Purpose
Sunscreen
Avene Mineral Sunscreen Face And Body Lotion
FDA Label NDC 64760-780
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 Face And Body (NDC 64760-780). 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 purpose, active ingredient, 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
Active Ingredient
Zinc Oxide 12%
Uses
helps prevent sunburn.
if used as directed with other sun protection measures (see Directions), decreased 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 Ask A Doctor
if rash occurs.
Keep Out Of Reach Of Children.
If product is swallowed, get medical help or contact a Poison Control Center right away.
Directions
Apply generously 15 minutes before sun exposure.
Reapply:
- after 80 minutes of swimming or sweating.
- immediately after towel drying.
- at least every 2 hours.
- children under 6 months of age: Ask a doctor.
- limit time in the sun, especially from 10 a.m. to 2 p.m.
- wear long-sleeve shirts, pants, hats, and sunglasses.
Sun Protection Measures. Spending time in te 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:
Other Information
Protect this product from excessive heat and direct sun.
Inactive Ingredients
Allantoin, avene thermal spring water (avene aqua), bisabolol, C12-C15 alkyl benzoate, caprylic/capric triglyceride, caprylyl glycol, coco-caprylate, glycerin, glyceryl behenate, glyceryl dibehenate, glyceryl stearate, isoamyl laurate, lecithin, methylpropanediol, neopentyl glycol diheptanoate, phenylpropanol, polyester-7, polyglyceryl-3 polricinoleate, polyglyceryl-4 diisostearate/polyhydroxystearate/sebacate, silica, sodium chloride, tocopherol, tocopheryl acetate, tribehenin, tridecyl salic
Questions?
1-866-41-AVENE (28363)
Package Label
EAU THERMALE
AVENE
LABORATORIE DERMATOLOGIQUE
MINERAL SUNSCREEN
SPRF 50 UVA-UVB
BROAD SPECTRUM SPF50
FACE & BODY LOTION
FOR SENSITIVE SKIN
CHILDREN & ADULTS
LIGHTWEIGHT TEXTURE
FAST-ABSORPTION
WATER-RESISTANT (80 MINUTES)
125ML 4.2 FL.OZ.
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