Home NDC 63354-784 HAWAIIAN TROPIC
Product NDC 63354-784
11-digit product format 633540784
Labeler code 63354
Product ID 63354-784_3fe83a06-b046-ac3b-e063-6294a90a3b37
Type HUMAN OTC DRUG
Nonproprietary name AVOBENZONE,OCTISALATE,OCTOCRYLENE
Dosage form OIL
Route TOPICAL
Labeler Edgewell Personal Care Brands LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-04-02
Substance OCTISALATE; AVOBENZONE; OCTOCRYLENE
Active strength 4.5; 2.7; 9 g/100g; g/100g; g/100g
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OCTISALATE 4.5 g/100g AVOBENZONE 2.7 g/100g OCTOCRYLENE 9 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4X49Y0596W Internal UNII lookup G63QQF2NOX Internal UNII lookup 5A68WGF6WM Internal UNII lookup
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 63354-784-16 HAWAIIAN TROPIC 236 g in 1 BOTTLE, PUMP OIL 236 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63354-784 HAWAIIAN TROPIC (AVOBENZONE,OCTISALATE,OCTOCRYLENE) OIL [EDGEWELL PERSONAL CARE BRANDS LLC] 1 Current NDC, 1 package rows 20250406_31d01fae-4085-d84a-e063-6294a90ab981.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 265 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Covergirl Advanced Radiance Age Defying Makeup plus Sunscreen SPF 10 (All shades) OCTINOXATE AND TITANIUM DIOXIDE Noxell 356af30e-82c7-4e28-94bb-b536e74d01e1 2024-11-19 Warnings Exact identifier application number: M020 Covergirl plus Olay Simply Ageless Foundation plus Titanium Dioxide Sunscreen Broad Spectrum SPF 28 (All shades) TITANIUM DIOXIDE Noxell Corporation fab59bd6-4ef6-4626-9f75-edcd4088e643 2024-11-19 Warnings Exact identifier application number: M020 Coral Care SPF 30 Sunscreen TITANIUM DIOXIDE 8.8% Stream2Sea 2749fa0e-aed5-6c9a-e063-6294a90a2bf1 2024-11-19 Warnings Exact identifier application number: M020 FULL SPECTRUM MATTE AMBITION SKIN PRIMER SPF 20 ENSULIZOLE Noxell Corporation 82f7bff9-718e-19ea-e053-2991aa0a3560 2024-11-19 Warnings Exact identifier application number: M020 Rimmel London Lasting Finish 25 HR Foundation SPF 20 OCTINOXATE Rimmel cfd041e9-ed40-dc93-e053-2995a90a9699 2024-11-19 Warnings Exact identifier application number: M020 ultimate miracle worker multi-rejuvenating spf 30 AVOBENZONE, OCTINOXATE, OCTOCRYLENE Philosophy, Inc. 4387abab-ee1c-4e93-bea9-01624e8b4832 2024-11-19 Warnings Exact identifier application number: M020 Sun Voyage Kit AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE Koco Life LLC 2732a8d2-6f56-c088-e063-6294a90af308 2024-11-18 Warnings Exact identifier application number: M020 Eminence Radiant Protection SPF Fluid ZINC OXIDE Eminence Organic Skin Care 002a4766-0c7e-4ec7-e063-6294a90a78d8 2024-11-18 Warnings Exact identifier application number: M020 Eryfotona Actinica Ultralight Emulsion SUNSCREEN ISDIN Corp 1d4b88d3-bee9-102c-e054-00144ff8d46c 2024-11-18 Warnings Exact identifier application number: M020 Rodan and Fields Plumping Lip SPF 28 Sunscreen OCTINOXATE, ZINC OXIDE Rodan & Fields edf05ccc-4299-48d5-8f8e-01255eca11c2 2024-11-15 Warnings Exact identifier application number: M020 Melan Mineral Antioxidant Body Mist Mineral Sunscreen SPF 30 ZINC OXIDE MELAN INC. 210823a0-94f9-4833-b279-fc26b9061195 2024-11-14 Warnings Exact identifier application number: M020 Luminous Sunscreen SPF 50 ZINC OXIDE, TITANIUM DIOXIDE CLINICAL SKIN LLC 26e2b82c-8d7a-7261-e063-6394a90a7c0d 2024-11-14 Warnings Exact identifier application number: M020 CoTZ Flawless Complexion ZINC OXIDE Fallien Cosmeceuticals, LTD 0973223b-e75f-4eb8-bcf1-7931b30b7b51 2024-11-14 Warnings Exact identifier application number: M020 TiZO Photoceutical Environmental Skin Protectant DIMETHICONE Fallien Cosmeceuticals, LTD 84a3299d-9b98-492e-a83f-ebd72ec58f8d 2024-11-14 Warnings Exact identifier application number: M020 TiZO Photoceutical AM Replenish Non-Tinted ZINC OXIDE Fallien Cosmeceuticals, LTD c52a1e04-f3ca-47a1-a26e-d6f5e77b47d6 2024-11-14 Warnings Exact identifier application number: M020 Neutrogena MINERAL UV TINT FACE LIGHT SPF 30 TITANIUM DIOXIDE, ZINC OXIDE Kenvue Brands LLC e7af4f58-90c8-2987-e053-2995a90a416b 2024-11-13 Warnings Exact identifier application number: M020 Neutrogena Healthy Skin Liquid Makeup Broad Spectrum SPF 20 - Classic Ivory 10 TITANIUM DIOXIDE Kenvue Brands LLC 143e0a1d-305f-9015-e063-6294a90aa025 2024-11-13 Warnings Exact identifier application number: M020 BANANA BOAT AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE Edgewell Personal Care Brands LLC 05cb5a91-205f-b652-e063-6294a90a0664 2024-11-13 Warnings Exact identifier application number: M020 Neutrogena Ultra Sheer Dry-Touch Sunscreen Broad Spectrum SPF 30 TITANIUM DIOXIDE, ZINC OXIDE Kenvue Brands LLC 18e40353-5c95-4d64-e063-6394a90a017c 2024-11-12 Warnings Exact identifier application number: M020 Neutrogena Healthy Skin Liquid Makeup SPF 20 - Classic Ivory 10 TITANIUM DIOXIDE Kenvue Brands LLC e0ed4537-8146-45e8-e053-2995a90ac51b 2024-11-12 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 63354-784-16 63354078416 236 g in 1 BOTTLE, PUMP (63354-784-16) 236 g 2025-04-02 No No Current