FUSIDYNE DERMA TROUBLE ZINC CALMING SUNSCREEN- zinc oxide lotion

FUSIDYNE DERMA TROUBLE Zinc Calming Sunscreen by

Drug Labeling and Warnings

FUSIDYNE DERMA TROUBLE Zinc Calming Sunscreen by is a Otc medication manufactured, distributed, or labeled by DONG WHA PHARM. CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients-Zinc Oxide 16.9%

Purpose-Sunscreen

Purpose-​Sunscreen

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

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

Directions

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.

Other information

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

Inactive Ingredients

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

Questions

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

Keep Out Of Children

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

Principal display panel

Principal display panel

INGREDIENTS AND APPEARANCE

FUSIDYNE DERMA TROUBLE ZINC CALMING SUNSCREEN 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51352-999
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	8.463275 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)
POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR)
ISODODECANE (UNII: A8289P68Y2)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
POLYGLYCERYL-2 ISOSTEARATE (UNII: 7B8OE71MQC)
NYMPHAEA ALBA FLOWER (UNII: 40KQ7Q535O)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
PROPANEDIOL (UNII: 5965N8W85T)
WATER (UNII: 059QF0KO0R)
PROPYLHEPTYL CAPRYLATE (UNII: 991Z19V2OD)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
CALCIUM SODIUM BOROSILICATE (UNII: 4MM76N4WMY)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
CRYPTOMERIA JAPONICA LEAF (UNII: SCM4971GZQ)
NELUMBO NUCIFERA LEAF (UNII: 60C608DPVT)
MAGNESIUM SULFATE (UNII: DE08037SAB)
HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
HECTORITE (UNII: 08X4KI73EZ)
TOCOPHEROL (UNII: R0ZB2556P8)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51352-999-11	96 in 1 CARTRIDGE	01/01/2026
1	NDC: 51352-999-10	50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	01/01/2026

Labeler - DONG WHA PHARM. CO., LTD. (963390339)