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 156 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ATTITUDE Sensitive natural Mineral Sunscreen Stick SPF 50 UnscentedZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE4495a302-51b9-3bf2-e063-6294a90a7e4f2025-11-28WarningsExact identifier
application number: M020
ATTITUDE Sunly Kids Mineral sunscreen Sprayer SPF 50 Watermelon and cocoZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE44aa1349-e3f1-9b80-e063-6294a90a0fbd2025-11-28WarningsExact identifier
application number: M020
ATTITUDE Sunly Mineral sunscreen SPF 50 UnscentedZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE44aaa3c8-ccc4-ae93-e063-6394a90aedc52025-11-28WarningsExact identifier
application number: M020
ATTITUDE Sunly Baby Mineral sunscreen SPF 50 UnscentedZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE44aba591-04da-fe09-e063-6394a90a912a2025-11-28WarningsExact identifier
application number: M020
ATTITUDE Sunly Kids Mineral sunscreen SPF 50 UnscentedZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE44aba6d7-7989-0637-e063-6394a90a6c8f2025-11-28WarningsExact identifier
application number: M020
ATTITUDE Sunly Mineral sunscreen SPF 50 Tropical cocoZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE44abca13-8ba9-8925-e063-6294a90accb52025-11-28WarningsExact identifier
application number: M020
ATTITUDE Sensitive natural baby Mineral sunscreen SPF 50 UnscentedZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE44abdfe1-ea6b-a158-e063-6294a90a3eb82025-11-28WarningsExact identifier
application number: M020
ATTITUDE Sunly Kids Mineral sunscreen SPF 50 Watermelon and cocoZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE44aca1d5-6e0a-def3-e063-6294a90aca262025-11-28WarningsExact identifier
application number: M020
ATTITUDE Sunly Mineral sunscreen SPF 50 Sun kissed vanillaZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE44aca181-2a90-20a6-e063-6394a90aff472025-11-28WarningsExact identifier
application number: M020
ATTITUDE Sunly Mineral sunscreen Sprayer SPF 50 Sun kissed vanillaZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE44aa529b-2077-3660-e063-6394a90aa4052025-11-28WarningsExact identifier
application number: M020
ATTITUDE Sunly Lip Balm SPF 15 UnscentedZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE44ad65f0-ec1d-1638-e063-6294a90a22442025-11-28WarningsExact identifier
application number: M020
HOEGOA Hair Scalp Sunscreen MineralTITANIUM DIOXIDEGuangzhou Hoegoa Biotechnology Co., Ltd.44b37930-b302-338c-e063-6394a90a5f7f2025-11-28WarningsExact identifier
application number: M020
OCEAURA Glitter SunscreenTITANIUM DIOXIDEGuangzhou Oceaura Biotechnology Co., Ltd.44b47284-57cd-2e61-e063-6394a90a50722025-11-28WarningsExact identifier
application number: M020
OUHOE Moisturizing And Translucent SunscreenTITANIUM DIOXIDEShantou Ouhoe Technology Co., Ltd.34e8e4a6-2782-9a3d-e063-6394a90a84c22025-11-27WarningsExact identifier
application number: M020
OUHOE Protection SunscreenTITANIUM DIOXIDEShantou Ouhoe Technology Co., Ltd.4272dcef-eda5-1013-e063-6294a90adf382025-11-27WarningsExact identifier
application number: M020
OUHOE SunscreenTITANIUM DIOXIDEShantou Ouhoe Technology Co., Ltd.42fcc9ed-083c-6582-e063-6394a90ae9e62025-11-27WarningsExact identifier
application number: M020
EELHOE Sun CreamTITANIUM DIOXIDEShantou Eelhoe Daily Chemical Technology Co., Ltd.305cb87e-450f-840a-e063-6294a90a883f2025-11-27WarningsExact identifier
application number: M020
EELHOE Bio Sun StickTITANIUM DIOXIDEShantou Eelhoe Daily Chemical Technology Co., Ltd.349a3d72-9969-855d-e063-6394a90a281c2025-11-27WarningsExact identifier
application number: M020
EELHOE Cica Cooling Sun StickTITANIUM DIOXIDEShantou Eelhoe Daily Chemical Technology Co., Ltd.305c13af-0843-f478-e063-6394a90a42de2025-11-27WarningsExact identifier
application number: M020
EELHOE Quick Sun Stick Protection BarTITANIUM DIOXIDEShantou Eelhoe Daily Chemical Technology Co., Ltd.3578c958-a457-402b-e063-6394a90a73422025-11-27WarningsExact 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