Home NDC 63354-071 HAWAIIAN TROPIC
Product NDC 63354-071
11-digit product format 633540071
Labeler code 63354
Product ID 63354-071_25821890-35a0-36c5-e063-6294a90a5e6b
Type HUMAN OTC DRUG
Nonproprietary name AVOBENZONE, HOMOSALATE, OCTOCRYLENE
Dosage form SPRAY
Route TOPICAL
Labeler Edgewell Personal Care Brands LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-01-05
Marketing end 2026-10-31
Substance OCTOCRYLENE; HOMOSALATE; AVOBENZONE
Active strength 6; 6; 2.7 g/100g; 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 6 g/100g HOMOSALATE 6 g/100g AVOBENZONE 2.7 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 5A68WGF6WM Internal UNII lookup V06SV4M95S Internal UNII lookup G63QQF2NOX Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63354-071-12 HAWAIIAN TROPIC 100 g in 1 BOTTLE, PUMP SPRAY 100 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63354-071 HAWAIIAN TROPIC (AVOBENZONE, HOMOSALATE, OCTOCRYLENE) SPRAY [EDGEWELL PERSONAL CARE BRANDS LLC] 2 Current NDC, 1 package rows 20241029_17670182-2b2e-ce40-e063-6294a90a2913.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 26 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 63354-071-12 63354007112 100 g in 1 BOTTLE, PUMP (63354-071-12) 100 g 2023-01-05 2026-10-31 No No Historical