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

Elizabeth Arden, Great 8, Moisturizer SPF 35 by

Drug Labeling and Warnings

Elizabeth Arden, Great 8, Moisturizer SPF 35 by is a Otc medication manufactured, distributed, or labeled by Revlon, Revlon, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

As needed

INDICATIONS & USAGE

Sunscreen

INACTIVE INGREDIENT

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10967-665
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10967-665-15	45 mL in 1 TUBE; Type 0: Not a Combination Product	06/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	06/01/2018

Labeler - Revlon (788820165)

Establishment
Name	Address	ID/FEI	Business Operations
Revlon, INC		809725570	manufacture(10967-665)