Home NDC 63354-894 HAWAIIAN TROPIC
Product NDC 63354-894
11-digit product format 633540894
Labeler code 63354
Product ID 63354-894_47bdc2f9-bdbf-fae8-e063-6294a90abf8a
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 2023-10-26
Substance AVOBENZONE; HOMOSALATE; OCTOCRYLENE; OCTISALATE
Active strength 2; 5.5; 4; 4.5 g/100g; g/100g; g/100g; g/100g
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes
Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 1 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 63354-894 63354-894-31 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
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 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AVOBENZONE 2 g/100g HOMOSALATE 5.5 g/100g OCTOCRYLENE 4 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 63354-894-31 HAWAIIAN TROPIC 51 g in 1 CAN AEROSOL, SPRAY 51 6 63354-894-34 HAWAIIAN TROPIC 170 g in 1 CAN AEROSOL, SPRAY 170 6 63354-894-39 HAWAIIAN TROPIC 170 g in 1 BOTTLE AEROSOL, SPRAY 170 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63354-894 HAWAIIAN TROPIC (AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE) AEROSOL, SPRAY [EDGEWELL PERSONAL CARE BRANDS LLC] 3 Current NDC, 3 package rows 20241108_088fa3cd-b9b8-d10b-e063-6394a90a7fd6.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 157 of 353 · 7,041 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Alba Botanica Sensitive Mineral SPF 50 ZINC OXIDE The Hain Celestial Group, Inc. 4484b16f-f29a-60cc-e063-6294a90a2b9d 2025-11-26 Warnings Exact identifier application number: M020 Alba Botanica Sheer Mineral SPF50 ZINC OXIDE The Hain Celestial Group, Inc. 0cf9c4b9-8e85-980c-e063-6394a90a9e7e 2025-11-26 Warnings Exact identifier application number: M020 Alba Botanica Sensitive Mineral SPF 30 ZINC OXIDE The Hain Celestial Group, Inc. 44867882-d9c1-7389-e063-6294a90a7f77 2025-11-26 Warnings Exact identifier application number: M020 Alba Botanica Sheer Mineral SPF30 ZINC OXIDE The Hain Celestial Group, Inc. 0cf9361f-f292-6429-e063-6294a90add0e 2025-11-26 Warnings Exact identifier application number: M020 ZO Skin Health Gel Sunscreen Broad-Spectrum SPF 50 AVOBENZONE, OCTISALATE, OCTOCRYLENE ZO Skin Health, Inc. ec8386f2-9cb7-40f4-e053-2995a90ac2d8 2025-11-26 Warnings Exact identifier application number: M020 WOODSLEEP Tallow Sunscreen TITANIUM DIOXIDE Shantou Woodsleep Biotechnology Co., Ltd. 330a9f2e-7ce1-f83f-e063-6394a90a184a 2025-11-26 Warnings Exact identifier application number: M020 WOODSLEEP Tallow Sunscreen TITANIUM DIOXIDE Shantou Woodsleep Biotechnology Co., Ltd. 33cdde09-e7ee-e003-e063-6394a90a8762 2025-11-26 Warnings Exact identifier application number: M020 Native Mineral Suncare Zinc Oxide Sunscreen Tropical Breeze Broad Spectrum SPF 30 ZINC OXIDE The Procter & Gamble Manufacturing Company 44718c3c-b081-bcfb-e063-6394a90a3786 2025-11-25 Warnings Exact identifier application number: M020 Native Mineral Suncare Zinc Oxide Sunscreen Unscented Broad Spectrum SPF 30 ZINC OXIDE The Procter & Gamble Manufacturing Company 4472cc1e-6b34-388b-e063-6394a90ac7b6 2025-11-25 Warnings Exact identifier application number: M020 Native Mineral Suncare Zinc Oxide Sunscreen Pear and Coconut Water Broad Spectrum SPF 30 ZINC OXIDE The Procter & Gamble Manufacturing Company 4472ef69-8992-fcab-e063-6294a90a6b90 2025-11-25 Warnings Exact identifier application number: M020 Native Mineral Suncare Zinc Oxide Sunscreen Vanilla Milk and Shea Broad Spectrum SPF 30 ZINC OXIDE The Procter & Gamble Manufacturing Company 44732f89-8ac3-8c5d-e063-6394a90aba73 2025-11-25 Warnings Exact identifier application number: M020 Native Mineral Suncare Zinc Oxide Sunscreen Unscented Broad Spectrum SPF 30 ZINC OXIDE The Procter & Gamble Manufacturing Company 447347d6-b8a3-7338-e063-6294a90abbf9 2025-11-25 Warnings Exact identifier application number: M020 Native Mineral Suncare Zinc Oxide Sunscreen Pear and Coconut Water Broad Spectrum SPF 30 ZINC OXIDE The Procter & Gamble Manufacturing Company 4473c4cc-f8b5-4a92-e063-6394a90ae690 2025-11-25 Warnings Exact identifier application number: M020 salmon colored sunscreen SALMON COLORED SUNSCREEN Guangzhou Fantesy Biotechnology Co.,Ltd 4477964b-28f3-a371-e063-6294a90a4230 2025-11-25 Warnings Exact identifier application number: M020 Safe Sea SPF 50 Mineral ZINC OXIDE Nidaria Technology Ltd. f6cf9454-552b-486e-a38b-ab3c183b24a1 2025-11-24 Warnings Exact identifier application number: M020 Safe Sea SPF 30 ZINC OXIDE Nidaria Technology Ltd. 91bf07ed-0be4-43c9-b5f3-4e8eb892bca5 2025-11-24 Warnings Exact identifier application number: M020 Olay Complete UV365 Daily Moisturizer Sensitive Broad Spectrum SPF 15 OCTINOXATE AND ZINC OXIDE The Procter & Gamble Manufacturing Company 5904baa8-3070-1d77-e053-2a91aa0a6852 2025-11-24 Warnings Exact identifier application number: M020 it cosmetics Bye Bye Foundation Full Coverage Moisturizer with 3D Skin Flex Broad Spectrum SPF 50 Plus UVA UVB Physical Sunscreen All Shades TITANIUM DIOXIDE AND ZINC OXIDE L'Oreal USA, Inc. 86eea4df-4191-4e05-9f05-4a98ef8c2a4d 2025-11-24 Warnings Exact identifier application number: M020 Cetaphil Sun Tinted Face SPF 40 TITANIUM DIOXIDE, ZINC OXIDE Galderma Laboratories, L.P. 22413f93-7219-4726-b741-2392e576b34a 2025-11-24 Warnings Exact identifier application number: M020 VEIL MINERAL PRIMER SUNSCREEN BROAD SPECTRUM SPF 15 ZINC OXIDE AND TITANIUM DIOXIDE Kingdom Animalia, LLC DBA Hourglass Cosmetics 28e23498-953f-47c0-838c-bbf0e858d903 2025-11-24 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 63354-894-31 63354089431 51 g in 1 CAN 51 g Historical 63354-894-34 63354089434 170 g in 1 CAN (63354-894-34) 170 g 2023-10-26 No No Current 63354-894-39 63354089439 170 g in 1 BOTTLE (63354-894-39) 170 g 2024-12-01 No No Current