Home NDC 63354-929-54 Hawaiian Tropic
Product NDC 63354-929
Requested package NDC 63354-929-54
11-digit product format 633540929
Labeler code 63354
Product ID 63354-929_77cdd346-d274-ed66-e053-2991aa0ae31d
Type HUMAN OTC DRUG
Nonproprietary name Avobenzone, Homosalate, Octisalate, Octocrylene
Dosage form LOTION
Route TOPICAL
Labeler Edgewell Personal Care Brands LLC
Application part352
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2018-10-11
Marketing end 0000-00-00
Substance HOMOSALATE; OCTOCRYLENE; AVOBENZONE; OCTISALATE
Active strength 9 g/100g; g/100g; g/100g; g/100g
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 3 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 63354-929 63354-929-54 I Inactivated by FDA excluded / ndc_excluded.zip fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 63354-929 63354-929-54 I Inactivated by FDA excluded / ndc_excluded.zip 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 63354-929 63354-929-54 I Inactivated by FDA excluded / ndc_excluded.zip bd6a592717d7…303034d00443…
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 AVOBENZONE 3 g/100g OCTISALATE 4 g/100g HOMOSALATE 9 g/100g OCTOCRYLENE 5 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 Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63354-929-54 Hawaiian Tropic 177 g in 1 TUBE LOTION 177 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63354-929 HAWAIIAN TROPIC (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [EDGEWELL PERSONAL CARE BRANDS LLC] 3 Legacy NDC, 1 package rows 20241102_77cdd346-d273-ed66-e053-2991aa0ae31d.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 1 of 1 · 1 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 63354-929-54 63354092954 177 g in 1 TUBE (63354-929-54) 177 g 2018-10-11 0000-00-00 No No Current