Active Ingredients
Titanium Dioxide 3.7% ...... Purpose: Sunscreen
Zinc Oxide 14% ...... Purpose: Sunscreen
Sunscreen-lotion
FDA Label NDC 73557-575
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Shanghai Chuangshi Medical Technology (group) Co., Ltd. for the product Sunscreen-lotion (NDC 73557-575). 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, stop use ..., when using this product, ... ask a doctor, 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
(See following 5 SECTIONs)
Do Not Use
on damaged or broken skin.
Stop Use ...
if rash occurs.
When Using This Product
keep out of eyes.
Rinse with water to remove.
... Ask A Doctor
if rash occurs.
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Shake well before use
- Apply liberally 15 minutes before sun exposure and as needed.
- Reapply:
- Children under 6 months of age: ask a doctor.
- 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:
· After 40 minutes of swimming or sweating
· Immediately after towel drying
· At least every 2 hours
· Limit your time in the sun, especially from 10 a.m. - 2 p.m.
· Wear long-sleeved shirts, pants, hats, and sunglasses.
Other Information
- Protect the product in the container from excessive heat and direct sun.
Inactive Ingredients
Argania Spinosa Kernel Oil, Auminum Hydroxide, Water (Aqua), Bisbolol, Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Cucumis Sativus (Cucumber) Fruit Extract, Caesalpinia Spinosa Gum, Dicaprylyl Ether, C13-15 Alkane, Carthamus Tinctorius (Safflower) Oleosomes, Caprylyl Glycol, Cocos Nucifera (Coconut) Oil, Helianthus Annuus (Sunflower) Seed Oil Unsaponifiables, Helianthus Annuus (Sunflower) Seed Oil, Hydroxyacetophenone, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Propanediol, Phenylpropanol, Pongamia Pinnata Seed Extract, Persea Gratissima (Avocado) Oil, Polyglyceryl-10 Mono/Dioleate, Polyhydroxystearic Acid, Rosa Rubiginosa Seed Oil, Stearyl Citrate, Sorbitan Sesquioleate, Silica, Stearic Acid, Sodium Phytate, Trioctyldodecyl Citrate, Tocopheryl Acetate, Vitis Vinifera (Grape) Seed Oil, 2-Hexanediol
Otc - Questions
Package Label.Principal Display Panel
Box Label (575 B)
Container Label (575 C)
* Please review the disclaimer below.
