FDA.reportPublic FDA data

Hawaiian Tropic

Product NDC
63354-832
11-digit product format
633540832
Labeler code
63354
Product ID
63354-832_7885f941-94f1-c936-e053-2991aa0acba5
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octocrylene
Dosage form
SPRAY
Route
TOPICAL
Labeler
Edgewell Personal Care Brands LLC
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2018-10-19
Marketing end
0000-00-00
Substance
HOMOSALATE; OCTOCRYLENE; AVOBENZONE
Active strength
6 g/100g; g/100g; g/100g
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63354-832DDiscontinued by firm2026-10-05
excluded productproduct63354-832DDiscontinued by firm2026-10-05
excluded packagepackage63354-83263354-832-11DDiscontinued by firm2026-10-05
excluded packagepackage63354-83263354-832-12DDiscontinued by firm2026-10-05

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 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Dataset, Scope, Package NDC table
DatasetScopePackage NDC
excluded productproduct
excluded productproduct
excluded packagepackage63354-832-12
excluded packagepackage63354-832-11

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63354-832HAWAIIAN TROPIC (AVOBENZONE, HOMOSALATE, OCTOCRYLENE) SPRAY [EDGEWELL PERSONAL CARE BRANDS LLC]3Legacy NDC20241102_7885f941-94f0-c936-e053-2991aa0acba5.zip
63354-832HAWAIIAN TROPIC (AVOBENZONE, HOMOSALATE, OCTOCRYLENE) SPRAY [EDGEWELL PERSONAL CARE BRANDS LLC]3Legacy NDC20241102_837332ab-caf4-6006-e053-2991aa0a4df9.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63354-832-116335408321126 g in 1 BOTTLE, SPRAY (63354-832-11) 26 g2019-03-060000-00-00NoNoCurrent
63354-832-1263354083212100 g in 1 BOTTLE, SPRAY (63354-832-12) 100 g2018-10-190000-00-00NoNoCurrent