HAWAIIAN TROPIC

Product NDC: 63354-355
11-digit product format: 633540355
Labeler code: 63354
Product ID: 63354-355_5de311d2-58ac-4fac-e063-6394a90ae9ec
Type: HUMAN OTC DRUG
Nonproprietary name: Avobenzone,Homosalate,Octisalate,Octocrylene
Dosage form: LOTION
Route: TOPICAL
Labeler: Edgewell Personal Care Brands, LLC
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2026-01-06
Marketing end: 2028-10-01
Substance: OCTISALATE; AVOBENZONE; HOMOSALATE; OCTOCRYLENE
Active strength: 4.5; 2; 5.5; 4 g/100g; g/100g; g/100g; g/100g
NDC exclude flag: No
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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OCTISALATE	4.5 g/100g
AVOBENZONE	2 g/100g
HOMOSALATE	5.5 g/100g
OCTOCRYLENE	4 g/100g

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 46 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Arizona Sun Kids Sunscreen SPF 30	SUNSCREEN	Arizona Sun Products	10f60367-6681-a589-e063-6394a90a6bb8	2026-04-09	Warnings	Exact identifier application number: M020
Arizona Sun Sunscreen Water Resistant SPF 30	SUNSCREEN	Arizona Sun Products	115b4d4c-51f1-ad62-e063-6294a90a3e53	2026-04-09	Warnings	Exact identifier application number: M020
Arizona Sun Sunscreen SPF 30	SUNSCREEN	Arizona Sun Products	10e48195-7bae-2422-e063-6394a90a261c	2026-04-09	Warnings	Exact identifier application number: M020
Arizona Sun Sunscreen SPF 30	SUNSCREEN	Arizona Sun Products	10e276e4-81f1-9429-e063-6394a90a800d	2026-04-09	Warnings	Exact identifier application number: M020
Arizona Sun Sunscreen SPF 8	SUNSCREEN	Arizona Sun Products	106a9608-f7a4-0f8c-e063-6394a90a26ab	2026-04-09	Warnings	Exact identifier application number: M020
Arizona Sun Products Bikerblok Lip Balm SPF 15	LIP BALM	Arizona Sun Products	11fced72-39f9-f3a3-e063-6294a90a8b73	2026-04-09	Warnings	Exact identifier application number: M020
Arizona Sun Products Golfblok Lip Balm SPF 15	LIP BALM	Arizona Sun Products	11fc2a82-260c-7cd3-e063-6394a90af2c1	2026-04-09	Warnings	Exact identifier application number: M020
Arizona Sun Products Cycleblok Lip Balm SPF 15	LIP BALM	Arizona Sun Products	11fd9aa5-dbd6-e5a7-e063-6394a90a3eac	2026-04-09	Warnings	Exact identifier application number: M020
Arizona Sun Products Golfblok Lip Balm SPF 15	LIP BALM	Arizona Sun Products	11fc93a7-f5be-965d-e063-6394a90ab335	2026-04-09	Warnings	Exact identifier application number: M020
Arizona Sun Products Bikerblok Lip Balm SPF 15	LIP BALM	Arizona Sun Products	11fd1661-1b91-b65b-e063-6394a90af89b	2026-04-09	Warnings	Exact identifier application number: M020
Arizona Sun Products Lipkist Lip Balm SPF 15	LIP BALM	Arizona Sun Products	11fbcb81-2735-53c8-e063-6394a90ab0fa	2026-04-09	Warnings	Exact identifier application number: M020
Arizona Sun Products Cycleblok Lip Balm SPF 15	LIP BALM	Arizona Sun Products	11fd8776-99f8-e5a4-e063-6394a90a2033	2026-04-09	Warnings	Exact identifier application number: M020
uLOOK Sunscreen SPF 50	SUNSCREEN	HAMEX GLOBAL COSMETICS LLC	4e05588c-486b-60e0-e063-6294a90af457	2026-04-09	Warnings	Exact identifier application number: M020
Pro-Tect Sports Sunscreen SPF 20	MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE	ABBE Laboratories, Inc.	35869e8d-8e48-4b22-8af3-6964fe8ac182	2026-04-09	Warnings	Exact identifier application number: M020
Sunright 50	AVOBENZONE, HOMOSALATE, AND OCTINOXATE	NSE Products, Inc.	b1b76481-da23-427f-9b34-b987019fa532	2026-04-09	Warnings	Exact identifier application number: M020
ThinkBaby SPF 30	ZINC OXIDE	thinkOperations,LLC	06862b00-c937-41af-ab5d-cea34160d035	2026-04-09	Warnings	Exact identifier application number: M020
Nutricentials Day Dream Protective	HOMOSALATE, OCTISALATE, AVOBENZONE, AND OCTOCRYLENE	NSE Products, Inc.	4a376e93-85e8-40a5-8641-d3e3d11fdeea	2026-04-08	Warnings	Exact identifier application number: M020
AGE20S UV MINERAL PRIMING SUNSCREEN	ZINC OXIDE	Aekyung Industrial Co., Ltd.	43c1f70b-0664-40be-e063-6394a90a2b48	2026-04-08	Warnings	Exact identifier application number: M020
AGE20S SUNSCREEN DUO	ZINC OXIDE, AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Aekyung Industrial Co., Ltd.	4eef11cd-85a1-0e44-e063-6394a90a5d44	2026-04-08	Warnings	Exact identifier application number: M020
Neutrogena MINERAL UV TINT FACE DEEP SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	Acupac Packaging, Inc.	4ef430e8-cdc8-2897-e063-6394a90a3ac7	2026-04-08	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4X49Y0596W	OCTISALATE	118-60-5	OCTISALATE
G63QQF2NOX	AVOBENZONE	70356-09-1	AVOBENZONE
V06SV4M95S	HOMOSALATE	118-56-9	HOMOSALATE
5A68WGF6WM	OCTOCRYLENE	6197-30-4	OCTOCRYLENE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63354-355-54	63354035554	177 g in 1 BOTTLE (63354-355-54)	177 g	2026-01-06	2028-10-01	No	No	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
HAWAIIAN TROPIC - Edgewell Personal Care Brands, LLC	Edgewell Personal Care Brands, LLC	2026-01-06	HUMAN OTC DRUG LABEL	1

HAWAIIAN TROPIC

Reported adverse events (FAERS/openFDA)#

Additional Listing Data#

Active Ingredients#

openFDA label cross-check#

Related Records#

Related UNII Ingredients#

Packages#

Related DailyMed Labels#