FDA.reportPublic FDA data

HAWAIIAN TROPIC

Product NDC
63354-802
11-digit product format
633540802
Labeler code
63354
Product ID
63354-802_3fe834a5-1e9e-b099-e063-6394a90a68f3
Type
HUMAN OTC DRUG
Nonproprietary name
AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE
Dosage form
AEROSOL, SPRAY
Route
TOPICAL
Labeler
Edgewell Personal Care Brands LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-10-31
Substance
OCTOCRYLENE; HOMOSALATE; AVOBENZONE; OCTISALATE
Active strength
3; 3; 1.5; 1 g/100g; 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
OCTOCRYLENE3 g/100g
HOMOSALATE3 g/100g
AVOBENZONE1.5 g/100g
OCTISALATE1 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5A68WGF6WMInternal UNII lookup
V06SV4M95SInternal UNII lookup
G63QQF2NOXInternal 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
128a3772-b9b7-0d10-e063-6294a90a3e05Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63354-802-34HAWAIIAN TROPIC170 g in 1 CANAEROSOL, SPRAY1702

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63354-802HAWAIIAN TROPIC (AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE) AEROSOL, SPRAY [EDGEWELL PERSONAL CARE BRANDS LLC]1Current NDC, 1 package rows20240302_128a3772-b9b7-0d10-e063-6294a90a3e05.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 196 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aruba Aloe Hydrating Aloe Rich Sunscreen SPF 15AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEAruba Aloe Balm NV6a398dad-2fb9-4cdb-86c5-2a392b88f29b2025-08-13WarningsExact identifier
application number: M020
SM SOLMIRAGE SUNCARE Solserum Mineral Sunscreen SPF 40ZINC OXIDEALL THE RAJE, LLC9ffbd53b-1295-42b4-9cd5-18cbb75921d02025-08-13WarningsExact identifier
application number: M020
MERIT The Uniform Tinted Mineral Sunscreen Broad Spectrum SPF 45 02 Umber, BistreZINC OXIDEPower Beauty Co.2e6eac42-0b70-44ea-e063-6294a90a49f82025-08-13WarningsExact identifier
application number: M020
BANANA BOATAVOBENZONE/OCTOCRYLENE/OXYBENZONEEdgewell Personal Care Brands LLC3c414e9b-6c3e-2c8d-e063-6394a90af4a62025-08-13WarningsExact identifier
application number: M020
Earth Mama Baby Mineral Sunscreen SPF 40ZINC OXIDEEleeo Brands LLC3c443347-0134-8c87-e063-6294a90a80462025-08-13WarningsExact identifier
application number: M020
Earth Mama Baby Face Mineral Sunscreen Stick SPF 40ZINC OXIDEEleeo Brands LLC3a22f0b9-2d6d-6230-e063-6294a90adf312025-08-13WarningsExact identifier
application number: M020
Earth Mama Lady Face Tinted Mineral Sunscreen Stick SPF 40ZINC OXIDEEleeo Brands LLC3c4567d6-879e-f995-e063-6394a90a319f2025-08-13WarningsExact identifier
application number: M020
Silk ScreenTITANIUM DIOXIDE, ZINC OXIDESkin Apeel, Inc.3c457455-b9b1-546b-e063-6294a90a41f62025-08-13WarningsExact identifier
application number: M020
Earth Mama Tinted Mineral Sunscreen SPF 40ZINC OXIDEEleeo Brands LLC3c455d29-df4e-f4d5-e063-6394a90a97ba2025-08-13WarningsExact identifier
application number: M020
Baby Bum Mineral 50 SunscreenTITANIUM DIOXIDE, ZINC OXIDESun Bum, LLC3c470ff8-37d6-a729-e063-6294a90aa5252025-08-13WarningsExact identifier
application number: M020
Sun Bum 50 Mineral Sunscreen 1 OZZINC OXIDESun Bum, LLC3c483d04-8942-5269-e063-6294a90a38812025-08-13WarningsExact identifier
application number: M020
BANANA BOATAVOBENZONE/OCTOCRYLENE/OXYBENZONEEdgewell Personal Care Brands LLC3c49c623-47c6-4dc9-e063-6294a90a00962025-08-13WarningsExact identifier
application number: M020
100% MINERAL SUNSCREEN100% MINERAL SUNSCREENGuangzhou Pallas Cosmetics Co.,Ltd.3c4a3b41-9183-3835-e063-6394a90aea612025-08-13WarningsExact identifier
application number: M020
ERBORIAN CC CREME Color Correcting SPF 25 FAIROCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDELABORATOIRES M&L4443d4e6-bdc9-4547-9189-e94e9e0bdd2d2025-08-12WarningsExact identifier
application number: M020
ERBORIAN CC Red Correct Color Correcting SPF 25OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDELABORATOIRES M&La6cd16cc-5fe3-41b5-b724-83e469cd4d5e2025-08-12WarningsExact identifier
application number: M020
ERBORIAN CC CREME Color Correcting SPF 25 BRONZEOCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDELABORATOIRES M&L4aa12cf0-0c48-4b40-9c9a-bd50523cce8a2025-08-12WarningsExact identifier
application number: M020
ERBORIAN CC CREME Color Correcting SPF 25 MEDIUMOCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDELABORATOIRES M&L5bdaa149-47aa-40ac-b17a-ea6d290998622025-08-12WarningsExact identifier
application number: M020
NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS Illuminating 40mL with Pink Algae SPF 50ZINC OXIDENAKED SUNDAYS PTY LTD1dda967c-2d69-8948-e063-6294a90ad2a42025-08-12WarningsExact identifier
application number: M020
NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS BRONZE 15mL with wild Rosella SPF 50ZINC OXIDENAKED SUNDAYS PTY LTD24e9a9b8-41ba-123a-e063-6394a90a73cb2025-08-12WarningsExact identifier
application number: M020
NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS BRONZE 40mL with wild Rosella SPF 50ZINC OXIDENAKED SUNDAYS PTY LTD1dd9fe59-9e40-fd06-e063-6394a90a4ca22025-08-12WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
63354-802-3463354080234170 g in 1 CAN (63354-802-34) 170 g2023-10-31NoNoCurrent