Avail Body With Sunscreen Lotion
FDA Label NDC 76293-015

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Emeis Cosmetics Pty Ltd for the product Avail Body With Sunscreen (NDC 76293-015). 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 other, active ingredients, purpose, uses, warnings, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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.