Home NDC 63354-613 HAWAIIAN TROPIC
Product NDC 63354-613
11-digit product format 633540613
Labeler code 63354
Product ID 63354-613_3fe8332b-e3f9-a32c-e063-6294a90a252a
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 AVOBENZONE; HOMOSALATE; OCTOCRYLENE; OCTISALATE
Active strength 2; 6; 6; 4.5 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 Ingredient Strength AVOBENZONE 2 g/100g HOMOSALATE 6 g/100g OCTOCRYLENE 6 g/100g OCTISALATE 4.5 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 4 matching rows.
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 63354-613-34 HAWAIIAN TROPIC 170 g in 1 CAN AEROSOL, SPRAY 170 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63354-613 HAWAIIAN TROPIC (AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE) AEROSOL, SPRAY [EDGEWELL PERSONAL CARE BRANDS LLC] 2 Current NDC, 1 package rows 20250410_08f3b27f-b233-d406-e063-6394a90ada76.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 167 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Well People Bio Tint SPF 30 Sunscreen 12w ZINC OXIDE e.l.f. Cosmetics, Inc c8a99278-21e0-c517-e053-2a95a90ade37 2025-11-07 Warnings Exact identifier application number: M020 Well People Bio Tint SPF 30 Sunscreen 1C ZINC OXIDE e.l.f. Cosmetics, Inc c8a82c8b-e308-15e9-e053-2995a90afa2a 2025-11-07 Warnings Exact identifier application number: M020 Well People Bio Tint SPF 30 Sunscreen 14w ZINC OXIDE e.l.f. Cosmetics, Inc c8aa4629-1573-48a7-e053-2995a90aa86c 2025-11-07 Warnings Exact identifier application number: M020 Well People Bio Tint SPF 30 Sunscreen 2w ZINC OXIDE e.l.f. Cosmetics, Inc. c8a82f54-839d-1de0-e053-2a95a90a2a97 2025-11-07 Warnings Exact identifier application number: M020 Well People Bio Tint SPF 30 Sunscreen 4W ZINC OXIDE e.l.f. Cosmetics, Inc c8a83921-3181-396e-e053-2a95a90a02ee 2025-11-07 Warnings Exact identifier application number: M020 Well People Bio Tint SPF 30 Sunscreen 3N ZINC OXIDE e.l.f. Cosmetics, Inc c8aa6047-ce3e-59f7-e053-2a95a90a678e 2025-11-07 Warnings Exact identifier application number: M020 Well People Bio Tint SPF 30 Sunscreen 5N ZINC OXIDE e.l.f. Cosmetics, Inc c8aa6047-ce42-59f7-e053-2a95a90a678e 2025-11-07 Warnings Exact identifier application number: M020 Well People Bio Tint SPF 30 Sunscreen 6w ZINC OXIDE e.l.f. Cosmetics, Inc c8a8ef6f-4426-a981-e053-2a95a90a9451 2025-11-07 Warnings Exact identifier application number: M020 Well People Lip Butter SPF 15 Sunscreen PEACH ZINC OXIDE e.l.f. Cosmetics, Inc c8aa931b-a3b4-6804-e053-2995a90a3eab 2025-11-07 Warnings Exact identifier application number: M020 Well People Bio Tint SPF 30 Sunscreen 7N ZINC OXIDE e.l.f. Cosmetics, Inc c8aa6047-ce45-59f7-e053-2a95a90a678e 2025-11-07 Warnings Exact identifier application number: M020 Well People Bio Tint SPF 30 Sunscreen 8N ZINC OXIDE e.l.f. Cosmetics, Inc c8aa662c-0f06-712b-e053-2995a90aae0b 2025-11-07 Warnings Exact identifier application number: M020 Well People Lip Butter SPF 15 Sunscreen AFTERGLOW ZINC OXIDE e.l.f. Cosmetics, Inc c8aa9325-4fad-ddf9-e053-2a95a90a6639 2025-11-07 Warnings Exact identifier application number: M020 Well People Bio Tint SPF 30 Sunscreen 9w ZINC OXIDE e.l.f. Cosmetics, Inc c8a92c58-d981-0948-e053-2a95a90a16f8 2025-11-07 Warnings Exact identifier application number: M020 Well People Lip Butter SPF 15 Sunscreen WINE ZINC OXIDE e.l.f. Cosmetics, Inc c8aa873e-8271-8cf0-e053-2995a90a3cec 2025-11-07 Warnings Exact identifier application number: M020 Well People Lip Butter SPF 15 Sunscreen NATURAL ZINC OXIDE e.l.f. Cosmetics, Inc c8aa7ae9-7d03-db7d-e053-2995a90ae72b 2025-11-07 Warnings Exact identifier application number: M020 Neutrogena Clear Face Serum Fragrance Free SPF 60 Plus AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Kenvue Brands LLC eb705402-f8cb-5079-e053-2a95a90a405c 2025-11-06 Warnings Exact identifier application number: M020 Neutrogena Cool Dry Sport Sunscreen Broad Spectrum SPF 70 AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE Kenvue Brands LLC 5c1a0437-c269-4cd3-b91a-e2de799b853e 2025-11-06 Warnings Exact identifier application number: M020 Neutrogena Clear Face Breakout Free oil Free Sunscreen Broad Spectrum SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE Kenvue Brands LLC 10ca67ca-c372-44a9-8933-84cce9fb9934 2025-11-06 Warnings Exact identifier application number: M020 Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE Kenvue Brands LLC 0464448b-342b-4e54-a20e-6ec6bd622889 2025-11-06 Warnings Exact identifier application number: M020 Neutrogena Hydro Boost Water Gel Sunscreen Broad Spectrum SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE Kenvue Brands LLC 7f60d6bd-1735-4390-bc8a-e3876ab7ad50 2025-11-06 Warnings 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 63354-613-34 63354061334 170 g in 1 CAN (63354-613-34) 170 g 2023-10-31 No No Current