AVAIL BODY WITH SUNSCREEN- homosalate, octocrylene, octisalate, and avobenzone lotion

Avail Body with Sunscreen by

Drug Labeling and Warnings

Avail Body 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 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.

Do not use on damaged or 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, get medical help or contact a Poison Control Center right away.

Directions

• Apply liberally 15 minutes before sun exposure.
• Reapply
  • After 80 minutes of swimming or sweating,
  • Immediately after towel drying,
  • At least every 2 hours.
• 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.

Inactive ingredients

Water ( Aqua), C12-15 Alkyl Benzoate, Triacontanyl PVP, Euphorbia Cerifera ( Candelilla) Wax, Silica, PEG-15 Cocamine, Acrylates/Steareth-20 Methacrylate Copolymer, PEG-40 Stearate, Glyceryl Behenate, Panthenol, Lavandula Angustifolia ( Lavender) Oil, Caprylyl Glycol, Mentha Viridis ( Spearmint) Leaf Oil, Aloe Barbadensis Leaf Juice, Ammonium Acryloyldimethyltaurate/VP Copolymer, Caprylhydroxamic Acid, Glycerin, Citrus Medica Limonum ( Lemon) Peel Oil, Persea Gratissima ( Avocado) Oil, Prunus Amygdalus Dulcis ( Sweet Almond ) Oil, Simmondsia Chinensis ( Jojoba) Seed Oil, Glycine Soja ( Soybean) Oil, Methyl Glucose Sesquistearate, Tocopheryl Acetate, Daucus Carota ( Carrot) Sativa Root Extract, Beta-Carotene, Tocopherol, Linalool, d-Limonene, Citral.

PRINCIPAL DISPLAY PANEL - 152.4 g Bottle Carton

Aēsop ®

SPF
50
Avail Body Lotion
with Sunscreen

Spearmint Leaf Panthenol Tocopherol

Broad-spectrum SPF50
Water Resistant (80 minutes)

Broad-spectrum moisturising sunscreen
with high SPF50 protection – formulated
to provide up to 80 minutes' water
resistance – with a lightweight skin feel
and refreshing aroma.

Massage generously into uncovered skin
fifteen minutes prior to sun exposure.
To maintain protection, reapply every 80
minutes and after perspiring, swimming or
towelling dry.

www.aesop.com
Net Wt. 152.4 g / 5.4 Oz.

INGREDIENTS AND APPEARANCE

AVAIL BODY WITH SUNSCREEN 
homosalate, octocrylene, octisalate, and avobenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76293-015
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	3500 mg  in 35 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2800 mg  in 35 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	1750 mg  in 35 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1050 mg  in 35 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
TRICONTANYL POVIDONE (UNII: N0SS3Q238D)
CANDELILLA WAX (UNII: WL0328HX19)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PEG-15 COCAMINE (UNII: 8L6LB12TSJ)
ETHYL ACRYLATE/METHACRYLIC ACID/STEARETH-20 METHACRYLATE COPOLYMER (UNII: EPA1872R1N)
PEG-40 STEARATE (UNII: ECU18C66Q7)
GLYCERYL DIBEHENATE (UNII: R8WTH25YS2)
PANTHENOL (UNII: WV9CM0O67Z)
LAVENDER OIL (UNII: ZBP1YXW0H8)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SPEARMINT OIL (UNII: C3M81465G5)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
GLYCERIN (UNII: PDC6A3C0OX)
LEMON OIL (UNII: I9GRO824LL)
AVOCADO OIL (UNII: 6VNO72PFC1)
ALMOND OIL (UNII: 66YXD4DKO9)
JOJOBA OIL (UNII: 724GKU717M)
SOYBEAN OIL (UNII: 241ATL177A)
METHYL GLUCOSE SESQUISTEARATE (UNII: V1YW10H14D)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
CARROT (UNII: L56Z1JK48B)
.BETA.-CAROTENE (UNII: 01YAE03M7J)
TOCOPHEROL (UNII: R0ZB2556P8)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76293-015-15	1 in 1 CARTON	11/04/2014
1		152.4 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	11/04/2014

Labeler - Emeis Cosmetics Pty Ltd (754271146)