Active Ingredient(S)
Zinc Oxide 2.85%
Titanium Dioxide 2.76%
EthylhexyI Salicylate 5%
Phenylbenzimidazole Sulfonic Acid 3.2%
Centella Calming Sunscreen Cream
FDA Label NDC 84558-007
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guangzhou Yusong Fine Chemicls Co., Ltd for the product Centella Calming Sunscreen (NDC 84558-007). 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 active ingredient(s), purpose, use, warnings, 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
Purpose
Sunscreen
Use
● Helps prevent sunburn.
● Ifused 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
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
Directions
●Apply liberally 15 minutes before sun exposure.
●Children under 6 months of age : Ask a doctor.
●Reapply at least every 2 hours, and after 40 minutes of 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 of 15 or higher and other sun protection measures including:
●limit time in the sun, especially from10 a.m.-2 p.m.
●wear long-sleeve shirts, pants, hats, and sunglasses
Other Information
●Protect the product in this container from excessive heat and direct sun.
●Sun alert : Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the
risks of skin aging, skin cancer, and other harmful effects of the sun.
Inactive Ingredients
Aqua, Glycerin, Silica, Butylene Glycol, Neopenty|l Gly-col Diheptanoate, Cyclopentasiloxane, Isohexadecane,
Cety| Peg/Ppg-10/1 Dimethicone, C12-15 AlkyI Benzo-ate, Cyclohexasiloxane, Niacinamide, Magnesium Sul-
fate, Disteardimonium Hectorite, Madecassoside,1,2-Hexanediol, Peg-10 Dimethicone, Sorbitan Sesqui-
oleate, Hydroxyacetophenone, Sodium Hydroxide,
Package Label - Principal Display Panel
Undefined (Label)
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