Otc - Active Ingredient
Active Ingredients-Zinc Oxide 16.9%
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Fusidyne Derma Trouble Zinc Calming Sunscreen Lotion
FDA Label NDC 51352-999
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dong Wha Pharm. Co., Ltd. for the product Fusidyne Derma Trouble Zinc Calming Sunscreen (NDC 51352-999). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, purpose-sunscreen, uses, warning, directions, other information, inactive ingredients, questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose-Sunscreen
Purpose-Sunscreen
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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
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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
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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.
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Other Information
Other information protect the product in this container from excessive heat and direct sun
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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
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Questions
Question? : Call +82-80-023-1897 (International rates may apply)
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Keep Out Of Children
* Keep out of Reach of Children. If swallowed, get medical
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Principal Display Panel
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