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 52 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Lancome Paris UV Expert Aquagel Defense 50 Plus Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE L'Oreal USA Products Inc c500e58f-38b0-454e-8923-912844276b17 2026-03-20 Warnings Exact identifier application number: M020 Protect by HEALTHY SKIN LAB MD SUNSCREEN TINTED MOISTURIZER TITANIUM DIOXIDE, ZINC OXIDE HEALTHY SKIN LAB LIMITED 4a1ec566-549f-45f2-a43d-dacfc7263361 2026-03-20 Warnings Exact identifier application number: M020 SOJO sunscreen ZINC OXIDE Guangdong Aimu Biological Technology Co., Ltd 4d44efb6-abc5-c346-e063-6394a90a6023 2026-03-19 Warnings Exact identifier application number: M020 VRC Lip balm SPF15 ZINC OXIDE Guangdong Aimu Biological Technology Co., Ltd 4d588fbe-e61a-2264-e063-6394a90aa060 2026-03-19 Warnings Exact identifier application number: M020 SOjO Lip balm SPF15 ZINC OXIDE Guangdong Aimu Biological Technology Co., Ltd 4d5ed865-fff2-ee44-e063-6294a90a67e2 2026-03-19 Warnings Exact identifier application number: M020 ActivDerm Radiant Shield Broad Spectrum SPF 40 ZINC OXIDE ACTIVDERM LLC 4d6307f1-bab6-5f44-e063-6294a90a8e36 2026-03-19 Warnings Exact identifier application number: M020 Mad Robbit DEFEND SPF30 SUNSCREEN MAD RABBIT TATTOO, INC. bf853d54-ecd9-40cc-9f10-cb546bfb8933 2026-03-19 Warnings Exact identifier application number: M020 Stay Ageless Tinted Mineral Sunscreen BROAD SPECTRUM SPF30 SKNVcare, LLC 4d67dfb4-3607-2af6-e063-6294a90ae01a 2026-03-19 Warnings Exact identifier application number: M020 Premier Tinted Mineral Sunscreen BROAD SPECTRUM SPF30 Premier Plastic Surgery 4d3a36b9-7d60-01ac-e063-6294a90af4fb 2026-03-18 Warnings Exact identifier application number: M020 GOODAL HEARTLEAF SOOTHING ZINC 100 MINERAL SUNSCREEN ZINC OXIDE CLIO COSMETICS Co., Ltd. c7b13245-a3e0-4d53-b7fe-9b2c9707ab9e 2026-03-18 Warnings Exact identifier application number: M020 TIR TIR SUN BOUNCY GLOW LIP BALM SPF 30 BURNT MAPLE ZINC OXIDE COSMAX USA 4d318f51-1a43-44d5-e063-6394a90a4970 2026-03-17 Warnings Exact identifier application number: M020 TIR TIR SUN BOUNCY GLOW LIP BALM SPF 30 HAZY MAUVE ZINC OXIDE COSMAX USA 4d319110-e6a4-1ad3-e063-6394a90aa99c 2026-03-17 Warnings Exact identifier application number: M020 TIR TIR SUN BOUNCY GLOW LIP BALM SPF 30 SUNLIT CORAL ZINC OXIDE COSMAX USA 4d31b201-9d6a-730a-e063-6394a90a6700 2026-03-17 Warnings Exact identifier application number: M020 OSKIN New York Coffee BB Cream SPF 30 TITANIUM DIOXIDE, OCTOCRYLENE, ZINC OXIDE O'Skin Studio NY 29dae75a-4368-432a-9cf8-f0f021f09e29 2026-03-17 Warnings Exact identifier application number: M020 Premier Tinted Mineral Sunscreen BROAD SPECTRUM SPF30 Premier Plastic Surgery 4d39b64c-2e27-afed-e063-6394a90a3812 2026-03-17 Warnings Exact identifier application number: M020 Powder TITANIUM DIOXIDE Oxygen Development LLC 4d39ed7a-ca80-893c-e063-6294a90a03e7 2026-03-17 Warnings Exact identifier application number: M020 Powder TITANIUM DIOXIDE Oxygen Development LLC 4d3a0a92-b0de-a1ea-e063-6294a90a8508 2026-03-17 Warnings Exact identifier application number: M020 Avobenzone, Homosalate, Octisalate, Octocrylene AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Trader Joe's Company 4d3a36b9-7d63-01ac-e063-6294a90af4fb 2026-03-17 Warnings, Adverse reactions Exact identifier application number: M020 Redneck SPF 50 Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Redneck Sunscreen LLC 4d3a460b-1b98-2906-e063-6294a90a3669 2026-03-17 Warnings Exact identifier application number: M020 Sunscreen BROAD SPECTRUM SPF 30 SKNVCARE, LLC 4d3ad051-3729-06fd-e063-6394a90ad0fe 2026-03-17 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