Hawaiian Tropic

Product NDC: 63354-432
11-digit product format: 633540432
Labeler code: 63354
Product ID: 63354-432_a862de42-1972-3e88-e053-2995a90a3012
Type: HUMAN OTC DRUG
Nonproprietary name: AVOBENZONE OCTOCRYLENE OXYBENZONE
Dosage form: LOTION
Route: TOPICAL
Labeler: Edgewell Personal Care Brands LLC
Application: part352
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2015-03-16
Marketing end: 0000-00-00
Substance: OXYBENZONE; OCTOCRYLENE; AVOBENZONE
Active strength: 3 g/100g; g/100g; g/100g
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	63354-432		D	Discontinued by firm	2026-10-12
excluded package	package	63354-432	63354-432-01	D	Discontinued by firm	2026-10-12
excluded package	package	63354-432	63354-432-11	D	Discontinued by firm	2026-10-12
excluded package	package	63354-432	63354-432-56	D	Discontinued by firm	2026-10-12
excluded package	package	63354-432	63354-432-57	D	Discontinued by firm	2026-10-12

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 2 · 75 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63354-432-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63354-432-56	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63354-432-11	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63354-432-57	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63354-432-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63354-432-56	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63354-432-11	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63354-432-57	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63354-432-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63354-432-56	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63354-432-11	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63354-432-57	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63354-432-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63354-432-56	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63354-432-11	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63354-432-57	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63354-432-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63354-432-56	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63354-432-11	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63354-432-57	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63354-432-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63354-432-56	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63354-432-11	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63354-432-57	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63354-432-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63354-432-56	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63354-432-11	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63354-432-57	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63354-432-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63354-432-56	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63354-432-11	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63354-432-57	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63354-432-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63354-432-56	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63354-432-11	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63354-432-57	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63354-432-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63354-432-56	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63354-432-11	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63354-432-57	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63354-432-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63354-432-56	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63354-432-11	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63354-432-57	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63354-432-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63354-432-56	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63354-432-11	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63354-432-57	`557ba5c1ecfa…`	`9c80585c8c6e…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
63354-432-01	2023-11-28	1168150f-74b0-6ca1-e054-00144ff8d46c
63354-432-11	2023-11-28	1168150f-74b0-6ca1-e054-00144ff8d46c
63354-432-56	2023-11-28	1168150f-74b0-6ca1-e054-00144ff8d46c
63354-432-57	2023-11-28	1168150f-74b0-6ca1-e054-00144ff8d46c
63354-432-01	2022-01-28	1168150f-74b0-6ca1-e054-00144ff8d46c
63354-432-11	2022-01-28	1168150f-74b0-6ca1-e054-00144ff8d46c
63354-432-56	2022-01-28	1168150f-74b0-6ca1-e054-00144ff8d46c
63354-432-57	2022-01-28	1168150f-74b0-6ca1-e054-00144ff8d46c

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AVOBENZONE	ACTIVE INGREDIENT	G63QQF2NOX	HAWAIIAN TROPIC (AVOBENZONE OCTOCRYLENE OXYBENZONE) LOTION [ENERGIZER PERSONAL CARE LLC]	1
OCTOCRYLENE	ACTIVE INGREDIENT	5A68WGF6WM	HAWAIIAN TROPIC (AVOBENZONE OCTOCRYLENE OXYBENZONE) LOTION [ENERGIZER PERSONAL CARE LLC]	1
OXYBENZONE	ACTIVE INGREDIENT	95OOS7VE0Y	HAWAIIAN TROPIC (AVOBENZONE OCTOCRYLENE OXYBENZONE) LOTION [ENERGIZER PERSONAL CARE LLC]	1
AVOBENZONE	ACTIVE MOIETY	G63QQF2NOX	HAWAIIAN TROPIC (AVOBENZONE OCTOCRYLENE OXYBENZONE) LOTION [ENERGIZER PERSONAL CARE LLC]	1
OCTOCRYLENE	ACTIVE MOIETY	5A68WGF6WM	HAWAIIAN TROPIC (AVOBENZONE OCTOCRYLENE OXYBENZONE) LOTION [ENERGIZER PERSONAL CARE LLC]	1
OXYBENZONE	ACTIVE MOIETY	95OOS7VE0Y	HAWAIIAN TROPIC (AVOBENZONE OCTOCRYLENE OXYBENZONE) LOTION [ENERGIZER PERSONAL CARE LLC]	1
2-ETHYLHEXYL BENZOATE	INACTIVE INGREDIENT	R63ZWW1A13	HAWAIIAN TROPIC (AVOBENZONE OCTOCRYLENE OXYBENZONE) LOTION [ENERGIZER PERSONAL CARE LLC]	1
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	HAWAIIAN TROPIC (AVOBENZONE OCTOCRYLENE OXYBENZONE) LOTION [ENERGIZER PERSONAL CARE LLC]	1
BUTYLOCTYL SALICYLATE	INACTIVE INGREDIENT	2EH13UN8D3	HAWAIIAN TROPIC (AVOBENZONE OCTOCRYLENE OXYBENZONE) LOTION [ENERGIZER PERSONAL CARE LLC]	1
CAPRYLYL GLYCOL	INACTIVE INGREDIENT	00YIU5438U	HAWAIIAN TROPIC (AVOBENZONE OCTOCRYLENE OXYBENZONE) LOTION [ENERGIZER PERSONAL CARE LLC]	1
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	HAWAIIAN TROPIC (AVOBENZONE OCTOCRYLENE OXYBENZONE) LOTION [ENERGIZER PERSONAL CARE LLC]	1
COCO GLUCOSIDE	INACTIVE INGREDIENT	ICS790225B	HAWAIIAN TROPIC (AVOBENZONE OCTOCRYLENE OXYBENZONE) LOTION [ENERGIZER PERSONAL CARE LLC]	1
DIHEXADECYL PHOSPHATE	INACTIVE INGREDIENT	2V6E5WN99N	HAWAIIAN TROPIC (AVOBENZONE OCTOCRYLENE OXYBENZONE) LOTION [ENERGIZER PERSONAL CARE LLC]	1
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	HAWAIIAN TROPIC (AVOBENZONE OCTOCRYLENE OXYBENZONE) LOTION [ENERGIZER PERSONAL CARE LLC]	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	HAWAIIAN TROPIC (AVOBENZONE OCTOCRYLENE OXYBENZONE) LOTION [ENERGIZER PERSONAL CARE LLC]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	HAWAIIAN TROPIC (AVOBENZONE OCTOCRYLENE OXYBENZONE) LOTION [ENERGIZER PERSONAL CARE LLC]	1
MANGIFERA INDICA SEED BUTTER	INACTIVE INGREDIENT	4OXD9M35X2	HAWAIIAN TROPIC (AVOBENZONE OCTOCRYLENE OXYBENZONE) LOTION [ENERGIZER PERSONAL CARE LLC]	1
NEOPENTYL GLYCOL DIHEPTANOATE	INACTIVE INGREDIENT	5LKW3C543X	HAWAIIAN TROPIC (AVOBENZONE OCTOCRYLENE OXYBENZONE) LOTION [ENERGIZER PERSONAL CARE LLC]	1
PANTHENOL	INACTIVE INGREDIENT	WV9CM0O67Z	HAWAIIAN TROPIC (AVOBENZONE OCTOCRYLENE OXYBENZONE) LOTION [ENERGIZER PERSONAL CARE LLC]	1
PAPAYA	INACTIVE INGREDIENT	KU94FIY6JB	HAWAIIAN TROPIC (AVOBENZONE OCTOCRYLENE OXYBENZONE) LOTION [ENERGIZER PERSONAL CARE LLC]	1
PARAFFIN	INACTIVE INGREDIENT	I9O0E3H2ZE	HAWAIIAN TROPIC (AVOBENZONE OCTOCRYLENE OXYBENZONE) LOTION [ENERGIZER PERSONAL CARE LLC]	1
PHENETHYL BENZOATE	INACTIVE INGREDIENT	0C143929GK	HAWAIIAN TROPIC (AVOBENZONE OCTOCRYLENE OXYBENZONE) LOTION [ENERGIZER PERSONAL CARE LLC]	1
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	HAWAIIAN TROPIC (AVOBENZONE OCTOCRYLENE OXYBENZONE) LOTION [ENERGIZER PERSONAL CARE LLC]	1
SODIUM ASCORBYL PHOSPHATE	INACTIVE INGREDIENT	836SJG51DR	HAWAIIAN TROPIC (AVOBENZONE OCTOCRYLENE OXYBENZONE) LOTION [ENERGIZER PERSONAL CARE LLC]	1
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	HAWAIIAN TROPIC (AVOBENZONE OCTOCRYLENE OXYBENZONE) LOTION [ENERGIZER PERSONAL CARE LLC]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	HAWAIIAN TROPIC (AVOBENZONE OCTOCRYLENE OXYBENZONE) LOTION [ENERGIZER PERSONAL CARE LLC]	1

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
95OOS7VE0Y	OXYBENZONE	131-57-7	OXYBENZONE
5A68WGF6WM	OCTOCRYLENE	6197-30-4	OCTOCRYLENE
G63QQF2NOX	AVOBENZONE	70356-09-1	AVOBENZONE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63354-432-01	63354043201	8 g in 1 PACKET (63354-432-01)	8 g	2015-03-16	0000-00-00	No	No	Current
63354-432-11	63354043211	59 g in 1 BOTTLE (63354-432-11)	59 g	2015-03-16	0000-00-00	No	No	Current
63354-432-56	63354043256	236 g in 1 BOTTLE (63354-432-56)	236 g	2015-03-16	0000-00-00	No	No	Current
63354-432-57	63354043257	319 g in 1 BOTTLE (63354-432-57)	319 g	2016-03-01	0000-00-00	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	2020-06-18	HUMAN OTC DRUG LABEL	5