Active Ingredients
Zinc Oxide 20%
Mineral Sunstick
FDA Label NDC 73088-108
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Tubby Todd for the product Mineral Sunstick (NDC 73088-108). 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 ask a doctor, • 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 damage or broken skin.
• When Using This Product
keep out of eyes. Rinse with water to remove.
• Stop Use And Ask A Doctor
if skin rash occurs.
• Keep Out Of Reach Of Children.
If swallowed, get medical help or contact Poison Control Center right away.
Directions
• Apply liberally 15 minutes before sun exposure.
• Reapply
-after 80 minutes of 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 the 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 from10am - 2pm
-wear long-sleeve shirts, pants, hats and sunglasses
• Children under 6 months of age: ask a doctor.
Inactive Ingredients
Cocos Nucifera (Coconut) Oil*, Helianthus Annuus (Sunflower) Seed Oil*, Cera Alba (Beeswax)*, Euphorbia Cerifera Cera (Candelilla Wax), Copernicia Cerifera (Carnauba) Wax*, Butyrospermum Parkii (Shea) Butter*, Ricinus Communis (Castor) Seed Oil*, Tocopherol Theobroma Cacao (Cocoa) Seed Butter*, Aloe Barbadensis Leaf Juice (Aloe Vera)*
*Certified Organic Ingredient(s)
* Please review the disclaimer below.
