TUBE in 1 CARTON (72169-550-02) / 50 mL in 1 TUBE (72169-550-01) 1 tube2025-01-02NoNoCurrent