FUSIDYNE DERMA TROUBLE Zinc Calming Sunscreen

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name: FUSIDYNE DERMA TROUBLE Zinc Calming Sunscreen
Generic name: ZINC OXIDE
Manufacturer: DONG WHA PHARM. CO., LTD.
Product type: HUMAN OTC DRUG
SPL set ID: 46457c78-74d6-ea6a-e063-6294a90a24ac
SPL ID: 46457c78-74d7-ea6a-e063-6294a90a24ac
Version: 1
Effective date: 2025-12-18
Source export date: 2026-09-28
Source partition: 3
Source file: https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/fd09911bd1bc81f7f2faeb048e63855fe224e494376ae919a0035190e315c050/drug-label-0003-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:18:59

Harmonized routes table
Harmonized routes
TOPICAL

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 12 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M020	openfda.application_number
brand name		FUSIDYNE DERMA TROUBLE Zinc Calming Sunscreen	openfda.brand_name
generic name		ZINC OXIDE	openfda.generic_name
manufacturer name		DONG WHA PHARM. CO., LTD.	openfda.manufacturer_name
ndc	package	51352-999-11	openfda.package_ndc
ndc	package	51352-999-10	openfda.package_ndc
ndc	product	51352-999	openfda.product_ndc
ndc11	package	51352099910	derived:openfda.package_ndc
ndc11	package	51352099911	derived:openfda.package_ndc
spl id		46457c78-74d7-ea6a-e063-6294a90a24ac	id
spl set id		46457c78-74d6-ea6a-e063-6294a90a24ac	set_id
unii		SOI2LOH54Z	openfda.unii

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warning 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 4

Reported adverse events (FAERS/openFDA)#

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