Home NDC 63354-784 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 Ingredient Strength OCTISALATE 4.5 g/100g AVOBENZONE 2.7 g/100g OCTOCRYLENE 9 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4X49Y0596W Internal UNII lookup G63QQF2NOX Internal UNII lookup 5A68WGF6WM Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63354-784-16 HAWAIIAN TROPIC 236 g in 1 BOTTLE, PUMP OIL 236 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63354-784 HAWAIIAN TROPIC (AVOBENZONE,OCTISALATE,OCTOCRYLENE) OIL [EDGEWELL PERSONAL CARE BRANDS LLC] 1 Current NDC, 1 package rows 20250406_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 129 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Age Defying Sunscreen ZINC OXIDE GINAMARIE Products 35837cf7-91e5-f9ec-e063-6394a90aa91e 2025-12-12 Exact identifier application number: M020 Mineral Sunscreen Face plus Body ZINC OXIDE KS Esthetics, LLC 390a4d8d-b47f-0d9a-e063-6394a90a9b53 2025-12-12 Exact identifier application number: M020 Mineral Sunscreen Tinted Zinc Oxide ZINC OXIDE KS Esthetics, LLC 3909e657-97a5-dd3c-e063-6394a90a10eb 2025-12-12 Exact identifier application number: M020 Prime Protection Sunscreen non tinted TITANIUM DIOXIDE, ZINC OXIDE KRISTI REDD ESTHETICS 36608832-22d8-bc76-e063-6394a90abac6 2025-12-12 Exact identifier application number: M020 Prime Protection Sunscreen, tinted TITANIUM DIOXIDE, ZINC OXIDE KRISTI REDD ESTHETICS 3660af9e-d60f-c33e-e063-6394a90a3a05 2025-12-12 Exact identifier application number: M020 Hydrating Antioxidant Sunscreen tinted ZINC OXIDE KRISTI REDD ESTHETICS 366149e2-b03c-e798-e063-6394a90a6a1d 2025-12-12 Exact identifier application number: M020 Prime Protection Sunscreen, tinted TITANIUM DIOXIDE, ZINC OXIDE KRISTI REDD ESTHETICS 3660e701-1373-eef4-e063-6394a90a6140 2025-12-12 Exact identifier application number: M020 Hydrating Antioxidant Sunscreen tinted ZINC OXIDE KRISTI REDD ESTHETICS 3661251d-b907-8df6-e063-6294a90a1c73 2025-12-12 Exact identifier application number: M020 sheer tinted sunscreen TITANIUM DIOXIDE, ZINC OXIDE SARA ELIZABETH SKINCARE 3b177c49-ed8c-42b9-e063-6294a90a82c6 2025-12-12 Warnings Exact identifier application number: M020 Canopy Untinted ZINC OXIDE BORREGO SPRINGS SKINCARE LLC 35824cd5-0036-7886-e063-6394a90ae678 2025-12-12 Exact identifier application number: M020 Canopy SPF 40 Tinted ZINC OXIDE BORREGO SPRINGS SKINCARE LLC 358319c5-ae35-cb3b-e063-6394a90ad77f 2025-12-12 Exact identifier application number: M020 Non-Tinted Matte Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Skin Philosophy by Kelly 3581ab49-ef55-3743-e063-6394a90a3bd5 2025-12-12 Exact identifier application number: M020 Matte Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Skin Philosophy by Kelly 3581cf33-3520-42f7-e063-6394a90a6f93 2025-12-12 Exact identifier application number: M020 Mineral Sunscreen For Face and Body ZINC OXIDE Skin Philosophy by Kelly 358248e6-16cf-6f9b-e063-6394a90a55d7 2025-12-12 Exact identifier application number: M020 Replenishing Mineral Sunscreen ZINC OXIDE Skin Philosophy by Kelly 35828e76-66db-49de-e063-6294a90a2b99 2025-12-12 Exact identifier application number: M020 Matte Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Skin Philosophy by Kelly 3592b2c7-295a-7c60-e063-6394a90a387b 2025-12-12 Exact identifier application number: M020 Mineral Sunscreen For Face and Body ZINC OXIDE Skin Philosophy by Kelly 3592fd5f-13d1-9aec-e063-6394a90abd67 2025-12-12 Exact identifier application number: M020 Replenishing Mineral Sunscreen ZINC OXIDE Skin Philosophy by Kelly 359371f2-2407-e1a1-e063-6294a90a2165 2025-12-12 Exact identifier application number: M020 Non Tinted Sheer Mineral Zinc Sunscreen ZINC OXIDE SKIN THERAPY PLLC 397fc3c9-9d30-adcf-e063-6394a90ac761 2025-12-12 Exact identifier application number: M020 Non Tinted Sheer Mineral Zinc Sunscreen ZINC OXIDE SKIN THERAPY PLLC 39800bf1-e01a-e1c8-e063-6294a90a53bf 2025-12-12 Exact identifier application number: M020
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 63354-784-16 63354078416 236 g in 1 BOTTLE, PUMP (63354-784-16) 236 g 2025-04-02 No No Current