FDA.reportPublic FDA data

MEDIFORDEAR CICA CALMING SUNSCREEN

Manufacturer
Youngwon Costech Co.,ltd. | KONAD CO LTD
Effective date
2025-01-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:52:50

Label at a glance#

ProductMEDIFORDEAR CICA CALMING SUNSCREEN
Active ingredientHOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient(s)


Homosalate 10.0%
Octocrylene 10.0%
Ethylhexyl Salicylate 5.0%
Avobenzone 3.0%

OTC - PURPOSE SECTION

Purpose

Sunscreen

INDICATIONS & USAGE SECTION

Use(s)

- 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 SECTION

Warning

- 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 irritation or rash occurs.

- Keep out of reach of children if product is swallowed, get medical help or contact a Poison Control Center right away.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children if product is swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

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 SPF value of 15 or higher and other sun protection measures including:

Limit time in the sun, especially from 10a.m.-2p.m.
Wear long-sleeved shirts, pants, hats and sunglasses.

OTHER SAFETY INFORMATION

Other Information

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

INACTIVE INGREDIENT SECTION

Inactive ingredients

Water, Butylene Glycol, Butyloctyl Salicylate, Polyglyceryl-6 Stearate, Ethylhexyl Methoxycrylene, Niacinamide, Poly C10-30 Alkyl Acrylate, Sorbitan Sesquioleate, Silica, Behenyl Alcohol, 1,2-Hexanediol, Hydroxyacetophenone, Sodium Polyacryloyldimethyl Taurate, Polyglyceryl-6 Behenate, Polyacrylate Crosspolymer-6, Sphingomonas Ferment Extract, Tocopheryl Acetate, Panthenol, Disodium EDTA, Adenosine, Centella Asiatica Extract, Monarda Didyma Leaf Extract, Mentha Piperita Leaf Extract, Lavandula Angustifolia Flower Extract, Freesia Refracta Extract, Rosmarinus Officinalis Leaf Extract, Chamomilla Recutita Flower Extract, Asiaticoside, Caprylyl Glycol, Madecassoside, Madecassic Acid, Asiatic Acid

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Carton ImageCarton Image

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

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72169-55072169-550-01, 72169-550-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
HOMOSALATEV06SV4M95SACTIB
POLYGLYCERYL-6 STEARATEETY9Q81E2TIACT
OCTISALATE4X49Y0596WACTIB
ETHYLHEXYL METHOXYCRYLENES3KFG6Q5X8IACT
OCTOCRYLENE5A68WGF6WMACTIB
AVOBENZONEG63QQF2NOXACTIB
WATER059QF0KO0RIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
NIACINAMIDE25X51I8RD4IACT
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
MEDIFORDEAR CICA CALMING SUNSCREENHOMOSALATE, OCTOCRYLENE, ETHYLHEXYL SALICYLATE, AVOBENZONEYoungwon Costech Co.,ltd.2bc94923-b221-5159-e063-6394a90ab8ff2025-01-15WarningsExact identifier
ndc (package): 72169-550-01
ndc (package): 72169-550-02
ndc (product): 72169-550
ndc11 (package): 72169055001
ndc11 (package): 72169055002
spl id: 2bc94923-b222-5159-e063-6394a90ab8ff
spl set id: 2bc94923-b221-5159-e063-6394a90ab8ff

Reported adverse events (FAERS/openFDA)#

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