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

AESOP Avail Facial Sunscreen Broad Spectrum SPF 25 by

Drug Labeling and Warnings

AESOP Avail Facial Sunscreen Broad Spectrum SPF 25 by is a Otc medication manufactured, distributed, or labeled by Emeis Cosmetics Pty Ltd, Ensign Laboratories Proprietary Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Avobenzone 3%
Homosalate 7%
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 reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

For sunscreen use:

• apply generously 15 minutes before sun exposure.
• 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-sleeved 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, coco-caprylate/caprate, tribehenin
PEG-20 esters, glycerin, copernicia
cerifera (carnauba) wax, silica,
ethylhexylglycerin, caprylic/capric
triglyceride, phenoxyethanol, benzyl
alcohol, glycine soja (soybean) oil,
tocopherol, panthenol, lavandula
angustifolia (lavender) oil, acrylates/
C10-30 alkyl acrylate crosspolymer,
rosmarinus officinalis (rosemary)
leaf oil, sodium stearoyl glutamate,
trisodium ethylenediamine disuccinate,
microcrystalline cellulose, sodium
dehydroacetate, tocopheryl acetate,
cedrus atlantica (cedarwood) bark
oil, sodium hydroxide, cellulose gum,
sodium carrageenan, camellia sinensis
leaf extract, sea salt (maris sal), lactic
acid, sodium benzoate, beta-carotene,
daucus carota sativa (carrot) root extract,
potassium sorbate, linalool, limonene,
geraniol

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

AESOP AVAIL FACIAL SUNSCREEN BROAD SPECTRUM SPF 25 
avobenzone, homosalate, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76293-928
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30.0 mg  in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	70.0 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (ETHYLHEXYL SALICYLATE - UNII:4X49Y0596W)	OCTISALATE	40.0 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	70.0 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
TRIBEHENIN PEG-20 ESTERS (UNII: 84K9EH29Y9)
GLYCERIN (UNII: PDC6A3C0OX)
COPERNICIA CERIFERA (CARNAUBA) WAX (UNII: R12CBM0EIZ)
SILICA (UNII: ETJ7Z6XBU4)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BENZYL ALCOHOL (UNII: LKG8494WBH)
SOYBEAN OIL (UNII: 241ATL177A)
TOCOPHEROL (UNII: R0ZB2556P8)
PANTHENOL (UNII: WV9CM0O67Z)
LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL (UNII: ZBP1YXW0H8)
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) (UNII: 8Z5ZAL5H3V)
ROSMARINUS OFFICINALIS (ROSEMARY) LEAF OIL (UNII: 8LGU7VM393)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
CEDRUS ATLANTICA BARK OIL (UNII: ZX5QRE4U60)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
CELLULOSE GUM (UNII: K679OBS311)
SODIUM CARRAGEENAN (UNII: 7CY8BVL34N)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
SEA SALT (UNII: 87GE52P74G)
LACTIC ACID, DL- (UNII: 3B8D35Y7S4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
BETA-CAROTENE (UNII: 01YAE03M7J)
CARROT (UNII: L56Z1JK48B)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
LINALOOL (UNII: D81QY6I88E)
LIMONENE, (+/-)- (UNII: 9MC3I34447)
GERANIOL (UNII: L837108USY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76293-928-01	1 in 1 CARTON	10/01/2025
1		47.5 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	10/01/2025

Labeler - Emeis Cosmetics Pty Ltd (754271146)

Establishment
Name	Address	ID/FEI	Business Operations
Ensign Laboratories Proprietary Limited		753228022	manufacture(76293-928)