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 69 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Surfers Barrier ZINC OXIDE Avasol LLC d6e2ac0a-3bf6-4d08-8647-6a23de2ac857 2026-01-26 Warnings Exact identifier application number: M020 SURFERS BARRIER SPF 50 ZINC OXIDE, TITANIUM DIOXIDE Avasol LLC ec55eef0-17e6-416d-bd5e-548f2f323cea 2026-01-26 Warnings Exact identifier application number: M020 Zenskin Watery Dew Nia-Cica Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE SUNSCREEN Zenskin Co. Ltd. 49584899-d523-9677-e063-6394a90a1403 2026-01-26 Warnings Exact identifier application number: M020 Caring mill sun serum with Vitamin C Niacinamide HOMOSALATE OCTOCRYLENE OCTISALATE AVOBENZONE FSA Store lnc. 4931ee71-1088-1ac1-e063-6294a90ad82b 2026-01-25 Warnings Exact identifier application number: M020 Caring mill Mineral Eye Cream ZINC OXIDE FSA STORE INC. 4932ea19-28cc-b245-e063-6394a90ac7aa 2026-01-25 Warnings Exact identifier application number: M020 Ceile SPF 30 prime PROTECT Broad Spectrum SPF 30 Sunscreen SUNSCREEN 30 MINERAL LE COSMETICS INC 2cee0413-d532-c192-e063-6294a90aa823 2026-01-25 Warnings Exact identifier application number: M020 BeginS by JUNGSAEMMOOL Blue Chamomile Hyaluronic Acid Aqua Sunscreen Broad Spectrum SPF 50 plus AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Jungsaemmool Beauty Co., Ltd. 62e23503-7233-434a-91f0-092f10d2717d 2026-01-24 Warnings Exact identifier application number: M020 BeginS by JUNGSAEMMOOL Blue Chamomile Hyaluronic Acid Airy Sun Stick Broad Spectrum SPF 50 plus AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Jungsaemmool Beauty Co., Ltd. 030a20fb-4846-4a5c-9808-a399aac2ff0b 2026-01-24 Warnings Exact identifier application number: M020 Mimosa Lane SPF45 OCTINOXATE, OCTISALATE, ZINC OXIDE SUNSCREEN R&G Divergency LLC 40f3b8ea-bfa5-4c66-9c79-c4408bda857a 2026-01-24 Warnings Exact identifier application number: M020 111 SKIN SUNSCREEN SPF 50 ZINC OXIDE Bentley Laboratories, LLC b1265797-71dd-4302-ab26-dbff6ccec856 2026-01-23 Warnings Exact identifier application number: M020 Mania Holic Sunscreen Pack OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONE Firstmarket Co., ltd. b95a460c-1f7b-4193-b305-466e073af640 2026-01-23 Warnings Exact identifier application number: M020 JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 320 HOMOSALATE,OCTISALATE,ZINC OXIDE Distribuidora Comercial Jafra, S.A. de C.V. 1cdbae71-441b-426d-99ee-c889d76af452 2026-01-23 Warnings Exact identifier application number: M020 JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 250 HOMOSALATE,OCTISALATE,ZINC OXIDE Distribuidora Comercial Jafra, S.A. de C.V. 8f4b5e0a-4578-4af3-b7d9-a19d4eb732e7 2026-01-23 Warnings Exact identifier application number: M020 ISA KNOX 365 BB SUNSCREEN Broad Spectrum SPF 40, PA TITANIUM DIOXIDE LG Household and Healthcare, Inc. 65e70306-9e79-494d-9217-a43002f16307 2026-01-23 Warnings Exact identifier application number: M020 O HUI Sun Science Ideal Cover Sunscreen Broad Spectrum TITANIUM DIOXIDE LG Household and Healthcare, Inc. c15ffd23-271d-458d-9048-9bc50331d5d7 2026-01-23 Warnings Exact identifier application number: M020 Aqua protection Sunscreen Broad Spectrum SPF50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE ENGLEWOOD LAB, INC. 627e6ea5-016b-4ab6-a50c-aa9c27e5cca1 2026-01-23 Warnings Exact identifier application number: M020 RODAN AND FIELDS REVERSE 4 BROAD SPECTRUM SPF 50 PLUS SUNSCREEN AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Rodan & Fields 7fe05ef6-dd5f-4f25-bbf7-24f939642707 2026-01-23 Warnings Exact identifier application number: M020 Ceile SPF 30 prime PROTECT RADIATE Broad Spectrum SPF 30 Sunscreen Nacre CEILE SPF 30 PRIME PROTECT RADIATE NACRE LE COSMETICS INC 4915de09-3a2c-cb75-e063-6394a90a6a57 2026-01-23 Warnings Exact identifier application number: M020 SPF 50 Sunscreen Stick ZINC OXIDE Australian Gold 248d761c-2120-4019-9463-9952bc367e73 2026-01-23 Warnings Exact identifier application number: M020 SOLBAR THIRTY SUNSCREEN Person and Covey 48ed3be8-d146-ec2c-e063-6394a90a6c4d 2026-01-22 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