FUSIDYNE DERMA TROUBLE Zinc Calming Sunscreen

Manufacturer
DONG WHA PHARM. CO., LTD.
Effective date
2025-12-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:35:25

Label at a glance#

ProductFUSIDYNE DERMA TROUBLE Zinc Calming Sunscreen
Active ingredientZINC OXIDE
Label structure10 sections

Indications and uses

helps prevent sunburn if used as directed with other sun protection measures, decreases the risk of skin cancer and early skin aging caused by the sun

Dosage and administration

Directions apply generously and evenly 15 minutes before sun exposure. apply to all skin exposed to the sun. reapply at least every 2 hours use a water resistant sunscreen if swimming or sweating.children under 6 months of age: ask a doctor.

Storage and handling

Other information protect the product in this container from excessive heat and direct sun

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients-Zinc Oxide 16.9%

11

Purpose-Sunscreen

OTC - PURPOSE SECTION

Purpose-​Sunscreen

22

USES

INDICATIONS & USAGE SECTION

helps prevent sunburn if used as directed with other sun protection measures, decreases the risk of skin cancer and early skin aging caused by the sun

33

Warning

WARNINGS SECTION

Warnings
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
• rash occurs

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

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

44

Directions

DOSAGE & ADMINISTRATION SECTION

Directions

apply generously and evenly 15 minutes before sun exposure. apply to all skin exposed to the sun. reapply at least every 2 hours

use a water resistant sunscreen if swimming or sweating.children under 6 months of age: ask a doctor.

88

Other information

STORAGE AND HANDLING SECTION

Other information protect the product in this container from excessive heat and direct sun

99

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Inactive ingredients Water, Butyloctyl Salicylate, Propyheptyl Caprylate, Propanediol, Hydrogenated Coco nut Oil, Isodadecane, Caprylic/Capric Triglyceride, Glycerin, Dicaprylyl Carbonate, Polyglyceryl-6 Polyricinoleate, Sodium Chloride, Fusidium Coccineum Ferment Lysate Extract Filtrate, Nymphaea Alba Flower Extract, Protease, Nelum bo Nicifera Leaf Extract, Sacccharomyces Ferment, Crypto meria Japonica Leaf Extract, Methyl Methacrylate Crosspolymer, Disteardimonium Hectorite, Calcium Sodium Borosilicate, Triethoxycaprylylsilane, Polyglyceryl-2 Isostearate, 1,2-Hexanediol, Polyglyceryl-2 Dipolyhydroxystearate, Coco-Caprylate/Caprate, Caprylyl Glycol, Glyceryl Caprylate, Sorbitan Isostearate, Hectorite, Magnesium Sulfate, Butylene Glycol, Tocopherol

1010

Questions

OTC - QUESTIONS SECTION

Question? : Call +82-80-023-1897 (International rates may apply)

1111

Keep Out Of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

* Keep out of Reach of Children. If swallowed, get medical 1414help or contact a Poison Control Center right away.

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1212Principal display panel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51352-999-10FUSIDYNE DERMA TROUBLE Zinc Calming Sunscreen50 mL in 1 TUBELOTION501
51352-999-11FUSIDYNE DERMA TROUBLE Zinc Calming Sunscreen96 in 1 CARTRIDGELOTION961

Products#

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

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51352-99951352-999-10, 51352-999-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 30 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
FUSIDYNE DERMA TROUBLE Zinc Calming SunscreenZINC OXIDEDONG WHA PHARM. CO., LTD.46457c78-74d6-ea6a-e063-6294a90a24ac2025-12-18WarningsExact identifier
ndc (package): 51352-999-11
ndc (package): 51352-999-10
ndc (product): 51352-999
ndc11 (package): 51352099910
ndc11 (package): 51352099911
spl id: 46457c78-74d7-ea6a-e063-6294a90a24ac
spl set id: 46457c78-74d6-ea6a-e063-6294a90a24ac

Reported adverse events (FAERS/openFDA)#

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