EAD

Product NDC: 63049-102
11-digit product format: 630490102
Labeler code: 63049
Product ID: 63049-102_0deaeb50-176d-4b16-b4a0-c2f9fcec093a
Type: HUMAN OTC DRUG
Nonproprietary name: Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone
Dosage form: LOTION
Route: TOPICAL
Labeler: EUROPEAN PERFUME WORKS CO. LLC
Application: part352
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2014-03-18
Marketing end: 0000-00-00
Substance: AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE
Active strength: 2 g/120mL; g/120mL; g/120mL; g/120mL; g/120mL
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	63049-102		D	Discontinued by firm	2026-10-05
excluded package	package	63049-102	63049-102-23	D	Discontinued by firm	2026-10-05
excluded package	package	63049-102	63049-102-25	D	Discontinued by firm	2026-10-05

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 1 · 36 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	63049-102-25	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63049-102-23	`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	63049-102-25	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63049-102-23	`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	63049-102-25	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63049-102-23	`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	63049-102-25	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63049-102-23	`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	63049-102-25	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63049-102-23	`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	63049-102-25	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63049-102-23	`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	63049-102-25	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63049-102-23	`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	63049-102-25	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63049-102-23	`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	63049-102-25	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63049-102-23	`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	63049-102-25	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63049-102-23	`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	63049-102-25	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63049-102-23	`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	63049-102-25	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63049-102-23	`557ba5c1ecfa…`	`9c80585c8c6e…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AVOBENZONE	ACTIVE INGREDIENT	G63QQF2NOX	EAD (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C]	5
HOMOSALATE	ACTIVE INGREDIENT	V06SV4M95S	EAD (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C]	5
OCTISALATE	ACTIVE INGREDIENT	4X49Y0596W	EAD (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C]	5
OCTOCRYLENE	ACTIVE INGREDIENT	5A68WGF6WM	EAD (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C]	5
OXYBENZONE	ACTIVE INGREDIENT	95OOS7VE0Y	EAD (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C]	5
AVOBENZONE	ACTIVE MOIETY	G63QQF2NOX	EAD (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C]	5
HOMOSALATE	ACTIVE MOIETY	V06SV4M95S	EAD (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C]	5
OCTISALATE	ACTIVE MOIETY	4X49Y0596W	EAD (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C]	5
OCTOCRYLENE	ACTIVE MOIETY	5A68WGF6WM	EAD (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C]	5
OXYBENZONE	ACTIVE MOIETY	95OOS7VE0Y	EAD (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C]	5
.ALPHA.-AMYLCINNAMALDEHYDE	INACTIVE INGREDIENT	WC51CA3418	EAD (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C]	5
ALPHA-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	EAD (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C]	5
ASCORBYL PALMITATE	INACTIVE INGREDIENT	QN83US2B0N	EAD (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C]	5
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	EAD (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C]	5
BUTYLPARABEN	INACTIVE INGREDIENT	3QPI1U3FV8	EAD (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C]	5
C12-15 ALKYL BENZOATE	INACTIVE INGREDIENT	A9EJ3J61HQ	EAD (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C]	5
CARBOMER 934	INACTIVE INGREDIENT	Z135WT9208	EAD (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C]	5
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	EAD (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C]	5
EDETATE SODIUM	INACTIVE INGREDIENT	MP1J8420LU	EAD (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C]	5
ETHYLPARABEN	INACTIVE INGREDIENT	14255EXE39	EAD (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C]	5
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	EAD (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C]	5
GLYCERYL STEARATE SE	INACTIVE INGREDIENT	FCZ5MH785I	EAD (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C]	5
ISOBUTYLPARABEN	INACTIVE INGREDIENT	0QQJ25X58G	EAD (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C]	5
LINALOOL, (+/-)-	INACTIVE INGREDIENT	D81QY6I88E	EAD (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C]	5
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	EAD (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C]	5
PEG-100 STEARATE	INACTIVE INGREDIENT	YD01N1999R	EAD (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C]	5
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	EAD (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C]	5
POLYOXYL 20 CETOSTEARYL ETHER	INACTIVE INGREDIENT	YRC528SWUY	EAD (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C]	5
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	EAD (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C]	5
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	EAD (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C]	5
SODIUM CETOSTEARYL SULFATE	INACTIVE INGREDIENT	7ZBS06BH4B	EAD (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C]	5
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	EAD (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C]	5
WATER	INACTIVE INGREDIENT	059QF0KO0R	EAD (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C]	5

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
G63QQF2NOX	AVOBENZONE	70356-09-1	AVOBENZONE
V06SV4M95S	HOMOSALATE	118-56-9	HOMOSALATE
4X49Y0596W	OCTISALATE	118-60-5	OCTISALATE
5A68WGF6WM	OCTOCRYLENE	6197-30-4	OCTOCRYLENE
95OOS7VE0Y	OXYBENZONE	131-57-7	OXYBENZONE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63049-102-23	63049010223	120 mL in 1 TUBE (63049-102-23)	120 ml	2014-03-18	0000-00-00	No	No	Current
63049-102-25	63049010225	95 mL in 1 TUBE (63049-102-25)	95 ml	2015-11-12	0000-00-00	No	No	Current

EAD

NDC auxiliary status#

Observed NDC auxiliary status history#

Reported adverse events (FAERS/openFDA)#

DailyMed Socrata Ingredients#

Related Records#

Related UNII Ingredients#

Packages#

Related DailyMed Labels#