Active Ingredient
Zinc oxide 10%
Avene Hydrance Moisturizing Spf 30 Lotion
FDA Label NDC 64760-783
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 Hydrance Moisturizing Spf 30 (NDC 64760-783). 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.
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 • Use a water resistant sunscreen if swimming or sweating • 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.
Inactive Ingredients
Water, Tridecyl Salicylate, Caprylic/Capric Triglyceride, Shea Butter Ethyl Esters, Propanediol, Coco-Caprylate, C13-15 Alkane, Glycerin, Undecane, Methylpropanediol, Polyglyceryl-3 Polyricinoleate, Pyrus Malus (Apple) Fruit Extract, Sodium Chloride, Disteardimonium Hectorite, Isoamyl Laurate, Silica, Tridecane, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Caprylyl Glycol, Bisabolol, Allantoin, Lecithin, Aloe Barbadensis Leaf Juice Powder, Phenylpropanol, Tetrasodium Glutamate Diacetate, Tocopherol, Sodium Hydroxide.
Other Information
• Protect this product in this container from excessive heat and direct sun.
Questions?
1-866-41-AVENE (28363)
1-877-441-2011 (CAN)
* Please review the disclaimer below.
