Elizabeth Arden, Great 8, Moisturizer SPF 35

Product NDC
10967-665
11-digit product format
109670665
Labeler code
10967
Product ID
10967-665_0ec6d442-3cb4-709b-e063-6394a90a795d
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Octisalate, Homosalate
Dosage form
EMULSION
Route
TOPICAL
Labeler
Revlon
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-06-01
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE
Active strength
3; 10; 5 mg/mL; mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Elizabeth Arden, Great 8, Moisturizer SPF 35
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE3 mg/mL
HOMOSALATE10 mg/mL
OCTISALATE5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G63QQF2NOXInternal UNII lookup
V06SV4M95SInternal UNII lookup
4X49Y0596WInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
b1b89565-7292-45eb-e053-2a95a90ae8d0Available on FDA.report

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

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 275 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CVS Health Sport SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECVS PHARMACYf799bad7-b3df-f9a5-e053-6294a90ab1042024-10-17WarningsExact identifier
application number: M020
CVS Health SPF 30 ClearAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECVS PHARMACYf41e145c-896e-2782-e053-2995a90a5f812024-10-17WarningsExact identifier
application number: M020
CVS Health AM Moisturizing Facial Broad Spectrum SPF 30 SunscreenHOMOSALATE, OCTOCRYLENE, ZINC OXIDECVS PHARMACYf9c89108-1568-ee3e-e053-6294a90ac7562024-10-17WarningsExact identifier
application number: M020
CVS Health 50 Clear Zinc Broad Spectrum SPF 50 SunscreenOCTOCRYLENE, ZINC OXIDECVS PHARMACYfa19e9d3-6ab8-cbd6-e053-6294a90aae9b2024-10-17WarningsExact identifier
application number: M020
CVS Health Sport 30 ClearAVOBENZONE, HOMOSALATE, OCTOCRYLENECVS PHARMACYfbe6ae15-28ef-2acf-e053-6394a90a8d422024-10-17WarningsExact identifier
application number: M020
CVS Health 45 Ultra SheerAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECVS Pharmacyfc4addf0-9a6e-292f-e053-6294a90ab9c02024-10-17WarningsExact identifier
application number: M020
CVS Health Sport 70AVOBENZONE. HOMOSALATE, OCTISALATE, OCTOCRYLENECVS PHARMACYfc4a79ce-208e-2aed-e053-6394a90a06bb2024-10-17WarningsExact identifier
application number: M020
CVS Health Sport 70 ClearAVOBENZONE, HOMOSALATE, OCTISALATE, OCTCRYLENECVS PHARMACYfc4bbb80-c3f6-c4f7-e053-6394a90a4cae2024-10-17WarningsExact identifier
application number: M020
SPF 50 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEDEMOULAS SUPER MARKETS, INCee782436-9eff-49e4-8edc-fd9783454c072024-10-17WarningsExact identifier
application number: M020
GLOW RECIPE WATERMELON GLOW DEW BALM SPF 45AVOBENZONE, HOMOSALATE, OCTISALATEAramara Beauty LLC dba Glow Recipe0c437f88-c731-5834-e063-6394a90a32992024-10-17WarningsExact identifier
application number: M020
SPF 30 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEDEMOULAS SUPER MARKETS, INC5ce3e436-37d1-4918-bb14-0be33b0bc86a2024-10-17WarningsExact identifier
application number: M020
MARKET BASKET KIDS SPF 50 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEDEMOULAS SUPER MARKETS, INC.a6a381da-6e34-bffe-e053-2a95a90a46f22024-10-17WarningsExact identifier
application number: M020
Market Basket Continuous Sunscreen SPF 50AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENEDEMOULAS SUPER MARKETS, INC.f4238107-c76c-266a-e053-2a95a90a89782024-10-17WarningsExact identifier
application number: M020
Market Basket Continuous Sunscreen General Protection SPF 70AVOBENZONE, HOMOSALATE, OCTISALATE, OCTCRYLENEDEMOULAS SUPER MARKETS, INC.e7182d07-a006-db4b-e053-2995a90aa9e12024-10-17WarningsExact identifier
application number: M020
EXCHANGE SELECT SPORT SUNSCREEN CONTINUOUS SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEArmy & Air Force Exchange Servicee467df80-9007-46c9-e053-2a95a90a1bef2024-10-17WarningsExact identifier
application number: M020
EXCHANGE SELECT KIDS SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEArmy & Air Force Exchange Servicee467c306-a2ed-4976-e053-2995a90a56ed2024-10-17WarningsExact identifier
application number: M020
Exchange Select Sport Sunscreen Continuous SPF 70AVOBENZONE, HOMOSALATE, OCTISALATE, OCTCRYLENEArmy & Air Force Exchange Servicee716ba8c-0148-07f2-e053-2a95a90a53df2024-10-17WarningsExact identifier
application number: M020
EXCHANGE SELECT SPORT SUNSCREEN CONTINUOUS SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEArmy & Air Force Exchange Servicef55828b4-f2a4-13ec-e053-2995a90a0f842024-10-17WarningsExact identifier
application number: M020
SPF50 Plus Mineral SunscreenZINC OXIDE AND TITANIUM DIOXIDEKAS Direct LLC dba BabyGanics08e8bc10-85d8-4215-8351-7ec12029416c2024-10-17WarningsExact identifier
application number: M020
bu SPF 30 Broad Spectrum Alcohol-Free Performance Sunscreen - Natural Citrus ScentOCTINOXATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONEBu Brands, LLC9ac92c96-5bcf-421d-9cd0-73ddfa10195c2024-10-17WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10967-665-151096706651545 mL in 1 TUBE (10967-665-15) 45 ml2018-06-010000-00-00NoNoCurrent