Otc - Active Ingredient
Zinc Oxide 21.8%
Renewaluxe Spf 50 Sunscreen Cream
FDA Label NDC 83447-005
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guangzhou Fantesy Biotechnology Co.,ltd for the product Renewaluxe Spf 50 Sunscreen (NDC 83447-005). 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, uses, warnings, otc - do not use, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
sunscreen
Uses
Uses 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.
Warnings
Warnings
For external use only
Do not use on damaged or broken skin.
When using the 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 Poison Control Center right away.
Otc - Do Not Use
Do not use on damaged or broken skin.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
If swallowed, get medical help or
contact Poison Control Center
right away.
Directions
Directions Apply liberally 15 minutes before sun exposure Reapply: After 40 minutes of
swimming or sweating
■Immediately after towel drying
■At least every 2 hours
■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 10a.m. - 2p.m.
■Wear long-sleeve shirts, pants, hats, and sunglasses.
■Children under 6 months: Ask a doctor.
Other Information
Protect the product in this container from excessive heat and direct sun
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