FDA.reportPublic FDA data

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 231 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
JAFRA Beauty advanced SILK MOISTURIZING SERUM FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 RICH COCOA ND20HOMOSALATE, OCTISALATE, ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.2e307ca4-9975-47ef-b13f-2cfbcc8467192025-02-03WarningsExact identifier
application number: M020
JAFRA Beauty advanced SILK MOISTURIZING SERUM FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 CAPUCCINO D8HOMOSALATE, OCTISALATE, ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.08628240-327d-4329-a0ff-fed239dde2062025-02-03WarningsExact identifier
application number: M020
JAFRA Beauty advanced SILK MOISTURIZING SERUM FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 NATURAL LG14HOMOSALATE, OCTISALATE, ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.768100d6-efd6-4a98-bdb8-2d1561ee356c2025-02-03WarningsExact identifier
application number: M020
JAFRA Beauty advanced SILK MOISTURIZING SERUM FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 IVORY LN18HOMOSALATE, OCTISALATE, ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.e6f33ec7-691f-4d4b-9086-b981c19f80d32025-02-03WarningsExact identifier
application number: M020
JAFRA Beauty advanced SILK MOISTURIZING SERUM FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 SUNTAN MDG14HOMOSALATE, OCTISALATE, ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.784bb8c4-ee3c-4a73-a828-5781f01f621d2025-02-03WarningsExact identifier
application number: M020
Brush On Block SPF 30 Mineral Powder Translucent Zinc Only-RefillZINC OXIDESPF Ventures, LLC2d47eb76-e644-4e04-e063-6294a90a93cc2025-02-03WarningsExact identifier
application number: M020
Brush On Block Sun Shine SPF 30 Protective Lip Oil Peony TintTITANIUM DIOXIDE/ZINC OXIDESPF Ventures LLC2d490531-af36-87d0-e063-6394a90acf492025-02-03WarningsExact identifier
application number: M020
YOUR TINTED MOISTURIZER HYDRATING ANTI AGING BROAD SPECTRUM SPF 30OCTISALATE, OCTINOXATE, OXYBENZONE, AVOBENZONESkin Ai, LLC2d8b7d07-2249-898b-e063-6394a90af6ad2025-02-01WarningsExact identifier
application number: M020
ESSENCE LIGHT SUNSCREEN SPF 50 PAAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEENGLEWOOD LAB, INC.f5c79f1a-cecd-2409-e053-2995a90ad06f2025-01-31WarningsExact identifier
application number: M020
RODAN - FIELDS ESSENTIALS Body Sunscreen BROAD SPECTRUM SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENERodan & Fields67b55df8-9623-4352-b136-b0bc8d1efe022025-01-31WarningsExact identifier
application number: M020
Oil-Free Daily Hydration SPF 15OCTINOXATE, AVOBENZONEBoscia LLCec322ae5-ab03-4c7b-9c6d-0bda3327c72a2025-01-31WarningsExact identifier
application number: M020
PAULAS CHOICE HYDRALIGHT SHINE-FREE DAILY MINERAL COMPLEX Broad Spectrum SPF 30TITANIUM DIOXIDE, ZINC OXIDEPaula's Choice, Incb90658d0-e422-4265-a6ee-39c29b6c116a2025-01-31WarningsExact identifier
application number: M020
SunStation USA SPF-30 SPORT SUNSCREENZINC OXIDERENU LABORATORIES, LLC11d3c60e-238d-999e-e063-6394a90a624b2025-01-31WarningsExact identifier
application number: M020
Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF30TITANIUM DIOXIDE AND ZINC OXIDEDERM ASSO. MID OHIO2d04bc5d-6f11-4f56-e063-6294a90ae7552025-01-31WarningsExact identifier
application number: M020
TiZO Mineral Sun Defense SPF 50TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals Ltd.2d0766a1-4091-e84a-e063-6394a90a004a2025-01-31WarningsExact identifier
application number: M020
Hello Sunday The Shimmer One Mineral Glow SPF 45ZINC OXIDEKao USA Inc.0c935521-4e8b-0605-e063-6394a90a0bbc2025-01-31WarningsExact identifier
application number: M020
Hello Sunday The Invisible One Sunscreen Plus Primer SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKao USA Inc.0c7ce5b9-5ab4-d845-e063-6394a90afa762025-01-31WarningsExact identifier
application number: M020
Hello Sunday The Mineral One Lightweight Serum SPF 50ZINC OXIDEKao USA Inc.0c91894f-a40e-73e9-e063-6394a90ab8072025-01-31WarningsExact identifier
application number: M020
Hello Sunday The One Thats a Serum Hydrating Serum SPF 45AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKao USA Inc.0c913096-c000-4336-e063-6394a90a560c2025-01-31WarningsExact identifier
application number: M020
Hello Sunday Bestseller Daily SPF DuoAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKao USA Inc.26cf264b-f68d-5691-e063-6394a90a8ab42025-01-31WarningsExact 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