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 97 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Sei Bella CC Brightening Creme Light OCTINOXATE 7.5%, TITANIUM DIOXIDE 5%, ZINC OXIDE 1% Melaleuca Inc. 6894b9d9-a5b5-4c98-e053-2991aa0a9ca2 2025-12-31 Warnings Exact identifier application number: M020 Sei Bella CC Brightening Creme Fair OCTINOXATE 7.5%, TITANIUM DIOXIDE 5%, ZINC OXIDE 1% Melaleuca Inc. 6892952a-d032-30bf-e053-2a91aa0a3bba 2025-12-31 Warnings Exact identifier application number: M020 Sei Bella CC Brightening Creme Medium Tan OCTINOXATE 7.5%, TITANIUM DIOXIDE 5%, ZINC OXIDE 1% Melaleuca Inc. 68a4e8b4-36cb-6306-e053-2a91aa0a6d25 2025-12-31 Warnings Exact identifier application number: M020 Sei Bella CC Brightening Creme Medium OCTINOXATE 7.5%, TITANIUM DIOXIDE 5%, ZINC OXIDE 1% Melaleuca Inc. 68a4ed34-f492-67a6-e053-2a91aa0a0428 2025-12-31 Warnings Exact identifier application number: M020 Sei Bella Daily UV Defense Broad-Spectrum SPF 25 Sunscreen SUNSCREEN Melaleuca Inc. 1f1d1575-cf37-5d66-e063-6394a90ab2a3 2025-12-31 Warnings Exact identifier application number: M020 Eucerin Daily Hydration AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Beiersdorf Inc c9bb7d33-783b-4cbb-a130-91f92d4cc137 2025-12-31 Warnings Exact identifier application number: M020 Sei Bella Tinted BB Moisturizing Creme Sheer to Light 140 N TITANIUM DIOXIDE 5% AND ZINC OXIDE 5% Melaleuca Inc. a13e5326-73c3-9fa8-e053-2a95a90aae9d 2025-12-31 Warnings Exact identifier application number: M020 Sei Bella Tinted BB Moisturizing Creme Sheer to Light 20 N TITANIUM DIOXIDE 5% AND ZINC OXIDE 5% Melaleuca Inc. a13e3f45-8e6f-6a3f-e053-2995a90a17d2 2025-12-31 Warnings Exact identifier application number: M020 Sei Bella Tinted BB Moisturizing Creme Deep 550 N TITANIUM DIOXIDE 5% AND ZINC OXIDE 5% Melaleuca Inc. 68e31a82-0cd0-5a1a-e053-2991aa0a33f8 2025-12-31 Warnings Exact identifier application number: M020 Sei Bella Tinted BB Moisturizing Creme Light to Medium 200 N TITANIUM DIOXIDE 5% AND ZINC OXIDE 5% Melaleuca Inc. 68e2dfaa-d173-e6a9-e053-2a91aa0a4663 2025-12-31 Warnings Exact identifier application number: M020 Sei Bella Tinted BB Moisturizing Creme Medium 300 W TITANIUM DIOXIDE 5% AND ZINC OXIDE 5% Melaleuca Inc. 68e2e541-c583-0f12-e053-2991aa0a4ab2 2025-12-31 Warnings Exact identifier application number: M020 Sei Bella Tinted BB Moisturizing Creme Medium to Deep 500 W TITANIUM DIOXIDE 5% AND ZINC OXIDE 5% Melaleuca Inc. 68e30231-4fba-35d4-e053-2991aa0a33cb 2025-12-31 Warnings Exact identifier application number: M020 Sei Bella Tinted BB Moisturizing Creme Medium 440 N TITANIUM DIOXIDE 5% AND ZINC OXIDE 5% Melaleuca Inc. 68e30255-5640-3b4a-e053-2991aa0ab3f7 2025-12-31 Warnings Exact identifier application number: M020 Sei Bella Tinted BB Moisturizing Creme Medium to Deep 450 W TITANIUM DIOXIDE 5% AND ZINC OXIDE 5% Melaleuca Inc. 68e30255-564f-3b4a-e053-2991aa0ab3f7 2025-12-31 Warnings Exact identifier application number: M020 Sei Bella Tinted BB Moisturizing Creme Medium 320 C TITANIUM DIOXIDE 5% AND ZINC OXIDE 5% Melaleuca Inc. 68e2e541-c596-0f12-e053-2991aa0a4ab2 2025-12-31 Warnings Exact identifier application number: M020 Sei Bella Tinted BB Moisturizing Creme Light to Medium 160 N TITANIUM DIOXIDE 5% AND ZINC OXIDE 5% Melaleuca Inc. 68e20c57-7b30-4e96-e053-2991aa0aab3e 2025-12-31 Warnings Exact identifier application number: M020 Sun Shades Lip Balm Pina Colada AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3% Melaleuca Inc. 16d0d2d2-b9c4-4491-8d8a-815843d342e8 2025-12-31 Warnings Exact identifier application number: M020 Sun Shades Lip Balm Mountain Mint AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3% Melaleuca Inc. 326d9623-0e67-43bd-83f8-ee7dfa3bdbe8 2025-12-31 Warnings Exact identifier application number: M020 Sun Shades Lip Balm Vanilla Bean AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3% Melaleuca Inc. 2037cc9d-b11b-47d6-8d65-c0f9decc8ba7 2025-12-31 Warnings Exact identifier application number: M020 Sun Shades Mineral Plus Sunscreen with Zinc Oxide OCTISALATE 5%, OCTOCRYLENE 3%, ZINC OXIDE 10.5% Melaleuca Inc. 8886cbd0-ed2b-4a2b-a724-a0d4f12296c9 2025-12-31 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