HAWAIIAN TROPIC SUNSCREEN SHEER TOUCH FACE SPF 30

Product NDC
63354-197
11-digit product format
633540197
Labeler code
63354
Product ID
63354-197_eb41b1ad-d3fc-bd78-e053-2995a90a925b
Type
HUMAN OTC DRUG
Nonproprietary name
AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE
Dosage form
LIQUID
Route
TOPICAL
Labeler
Edgewell Personal Care Brands LLC
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2022-10-01
Marketing end
0000-00-00
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength
3 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 productproduct63354-197DDiscontinued by firm2026-10-05
excluded packagepackage63354-19763354-197-21DDiscontinued 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.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63354-197-21d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63354-197-21f5e01cc5f278…a2eaf40c39c3…

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
63354-197HAWAIIAN TROPIC SUNSCREEN SHEER TOUCH FACE SPF 30 (AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE) LIQUID [EDGEWELL PERSONAL CARE BRANDS LLC]2Legacy NDC20241029_eb41b1ad-d3fb-bd78-e053-2995a90a925b.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63354-197-216335401972141 g in 1 TUBE (63354-197-21) 41 g2022-10-010000-00-00NoNoCurrent