Package Label.Principal Display Panel
Drug Facts
Sensible Spf 32 Mineral Sunscreen
FDA Label NDC 73369-1501
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kabana Skin Care for the product Sensible Spf 32 Mineral Sunscreen (NDC 73369-1501). 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 package label.principal display panel, active ingredients, purpose, uses, warnings, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Zinc Oxide USP** 25%
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 if used as directed with other sun protection measures
Otc - Do Not Use
Do not use on damaged or broken skin
Otc - When Using
When using this product keep out of eyes. Rinse with water to remove.
Otc - Stop Use
Stop use and ask a doctor if rash occurs
Otc - Keep Out Of Reach Of Children
Keep out of reach of children, if product is swallowed, get medical help or contact a Poison Control Center right away.
Directions
• apply liberally 15 minutes before sun exposure
• use a water resistant sunscreen if swimming or sweating
• reapply:
• after swimming or sweating
• immediately after towel drying
• 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 this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
• limit time in the sun, especially from 10 AM – 2 PM.
• wear long-sleeved shirts, pants, hats and sunglasses.
• Children under 6 months. Ask a doctor.
Inactive Ingredients
Artesian Spring Water, Extra Virgin Olive Oil*, Vegetable Gycerin*, Jojoba Oil*, Shea Butter*, Vegetable Emulsifying Wax NF# (polysorbate 60 and cetearyl alcohol), Vitamin E.
*Certified Organic by USDA/NOP **non-nano, uncoated, French Process zinc oxide
Other Information
• protect this product from excessive heat and direct sun
* Please review the disclaimer below.
