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 164 of 353 · 7,041 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join TuroSkin Daily Moisturizing Sunscreen broadspectrum spf15 AVOBENZONE,HOMOSALATE,OCTISALATE Renuskin LLC e36efd74-11c2-4850-9529-1c88b7364a33 2025-11-12 Warnings Exact identifier application number: M020 TuroSkin Sport Sunscreen Broad Spectrum SPF 30 WR SR 80min AVOBENZONE,HOMOSALATE,OCTISALATE Renuskin LLC 22a40d93-ca67-4b7d-a95c-22f52cd6d297 2025-11-12 Warnings Exact identifier application number: M020 Practical Alchemy Hydrating SPF 30 ZINC OXIDE Over Here, LLC 2f07df5b-dbd4-494c-a7cf-55843fb4d7c2 2025-11-12 Warnings Exact identifier application number: M020 Dr Lift SPF 50 Mineral Sunscreen Stick ZINC OXIDE Spa de Soleil 436fdf4f-11db-7c5b-e063-6294a90a8731 2025-11-12 Warnings Exact identifier application number: M020 CeraVe Developed with Dermatologists Skin Renewing Brightening with Sunscreen Broad Spectrum SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE L'Oreal USA Products Inc 3676aa91-c90d-4a7a-b02e-d5b35304a04d 2025-11-12 Warnings Exact identifier application number: M020 HYDRATING GLOW MIST SPF 50 AVOBENZONE, OCTISALATE, OCTOCRYLENE NAKED SUNDAYS PTY LTD df3bd18d-63b4-460f-bf1c-115ad35edd96 2025-11-11 Warnings Exact identifier application number: M020 Zinka Clear Zinc Oxide Sunscreen OCTINOXATE, ZINC OXIDE, OCTISALATE, OXYBENZONE Zinka, Inc. 7b097f5e-8127-49e6-8a77-4ee1fded5ff1 2025-11-11 Warnings Exact identifier application number: M020 Total Sun Protection OCTINOXATE, OCTISALATE, OXYBENZONE, ZINC OXIDE Cosmed Dermaceuticals, Inc. dbb16ef1-ab8c-4e71-a2a2-a507d104ff0f 2025-11-11 Warnings Exact identifier application number: M020 Sunsorb Reef Safe SPF15 HOMOSALATE, OCTOCRYLENE, AVOBENZONE QS Key West Aloe, LLC 1a1c17c4-4912-4573-9f59-cbd14a014cb4 2025-11-11 Warnings Exact identifier application number: M020 Sunsorb Reef Safe SPF30 HOMOSALATE, OCTOCRYLENE, AVOBENZONE QS Key West Aloe, LLC 14f65b3d-90bf-4689-aa6e-879e06153db9 2025-11-11 Warnings Exact identifier application number: M020 Sunsorb Reef Safe SPF50 HOMOSALATE, ZINC OXIDE, OCTOCRYLENE QS Key West Aloe, LLC b4fc7a51-a163-4057-8790-f2111668ec67 2025-11-11 Warnings Exact identifier application number: M020 Dr. Idriss Major Fade Disco Block Whipped Sunscreen SPF 50 AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE PILLOWTALKDERM LLC 30e10a62-8430-649b-e063-6394a90a97eb 2025-11-11 Warnings Exact identifier application number: M020 Essential Defense Mineral Shield Broad Spectrum SPF 32 Sunscreen TINTED TITANIUM DIOXIDE AND ZINC OXIDE Allergan, Inc. 279a5214-79b2-44e9-b003-378d0b992395 2025-11-11 Warnings Exact identifier application number: M020 Tinted Moisturizer SPF 46 Universal Tint ZINC OXIDE, OCTINOXATE Drmtlgy, LLC 5304b568-f891-4094-9182-363ae7bcfbe4 2025-11-11 Warnings Exact identifier application number: M020 C Lip Serum Mineral Broad Spectrum SPF 30 SUNSCREEN Simply Active Cosmetics 323661a6-3602-1ce2-e063-6394a90a8e91 2025-11-10 Warnings Exact identifier application number: M020 buttah Tinted Mineral Sunscreen SPF-30 TITANIUM DIOXIDE, ZINC OXIDE Buttah Enterprises, LLC. 43458152-0775-dd9c-e063-6394a90a6140 2025-11-10 Warnings Exact identifier application number: M020 Aspen Glow 100% Mineral Broad Spectrum SPF 30 Powder Sunscreen 0.16 oz / 4.6 g ZINC OXIDE Aspen Glow Cosmetics, LLC 142eda44-76e1-7960-e063-6394a90a9ad6 2025-11-10 Warnings Exact identifier application number: M020 TriLipiderm Broad Spectrum SPF 30 BUTYL METHOXYDIBENZOYLMETHANE, ETHYLHEXYL METHOXYCINNAMATE, HOMOSALATE, OCTOCRYLENE TriLipid Research Institute, LLC 617fc696-c2a1-4855-bafb-0454e6497101 2025-11-10 Warnings Exact identifier application number: M020 TriLipiderm Protective Day HOMOSALATE, ETHYLHEXYL METHOXYCINNAMATE,BUTYL METHOXYDIBENZOYLMETHANE, OCTOCRYLENE TriLipid Research Institute, LLC 66726c2b-27e9-5dd1-e053-2991aa0a1ba7 2025-11-10 Warnings Exact identifier application number: M020 Eucerin Sensitive Mineral SPF 50 Sunscreen ZINC OXIDE Beiersdorf Inc cdb25154-e4e3-efc7-e053-2a95a90a2df6 2025-11-10 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