AVAIL FACIAL SUNSCREEN SPF 25- homosalate, octocrylene, octisalate, avobenzone lotion

Avail Facial Sunscreen SPF 25 by

Drug Labeling and Warnings

Avail Facial Sunscreen SPF 25 by is a Otc medication manufactured, distributed, or labeled by Emeis Cosmetics Pty Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Avobenzone 3%

Homosalate 9%

Octisalate 4%

Octocrylene 7%

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 the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• apply liberally 20 minutes before sun exposure.
• children under 6 months: Ask a doctor.

Reapply

• at least every 2 hours.
• use a water resistant sunscreen if swimming or sweating.

Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value 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

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, P.O. Box 22, Plainsboro, NJ 08536-0222

Inactive ingredients

Water (Aqua), Coco-Caprylate, Tribehenin PEG-20 Esters, Glycerin, Silica, Squalane, Phenoxyethanol, Ethylhexylglycerin, Benzyl Alcohol, Tocopheryl Acetate, Tocopherol, Glycine Soja (Soybean) Oil, Panthenol, Lavandula Angustifolia (Lavender) Oil, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Rosmarinus Officinalis (Rosemary) Leaf Oil, Sodium Stearoyl Glutamate, Microcrystalline Cellulose, Sodium Dehydroacetate, Cedrus Atlantica (Cedarwood) Bark Oil, Sodium Hydroxide, Cellulose Gum, Sodium Carrageenan, Camellia Sinensis Leaf Extract, Daucus Carota Sativa (Carrot) Root Extract, Sea Salt (Maris sal), Lactic Acid, Sodium Benzoate, Beta-Carotene, Potassium Sorbate, Linalool, Limonene, Geraniol.

Company information

Aesop, 25 Smith Street, Fitzroy 3065, Australia.

+61 3 9412 8900

aesop@aesop.com

Aesop USA Inc, 48 West 25th St, New York, NY, 10010

Product Packaging

Aēsop

Avail Facial Lotion with Sunscreen SPF 25

Green Tea · Panthenol · Tocopherol

Broad-spectrum SPF 25 sunscreen lotion for daily use.

Following hydration, massage generously into skin twenty minutes before sun exposure. Reapply every two hours. Use water-resistant sunscreen if swimming or sweating.

www.aesop.com

Net wt. 50.8g/1.79Oz.

INGREDIENTS AND APPEARANCE

AVAIL FACIAL SUNSCREEN SPF 25 
homosalate, octocrylene, octisalate, avobenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76293-055
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	90 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	40 mg  in 1 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	70 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
TOCOPHEROL (UNII: R0ZB2556P8)
PANTHENOL (UNII: WV9CM0O67Z)
LAVENDER OIL (UNII: ZBP1YXW0H8)
ROSEMARY OIL (UNII: 8LGU7VM393)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
LACTIC ACID, L- (UNII: F9S9FFU82N)
SEA SALT (UNII: 87GE52P74G)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
TRIBEHENIN PEG-20 ESTERS (UNII: 84K9EH29Y9)
GLYCERIN (UNII: PDC6A3C0OX)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SQUALANE (UNII: GW89575KF9)
SOYBEAN OIL (UNII: 241ATL177A)
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)
CEDRUS ATLANTICA BARK OIL (UNII: ZX5QRE4U60)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM BENZOATE (UNII: OJ245FE5EU)
.BETA.-CAROTENE (UNII: 01YAE03M7J)
GERANIOL (UNII: L837108USY)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
BENZYL ALCOHOL (UNII: LKG8494WBH)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
CARROT (UNII: L56Z1JK48B)
LIMONENE, (+/-)- (UNII: 9MC3I34447)
COCO-CAPRYLATE (UNII: 4828G836N6)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
CARRAGEENAN (UNII: 5C69YCD2YJ)

Product Characteristics
Color	white (Off-white to pale yellow)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76293-055-01	1 in 1 CARTON	01/01/2019
1		50.8 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
2	NDC: 76293-055-02	1 in 1 CARTON	01/01/2019
2		5 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 not final	part352	01/01/2019

Labeler - Emeis Cosmetics Pty Ltd (754271146)