Home NDC 63354-804 HAWAIIAN TROPIC
Product NDC 63354-804
11-digit product format 633540804
Labeler code 63354
Product ID 63354-804_47a412fd-9496-7241-e063-6394a90ac0db
Type HUMAN OTC DRUG
Nonproprietary name AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE
Dosage form GEL
Route TOPICAL
Labeler Edgewell Personal Care Brands LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-10-01
Substance OCTISALATE; HOMOSALATE; AVOBENZONE; OCTOCRYLENE
Active strength 4.5; 5; 2.7; 9 g/100g; g/100g; g/100g; g/100g
NDC exclude flag No
Listing certified through 2027-12-31
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 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OCTISALATE 4.5 g/100g HOMOSALATE 5 g/100g AVOBENZONE 2.7 g/100g OCTOCRYLENE 9 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 63354-804-21 HAWAIIAN TROPIC 9.9 g in 1 TUBE GEL 9.9 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63354-804 HAWAIIAN TROPIC (AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE) GEL [EDGEWELL PERSONAL CARE BRANDS LLC] 1 Current NDC, 1 package rows 20241003_228fab45-e0d2-f219-e063-6294a90a1ef6.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 Sample Exclude flag Status 63354-804-21 63354080421 9.9 g in 1 TUBE (63354-804-21) 9.9 g 2024-10-01 No No Current