Hawaiian Tropic Silk Hydration Broad Spectrum SPF 15

Product NDC
63354-311
11-digit product format
633540311
Labeler code
63354
Product ID
63354-311_e41aba4c-09cc-85fd-e053-2a95a90a8c37
Type
HUMAN OTC DRUG
Nonproprietary name
AVOBENZONE,HOMOSALATE,OCTOCRYLENE
Dosage form
OIL
Route
TOPICAL
Labeler
Edgewell Personal Care Brands LLC
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-09-21
Marketing end
0000-00-00
Substance
AVOBENZONE; HOMOSALATE; OCTOCRYLENE
Active strength
2 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 productproduct63354-311DDiscontinued by firm2026-10-15
excluded packagepackage63354-31163354-311-13DDiscontinued by firm2026-10-15

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 productproduct63354-311DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63354-31163354-311-13DDiscontinued 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
63354-311HAWAIIAN TROPIC SILK HYDRATION BROAD SPECTRUM SPF 15 (AVOBENZONE,HOMOSALATE,OCTOCRYLENE) OIL [EDGEWELL PERSONAL CARE BRANDS LLC]4Legacy NDC20241102_af9c1a1a-c713-4a75-e053-2a95a90a27b2.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63354-311-1363354031113148 g in 1 BOTTLE (63354-311-13) 148 g2020-09-210000-00-00NoNoCurrent