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 99 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join DR.JART EVERY SUN DAY MINERAL SUN SCREEN TITANIUM DIOXIDE, ZINC OXIDE Have & Be Co., Ltd. f06c31b4-da5f-6495-e053-2995a90ae67c 2025-12-31 Warnings Exact identifier application number: M020 ALMOST powder MAKEUP BROAD SPECTRUM SPF 18 OCTINOXATE AND TITANIUM DIOXIDE CLINIQUE LABORATORIES LLC 402add6d-a81e-4c9e-aee1-4abeb480894f 2025-12-31 Warnings Exact identifier application number: M020 RED GECKO BROAD SPECTRUM SPF 30 SUNSCREEN ZINC OXIDE Formula 7venz L.L.C. e8e350e7-9225-4802-89a6-66e45ebc442d 2025-12-31 Warnings Exact identifier application number: M020 Kinfield Daily Dew Sea Kelp Moisturizer Sunscreen Broad Spectrum SPF 35 KINFIELD DAILY DEW SEA KELP MOISTURIZER SUNSCREEN LOTION BROAD SPECTRUM SPF 35 Kinfield, Inc. 0710db9f-fe91-4b98-a337-5fde33d98a9d 2025-12-30 Warnings Exact identifier application number: M020 Kinfield Cloud Cover Mineral Body Sunscreen Broad Spectrum SPF 35 KINFIELD CLOUD COVER MINERAL BODY SUNSCREEN BROAD SPECTRUM SPF 35 Kinfield, Inc. 1030c5a4-3067-48e6-a21c-0d327ef434d0 2025-12-30 Warnings Exact identifier application number: M020 Kinfield Cloud Cover Mineral Body Sunscreen Broad Spectrum SPF 35 KINFIELD CLOUD COVER MINERAL BODY SUNSCREEN BROAD SPECTRUM SPF 35 Kinfield, Inc. 612c5730-c3b4-486e-8ce9-8a861f676fa8 2025-12-30 Warnings Exact identifier application number: M020 Kinfield Liplock SPF 15 Lip Balm Broad Spectrum Sunscreen KINFIELD LIPLOCK SUNSCREEN Kinfield, Inc. 477aa1a2-c893-4750-84da-e5afe7ccd45b 2025-12-30 Warnings Exact identifier application number: M020 Kinfield Sunglow Luminizing Facial Sunscreen Broad Spectrum SPF 35 KINFIELD SUNGLOW LUMINIZING FACIAL SUNSCREEN BROAD SPECTRUM SPF 35 Kinfield, Inc. cbdfd0ae-514b-4b53-98ad-4270163bd0df 2025-12-30 Warnings Exact identifier application number: M020 Perfect Glow BB Cream Sunscreen SPF 30 - Fair OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE Pur-lisse Beauty, LLC 472f4f34-99bc-2ff6-e063-6294a90a33c9 2025-12-30 Warnings Exact identifier application number: M020 EVEN BETTER CLINICAL VITAMIN MAKEUP BROAD SPECTRUM SPF 45 ENSULIZOLE, OCTINOXATE, OCTISALATE, AND ZINC OXIDE CLINIQUE LABORATORIES LLC 2397aca5-bf0a-619d-e063-6394a90a7ab9 2025-12-30 Warnings Exact identifier application number: M020 Resource Essentials Sun Protection Mineral SPF 30 14% ZINC OXIDE Skinresource.md, L.L.C. 45b486cf-28ee-6392-e063-6394a90affb0 2025-12-30 Warnings Exact identifier application number: M020 Perfect Glow BB Cream Sunscreen SPF 30 - Light Medium OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE Pur-lisse Beauty, LLC 47313277-8884-70b5-e063-6394a90a5fca 2025-12-30 Warnings Exact identifier application number: M020 Perfect Glow BB Cream Sunscreen SPF 30 - Medium OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE Pur-lisse Beauty, LLC 47320858-0aea-6ee9-e063-6294a90a9fa9 2025-12-30 Warnings Exact identifier application number: M020 Perfect Glow BB Cream Sunscreen SPF 30 - Light Warm OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE Pur-lisse Beauty, LLC 47325530-b097-db9a-e063-6294a90a335d 2025-12-30 Warnings Exact identifier application number: M020 Perfect Glow BB Cream Sunscreen SPF 30 - Tan OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE Pur-lisse Beauty, LLC 47328eb4-8ad7-28b5-e063-6294a90a20b1 2025-12-30 Warnings Exact identifier application number: M020 Perfect Glow BB Cream Sunscreen SPF 30 - Tan Deep OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE Pur-lisse Beauty, LLC 4732bbec-d9f9-1639-e063-6394a90aff82 2025-12-30 Warnings Exact identifier application number: M020 Perfect Glow BB Cream Sunscreen SPF 30 - Deep OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE Pur-lisse Beauty, LLC 4732ecd0-5261-7f11-e063-6394a90a26f3 2025-12-30 Warnings Exact identifier application number: M020 ScalpProtectionSpray SCALP PROTECTION SPRAY Naturich Labs c227ff3a-bbbb-5cc5-e053-2a95a90a8e32 2025-12-30 Warnings Exact identifier application number: M020 HAWAIIAN TROPIC AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE Edgewell Personal Care Brands LLC 0918fdd3-cffb-78e9-e063-6394a90ad5c7 2025-12-30 Warnings Exact identifier application number: M020 SLMD AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE Skin PS Brands 1aa36c01-21b5-f06e-e063-6294a90a608f 2025-12-30 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