Home NDC 63354-802 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 Ingredient Strength OCTOCRYLENE 3 g/100g HOMOSALATE 3 g/100g AVOBENZONE 1.5 g/100g OCTISALATE 1 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 63354-802-34 HAWAIIAN TROPIC 170 g in 1 CAN AEROSOL, SPRAY 170 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63354-802 HAWAIIAN TROPIC (AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE) AEROSOL, SPRAY [EDGEWELL PERSONAL CARE BRANDS LLC] 1 Current NDC, 1 package rows 20240302_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 216 of 353 · 7,049 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join LBEL FOREVER MATTE LONGWEAR AND CONTROL FOUNDATION 72H SPF 15 CHAMPAGNE 170N OCTINOXATE, ZINC OXIDE BEL STAR S.A. 338c2c66-497a-f7d1-e063-6294a90a7789 2025-04-24 Warnings Exact identifier application number: M020 The Ordinary UV Filters SPF 45 Serum HOMOSALATE, OCTOCRYLENE, AVOBENZONE, OCTISALATE Deciem 10cde253-26ee-b97d-e063-6394a90a8302 2025-04-23 Warnings Exact identifier application number: M020 BareBack sunscreen SPF50 infused with Hyaluronic acid and vitamin C ZINC OXIDE VeganicSKN 3123aab6-0407-19e5-e063-6394a90a5bd8 2025-04-23 Warnings Exact identifier application number: M020 Sephora Daily Sunscreen Cream Broad Spectrum SPF 30 ZINC OXIDE S+ b49e043b-8164-421c-a02b-3dab0be1454d 2025-04-22 Warnings Exact identifier application number: M020 YAYA Organics SPF-50 Sports Cream ZINC OXIDE YAYA ORGANICS L.L.C. 9eabf1f8-698b-4fa8-98d3-3696c35b044c 2025-04-22 Warnings Exact identifier application number: M020 YAYA Organics SPF-50 Baby Kids Mineral Sunscreen ZINC OXIDE YAYA ORGANICS L.L.C. 3275303d-a448-4fb4-bdce-6442823f8996 2025-04-22 Warnings Exact identifier application number: M020 Oathology Inzincable Sunscreen SPF 50 HOMOSALATE, OCTOCRYLENE, ZINC OXIDE SKINOATH LLC d245dfca-9e32-4e71-9df8-58fff84ef6a9 2025-04-22 Warnings Exact identifier application number: M020 Back9ine Skincare Pure Invisible Sunscreen SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Back 9ine Skincare, LLC 974ede40-cfb5-4612-b168-5d42dd137f63 2025-04-22 Warnings Exact identifier application number: M020 Algenist OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE Solazyme, Inc. 4ece1847-1c94-4bf7-b936-109556a460a7 2025-04-22 Warnings Exact identifier application number: M020 Sulwhasoo Perfecting Cushion NO.17N1 Vanilla OCTINOXATE, TITANIUM DIOXIDE, AND HOMOSALATE Amorepacific Corporation 3350f28e-22b4-904c-e063-6394a90a1c81 2025-04-21 Warnings Exact identifier application number: M020 Neutrogena Sheer Zinc Kids Mineral Sunscreen Broad Spectrum SPF 50 Plus ZINC OXIDE Kenvue Brands LLC c914c4cd-99a2-4d9f-8f04-8af2ace3c345 2025-04-18 Warnings Exact identifier application number: M020 Charlis Neutral Tinted Face Moisturizer Mineral Sunscreen SPF 25 ZINC OXIDE CHARLIS LLC 330f7470-0d53-7361-e063-6394a90a5d59 2025-04-18 Warnings Exact identifier application number: M020 Chardonnay Lip Oil AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE Vacation Inc 1318a429-d382-f5b8-e063-6394a90a3bd4 2025-04-18 Warnings Exact identifier application number: M020 Shimmer Oil AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE Vacation Inc. 131c63ba-57fc-9ce8-e063-6294a90acd92 2025-04-18 Warnings Exact identifier application number: M020 HAWAIIAN TROPIC AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE Edgewell Personal Care Brands LLC 055431a6-e9e0-99b4-e063-6394a90acb11 2025-04-17 Warnings Exact identifier application number: M020 SILKEN pore perfecting sunscreen broad spectrum SPF 35 OCTISALATE, ZINC OXIDE TATCHA INC. 251566a1-0e21-4030-9d4e-52c4a8bd3330 2025-04-16 Warnings Exact identifier application number: M020 Dermatone SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Dermatone Labs LLC 32e5bddf-a0b5-c511-e063-6294a90aaf66 2025-04-16 Warnings Exact identifier application number: M020 Sunscreen Lip Balm SPF 30 Cool Mint AVOBENZONE 3%, HOMOSALATE 7%, OCTISALATE 4.5%, OCTOCRYLENE 9% USRX 3271ab14-3bf5-a24f-e063-6294a90a59bc 2025-04-16 Warnings Exact identifier application number: M020 goodal GREEN TANGERINE VITA C DARK SPOT UV DEFENSE SUNSCREEN SPF50 HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE CLIO COSMETICS Co., Ltd. 77a0d190-f558-474b-89d2-c79b37c50c0d 2025-04-16 Warnings Exact identifier application number: M020 Brush On Block SPF 30 Mineral Powder Touch of Tan Zinc Only - REFILL ZINC OXIDE SPF Ventures, LLC 32ccb93a-50cf-f436-e063-6294a90a2492 2025-04-15 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 63354-802-34 63354080234 170 g in 1 CAN (63354-802-34) 170 g 2023-10-31 No No Current