Label: ELIZABETH ARDEN, GREAT 8, MOISTURIZER SPF 35- avobenzone, octisalate, homosalate emulsion
- NDC Code(s): 10967-665-15
- Packager: Revlon
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 12, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Uses
- When using this product
- Stop using and ask a doctor
- Keep out of reach of children.
- Directions
-
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
- DOSAGE & ADMINISTRATION
- INDICATIONS & USAGE
-
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 emulsionProduct 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)