Spit And Polish Sun Smart Sunscreen Lotion
FDA Label NDC 80325-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Naturally Uncommon, Llc for the product Spit And Polish Sun Smart Sunscreen (NDC 80325-001). 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 drug facts, active ingredients, purpose, uses:, warning:, do not use, when using this product, stop use and ask a doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Titanium Dioxide 7% and Zinc Oxide 10%
Purpose
Sunscreen
Uses:
Helps prevent sunburn. If used as directed with other sun protection measures decreases the risk of skin cancer and early aging caused by the sun.
Warning:
For external use only.
Do Not Use
on damaged or broken skin.
When Using This Product
avoid contact with eyes, contact with eyes occurs, flush with water to remove.
Stop Use And Ask A Doctor
If irritation or rash develops or persists.
Keep Out Of Reach Of Children.
If swallowed, seek immediate medical attention of contact a Poison Control Center right away.
Directions:
Apply liberally and evenly 15 minutes prior to sun exposure. Reapply after 80 minutes of swimming or sweating Reapply after towel drying. Reapply 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 the risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including limiting time in the sun. especially between 10 a.m. and 2 pm, and wear long-sleeved shirts, pants, hats and sunglasses.
For use on children under 6: Consult a physician.
Other Information:
Protect this product from excessive heat or direct sun.
Inactive Ingredients:
ALOE BARBADENSIS LEAF GEL,BUTYLOCTYL SALICYLATE, CAPRYLIC/ CAPRIC/ MYRISTIC/STEARIC TRIGLYCERIDES, CAPRYLIC/CAPRIC/TRIGLYCERIDE (AND) STEARALKONIUM HECTORITE (AND) PROPYLENE CARBONATE, CERA ALBA, DAUCUS CAROTA SATIVA (CARROT) EXTRACT, GLYCERIN (AND) CAMELLIA SINENSIS LEAF EXTRACT, HYDROGENATED COCO-GLYCERIDES, GLYCRRHIZA GLABRA (LICORICE) ROOT EXTRACT, LEUCONO STOC/RADISH ROOT FERMENT FILTRATE, MAGNESIUM SULFATE. POLYGLYCERYL 3 POLYRICINOLEATE, POLY- HYDROXYSTEARIC ACID, SORBITAN OLEATE, WATER.
Package Labeling:
Label2 (Label2)
Label (Label)
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