Otc - Active Ingredient
Zinc Oxide 24%
Centella Sunscreen Cream
FDA Label NDC 84763-010
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Yunqi Cosmetics (shenzhen) Co., Ltd for the product Centella Sunscreen Cream (NDC 84763-010). 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, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Sunscreen
Indications & Usage
Uses helps prevent sunburn
Warnings
For external use only.
Otc - Do Not Use
Do not use on damaged or broken skin.
Otc - When Using
When using this product keep out of eyes.
Rinse with water to remove.
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.
If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Shake well prior to use. Apply liberally 15 minutes before sun exposure.Children under 6 months of age: Ask a doctor.Reapply:·After80 minutes of swimming or sweating."lmmediately after towel drying. At least every 2 hours. Sun Protection Measures.Spendingtime in the sun increases your risk of skin cancerand 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-sleeved shirts, pants, hats and sunglasses.
Inactive Ingredient
Water
Helianthus Annuus (Sunflower) Seed Oil
Cera Alba (Beeswax)
Cetyl Dimethicone
Polyhydroxystearic Acid
Polyglyceryl-4 Isostearate
Glycerin
Centella Asiatica Extract
Euphorbia Cerifera (Candelilla) Wax
Propanediol
Magnesium Sulfate
Aluminum Stearate
Tocopherol
Package Label.Principal Display Panel
Label (Label)
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