JOURNEE

Product NDC: 52318-002
11-digit product format: 523180002
Labeler code: 52318
Product ID: 52318-002_60eff1e9-f41c-1fc4-e053-2991aa0abdf0
Type: HUMAN OTC DRUG
Nonproprietary name: OCTINOXATE, ZINC OXIDE
Dosage form: CREAM
Route: TOPICAL
Labeler: Neocutis, Inc.
Application: part352
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2012-06-18
Marketing end: 0000-00-00
Substance: OCTINOXATE; ZINC OXIDE
Active strength: 75 mg/mL; mg/mL
NDC exclude flag: No
Listing certified through: 2019-12-31
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	52318-002		D	Discontinued by firm	2026-10-20
excluded package	package	52318-002	52318-002-01	D	Discontinued by firm	2026-10-20
excluded package	package	52318-002	52318-002-02	D	Discontinued by firm	2026-10-20
excluded package	package	52318-002	52318-002-03	D	Discontinued by firm	2026-10-20
excluded package	package	52318-002	52318-002-04	D	Discontinued by firm	2026-10-20

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 · 60 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	52318-002-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52318-002-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52318-002-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52318-002-01	`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	52318-002-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52318-002-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52318-002-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52318-002-01	`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	52318-002-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52318-002-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52318-002-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52318-002-01	`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	52318-002-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52318-002-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52318-002-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52318-002-01	`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	52318-002-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52318-002-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52318-002-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52318-002-01	`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	52318-002-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52318-002-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52318-002-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52318-002-01	`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	52318-002-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52318-002-04	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52318-002-03	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52318-002-01	`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	52318-002-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	52318-002-04	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	52318-002-03	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	52318-002-01	`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	52318-002-02	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	52318-002-04	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	52318-002-03	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	52318-002-01	`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	52318-002-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	52318-002-04	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	52318-002-03	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	52318-002-01	`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	52318-002-02	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	52318-002-04	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	52318-002-03	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	52318-002-01	`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	52318-002-02	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	52318-002-04	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	52318-002-03	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	52318-002-01	`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
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	JOURNEE (OCTINOXATE, ZINC OXIDE) CREAM [NEOCUTIS, INC.]	6
ZINC OXIDE	ACTIVE INGREDIENT	SOI2LOH54Z	JOURNEE (OCTINOXATE, ZINC OXIDE) CREAM [NEOCUTIS, INC.]	6
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	JOURNEE (OCTINOXATE, ZINC OXIDE) CREAM [NEOCUTIS, INC.]	6
ZINC OXIDE	ACTIVE MOIETY	SOI2LOH54Z	JOURNEE (OCTINOXATE, ZINC OXIDE) CREAM [NEOCUTIS, INC.]	6
ALPHA-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	JOURNEE (OCTINOXATE, ZINC OXIDE) CREAM [NEOCUTIS, INC.]	6
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	JOURNEE (OCTINOXATE, ZINC OXIDE) CREAM [NEOCUTIS, INC.]	6
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	JOURNEE (OCTINOXATE, ZINC OXIDE) CREAM [NEOCUTIS, INC.]	6
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	JOURNEE (OCTINOXATE, ZINC OXIDE) CREAM [NEOCUTIS, INC.]	6
ETHYLPARABEN	INACTIVE INGREDIENT	14255EXE39	JOURNEE (OCTINOXATE, ZINC OXIDE) CREAM [NEOCUTIS, INC.]	6
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	JOURNEE (OCTINOXATE, ZINC OXIDE) CREAM [NEOCUTIS, INC.]	6
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	JOURNEE (OCTINOXATE, ZINC OXIDE) CREAM [NEOCUTIS, INC.]	6
GREEN TEA LEAF	INACTIVE INGREDIENT	W2ZU1RY8B0	JOURNEE (OCTINOXATE, ZINC OXIDE) CREAM [NEOCUTIS, INC.]	6
HEXYLDECANOL	INACTIVE INGREDIENT	151Z7P1317	JOURNEE (OCTINOXATE, ZINC OXIDE) CREAM [NEOCUTIS, INC.]	6
HYALURONATE SODIUM	INACTIVE INGREDIENT	YSE9PPT4TH	JOURNEE (OCTINOXATE, ZINC OXIDE) CREAM [NEOCUTIS, INC.]	6
HYDROGENATED PALM GLYCERIDES	INACTIVE INGREDIENT	YCZ8EM144Q	JOURNEE (OCTINOXATE, ZINC OXIDE) CREAM [NEOCUTIS, INC.]	6
MEDIUM-CHAIN TRIGLYCERIDES	INACTIVE INGREDIENT	C9H2L21V7U	JOURNEE (OCTINOXATE, ZINC OXIDE) CREAM [NEOCUTIS, INC.]	6
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	JOURNEE (OCTINOXATE, ZINC OXIDE) CREAM [NEOCUTIS, INC.]	6
PEG-100 STEARATE	INACTIVE INGREDIENT	YD01N1999R	JOURNEE (OCTINOXATE, ZINC OXIDE) CREAM [NEOCUTIS, INC.]	6
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	JOURNEE (OCTINOXATE, ZINC OXIDE) CREAM [NEOCUTIS, INC.]	6
POLYSORBATE 60	INACTIVE INGREDIENT	CAL22UVI4M	JOURNEE (OCTINOXATE, ZINC OXIDE) CREAM [NEOCUTIS, INC.]	6
POTASSIUM CETYL PHOSPHATE	INACTIVE INGREDIENT	03KCY6P7UT	JOURNEE (OCTINOXATE, ZINC OXIDE) CREAM [NEOCUTIS, INC.]	6
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	JOURNEE (OCTINOXATE, ZINC OXIDE) CREAM [NEOCUTIS, INC.]	6
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	JOURNEE (OCTINOXATE, ZINC OXIDE) CREAM [NEOCUTIS, INC.]	6
SODIUM ASCORBYL PHOSPHATE	INACTIVE INGREDIENT	836SJG51DR	JOURNEE (OCTINOXATE, ZINC OXIDE) CREAM [NEOCUTIS, INC.]	6
SQUALANE	INACTIVE INGREDIENT	GW89575KF9	JOURNEE (OCTINOXATE, ZINC OXIDE) CREAM [NEOCUTIS, INC.]	6
STEARETH-21	INACTIVE INGREDIENT	53J3F32P58	JOURNEE (OCTINOXATE, ZINC OXIDE) CREAM [NEOCUTIS, INC.]	6
STYRENE	INACTIVE INGREDIENT	44LJ2U959V	JOURNEE (OCTINOXATE, ZINC OXIDE) CREAM [NEOCUTIS, INC.]	6
TRIETHOXYCAPRYLYLSILANE	INACTIVE INGREDIENT	LDC331P08E	JOURNEE (OCTINOXATE, ZINC OXIDE) CREAM [NEOCUTIS, INC.]	6
WATER	INACTIVE INGREDIENT	059QF0KO0R	JOURNEE (OCTINOXATE, ZINC OXIDE) CREAM [NEOCUTIS, INC.]	6
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	JOURNEE (OCTINOXATE, ZINC OXIDE) CREAM [NEOCUTIS, INC.]	6

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4Y5P7MUD51	OCTINOXATE	83834-59-7	OCTINOXATE
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
JOURNEE Bio-restorative Day Cream Broad Spectrum Sunscreen SPF 30	Neocutis, Inc.	2019-06-07	HUMAN OTC DRUG LABEL	8

JOURNEE

NDC auxiliary status#

Observed NDC auxiliary status history#

Reported adverse events (FAERS/openFDA)#

DailyMed Socrata Ingredients#

Related Records#

Related UNII Ingredients#

Related DailyMed Labels#