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 93 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Olay Age Defying Classic Daily Renewal Broad Spectrum SPF 15	OCTINOXATE AND ZINC OXIDE	The Procter & Gamble Manufacturing Company	60183a47-fd02-052b-e053-2991aa0a1b5c	2025-12-31	Warnings	Exact identifier application number: M020
Native Mineral Sunscreen Broad Spectrum SPF 30 Sweet Peach and Nectar	ZINC OXIDE	The Procter & Gamble Manufacturing Company	026dcaee-d33c-b874-e063-6394a90ad2e7	2025-12-31	Warnings	Exact identifier application number: M020
Radiant Glow Illuminating BB Cream Sunscreen SPF 30 - Tan	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	Pur-lisse Beauty, LLC	4745ab56-abaa-42de-e063-6394a90a6310	2025-12-31	Warnings	Exact identifier application number: M020
Olay Complete Plus Daily Facial Moisturizer with Sunscreen Broad Spectrum SPF 40	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	The Procter & Gamble Manufacturing Company	22f645cf-5182-9e3f-e063-6394a90adc84	2025-12-31	Warnings	Exact identifier application number: M020
Native Mineral Sunscreen Broad Spectrum SPF 30 Tropical Breeze	ZINC OXIDE	The Procter & Gamble Manufacturing Company	232032b7-803f-40ec-e063-6394a90a4b38	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Sport Sunscreen SPF 100	AVOBENZONE 3%, HOMOSALATE 15%, OCTINOXATE 2% OCTISALATE 5%, OCTOCRYLENE 10%, OXYBENZONE 6%	Beiersdorf Inc	e1a9a831-a0b9-17ba-e053-2a95a90a3fa7	2025-12-31	Warnings	Exact identifier application number: M020
Radiant Glow Illuminating BB Cream Sunscreen SPF 30 - Tan Deep	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	Pur-lisse Beauty, LLC	4745ebec-acb0-77c4-e063-6394a90aee07	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Pure and Simple Baby Sunscreen SPF 50	ZINC OXIDE 24.08%	Beiersdorf Inc	08134b95-1879-27e5-e063-6294a90a29af	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Oil Free SPF 50 Sunscreen	AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 4.5%, OCTOCRYLENE 8%	Beiersdorf Inc	ded1f158-36d1-153f-e053-2995a90ace30	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Pure and Simple Kids Suncreen SPF 50	ZINC OXIDE 24.08%	Beiersdorf Inc	08147940-0e8b-c894-e063-6394a90af8ac	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Sport Sunscreen SPF 70	AVOBENZONE 3%, HOMOSALATE 13%, OCTISALATE 5%, OCTOCRYLENE 10%, OXYBENZONE 6%	Beiersdorf Inc	e468d703-fa6c-095a-e053-2a95a90a5194	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Waterbabies Pure and Simple Sunscreen SPF 50	ZINC OXIDE 24.08%	Beiersdorf Inc	0806bdb9-961f-3146-e063-6294a90a4625	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Sport Sunscreen SPL 15	AVOBENZONE 2%, HOMOSALATE 5%, OCTISALATE 4.5%, OCTOCRYLENE 3%	Beiersdorf Inc	df4b522e-93d4-1284-e053-2a95a90a1cd9	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Pure and Simple Baby Sunscreen SPF 50	ZINC OXIDE 24.08%	Beiersdorf Inc	088b7152-d3d1-9e74-e063-6394a90a4152	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Sport Sunscreen SPF 50	(TO DELIVER) AVOBENZONE 3%, HOMOSALATE 10%,OCTISALATE 5%, OCTOCRYLENE 5%	Beiersdorf Inc	0a5a40ff-a014-3995-e063-6394a90a11e6	2025-12-31	Warnings	Exact identifier application number: M020
Radiant Glow Illuminating BB Cream Sunscreen SPF 30 - Deep	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	Pur-lisse Beauty, LLC	47461ad3-a11e-2a11-e063-6294a90a0f8f	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Oil Free Sunscreen SPF 30	AVOBENZONE 3%, HOMOSALATE 8%, OCTISALATE 4.5%, OCTOCRYLENE 6%	Beiersdorf Inc	e451ecfb-cf17-c622-e053-2a95a90a4d4b	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Pure and Simple Sunscreen SPF 50	ZINC OXIDE 24.08%	Beiersdorf Inc	081484f8-58f5-f2a4-e063-6394a90a3379	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Pure and Simple Kids Sunscreen SPF 50	ZINC OXIDE (24.08%)	Beiersdorf Inc	09a97e3f-f6dc-eaa7-e063-6294a90ad274	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Kids Roll-On Sunscreen SPF 50	ZINC OXIDE 24.08%	Beiersdorf Inc	f3e1ea21-4a07-3e18-e053-2995a90a0fe7	2025-12-31	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