FDA.reportPublic FDA data

Aureli

Manufacturer
Emilia Personal Care
Effective date
2021-11-04
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:29:26

Label at a glance#

ProductAureli Broad Spectrum
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE
Label structure9 sections

Storage and handling

Other information -protect the product in this container from excessive heat and direct sun

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

Avobenzone, 3.0%

Homosalate, 10.0%

Octisalate, 5.0%

Octocrylene, 2.0%

Oxybenzone, 4.0%

OTC - PURPOSE SECTION

Purpose

Sunscreen

Sunscreen

Sunscreen

Sunscreen

Sunscreen

INDICATIONS & USAGE SECTION

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 SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get

medical help or contact a Poison Control Center

right away.

DOSAGE & ADMINISTRATION SECTION


Directions

-Apply liberally 15 minutes before sun exposure

-Reapply at least every 2 hours

-Use water-resistant sunscreen if swimming or sweating

-Children under 6 months of age: ask a doctor

- 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



STORAGE AND HANDLING SECTION

Other information -protect the product in this

container from excessive heat and direct sun

INACTIVE INGREDIENT SECTION

Inactive ingredients - isododecane,

dimethicone/bis-isobutyl PPG-20 crosspolymer,

dicaprylyl ether, helianthus annuus (sunflower) seed

oil, daucus carota sativa (carrot) root extract,

beta-carotene, fragrance, astazanthin, tocopheryl

acetate (vitamin E), plukenetia volubilis seed oil

(inca inchi), tocopherol


PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

copy of label
copy of label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42421-328-152023-06-17C16284748780-19d75b9d1-09ae-f424-e053-dadaa90a57ceAureli Carrot Body
42421-328-152023-01-30C16284748780-19d75b9d1-09ae-f424-e053-dadaa90a57ceAureli Carrot Body
42421-328-152021-11-04C16284748780-19d75b9d1-09ae-f424-e053-dadaa90a57ceAureli Carrot Body
42421-328-152020-01-31C16284748780-19d75b9d1-09ae-f424-e053-dadaa90a57ceAureli Carrot Body

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOX1
HOMOSALATEACTIVE INGREDIENTV06SV4M95S1
OCTISALATEACTIVE INGREDIENT4X49Y0596W1
OCTOCRYLENEACTIVE INGREDIENT5A68WGF6WM1
OXYBENZONEACTIVE INGREDIENT95OOS7VE0Y1
AVOBENZONEACTIVE MOIETYG63QQF2NOX1
HOMOSALATEACTIVE MOIETYV06SV4M95S1
OCTISALATEACTIVE MOIETY4X49Y0596W1
OCTOCRYLENEACTIVE MOIETY5A68WGF6WM1
OXYBENZONEACTIVE MOIETY95OOS7VE0Y1
.ALPHA.-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ11
.BETA.-CAROTENEINACTIVE INGREDIENT01YAE03M7J1
ASTAXANTHININACTIVE INGREDIENT8XPW32PR7I1
CARROTINACTIVE INGREDIENTL56Z1JK48B1
DIDECYL ETHERINACTIVE INGREDIENTDA81HI310Z1
DIMETHICONE/BIS-ISOBUTYL PPG-20 CROSSPOLYMERINACTIVE INGREDIENTO4I3UFO6ZF1
ISODODECANEINACTIVE INGREDIENTA8289P68Y21
PLUKENETIA VOLUBILIS SEED OILINACTIVE INGREDIENT8ED72Z8J1Z1
SUNFLOWER OILINACTIVE INGREDIENT3W1JG795YI1
TOCOPHEROLINACTIVE INGREDIENTR0ZB2556P81

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42421-32842421-328-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
ISODODECANEA8289P68Y2IACT
DIMETHICONE/BIS-ISOBUTYL PPG-20 CROSSPOLYMERO4I3UFO6ZFIACT
DIDECYL ETHERDA81HI310ZIACT
SUNFLOWER OIL3W1JG795YIIACT
CARROTL56Z1JK48BIACT
.BETA.-CAROTENE01YAE03M7JIACT
ASTAXANTHIN8XPW32PR7IIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
PLUKENETIA VOLUBILIS SEED OIL8ED72Z8J1ZIACT
TOCOPHEROLR0ZB2556P8IACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
OXYBENZONE95OOS7VE0YACTIB

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 1 · 17 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1TABLET, EXTENDED RELEASE / ORAL4 mgExact identifier — unii candidate
10 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1OINTMENT / TOPICALNAExact identifier — unii candidate
10 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1SYSTEM / TOPICAL0.1 mgExact identifier — unii candidate
10 equally ranked IID candidates
TOCOPHEROLTOCOPHEROLR0ZB2556P8INJECTION, EMULSION / INTRAVENOUS0.02 %w/vExact identifier — unii candidate
5 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1TABLET, FILM COATED / ORAL246 mgExact identifier — unii candidate
10 equally ranked IID candidates
TOCOPHEROLTOCOPHEROLR0ZB2556P8CAPSULE / ORALNAExact identifier — unii candidate
5 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1TABLET / ORAL2 mgExact identifier — unii candidate
10 equally ranked IID candidates
TOCOPHEROLTOCOPHEROLR0ZB2556P8CAPSULE, COATED / ORAL0.25 mgExact identifier — unii candidate
5 equally ranked IID candidates
.BETA.-CAROTENEBETA CAROTENE01YAE03M7JEMULSION / ORALNAExact identifier — unii candidate
2 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1SOLUTION / ORAL1.05 mg/1mlExact identifier — unii candidate
10 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1CAPSULE / ORAL16 mgExact identifier — unii candidate
10 equally ranked IID candidates
TOCOPHEROLTOCOPHEROLR0ZB2556P8TABLET / ORAL0.08 mgExact identifier — unii candidate
5 equally ranked IID candidates
.BETA.-CAROTENEBETA CAROTENE01YAE03M7JCREAM / TOPICALNAExact identifier — unii candidate
2 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS0.64 mgExact identifier — unii candidate
10 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1FILM, SOLUBLE / BUCCAL0.07 mgExact identifier — unii candidate
10 equally ranked IID candidates
TOCOPHEROLTOCOPHEROLR0ZB2556P8CREAM / TOPICALNAExact identifier — unii candidate
5 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1TABLET, CHEWABLE / ORAL0.1 mgExact identifier — unii candidate
10 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
fe52ae54-1ef8-7386-e053-6394a90ae1f4e284022a-6308-4ea8-a9a0-db4de11135412023-06-17WarningsExact identifier
spl set id: e284022a-6308-4ea8-a9a0-db4de1113541

Reported adverse events (FAERS/openFDA)#

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