Active Ingredients
Zinc Oxide 6.00%
Homosalate 10.00%
Octisalate 5.00%
Octocrylene 5.00%
Jacket Spf-50 Broad Spectrum Sunscreen Lotion
FDA Label NDC 71070-868
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Balshi Md Dermaceuticals for the product Jacket Spf-50 Broad Spectrum Sunscreen (NDC 71070-868). 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 and consult physician, 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
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
on damaged or broken skin.
When Using This Product
keep out of eyes. Rinse with water to remove.
Stop Use And Consult Physician
if irritation or rash develops
Keep Out Of Reach Of Children.
If product is swallowed, get medical attention or contact poison control center immediately.
Directions
• Apply liberally 15 minutes before sun exposure • Reapply: *At least every 2 hours *Immediately after swimming, sweating or towel drying
Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use sunscreen with broad spectrum protection and an SPF rating of 15 or higher, along with other sun protection measures including:
*Limit time in the sun, especially between 10am -2pm *Wear long sleeve shirts, pants, hats and sunglasses *For children under 6 months, consult a physician.
Other Ingredients
Acrylates Copolymer, Allantoin, Aloe Barbadensis (Aloe Vera Gel) Juice, Aqua (Deionized Water), a-Arbutin, Ascorbic Acid (Vitamin C), Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Ceteareth 20, Cetearyl Olivate, Cetyl Alcohol, Cucumis Sativus (Cucumber) Fruit Extract, Cyclopentasiloxane, Cyclotetrasiloxane, Cymbopogon Schoenanthus (Lemongrass) Oil, Dimethicone, Ethylhexylglycerin, Ethylhexyl Palmitate, Glycerin, Glyceryl Stearate, Glycyrrhiza Glabra (Licorice) Root Extract, Helianthus Annuus (Sunflower) Oil, Magnesium Aluminum Silicate, Phenoxyethanol, Polysorbate 20, Punica Granatum (Pomegranate) Extract, Sorbitan Olivate, Stearyl Alcohol, Tocopheryl Acetate (Vitamin E), Tridecyl Salicylate, Zema (Corn) Propanediol
Other Information
Protect this product from excessive heat and direct sunlight.
Package Labeling:
Label (Label)
* Please review the disclaimer below.
