Home NDC 63354-593 HAWAIIAN TROPIC
Product NDC 63354-593
11-digit product format 633540593
Labeler code 63354
Product ID 63354-593_5de3805f-8ee3-971d-e063-6294a90a6aa9
Type HUMAN OTC DRUG
Nonproprietary name AVOBENZONE,OCTOCRYLENE
Dosage form SPRAY
Route TOPICAL
Labeler Edgewell Personal Care Brands LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-10-31
Marketing end 2028-10-01
Substance OCTOCRYLENE; AVOBENZONE
Active strength 3; 1 g/100g; g/100g
NDC exclude flag No
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 HAWAIIAN TROPIC Active Ingredients# Ingredient, Strength table Ingredient Strength OCTOCRYLENE 3 g/100g AVOBENZONE 1 g/100g
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63354-593-16 HAWAIIAN TROPIC 236 g in 1 BOTTLE, PUMP SPRAY 236 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63354-593 HAWAIIAN TROPIC (AVOBENZONE,OCTOCRYLENE) SPRAY [EDGEWELL PERSONAL CARE BRANDS LLC] 1 Current NDC, 1 package rows 20231031_08f34b31-6337-ef7c-e063-6294a90a1c4c.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 45 of 357 · 7,139 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63354-593-16 63354059316 236 g in 1 BOTTLE, PUMP (63354-593-16) 236 g 2023-10-31 2028-10-01 No No Historical