AVAIL LIP BALM WITH SUNSCREEN- zinc oxide and octocrylene stick

Avail Lip Balm with Sunscreen by

Drug Labeling and Warnings

Avail Lip Balm with Sunscreen by is a Otc medication manufactured, distributed, or labeled by Emeis Cosmetics Pty Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

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

Uses

• Helps prevent sunburn.

Warnings

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.

Do not use on damaged or broken skin.

Stop use and ask a doctor if rash occurs.

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

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.

INGREDIENTS AND APPEARANCE

AVAIL LIP BALM WITH SUNSCREEN 
zinc oxide and octocrylene stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76293-052
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	0.00058 g  in 0.011 g
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	0.00047 g  in 0.011 g

Inactive Ingredients
Ingredient Name	Strength
Castor Oil (UNII: D5340Y2I9G)
Hydrogenated Jojoba Oil/Jojoba Oil, Randomized (Iodine Value 57-61) (UNII: 12GIN16K1G)
Pentaerythrityl tetraisostearate (UNII: 9D7IK5483F)
Candelilla Wax (UNII: WL0328HX19)
Sunflower Oil (UNII: 3W1JG795YI)
Tocopherol (UNII: R0ZB2556P8)
Jojoba Oil (UNII: 724GKU717M)
Glyceryl Dibehenate (UNII: R8WTH25YS2)
Carnauba Wax (UNII: R12CBM0EIZ)
Mandarin Oil (UNII: NJO720F72R)
Hydrogenated Castor Oil (UNII: ZF94AP8MEY)
Glyceryl Isostearate (UNII: HYE7O27HAO)
Polyhydroxystearic Acid (2300 MW) (UNII: YXH47AOU0F)
Lavender Oil (UNII: ZBP1YXW0H8)
Cananga Oil (UNII: 8YOY78GNNX)

Product Characteristics
Color	YELLOW (Pale yellow)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76293-052-47	1 in 1 CARTON
1		5.5 g in 1 CYLINDER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	12/01/2013

Labeler - Emeis Cosmetics Pty Ltd (754271146)