FDA Label for Avail Body With Sunscreen

View Indications, Usage & Precautions

Avail Body With Sunscreen Product Label

The following document was submitted to the FDA by the labeler of this product Emeis Cosmetics Pty Ltd. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



Drug Facts


Active Ingredients



Avobenzone 3%
Homosalate 10%
Octisalate 5%
Octocrylene 8%


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.


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 swallowed, get medical help or contact a Poison Control Center right away.


Directions



  • Apply liberally 15 minutes before sun exposure.
  • Reapply
  • At least every 2 hours
  • Immediately after swimming, sweating, or towel drying.
  • 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 of 15 or higher and other sun protection measures including:
    • Limit time in the sun, especially from 10 a.m. - 2 p.m.
    • Wear long-sleeve shirts, pants, hats, and sunglasses.
    • Children under 6 months of age: Ask a doctor.

Other Information



  • Protect the product in this container from excessive heat and direct sun.
  • You may report a serious adverse reaction to Report Reaction LLC, PO Box 22, Plainsboro, NJ 08536-0222.

* Please review the disclaimer below.