Hawaiian Tropic Matte Effect Mineral Enriched Sunscreen SPF 30

Product NDC
63354-502
11-digit product format
633540502
Labeler code
63354
Product ID
63354-502_ee119a8f-cd14-623a-e053-2995a90a1838
Type
HUMAN OTC DRUG
Nonproprietary name
Homosalate, Octisalate, Octocrylene, Zinc Oxide
Dosage form
LOTION
Route
TOPICAL
Labeler
Edgewell Personal Care Brands, LLC
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2019-09-06
Marketing end
0000-00-00
Substance
HOMOSALATE; OCTISALATE; OCTOCRYLENE; ZINC OXIDE
Active strength
6 g/100g; g/100g; g/100g; g/100g
NDC exclude flag
No
Listing certified through
2023-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63354-502DDiscontinued by firm2026-10-05
excluded packagepackage63354-50263354-502-24DDiscontinued 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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproduct63354-502DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63354-50263354-502-24DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

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
63354-502HAWAIIAN TROPIC MATTE EFFECT MINERAL ENRICHED SUNSCREEN SPF 30 (HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE) LOTION [EDGEWELL PERSONAL CARE BRANDS, LLC]5Legacy NDC20241102_91d415a3-9895-6755-e053-2995a90aecdc.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63354-502-01633540502017.39 g in 1 PACKET (63354-502-01) 7.39 g2019-09-060000-00-00NoNoCurrent
63354-502-2463354050224177.44 g in 1 BOTTLE (63354-502-24) 177.44 g2019-09-060000-00-00NoNoCurrent