Home NDC 63354-317 HAWAIIAN TROPIC
Product NDC 63354-317
11-digit product format 633540317
Labeler code 63354
Product ID 63354-317_419b8062-17ab-d130-e063-6294a90a6dcf
Type HUMAN OTC DRUG
Nonproprietary name AVOBENZONE OCTISALATE OCTOCRYLENE
Dosage form OIL
Route TOPICAL
Labeler Edgewell Personal Care Brands LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-09-11
Substance OCTISALATE; AVOBENZONE; OCTOCRYLENE
Active strength 2.5; 2; 3 g/100g; g/100g; g/100g
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 HAWAIIAN TROPIC
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OCTISALATE 2.5 g/100g AVOBENZONE 2 g/100g OCTOCRYLENE 3 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4X49Y0596W Internal UNII lookup G63QQF2NOX Internal UNII lookup 5A68WGF6WM Internal UNII lookup
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 63354-317-16 HAWAIIAN TROPIC 236 g in 1 BOTTLE, PUMP OIL 236 1
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 63354-317-16 63354031716 236 g in 1 BOTTLE, PUMP (63354-317-16) 236 g 2023-09-11 No No Current