Otc - Active Ingredient
Active ingredients--------------purpose
HOMOSALATE 3%------------Sunscreen SPF15
OCTINOXATE 6%
Sun Block Sprary
FDA Label NDC 47993-215
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Ningbo Jiangbei Ocean Star Trading Co.,ltd for the product Sun Block Sprary (NDC 47993-215). 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, otc - purpose, warnings, indications & usage, otc - keep out of reach of children, inactive ingredient, 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
Otc - Purpose
Uses:
help prevent sunburn
Warnings
Warnings:
Skin Cancer / Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging. For external use only. Kepp out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash or irritation develops and lasts. Keep out of reach of children. If swallowed: seek medical help or contact a poison control center right away.
Indications & Usage
Directions:
Apply liberally 15mintues before sun exposure and reapply as needed.
Otc - Keep Out Of Reach Of Children
Children under 6 months: ask a doctor before use.
Inactive Ingredient
Inactive Ingredients:
PROPYLENE GLYCOL, CYCLOMETHICONE, PEG-40 CASTOR OIL, SODIUM HYDROXIDE, CARBOMER 1342, METHYLPARABEN, IODOPROPYNYL BUTYLCARBAMATE, DISODIUM EDTA-COPPER, WATER
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