Active Ingredients
Zinc Oxide 25%
Sky And Sol Body Sunscreen Spf50 Cream
FDA Label NDC 83447-011
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 Sky And Sol Body Sunscreen Spf50 (NDC 83447-011). 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 active ingredients, purpose, uses, warnings, do not use, when using this product, stop use, keep out of, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Sunscreen
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
For external use only.
Do Not Use
Do not use on damaged or broken skin.
When Using This Product
When using this product, keep out of eyes. Rinse with water to remove.
Stop Use
Stop use and ask a doctor if rash occurs.
Keep Out Of
Keep out of reach of children . If product is swallowed . get medical help or contact a Poison Control Center right away.
Directions
1.shake well before use
2.apply liberally 15 minutes before sun exposure
3.reapply:●after 80 minutes of swimming or sweating ●immediately after towel drying●at least every 2 hours
4.children after 6 months of age: ask a doctor
5.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 of 15 or higher and other sun protection
measures including:
●limit time in the sun, especially from 10am-2pm
●wear long-sleeve shirts, pants, hats, and sunglasses
Other Information
Protect the product in this container from excessive heat and direct sun.
Inactive Ingredients
Aqua (Water), Tllow, Olea Europaea (Olive) Oil, Butyrospermum Parki Butter (Shea Butter), Lecithin,
Cera Alba (Beeswax), Silica, Tocopherol (Vitamin E), Leuconostoc/Radish Root Ferment Filtrate
Package Label.Principal Display Panel
Undefined (Label)
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