HAWAIIAN TROPIC

Product NDC
63354-593
11-digit product format
633540593
Labeler code
63354
Product ID
63354-593_5de3805f-8ee3-971d-e063-6294a90a6aa9
Type
HUMAN OTC DRUG
Nonproprietary name
AVOBENZONE,OCTOCRYLENE
Dosage form
SPRAY
Route
TOPICAL
Labeler
Edgewell Personal Care Brands LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-10-31
Marketing end
2028-10-01
Substance
OCTOCRYLENE; AVOBENZONE
Active strength
3; 1 g/100g; g/100g
NDC exclude flag
No
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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTOCRYLENE3 g/100g
AVOBENZONE1 g/100g

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63354-593-16HAWAIIAN TROPIC236 g in 1 BOTTLE, PUMPSPRAY2362

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63354-593HAWAIIAN TROPIC (AVOBENZONE,OCTOCRYLENE) SPRAY [EDGEWELL PERSONAL CARE BRANDS LLC]1Current NDC, 1 package rows20231031_08f34b31-6337-ef7c-e063-6294a90a1c4c.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 166 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
e.l.f Sun Boss Gloss SPF 25 Sunscreen Blush MuchZINC OXIDEe.l.f. Cosmetics, Inc.53d64042-f9ef-494d-a347-490c6a3c49b82025-11-07WarningsExact identifier
application number: M020
e.l.f. Suntouchable Invisi SPF 50OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONEe.l.f cosmetics,Inc.547eac8c-492e-4a6b-ac58-4f0d1e0ccb3d2025-11-07WarningsExact identifier
application number: M020
e.l.f Sun Boss Gloss SPF 25 Sunscreen Thats my JamZINC OXIDEe.l.f. Cosmetics, Inc.b7d56015-4734-4ce4-b40d-64236df810e32025-11-07WarningsExact identifier
application number: M020
elf Sun Boss Gloss SPF 25 Sunscreen Peachy KweenZINC OXIDEe.l.f. Cosmetics, Inc.4d9784b6-c54d-483d-a5ba-c557a05300ec2025-11-07WarningsExact identifier
application number: M020
ITP DAILY BAWSE CLEAN, TINTED SUNSCREEN SERUM SPF 28 ON THE GLOWZINC OXIDEIn The Pynk LLC13badac4-e310-9589-e063-6394a90ab06b2025-11-07WarningsExact identifier
application number: M020
ITP DAILY BAWSE CLEAN, TINTED SUNSCREEN SERUM SPF 28 GOLDEN HOURZINC OXIDEIn The Pynk LLC13bb8426-27cd-fbc9-e063-6294a90a8bf82025-11-07WarningsExact identifier
application number: M020
ITP DAILY BAWSE CLEAN, TINTED SUNSCREEN SERUM SPF 28 DEW YOUZINC OXIDEIn The Pynk LLC1365c6d8-64cb-3cb3-e063-6394a90a9d642025-11-07WarningsExact identifier
application number: M020
Well People Bio Tint SPF 30 Sunscreen 10wZINC OXIDEe.l.f. Cosmetics, Incc8a935e6-f7ac-4e3a-e053-2a95a90a877a2025-11-07WarningsExact identifier
application number: M020
Well People Bio Tint SPF 30 Sunscreen 11wZINC OXIDEe.l.f. Cosmetics, Incc8a94fb4-8752-587c-e053-2995a90a1e9a2025-11-07WarningsExact identifier
application number: M020
Well People Bio Tint SPF 30 Sunscreen 13wZINC OXIDEe.l.f. Cosmetics, Incc8a9bf6c-80cd-5884-e053-2a95a90a4a662025-11-07WarningsExact identifier
application number: M020
Well People Bio Tint SPF 30 Sunscreen 12wZINC OXIDEe.l.f. Cosmetics, Incc8a99278-21e0-c517-e053-2a95a90ade372025-11-07WarningsExact identifier
application number: M020
Well People Bio Tint SPF 30 Sunscreen 1CZINC OXIDEe.l.f. Cosmetics, Incc8a82c8b-e308-15e9-e053-2995a90afa2a2025-11-07WarningsExact identifier
application number: M020
Well People Bio Tint SPF 30 Sunscreen 14wZINC OXIDEe.l.f. Cosmetics, Incc8aa4629-1573-48a7-e053-2995a90aa86c2025-11-07WarningsExact identifier
application number: M020
Well People Bio Tint SPF 30 Sunscreen 2wZINC OXIDEe.l.f. Cosmetics, Inc.c8a82f54-839d-1de0-e053-2a95a90a2a972025-11-07WarningsExact identifier
application number: M020
Well People Bio Tint SPF 30 Sunscreen 4WZINC OXIDEe.l.f. Cosmetics, Incc8a83921-3181-396e-e053-2a95a90a02ee2025-11-07WarningsExact identifier
application number: M020
Well People Bio Tint SPF 30 Sunscreen 3NZINC OXIDEe.l.f. Cosmetics, Incc8aa6047-ce3e-59f7-e053-2a95a90a678e2025-11-07WarningsExact identifier
application number: M020
Well People Bio Tint SPF 30 Sunscreen 5NZINC OXIDEe.l.f. Cosmetics, Incc8aa6047-ce42-59f7-e053-2a95a90a678e2025-11-07WarningsExact identifier
application number: M020
Well People Bio Tint SPF 30 Sunscreen 6wZINC OXIDEe.l.f. Cosmetics, Incc8a8ef6f-4426-a981-e053-2a95a90a94512025-11-07WarningsExact identifier
application number: M020
Well People Lip Butter SPF 15 Sunscreen PEACHZINC OXIDEe.l.f. Cosmetics, Incc8aa931b-a3b4-6804-e053-2995a90a3eab2025-11-07WarningsExact identifier
application number: M020
Well People Bio Tint SPF 30 Sunscreen 7NZINC OXIDEe.l.f. Cosmetics, Incc8aa6047-ce45-59f7-e053-2a95a90a678e2025-11-07WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63354-593-1663354059316236 g in 1 BOTTLE, PUMP (63354-593-16) 236 g2023-10-312028-10-01NoNoHistorical