Otc - Active Ingredient
octinoxate, octisalate, ensulizole
Dr Nikko Sheer Sunscreen
FDA Label NDC 69133-050
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cit Co., Ltd. for the product Dr Nikko Sheer Sunscreen (NDC 69133-050). 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, inactive ingredient, otc - purpose, warnings, otc - keep out of reach of children, indications & usage, dosage & administration, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredient
water, glycerin, dipropylene glycol, etc.
Otc - Purpose
helps prevent sunburn
Warnings
1. If the following symptoms occur after product use, stop using the product immediately and consult a dermatologist (continuous use can exacerbate the symptoms).
1) Occurrence of red spots, swelling, itchiness, and other irritation
2) If the symptoms above occur after the application area is exposed to direct sunlight
2. Do not use on open wounds, eczema, and other irritations
3. Precaution for Storage and Handling
1) Close the lid after use
2) Keep out of reach of infants and children
3) Do not to store in a place with high/low temperature and exposed to direct sunlight
4. Use as avoiding eye areas.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Indications & Usage
Apply liberally 15 minutes before sun exposure
Dosage & Administration
external use only
Package Label.Principal Display Panel
Label (Label)
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