Jacket Ultimate Performance Sunscreen Spf 30 Liquid
FDA Label NDC 71070-599

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 Ultimate Performance Sunscreen Spf 30 (NDC 71070-599). 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:, warnings:, do not use, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredients

Avobenzone (3.00%)
Octisalate (5.00%)
Octocrylene (5.00%)

Purpose

Sunscreen

Uses:

  • Helps prevent sunburn.
  • higher SPF gives more sunburn protection
  • Retains SPF after 80 minutes of swimming or sweating
  • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin agingcaused 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.

  • Do not puncture or incinerate. Contents under pressure. Do not store it at temperatures above 120°F.

Stop Use And Ask A Doctor If

  • rash or irritation develops and lasts.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

If Pregnant Or Breast-Feeding,

ask a health professional before use.

Directions.

  • Apply liberally 15 minutes before sun exposure and as needed.
  • Children under 6 months of age: ask a doctor.
  • Reapply:
  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
  • do not spray directly on face. Spray into hands and apply to face.
  • Use in well-ventilated areas.
  • Sun Protection Measures.Spending time in the sun increase 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 from 10 a.m.-2p.m.
  • Wear long-sleeved shirts, pants,hats,and sunglasses.

Other Information

  • Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients

Alcohol, Aloe Barbadensis Leaf Extract, Alpha-Arbutin, Ascorbyl Palmitate, Butyloctyl Salicylate, Camellia Sinensis Leaf Extract, Cocos Nucifera (Coconut) Oil, Cucumis Sativus (Cucumber) Fruit Extract, Cymbopogon Schoenanthus Oil, Helianthus Annuus (Sunflower) Seed Oil, Linum Usitatissimum (Linseed) Seed Oil, Methyl Dihydroabietate, Nelumbo Nucifera Flower Extract, Salvia Officinalis (Sage) Leaf Extract, Tocopheryl Acetate.

Questions?

www.jacketsunscreen.com

Package Labeling:

Can (Can)

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