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 154 of 353 · 7,041 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ATTITUDE Super Leaves Lip Balm SPF15 Unscented ZINC OXIDE 9055-7588 Qubec Inc.DBA ATTITUDE 44ff1fc0-9ac5-2c9a-e063-6294a90a4632 2025-12-02 Warnings Exact identifier application number: M020 ATTITUDE Sunly Lip Balm SPF 15 Coconut ZINC OXIDE 9055-7588 Qubec Inc.DBA ATTITUDE 44ff5675-fd8d-b665-e063-6294a90a1e0b 2025-12-02 Warnings Exact identifier application number: M020 ATTITUDE Sunly Lip Balm SPF 15 Pineapple ZINC OXIDE 9055-7588 Qubec Inc.DBA ATTITUDE 44ffb35b-80f4-7ddb-e063-6394a90a2cbb 2025-12-02 Warnings Exact identifier application number: M020 BANANA BOAT AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE Edgewell Personal Care Brands LLC 44ffd469-0205-846f-e063-6294a90af6b5 2025-12-02 Warnings Exact identifier application number: M020 COSRX VITAMIN E VITALIZING SUNSCREEN COSRX inc. daf0291e-770c-eaf2-e053-2a95a90a0b67 2025-12-01 Warnings Exact identifier application number: M020 Centellian24 Madeca Derma Shield Vital Dewy Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTROCRYLENE 70541 44e0098c-170f-ca51-e063-6294a90aed20 2025-12-01 Warnings Exact identifier application number: M020 Centellian24 Madeca Derma Shield Vital Sun Essence AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE 70541 44e194cd-ea61-71b3-e063-6394a90ac486 2025-12-01 Warnings Exact identifier application number: M020 Venture Performance Sun Protection Mineral Sunscreen SPF 50 ZINC OXIDE Venture Performance Inc 630fc5c2-a315-4e26-9bd9-5f8533d75908 2025-12-01 Warnings Exact identifier application number: M020 EMINENCE Red Currant Protective Moisturizer OCTINOXATE, ZINC OXIDE Eminence Organic Skin Care 7eca62af-6f70-44ec-879e-74712163c4e0 2025-12-01 Warnings Exact identifier application number: M020 CHARLOTTE TILBURY Broad Spectrum SPF 50 Sunscreen Invisible UV Flawless Poreless Primer AVOBENZONE, OCTINOXATE, OCTISALATE AND OCTOCRYLENE Charlotte Tilbury Beauty Ltd. 2b215ecb-7c3a-63db-e063-6394a90aa88f 2025-12-01 Warnings Exact identifier application number: M020 P.CALM Water Barrier Sunscreen SPF 50 Broad Spectrum HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE LIFE WITHCORPORATION Inc. 44ea9fb4-8e01-6969-e063-6294a90a6a94 2025-12-01 Warnings Exact identifier application number: M020 UNCOMPLIKATED MAKEUP SETTING SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE Rare Beauty Brands Inc. 44ec0db5-4437-e4a3-e063-6294a90a9a00 2025-12-01 Warnings Exact identifier application number: M020 RoC Retinol Correxion Wrinkle Correct Daily Moisturizer SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE RoC Skincare 2888a198-116b-8441-e063-6394a90a0f95 2025-12-01 Warnings Exact identifier application number: M020 ReefSafe Very High Sun Protection sunscreen ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 44ec619f-ed3b-2fd3-e063-6294a90a858b 2025-12-01 Warnings Exact identifier application number: M020 Reef safe - Face and Body sunscreen SPF50 ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 38603298-e8da-e4c7-e063-6394a90aca3b 2025-12-01 Warnings Exact identifier application number: M020 ReefSafe Baby and Toddlers Sunscreen SPF50 ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 44dd513e-ebaa-0d6a-e063-6394a90a78b7 2025-11-30 Warnings Exact identifier application number: M020 Safe4Kidz Natural Mineral Sunscreen SPF50 ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 44ddc0ae-a977-3adf-e063-6294a90a0898 2025-11-30 Warnings Exact identifier application number: M020 Safe4Kidz Baby Zinc Sunscreen SPF50 ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 44ddc4d8-3f3b-5d11-e063-6294a90ae88a 2025-11-30 Warnings Exact identifier application number: M020 Clarite Makeup Foundation for a Clearer Appearance SPF 30 170-N OCTINOXATE, ZINC OXIDE BEL STAR S A b56f5883-be57-e0e5-e053-2a95a90adb0c 2025-11-29 Warnings Exact identifier application number: M020 ATTITUDE Sunly Baby Mineral sunscreen Sprayer SPF 50 Unscented ZINC OXIDE 9055-7588 Qubec Inc.DBA ATTITUDE 44a94a24-e292-41e6-e063-6394a90abe47 2025-11-28 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