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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
31d01fae-4085-d84a-e063-6294a90ab981	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
baf7f49c-75b6-496b-a00e-8e766a8e4f03	Product name	1	20210127
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
ebc62596-fc97-4d03-9483-7ba095d25db7	Product name	1	20151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
1681bc73-b05f-12c3-1075-382ae39f449c	Product name	1	20140508

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 318 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CCC Clean Corrective with Vitamin C Tinted Moisturizer Broad Spectrum SPF 30	ZINC OXIDE	The Honest Company, Inc.	c172d584-7cb6-a078-e053-2995a90ac78f	2023-12-05	Warnings	Exact identifier application number: M020
EltaMD UV Sheer	ZINC OXIDE AND OCTOCRYLENE SUNSCREEN	CP Skin Health Group, Inc.	2564e811-70f5-4d00-be8e-686b55e31630	2023-12-05	Warnings	Exact identifier application number: M020
CCC Clean Corrective with Vitamin C Tinted Moisturizer Broad Spectrum SPF 30	ZINC OXIDE, TITANIUM DIOXIDE	The Honest Company, Inc.	c1720cff-a897-68cb-e053-2995a90a30b6	2023-12-05	Warnings	Exact identifier application number: M020
CCC Clean Corrective with Vitamin C Tinted Moisturizer Broad Spectrum SPF 30	ZINC OXIDE, TITANIUM DIOXIDE	The Honest Company, Inc.	c12272c3-d4ed-2212-e053-2995a90add37	2023-12-05	Warnings	Exact identifier application number: M020
CCC Clean Corrective with Vitamin C Tinted Moisturizer Broad Spectrum SPF 30	ZINC OXIDE, TITANIUM DIOXIDE	The Honest Company, Inc.	c12272c3-d4f0-2212-e053-2995a90add37	2023-12-05	Warnings	Exact identifier application number: M020
CCC Clean Corrective with Vitamin C Tinted Moisturizer Broad Spectrum SPF 30	ZINC OXIDE, TITANIUM DIOXIDE	The Honest Company, Inc.	c1228ca6-8fb4-5964-e053-2a95a90a30ca	2023-12-05	Warnings	Exact identifier application number: M020
CCC Clean Corrective with Vitamin C Tinted Moisturizer Broad Spectrum SPF 30	ZINC OXIDE, TITANIUM DIOXIDE	The Honest Company, Inc.	c12292a8-c98f-eb27-e053-2a95a90a9bbc	2023-12-05	Warnings	Exact identifier application number: M020
CCC Clean Corrective with Vitamin C Tinted Moisturizer Broad Spectrum SPF 30	ZINC OXIDE	The Honest Company, Inc.	c172d22a-0315-8e84-e053-2995a90a30b5	2023-12-05	Warnings	Exact identifier application number: M020
CCC Clean Corrective with Vitamin C Tinted Moisturizer Broad Spectrum SPF 30	ZINC OXIDE	The Honest Company, Inc.	c172cabe-faab-6458-e053-2995a90aef66	2023-12-05	Warnings	Exact identifier application number: M020
Sea Clearly Translucent Gel Sunscreen BS SPF 50	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	Allure Labs	0bb4ec66-64ba-9583-e063-6394a90ac512	2023-12-04	Warnings	Exact identifier application number: M020
Clearly Zinq Mineral Gel Sunscreen BS SPF 60	ZINC OXIDE	Allure Labs	0bb7f0a4-13df-7734-e063-6294a90a242b	2023-12-04	Warnings	Exact identifier application number: M020
RECHARGE Regimen for Balancing, Boosting and Defending Healthy-Looking skin	TITANIUM DIOXIDE, ZINC OXIDE	Rodan & Fields	b7401ff8-ca47-4c74-813c-99c5f28c0b6d	2023-12-04	Warnings	Exact identifier application number: M020
Eminence Bright Skin Moisturizer SPF 40 Sunscreen	ZINC OXIDE	Eminence Organic Skin Care	4f2ba93d-ec19-40c1-b4ca-53898841f55b	2023-12-02	Warnings	Exact identifier application number: M020
Lilikoi Mineral Defense Sport Sunscreen SPF 30	ZINC OXIDE	Eminence Organic Skin Care Ltd.	5375522a-17e3-48a1-8248-dd811c3823bf	2023-12-02	Warnings	Exact identifier application number: M020
Eminence Lilikoi Daily Defense Moisturizer SPF 40 Sunscreen	ZINC OXIDE	Eminence Organic Skin Care	edc9972a-affd-4099-aec1-3549a07fa83c	2023-12-02	Warnings	Exact identifier application number: M020
Perbelle CC SPF43 UVA UVB Broad Spectrum	TITANIUM DIOXIDE	Perbelle Cosmetics Global Ltd.	b5e2724e-9806-5bcc-e053-2a95a90a0508	2023-12-01	Warnings	Exact identifier application number: M020
A PERFECT WORLD SPF 40 AGE DEFENSE BROAD SPECTRUM MOISTURIZER WITH WHITE TEA	AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, AND OCTOCRYLENE	ORIGINS NATURAL RESOURCES INC.	abd8b302-a01c-478d-919a-22e686cb88da	2023-12-01	Warnings	Exact identifier application number: M020
SHADE and ILLUMINATE SOFT RAD PRMR SPF	OCTINOXATE,OCTISALATE,ZINC OXIDE	TOM FORD BEAUTY DIST	eac7d416-c243-4647-e053-2a95a90abcb7	2023-12-01	Warnings	Exact identifier application number: M020
CCC Clean Corrective with Vitamin C Tinted Moisturizer Broad Spectrum SPF 30	ZINC OXIDE, TITANIUM DIOXIDE	The Honest Company, Inc.	c1228d15-a157-6989-e053-2995a90a44ea	2023-12-01	Warnings	Exact identifier application number: M020
CAO Cosmetic Lip Sunscreen SPF 30	AVOBENZONE, OCTOCRYLENE	S & J INTERNATIONAL ENTERPRISES PUBLIC COMPANY LIMITED	d912b9e9-f351-e2b0-e053-2a95a90a9ca2	2023-11-30	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
5A68WGF6WM	OCTOCRYLENE	6197-30-4	OCTOCRYLENE

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
HAWAIIAN TROPIC - Edgewell Personal Care Brands LLC	Edgewell Personal Care Brands LLC	2025-09-28	HUMAN OTC DRUG LABEL	2