ELIZABETH ARDEN, GREAT 8, MOISTURIZER SPF 35- avobenzone, octisalate, homosalate emulsion 
Revlon

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Elizabeth Arden Great 8, Eight Hour Daily Defense Moisturizer Broad Spectrum Sunscreen SPF35

Active Ingredients

Avobenzone 3%

Homosalate 10%

Octisalate 5%

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

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

Directions

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

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

As needed

Sunscreen

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.

Great 8

ELIZABETH ARDEN, GREAT 8, MOISTURIZER SPF 35 
avobenzone, octisalate, homosalate emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10967-665
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
TROLAMINE (UNII: 9O3K93S3TK)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
AMMONIUM ACRYLOYLDIMETHYLTAURATE (UNII: KBC00G95HI)  
2'-HYDROXYACETOPHENONE (UNII: 3E533Z76W0)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
IMPERATA CYLINDRICA ROOT (UNII: VYT2JA85NH)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
GLYCERIN (UNII: PDC6A3C0OX)  
THERMUS THERMOPHILUS LYSATE (UNII: 775R692494)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
OLEANOLIC ACID (UNII: 6SMK8R7TGJ)  
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
ANNICKIA CHLORANTHA BARK (UNII: H70115MP4A)  
WATER (UNII: 059QF0KO0R)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
SCLAREOLIDE (UNII: 37W4O0O6E6)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10967-665-1545 mL in 1 TUBE; Type 0: Not a Combination Product06/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02006/01/2018
Labeler - Revlon (788820165)
Establishment
NameAddressID/FEIBusiness Operations
Revlon, INC809725570manufacture(10967-665)

Revised: 1/2024
Document Id: 0ec6d442-3cb4-709b-e063-6394a90a795d
Set id: b1b89565-7292-45eb-e053-2a95a90ae8d0
Version: 4
Effective Time: 20240112
 
Revlon