Elizabeth Arden, Great 8, Moisturizer SPF 35

Manufacturer
Revlon | Revlon, INC
Effective date
2024-01-12
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:07:10

Label at a glance#

ProductElizabeth Arden, Great 8, Moisturizer SPF 35
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE
Label structure12 sections

Indications and uses

- helps provent sunburn - if used as directed with other sun protection measures decreases the risk of cancer and early skin aging caused by the sun

Dosage and administration

For Sunscreen Use: - Apply liberally 15 minutes before sun exposure - reapply: at least every 2 hours use water resistant sunscreen if swimming or sweating

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Uses

OTC - PURPOSE SECTION

- helps provent sunburn

- if used as directed with other sun protection measures decreases the risk of cancer and early skin aging caused by the sun

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

Stop using and ask a doctor

OTC - STOP USE SECTION

if rash occurs.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

INSTRUCTIONS FOR USE SECTION

For Sunscreen Use:

- Apply liberally 15 minutes before sun exposure

- reapply:

at least every 2 hours

use water resistant sunscreen if swimming or sweating

Sun Protection Measures

USER SAFETY WARNINGS SECTION

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 10am-2pm

wear long-sleede shirts, pants, hats, and sunglasses

children under 6 months: ask a doctor

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 using and ask a doctor if rash occurs
  • keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away

DOSAGE & ADMINISTRATION SECTION

As needed

INDICATIONS & USAGE SECTION

Sunscreen

INACTIVE INGREDIENT SECTION

Aqua/water/eau, dipropylene glycol, glycerin, thermus thermophillus ferment, butylene glycol, imperata cylindrica root extract, enantia chlorantha bark extract, marrubium vulgare extract, acrylates/C10-30 alkyl acrylate crosspolymer, ammonium acryloyldimethyltaurate/beheneth-25 methacrylate crosspolymer, caprylyl glycol, carbomer, dimethylmethoxy chromanol disodium EDTA, hydroxyacetophenone, oleanolic acid, sclareolide, triethanolamine, parfum (fragrance), geraniol, hexyl cinnamal, limonene, linalool, chlorphenesin.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Great 8Great 8

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10967-665-15Elizabeth Arden, Great 8, Moisturizer SPF 3545 mL in 1 TUBEEMULSION454

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10967-665ELIZABETH ARDEN, GREAT 8, MOISTURIZER SPF 35 (AVOBENZONE, OCTISALATE, HOMOSALATE) EMULSION [REVLON]4Current NDC, Legacy NDC, 1 package rows20240113_b1b89565-7292-45eb-e053-2a95a90ae8d0.zip

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10967-66510967-665-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Source Document#

Source XML

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
Elizabeth Arden, Great 8, Moisturizer SPF 35AVOBENZONE, OCTISALATE, HOMOSALATERevlonb1b89565-7292-45eb-e053-2a95a90ae8d02024-01-12WarningsExact identifier
ndc (package): 10967-665-15
ndc (product): 10967-665
ndc11 (package): 10967066515
spl id: 0ec6d442-3cb4-709b-e063-6394a90a795d
spl set id: b1b89565-7292-45eb-e053-2a95a90ae8d0

Reported adverse events (FAERS/openFDA)#

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