Home NDC 63354-199 HAWAIIAN TROPIC
Product NDC 63354-199
11-digit product format 633540199
Labeler code 63354
Product ID 63354-199_3cf3e2f3-1222-33ad-e063-6294a90ad63b
Type HUMAN OTC DRUG
Nonproprietary name AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE
Dosage form LOTION
Route TOPICAL
Labeler Edgewell Personal Care Brands LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-10-01
Marketing end 2026-10-31
Substance HOMOSALATE; OCTISALATE; OCTOCRYLENE; AVOBENZONE
Active strength 9; 4.5; 6.5; 3 g/100g; 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 HOMOSALATE 9 g/100g OCTISALATE 4.5 g/100g OCTOCRYLENE 6.5 g/100g AVOBENZONE 3 g/100g
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 Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63354-199-22 HAWAIIAN TROPIC 97 g in 1 TUBE LOTION 97 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 Marketing end Sample Exclude flag Status 63354-199-22 63354019922 97 g in 1 TUBE (63354-199-22) 97 g 2022-10-01 2026-10-31 No No Historical