Active Ingredient
Zinc oxide 12%
Avene Mineral Sunscreen Stick Spf 50 Stick
FDA Label NDC 64760-784
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pierre Fabre Usa Inc. for the product Avene Mineral Sunscreen Stick Spf 50 (NDC 64760-784). 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 ingredient, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, 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 broken skin.
When Using This Product
• keep out of eyes. Rinse with water to remove.
Stop Use And Ask A Doctor If
• rash occurs.
Keep Out Of Reach Of Children
If swallowed, call a poison control center or get medical help right away.
Directions
Adults and children 6 months and older:
• Apply generously 15 minutes before sun exposure
• Reapply:
• at least every 2 hours
• after 80 minutes of swimming or sweating
• immediately after towel drying
• Children under 6 months of age: Ask a doctor
• 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 a.m. to 2 p.m. • Wear long-sleeve shirts, pants, hats, and sunglasses.
Other Information
• Protect this product in this container from excessive heat and direct sun.
Inactive Ingredients
Caprylic/Capric Triglyceride, Helianthus Annuus (Sunflower) Seed Wax, C12-15 Alkyl Benzoate, Jojoba Esters, Octyldodecyl Neopentanoate, Shea Butter Ethyl Esters, Tridecyl Salicylate, Euphorbia Cerifera (Candelilla) Wax, Methylpropanediol, Silica, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Allantoin, Caprylyl Glycol, Lecithin, Phenylpropanol, Tocopherol.
Questions?
1-866-41-AVENE (28363)
1-877-441-2011 (CAN)
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