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 23:02:05

Label at a glance#

ProductEAD
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE
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: - limit time in the...

Storage and handling

protect this product from excessive heat and direct sun.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone    2.0%

Homosalate     6.0%

Octisalate        5.0%

Octocrylene     2.0%

Oxybenzone    2.0%

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

EAD SPF 30EAD SPF 30

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOX5
HOMOSALATEACTIVE INGREDIENTV06SV4M95S5
OCTISALATEACTIVE INGREDIENT4X49Y0596W5
OCTOCRYLENEACTIVE INGREDIENT5A68WGF6WM5
OXYBENZONEACTIVE INGREDIENT95OOS7VE0Y5
AVOBENZONEACTIVE MOIETYG63QQF2NOX5
HOMOSALATEACTIVE MOIETYV06SV4M95S5
OCTISALATEACTIVE MOIETY4X49Y0596W5
OCTOCRYLENEACTIVE MOIETY5A68WGF6WM5
OXYBENZONEACTIVE MOIETY95OOS7VE0Y5
.ALPHA.-AMYLCINNAMALDEHYDEINACTIVE INGREDIENTWC51CA34185
ALPHA-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L05
ASCORBYL PALMITATEINACTIVE INGREDIENTQN83US2B0N5
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBH5
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV85
C12-15 ALKYL BENZOATEINACTIVE INGREDIENTA9EJ3J61HQ5
CARBOMER 934INACTIVE INGREDIENTZ135WT92085
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1S5
EDETATE SODIUMINACTIVE INGREDIENTMP1J8420LU5
ETHYLPARABENINACTIVE INGREDIENT14255EXE395
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE45
GLYCERYL STEARATE SEINACTIVE INGREDIENTFCZ5MH785I5
ISOBUTYLPARABENINACTIVE INGREDIENT0QQJ25X58G5
LINALOOL, (+/-)-INACTIVE INGREDIENTD81QY6I88E5
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T5
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999R5
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T5
POLYOXYL 20 CETOSTEARYL ETHERINACTIVE INGREDIENTYRC528SWUY5
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V35
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OH5
SODIUM CETOSTEARYL SULFATEINACTIVE INGREDIENT7ZBS06BH4B5
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32I5
WATERINACTIVE INGREDIENT059QF0KO0R5

Products#

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

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63049-10263049-102-23, 63049-102-25

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

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 ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHINJECTION / INTRALESIONAL0.02 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / AURICULAR (OTIC)56.55 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
ETHYLPARABENETHYLPARABEN14255EXE39SOLUTION / ORAL14 mgExact identifier — unii candidate
4 equally ranked IID candidates
POLYOXYL 20 CETOSTEARYL ETHERPOLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYGEL / TOPICAL2 %w/wExact identifier — unii candidate
7 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4OINTMENT / TOPICAL5 %w/wExact identifier — unii candidate
21 equally ranked IID candidates
GLYCERYL STEARATE SEGLYCERYL STEARATE SEFCZ5MH785ICREAM / TOPICAL4 %w/wExact identifier — unii candidate
2 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ILIQUID / ORAL2 mg/5mlExact identifier — unii candidate
174 equally ranked IID candidates
BUTYLPARABENBUTYLPARABEN3QPI1U3FV8CAPSULE, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
15 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSOLUTION / RESPIRATORY (INHALATION)0.01 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SUSPENSION / SUBCUTANEOUSADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IFILM, SOLUBLE / BUCCAL5 mgExact identifier — unii candidate
174 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSUPPOSITORY / VAGINALNAExact identifier — unii candidate
50 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISPRAY / NASALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / ORAL27120 mgExact identifier — unii candidate
81 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / EPIDURALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / INTRAOCULARADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHPOWDER / ORALNAExact identifier — unii candidate
68 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISUSPENSION / SUBCUTANEOUSADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSOLUTION / INTRAVENOUS0.02 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3AEROSOL, FOAM / TOPICAL1800 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSOLUTION / TOPICAL24 mgExact identifier — unii candidate
68 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / RESPIRATORY (INHALATION)8 %w/vExact identifier — unii candidate
174 equally ranked IID candidates
ASCORBYL PALMITATEASCORBYL PALMITATEQN83US2B0NCREAM / TOPICAL0.02 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TDROPS / ORAL1 mg/1mlExact identifier — unii candidate
79 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ITABLET, EXTENDED RELEASE / ORAL13 mgExact identifier — unii candidate
174 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSOLUTION / RESPIRATORY (INHALATION)0.03 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
CARBOMER 934CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)Z135WT9208LOTION / TOPICAL0.5 %w/wExact identifier — unii candidate
14 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3GEL / RECTAL3315 mgExact identifier — unii candidate
81 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, EMULSION / INTRAVENOUS45 mgExact identifier — unii candidate
50 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION / INTRA-ARTICULAR0.24 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHEMULSION / TOPICAL0.06 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION / INTRA-ARTERIAL0.9 %w/vExact identifier — unii candidate
50 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / ORAL22602 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHCAPSULE, EXTENDED RELEASE / ORAL0.22 mgExact identifier — unii candidate
68 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TJELLY / NASAL250 mgExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / DENTAL2 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4CREAM / TOPICAL836 mgExact identifier — unii candidate
21 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SHAMPOO / TOPICAL8 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHLOTION / TOPICAL4000 mgExact identifier — unii candidate
50 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TLOTION / TOPICAL351 mgExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TABLET, EXTENDED RELEASE / ORAL9 mgExact identifier — unii candidate
81 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IENEMA / RECTAL0.44 %v/vExact identifier — unii candidate
174 equally ranked IID candidates
BUTYLPARABENBUTYLPARABEN3QPI1U3FV8CAPSULE / ORALNAExact identifier — unii candidate
15 equally ranked IID candidates
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1SSUPPOSITORY / VAGINALNAExact identifier — unii candidate
9 equally ranked IID candidates
CARBOMER 934CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)Z135WT9208ENEMA / RECTAL0.24 %w/vExact identifier — unii candidate
14 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS0.8 mgExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SPRAY / NASAL5 mgExact identifier — unii candidate
81 equally ranked IID candidates
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1STABLET, EXTENDED RELEASE / ORAL800 mgExact identifier — unii candidate
9 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ILOTION, AUGMENTED / TOPICALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISUSPENSION / OPHTHALMICADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IPOWDER, FOR SUSPENSION / ORAL9 mgExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / PARENTERALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSUSPENSION / ORAL388 mgExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3OINTMENT, AUGMENTED / TOPICAL714 mgExact identifier — unii candidate
81 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TTABLET, EXTENDED RELEASE / ORAL0.17 mgExact identifier — unii candidate
79 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TCREAM / VAGINAL22 mgExact identifier — unii candidate
79 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ICONCENTRATE / ORAL10 mg/5mlExact identifier — unii candidate
174 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TTABLET, COATED / ORAL0.8 mgExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SPRAY / SUBLINGUAL36 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TABLET, FILM COATED / ORAL96 mgExact identifier — unii candidate
81 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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
267a090f-6df8-4f4e-a42c-4b686bb3a3c1e346ea58-dd0d-4af5-99b1-008196897ff62022-04-19WarningsExact identifier
spl set id: e346ea58-dd0d-4af5-99b1-008196897ff6

Reported adverse events (FAERS/openFDA)#

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