Home NDC 10967-788 Elizabeth Arden Eight Hour Hydraplay SPF 40
Product NDC 10967-788
11-digit product format 109670788
Labeler code 10967
Product ID 10967-788_37b28f93-a43b-abd0-e063-6394a90aa079
Type HUMAN OTC DRUG
Nonproprietary name Octisalate, Homosalate, Avobenzone, Octocrylene
Dosage form CREAM
Route TOPICAL
Labeler Revlon Consumer Products Corp
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-03-04
Substance HOMOSALATE; OCTOCRYLENE; OCTISALATE; AVOBENZONE
Active strength 3.5; 4.5; 2.5; 1.5 g/50g; g/50g; g/50g; g/50g
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 Eight Hour Hydraplay SPF 40
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HOMOSALATE 3.5 g/50g OCTOCRYLENE 4.5 g/50g OCTISALATE 2.5 g/50g AVOBENZONE 1.5 g/50g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 4 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 10967-788-17 Elizabeth Arden Eight Hour Hydraplay SPF 40 50 g in 1 BOTTLE CREAM 50 2 10967-788-50 Elizabeth Arden Eight Hour Hydraplay SPF 40 1 in 1 BOX CREAM 1 2
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 26 of 357 · 7,139 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 10967-788-17 10967078817 50 g in 1 BOTTLE 50 g Historical 10967-788-50 10967078850 1 BOTTLE in 1 BOX (10967-788-50) / 50 g in 1 BOTTLE (10967-788-17) 1 bottle 2025-03-04 No No Current