FDA.reportPublic FDA data

Hawaiian Tropic Everyday Active SPF15

Product NDC
63354-549
Requested package NDC
63354-549-56
11-digit product format
633540549
Labeler code
63354
Product ID
63354-549_dc8ca3ed-5412-6278-e053-2995a90a0efc
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
2022-04-13
Marketing end
0000-00-00
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength
2 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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage63354-54963354-549-56DDiscontinued by firm2026-11-02

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 Everyday Active SPF15

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE2 g/100g
OCTOCRYLENE3 g/100g
HOMOSALATE3 g/100g
OCTISALATE2 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G63QQF2NOXInternal UNII lookup
5A68WGF6WMInternal UNII lookup
V06SV4M95SInternal UNII lookup
4X49Y0596WInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
dc8ca3ed-5411-6278-e053-2995a90a0efcAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63354-549-56Hawaiian Tropic Everyday Active SPF15236 g in 1 BOTTLELOTION2363

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63354-549HAWAIIAN TROPIC EVERYDAY ACTIVE SPF15 (AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE) LOTION [EDGEWELL PERSONAL CARE BRANDS LLC]3Legacy NDC, 1 package rows20241029_dc8ca3ed-5411-6278-e053-2995a90a0efc.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hawaiian Tropic Everyday Active SPF15AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLCdc8ca3ed-5411-6278-e053-2995a90a0efc2024-10-27WarningsExact identifier
ndc (package): 63354-549-56
ndc (product): 63354-549
ndc11 (package): 63354054956

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63354-549-5663354054956236 g in 1 BOTTLE (63354-549-56) 236 g2022-04-130000-00-00NoNoCurrent