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 29 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
INNISFREE DAILY UV INVISIBLE BARRIER SUNSCREEN SERUMAVOBENZONE, HOMOSALATE, AND OCTISALATEInnisfree Corporation524264b8-d360-1d7b-e063-6394a90ab1152026-05-21WarningsExact identifier
application number: M020
ILIA SUPER SERUM SKIN TINT (ST12 KOKKINI)ZINC OXIDEIlia, Inc.b595bcc6-a1ab-25c9-e053-2995a90a87aa2026-05-21WarningsExact identifier
application number: M020
ILIA SUPER SERUM SKIN TINT (ST11.5 MORGAT)ZINC OXIDEIlia, Inc.b97f7fe9-c070-7c11-e053-2a95a90a6a6d2026-05-21WarningsExact identifier
application number: M020
ILIA SUPER SERUM SKIN TINT (ST0.5 SKYE)ZINC OXIDEIlia, Inc.b959e3c3-ca92-ee41-e053-2a95a90a60642026-05-21WarningsExact identifier
application number: M020
ILIA SUPER SERUM SKIN TINT (ST17 MIHO)ZINC OXIDEIlia, Inc.b595f875-b774-f847-e053-2995a90a28862026-05-21WarningsExact identifier
application number: M020
LBEL FOREVER MATTE SHINE CONTROL AND 90H HYDRATION FOUNDATION SPF 15 CREME 110COCTINOXATE, ZINC OXIDEBEL STAR S.A.526a8e50-b1de-47e5-e063-6394a90a3a292026-05-21WarningsExact identifier
application number: M020
Live Tinted Hueguard Skin TintZINC OXIDELive Tinted0ff39ab1-e8d3-cad9-e063-6394a90af0eb2026-05-21WarningsExact identifier
application number: M020
Sunsolve MD Mineral Shade Quartz 001ZINC OXIDESunsolve MD Inc26a54f00-d84d-8fe3-e063-6394a90a03e82026-05-21WarningsExact identifier
application number: M020
Inde WildZINC OXIDEInde Wild01529c59-8806-6423-e063-6294a90a49e32026-05-21WarningsExact identifier
application number: M020
CARDON SPF and MOISTURIZERAVOBENZONE, HOMOSALATE, OCTYL SALICYLATECardon, Inc52122434-6e6f-39fc-e063-6394a90a1fd02026-05-21WarningsExact identifier
application number: M020
Reactive Plus Anti-Oxidant Serum plus Broad-spectrum SPF 45OCTINOXATE AND ZINC OXIDEMerz North America, Inc62c822d9-c8ed-4b95-8d88-806295f5a9362026-05-20WarningsExact identifier
application number: M020
SkinCeuticals Future Mineral UV Defense Invisble Sunscreen Mineral Filters Broad Spectrum SPF 50TITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc0b92a940-0dd4-4266-bd47-88c27def62c02026-05-20WarningsExact identifier
application number: M020
Stream2Sea SPF 50ZINC OXIDEStream2Sea5243f110-fe5b-946a-e063-6394a90add7e2026-05-20WarningsExact identifier
application number: M020
SP-FB0D-L0TNBarrierProtectionMineralSunscreenBARRIER PROTECTION MINERAL SUNSCREENEpic Etailers, LLC (DBA: Beauty by Earth)50786950-1c31-e467-e063-6394a90a6fc82026-05-20WarningsExact identifier
application number: M020
IT COSMETICS HELLO SUNSHINE Invisible Sunscreen Broad Spectrum SPF 50 UVA UVB Mineral 50TITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc.fded7dfb-ffb9-4fb0-9511-273e0e1269692026-05-20WarningsExact identifier
application number: M020
Freaks of Nature Peak Performance Broad Spectrum SPF 50FREAKS OF NATURE PEAK PERFORMANCE BROAD SPECTRUM SPF 50THE FREAKS OF NATURE, INC.5247187d-a14c-6468-e063-6394a90ace3e2026-05-20WarningsExact identifier
application number: M020
Journee Bio-restorative Day Balm Broad-spectrum Suncreen SPF 30OCTINOXATE AND ZINC OXIDEMerz North America, Inc.e120a659-0dfc-42ca-8158-58e8a0b457e52026-05-20WarningsExact identifier
application number: M020
Evereden Cooling Mineral Sunstick SPF 30ZINC OXIDEEden Brands Inc.4af9e668-0d88-74ad-e063-6394a90a52432026-05-19WarningsExact identifier
application number: M020
Freaks of Nature Peak Performance Broad Spectrum SPF 30FREAKS OF NATURE PEAK PERFORMANCE BROAD SPECTRUM SPF 30THE FREAKS OF NATURE, INC.522addd5-9701-3234-e063-6294a90aaa9d2026-05-19WarningsExact identifier
application number: M020
Freaks of Nature Peak Performance Broad Spectrum SPF 30FREAKS OF NATURE PEAK PERFORMANCE BROAD SPECTRUM SPF 30THE FREAKS OF NATURE, INC.522b4aca-fe5b-dfe2-e063-6394a90ae5782026-05-19WarningsExact 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