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 138 of 353 · 7,049 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join SHADED TITANIUM DIOXIDE, ZINC OXIDE Potency No. 710 LLC 3117e138-83a1-0931-e063-6394a90abe43 2025-12-10 Warnings Exact identifier application number: M020 SHADED TITANIUM DIOXIDE, ZINC OXIDE Potency No. 710 LLC 31188175-a4ca-449f-e063-6394a90a3c05 2025-12-10 Warnings Exact identifier application number: M020 COVERED ZINC OXIDE Potency No. 710 LLC 3118c3ed-f0f0-f997-e063-6294a90a53a9 2025-12-10 Warnings Exact identifier application number: M020 COVERED ZINC OXIDE Potency No. 710 LLC 3117faeb-1792-1b2e-e063-6294a90a92df 2025-12-10 Warnings Exact identifier application number: M020 Non-Tinted Mineral Foaming Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Restore Skin Therapy, LLC 364b6af2-a0ed-4a17-e063-6394a90a3a17 2025-12-10 Exact identifier application number: M020 Morning Replenish ZINC OXIDE Restore Skin Therapy, LLC 364b26c2-a1bb-9660-e063-6294a90a14d1 2025-12-10 Exact identifier application number: M020 Glass Skin Sunscreen Tinted ZINC OXIDE Fleur de Lune, LLC 34288989-35b8-3aa3-e063-6394a90ac2c4 2025-12-10 Exact identifier application number: M020 Glass Skin Sunscreen Tinted ZINC OXIDE Fleur de Lune, LLC 3418394b-fede-65ce-e063-6394a90ad5f9 2025-12-10 Exact identifier application number: M020 Glass Skin Sunscreen Non-Tinted ZINC OXIDE Fleur de Lune, LLC 341871e5-c170-7560-e063-6394a90a8eee 2025-12-10 Exact identifier application number: M020 Glass Skin Sunscreen Non-Tinted ZINC OXIDE Fleur de Lune, LLC 3428bdbb-1f18-a29b-e063-6294a90addbc 2025-12-10 Exact identifier application number: M020 Sheer Facial Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE BB MEDICAL & DERMATOLOGY INC 342b2403-4f4a-3e77-e063-6294a90a4f0a 2025-12-10 Exact identifier application number: M020 Sheer Mineral Sunscreen Bar TITANIUM DIOXIDE, ZINC OXIDE BB MEDICAL & DERMATOLOGY INC 342b69d5-f0e1-99cd-e063-6294a90abb6e 2025-12-10 Exact identifier application number: M020 Sheer Facial Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE BB MEDICAL & DERMATOLOGY INC 342c3f42-c17f-f777-e063-6394a90a8058 2025-12-10 Exact identifier application number: M020 Lip SPF TITANIUM DIOXIDE, ZINC OXIDE FRANCISCO FLORES, M.D., P.A. 396d3fdd-99d8-77e8-e063-6294a90aec2f 2025-12-10 Exact identifier application number: M020 Non-Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE FRANCISCO FLORES, M.D., P.A. 396cae82-7641-e1b2-e063-6394a90a7c07 2025-12-10 Exact identifier application number: M020 Solar Knight SPF 40 Broad Spectrum TITANIUM DIOXIDE, ZINC OXIDE MASCARENAS ENTERPRISES, INC. 36c27c91-22ac-205c-e063-6294a90ab379 2025-12-10 Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE FRANCISCO FLORES, M.D., P.A. 396ce15a-06ad-4055-e063-6294a90a27fb 2025-12-10 Exact identifier application number: M020 Dermablue Daily Replenishing ZINC OXIDE Dermablue, P.C. 308da9c9-544e-d5d1-e063-6294a90aa49b 2025-12-10 Warnings Exact identifier application number: M020 Recoverie Mineral Matte ZINC OXIDE Clear Day Acne Clinic 308f41de-fb14-40f9-e063-6394a90a008f 2025-12-10 Warnings Exact identifier application number: M020 AL0043600 Alba Botanica VE Herbal Healing Body COLLOIDAL OATMEAL The Hain Celestial Group, Inc. 60672feb-141f-651e-e053-2a91aa0af41d 2025-12-10 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