Jacket Spf 50 Cream
FDA Label NDC 71070-768

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 (NDC 71070-768). 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 if, keep out if reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Zinc Oxide 7.50%

Octinoxate 7.50%

Octisalate 5.00%

Oxybenzone 5.00%

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 If 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, 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 Alcohol, Cetearyl Olivate, Cetyl Alcohol Cucumis Sativus (Cucumber) Fruit Extract, Cymbopogon Schoenanthus (Lemongrass) Oil, Dimethicone, Ethylhexylgycerin, Ethylhexyl Palmitate, Glycerin, Glyceryl Stearate, Glycyrrhiza Glabra (Licorice) Root Extract, Helianthus Annuus (Sunflower) Oil, Phenoxyethanol, Polysorbate 20, Punica Granatum (Pomegranate) Extract, Sorbitan Olivate, Stearyl Alcohol, Tocopheyl Acetate (Vitamin E), Zema (Corn), Propanediol

Package Labeling:

Label2 (Label2)

Label2 (Label2)

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