Otc - Active Ingredient
Titanium Dioxide、Ensulizole/Phenylbenz imidazole Sulfonic Acid、Avobenzone 、Octocrylene
Broad Spectrum Spf 50 Universal Tinted Sunscreen Cream
FDA Label NDC 85053-007
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Shantou Woodsleep Biotechnology Co., Ltd. for the product Broad Spectrum Spf 50 Universal Tinted Sunscreen (NDC 85053-007). 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, otc - when using, warnings, otc - do not use, otc - stop use, otc - keep out of reach of children, storage and handling, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Helps prevent sunburn
If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
Otc - When Using
Apply liberally 15 minutes before sun exposure.
Reapply at least every 2 hours.
Use a water resistant sunscreen if swimming or sweating.
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-sleeve shirts, pants, hats, and sunglasses.
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 product is swallowed, get medical help or contact a Poison Control Center right away.
Otc - Do Not Use
Do not use on damaged or broken skin.
Otc - Stop Use
Stop use and ask a doctor if rash occurs.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Storage And Handling
Store in a cool place
Inactive Ingredient
Water, Alcohol Denat., Glycerin, Cyclopentasiloxane, Titanium Dioxide, Niacinamide, Polyacrylate Crosspolymer-6, Dimethicone, Isododecane, PEG-10 Dimethicone, Triethylhexanoin, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Disodium EDTA, Tocopherol, Iron Oxides (CI 77491)
Dosage & Administration
Apply liberally 15 minutes before sun exposure.
Reapply at least every 2 hours.
Use a water resistant sunscreen if swimming or sweating.
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-sleeve shirts, pants, hats, and sunglasses.
Indications & Usage
Apply liberally 15 minutes before sun exposure.
Reapply at least every 2 hours.
Use a water resistant sunscreen if swimming or sweating.
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-sleeve shirts, pants, hats, and sunglasses.
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Label (F)
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