FDA.reportPublic FDA data

HAWAIIAN TROPIC

Product NDC
63354-784
11-digit product format
633540784
Labeler code
63354
Product ID
63354-784_3fe83a06-b046-ac3b-e063-6294a90a3b37
Type
HUMAN OTC DRUG
Nonproprietary name
AVOBENZONE,OCTISALATE,OCTOCRYLENE
Dosage form
OIL
Route
TOPICAL
Labeler
Edgewell Personal Care Brands LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-04-02
Substance
OCTISALATE; AVOBENZONE; OCTOCRYLENE
Active strength
4.5; 2.7; 9 g/100g; g/100g; g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTISALATE4.5 g/100g
AVOBENZONE2.7 g/100g
OCTOCRYLENE9 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
31d01fae-4085-d84a-e063-6294a90ab981Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63354-784-16HAWAIIAN TROPIC236 g in 1 BOTTLE, PUMPOIL2362

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63354-784HAWAIIAN TROPIC (AVOBENZONE,OCTISALATE,OCTOCRYLENE) OIL [EDGEWELL PERSONAL CARE BRANDS LLC]1Current NDC, 1 package rows20250406_31d01fae-4085-d84a-e063-6294a90ab981.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 114 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Kind Restore Tinted Mineral SunscreenZINC OXIDEPOLISH BEAUTY3980d278-c0f4-2c59-e063-6394a90aac372025-12-16Exact identifier
application number: M020
Solar Eclipse Extreme SunscreenZINC OXIDEULTRAVIOLET SKINCARE LLC36bfa691-48c0-8033-e063-6294a90ad8992025-12-16Exact identifier
application number: M020
Kind Restore Moisturizing Lip BalmTITANIUM DIOXIDE, ZINC OXIDEPOLISH BEAUTY39814e27-4f3f-5ee6-e063-6394a90a941b2025-12-16Exact identifier
application number: M020
Yoali SPF 40ZINC OXIDEYOALI STUDIO LLC390b7f9c-bc04-80ec-e063-6294a90a40922025-12-16Exact identifier
application number: M020
Skin Defense Matte Tinted SunscreenZINC OXIDEGentlehomme LLC365eb727-3e7f-f1dd-e063-6394a90aa4692025-12-16Exact identifier
application number: M020
Dr B Clinical Skin Care Tinted SunscreenTITANIUM DIOXIDE, ZINC OXIDENAIRA BABAIAN, M.D., P.A.365da1f8-5250-7589-e063-6294a90a3e682025-12-16Exact identifier
application number: M020
Dr B Clinical Skin Care Non Tinted SunscreenTITANIUM DIOXIDE, ZINC OXIDENAIRA BABAIAN, M.D., P.A.365d7564-3025-257b-e063-6294a90ad1702025-12-16Exact identifier
application number: M020
Tinted Mineral SunscreenZINC OXIDEGentlehomme LLC365e7d8e-e3e0-4c08-e063-6294a90af4152025-12-16Exact identifier
application number: M020
Daily Replenish mineral sunscreenZINC OXIDEPURE VITALITY SKIN AND BODY, INC369896b1-f4b4-6201-e063-6394a90a5bca2025-12-16Exact identifier
application number: M020
Zinc 20 mineral sunscreen face Plus bodyZINC OXIDEPURE VITALITY SKIN AND BODY, INC36985373-22dd-2232-e063-6394a90a76fb2025-12-16Exact identifier
application number: M020
Matte Defense Mineral Sunscreen non tintedTITANIUM DIOXIDE, ZINC OXIDEPURE VITALITY SKIN AND BODY, INC3698090a-1639-00f9-e063-6394a90a7dd12025-12-16Exact identifier
application number: M020
Daily Replenish mineral sunscreenZINC OXIDEPURE VITALITY SKIN AND BODY, INC3698d309-b9bf-e197-e063-6294a90af5a12025-12-16Exact identifier
application number: M020
Zinc 20 mineral sunscreen face Plus bodyZINC OXIDEPURE VITALITY SKIN AND BODY, INC3698f29e-5d80-94af-e063-6394a90a04892025-12-16Exact identifier
application number: M020
Tinted Mineral Primer SPF 40TITANIUM DIOXIDE, ZINC OXIDEJOSEPHINA RAMIREZ365cf2be-8862-3622-e063-6394a90ac4e32025-12-16Exact identifier
application number: M020
SANCTUARY Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDECHAMPAGNE APOTHECARY LLC365ca99c-c878-1f4b-e063-6394a90a1f532025-12-16Exact identifier
application number: M020
Tinted Mineral Defense SPF 40ZINC OXIDEJOSEPHINA RAMIREZ365d299a-5886-5597-e063-6394a90a336c2025-12-16Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEMILL VALLEY DERMATOLOGY, INC.3b171a89-c757-47a1-e063-6294a90a7a642025-12-16WarningsExact identifier
application number: M020
Tinted BB CreamZINC OXIDEEco Esthetics LLC38f3e618-59e1-4504-e063-6394a90afa552025-12-16Exact identifier
application number: M020
Tinted Mineral SunscreenZINC OXIDEMADRE TIERRA, INC.3f697463-d3db-7b73-e063-6394a90ac2222025-12-16WarningsExact identifier
application number: M020
Non-Tinted Replenishing Daily ProtectionZINC OXIDEMADRE TIERRA, INC.3f69d6f3-454b-e60a-e063-6394a90a87812025-12-16WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
63354-784-1663354078416236 g in 1 BOTTLE, PUMP (63354-784-16) 236 g2025-04-02NoNoCurrent