EAD

Manufacturer: EUROPEAN PERFUME WORKS CO. LLC
Effective date: 2020-12-14
Label type: HUMAN OTC DRUG LABEL
Version: 8
Source: legacy-cache
Hydrated at: 2026-08-01 23:01:51

Label at a glance#

ProductEAD

Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE

Label structure11 sections

Indications and 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.

Dosage and administration

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 this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: ...

Storage and handling

protect this product from excessive heat and direct sun.

Contacts and useful links#

PhoneLabel contact1-844-875-4176

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 1.2%

Homosalate 2.0%

Octisalate 5.0%

Octocrylene 1.0%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

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.

Directions

DOSAGE & ADMINISTRATION SECTION

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 this 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: Ask a doctor

Inactive Ingredients

INACTIVE INGREDIENT SECTION

amyl cinnamal, ascorbyl palmitate, benzyl alcohol, butylparaben, C12-15 alkyl benzoate,

carbomer, ceteareth-20, cetearyl alcohol, ethylparaben, fragrance, glyceryl stearate, glyceryl

stearate SE, isobutylparaben, linalool, methylparaben, PEG-100 stearate, phenoxyethanol,

propylene glycol, propylparaben, sodium hydroxide, sodium cetearyl sulfate, tetrasodium

EDTA, tocopheryl acetate, water.

Other Information

STORAGE AND HANDLING SECTION

protect this product from excessive heat and direct sun.

Questions or Comments?

OTC - QUESTIONS SECTION

Call toll free 1-844-875-4176 (Mon- Fri 9AM-5PM CST)

USA Distributor

SPL UNCLASSIFIED SECTION

ARION PERFUME & BEAUTY INC,

SAN ANTONIO, TX - 78212

U.S.A.

Manufactured By

EUROPEAN PERFUME WORKS CO.LLC

P.O Box 23121, Sharjah, United Arab Emirates

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SPF 15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
AVOBENZONE	ACTIVE INGREDIENT	G63QQF2NOX	5
HOMOSALATE	ACTIVE INGREDIENT	V06SV4M95S	5
OCTISALATE	ACTIVE INGREDIENT	4X49Y0596W	5
OCTOCRYLENE	ACTIVE INGREDIENT	5A68WGF6WM	5
AVOBENZONE	ACTIVE MOIETY	G63QQF2NOX	5
HOMOSALATE	ACTIVE MOIETY	V06SV4M95S	5
OCTISALATE	ACTIVE MOIETY	4X49Y0596W	5
OCTOCRYLENE	ACTIVE MOIETY	5A68WGF6WM	5
.ALPHA.-AMYLCINNAMALDEHYDE	INACTIVE INGREDIENT	WC51CA3418	5
ALPHA-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	5
ASCORBYL PALMITATE	INACTIVE INGREDIENT	QN83US2B0N	5
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	5
BUTYLPARABEN	INACTIVE INGREDIENT	3QPI1U3FV8	5
C12-15 ALKYL BENZOATE	INACTIVE INGREDIENT	A9EJ3J61HQ	5
CARBOMER 934	INACTIVE INGREDIENT	Z135WT9208	5
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	5
EDETATE SODIUM	INACTIVE INGREDIENT	MP1J8420LU	5
ETHYLPARABEN	INACTIVE INGREDIENT	14255EXE39	5
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	5
GLYCERYL STEARATE SE	INACTIVE INGREDIENT	FCZ5MH785I	5
ISOBUTYLPARABEN	INACTIVE INGREDIENT	0QQJ25X58G	5
LINALOOL, (+/-)-	INACTIVE INGREDIENT	D81QY6I88E	5
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	5
PEG-100 STEARATE	INACTIVE INGREDIENT	YD01N1999R	5
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	5
POLYOXYL 20 CETOSTEARYL ETHER	INACTIVE INGREDIENT	YRC528SWUY	5
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	5
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	5
SODIUM CETOSTEARYL SULFATE	INACTIVE INGREDIENT	7ZBS06BH4B	5
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	5
WATER	INACTIVE INGREDIENT	059QF0KO0R	5

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 29 matching rows.

EAD
Avobenzone,Homosalate,Octisalate,Octocrylene
AVOBENZONE
HOMOSALATE
OCTISALATE
OCTOCRYLENE
.ALPHA.-AMYLCINNAMALDEHYDE
ASCORBYL PALMITATE
BENZYL ALCOHOL
BUTYLPARABEN
ALKYL (C12-15) BENZOATE
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)
POLYOXYL 20 CETOSTEARYL ETHER
CETOSTEARYL ALCOHOL
ETHYLPARABEN
GLYCERYL MONOSTEARATE
GLYCERYL STEARATE SE
ISOBUTYLPARABEN
LINALOOL, (+/-)-
METHYLPARABEN
PEG-100 STEARATE
PHENOXYETHANOL
PROPYLENE GLYCOL
PROPYLPARABEN
SODIUM HYDROXIDE
SODIUM CETOSTEARYL SULFATE
EDETATE SODIUM
ALPHA-TOCOPHEROL ACETATE
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
63049-101	63049-101-23, 63049-101-25

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
AVOBENZONE	G63QQF2NOX	ACTIB
HOMOSALATE	V06SV4M95S	ACTIB
OCTISALATE	4X49Y0596W	ACTIB
OCTOCRYLENE	5A68WGF6WM	ACTIB
.ALPHA.-AMYLCINNAMALDEHYDE	WC51CA3418	IACT
ASCORBYL PALMITATE	QN83US2B0N	IACT
BENZYL ALCOHOL	LKG8494WBH	IACT
BUTYLPARABEN	3QPI1U3FV8	IACT
ALKYL (C12-15) BENZOATE	A9EJ3J61HQ	IACT
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)	Z135WT9208	IACT
POLYOXYL 20 CETOSTEARYL ETHER	YRC528SWUY	IACT
CETOSTEARYL ALCOHOL	2DMT128M1S	IACT
ETHYLPARABEN	14255EXE39	IACT
GLYCERYL MONOSTEARATE	230OU9XXE4	IACT
GLYCERYL STEARATE SE	FCZ5MH785I	IACT
ISOBUTYLPARABEN	0QQJ25X58G	IACT
LINALOOL, (+/-)-	D81QY6I88E	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
PEG-100 STEARATE	YD01N1999R	IACT
PHENOXYETHANOL	HIE492ZZ3T	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
SODIUM HYDROXIDE	55X04QC32I	IACT
SODIUM CETOSTEARYL SULFATE	7ZBS06BH4B	IACT
EDETATE SODIUM	MP1J8420LU	IACT
ALPHA-TOCOPHEROL ACETATE	9E8X80D2L0	IACT
WATER	059QF0KO0R	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 10 · 555 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / INTRALESIONAL	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	SUSPENSION / AURICULAR (OTIC)	0.5 %w/v		Exact identifier — unii candidate 21 equally ranked IID candidates
BUTYLPARABEN	BUTYLPARABEN	3QPI1U3FV8	LIQUID / TOPICAL	0.02 %w/w		Exact identifier — unii candidate 15 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	LOTION, AUGMENTED / TOPICAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRA-ARTERIAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	OINTMENT, AUGMENTED / TOPICAL	0.11 %w/w		Exact identifier — unii candidate 174 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	EMULSION / OPHTHALMIC	1.5 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	SOLUTION / INTRAMUSCULAR		54 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION / INTRA-ARTICULAR	1 %w/v		Exact identifier — unii candidate 50 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL / TOPICAL		4522 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	CAPSULE, COATED / ORAL	0.08 mg		Exact identifier — unii candidate 174 equally ranked IID candidates
ASCORBYL PALMITATE	ASCORBYL PALMITATE	QN83US2B0N	SYSTEM / TOPICAL	0.04 mg		Exact identifier — unii candidate 6 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	OINTMENT / RECTAL		27 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	CAPSULE, EXTENDED RELEASE / ORAL	32.4 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SUSPENSION / ENDOTRACHEAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	DROPS / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	GEL / TOPICAL		4 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION, EXTENDED RELEASE / ORAL		40 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SUSPENSION / INTRA-ARTICULAR	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	CAPSULE / ORAL		7 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / INTRA-ARTICULAR	0.03 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	FILM, SOLUBLE / ORAL		11 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SYSTEM / TOPICAL		4200 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
ASCORBYL PALMITATE	ASCORBYL PALMITATE	QN83US2B0N	CAPSULE / ORAL	12 mg		Exact identifier — unii candidate 6 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION / SUBMUCOSAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SOLUTION / PARENTERAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / RESPIRATORY (INHALATION)	0.01 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	0.8 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION / SUBCUTANEOUS		90 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION / ENDOTRACHEAL		54 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	CAPSULE, DELAYED RELEASE / ORAL	0.25 mg		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SUSPENSION / OPHTHALMIC	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	SUPPOSITORY / RECTAL	35 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SOLUTION / SUBMUCOSAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
PEG-100 STEARATE	PEG-100 MONOSTEARATE	YD01N1999R	CREAM / VAGINAL		100 mg	Exact identifier — unii candidate 3 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, POWDER, FOR SOLUTION / INTRADISCAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
EDETATE SODIUM	EDETATE SODIUM	MP1J8420LU	EMULSION / OPHTHALMIC	0.02 %w/v		Exact identifier — unii candidate 12 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	TABLET, DELAYED RELEASE / ORAL	2.31 mg		Exact identifier — unii candidate 50 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	EMULSION / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM CETOSTEARYL SULFATE	SODIUM CETOSTEARYL SULFATE	7ZBS06BH4B	CREAM / TOPICAL	1 %w/w		Exact identifier — unii candidate
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION / ENDOTRACHEAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TAMPON / VAGINAL	62.1 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	LIQUID / INTRAVENOUS	1.04 %w/v		Exact identifier — unii candidate 50 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SUSPENSION/ DROPS / OPHTHALMIC	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SYRUP / ORAL		81 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	POWDER, FOR SOLUTION / ORAL		126 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION/ DROPS / TOPICAL	0.75 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVITARY	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
ETHYLPARABEN	ETHYLPARABEN	14255EXE39	SUSPENSION / ORAL		8 mg	Exact identifier — unii candidate 4 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / INFILTRATION		80 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SHAMPOO / TOPICAL	8 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	TABLET, COATED / ORAL	0.8 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	LOTION / TOPICAL		140 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / PARENTERAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SPRAY / TOPICAL	0.8 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	FILM / BUCCAL	1.48 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	AEROSOL, METERED / RECTAL	NA		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / DENTAL	2 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	DROPS / OPHTHALMIC	0.01 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	GEL / TOPICAL		70 mg	Exact identifier — unii candidate 174 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
eeb15000-546e-49c8-9510-69a7a785b5f0			277c4c8c-f771-4e33-83a5-2aa773cf49af	2022-04-19	Warnings	Exact identifier spl set id: 277c4c8c-f771-4e33-83a5-2aa773cf49af

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.