Avail Lip Balm With Sunscreen
FDA Label NDC 76293-052

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 Lip Balm With Sunscreen (NDC 76293-052). 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, otc - purpose, uses, skin cancer/skin aging alert, otc - do not use, otc - stop use, otc - when using, otc - 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

Other

Drug Facts

Otc - Purpose

Active ingredients:Purpose
Octocrylene 4.25%Sunscreen
Zinc Oxide 5.25%Sunscreen

Uses

  • Helps prevent sunburn.

Skin Cancer/Skin Aging Alert

Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

For external use only.

Otc - Do Not Use

Do not use on damaged or broken skin.

Otc - Stop Use

Stop use and ask a doctor if rash occurs.

Otc - When Using

When using this product keep out of eyes. Rinse with water to remove.

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
  • Use a water-resistant sunscreen if swimming or sweating
  • Reapply at least every 2 hours
  • 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.

Inactive Ingredients

Ricinus Communis (Castor) Seed Oil, Jojoba Esters, Pentaerythrityl Tetraisostearate, Euphorbia Cerifera (Candelilla) Wax, Helianthus Annuus (Sunflower) Seed Oil, Tocopherol, Simmondsia Chinensis (Jojoba) Seed Oil, Glyceryl Behenate, Copernicia Cerifera (Carnauba) Wax, Citrus Tangerina (Tangerine) Peel Oil, Hydrogenated Castor Oil, Glyceryl Isostearate, Polyhydroxystearic Acid, Lavandula Angustifolia (Lavender) Oil, Cananga Odorata Flower Oil.

Principal Display Panel - 5.5 G Cylinder Carton

Aēsop®

SPF
30

Avail Lip Balm with Sunscreen

Zinc Oxide • Tocopherol • Castor Seed

Rich hydration for lips, with SPF30 protection. Apply generously as often as required.

www.aesop.com
Net Wt. 5.5 g / 0.2 Oz.

Principal Display Panel (5.5 g Cylinder Carton)

Principal Display Panel (5.5 g Cylinder Carton)

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