DAY HYDRATOR

Product NDC: 57367-027
11-digit product format: 573670027
Labeler code: 57367
Product ID: 57367-027_de535765-6fa3-4715-9dcc-037f6dc80577
Type: HUMAN OTC DRUG
Nonproprietary name: OCTINOXATE and OCTISALATE and OXYBENZONE
Dosage form: LOTION
Route: TOPICAL
Labeler: 220 Laboratories Inc.
Application: part352
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2006-02-01
Marketing end: 0000-00-00
Substance: OCTINOXATE; OCTISALATE; OXYBENZONE
Active strength: 75 mg/g; mg/g; mg/g
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	57367-027		I	Inactivated by FDA		2026-11-02
excluded package	package	57367-027	57367-027-19	I	Inactivated by FDA		2026-11-02

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 · 44 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	57367-027-19	`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	57367-027-19	`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	57367-027-19	`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	57367-027-19	`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	57367-027-19	`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	57367-027-19	`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	57367-027-19	`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	57367-027-19	`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	57367-027-19	`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	57367-027-19	`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	57367-027-19	`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	57367-027-19	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	57367-027-19	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	57367-027-19	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	57367-027-19	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	57367-027-19	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	57367-027-19	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	57367-027-19	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	57367-027-19	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	57367-027-19	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	57367-027-19	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	57367-027-19	`110d247fa046…`	`a55b01930146…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
57367-027-19	2019-10-21	C162847	48780-1	956f9ecf-c26a-621f-e053-dbdaa90a74ad	DAY HYDRATOR SPF-15 ARTWORK

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
57367-027-18	DAY HYDRATORSPF-15	56 g in 1 TUBE	LOTION	56		2
57367-027-19	DAY HYDRATORSPF-15	1 in 1 CARTON	LOTION	1		2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	DAY HYDRATOR SPF-15 (OCTINOXATE AND OCTISALATE AND OXYBENZONE) LOTION [220 LABORATORIES INC.]	2
OCTISALATE	ACTIVE INGREDIENT	4X49Y0596W	DAY HYDRATOR SPF-15 (OCTINOXATE AND OCTISALATE AND OXYBENZONE) LOTION [220 LABORATORIES INC.]	2
OXYBENZONE	ACTIVE INGREDIENT	95OOS7VE0Y	DAY HYDRATOR SPF-15 (OCTINOXATE AND OCTISALATE AND OXYBENZONE) LOTION [220 LABORATORIES INC.]	2
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	DAY HYDRATOR SPF-15 (OCTINOXATE AND OCTISALATE AND OXYBENZONE) LOTION [220 LABORATORIES INC.]	2
OCTISALATE	ACTIVE MOIETY	4X49Y0596W	DAY HYDRATOR SPF-15 (OCTINOXATE AND OCTISALATE AND OXYBENZONE) LOTION [220 LABORATORIES INC.]	2
OXYBENZONE	ACTIVE MOIETY	95OOS7VE0Y	DAY HYDRATOR SPF-15 (OCTINOXATE AND OCTISALATE AND OXYBENZONE) LOTION [220 LABORATORIES INC.]	2
ALLANTOIN	INACTIVE INGREDIENT	344S277G0Z	DAY HYDRATOR SPF-15 (OCTINOXATE AND OCTISALATE AND OXYBENZONE) LOTION [220 LABORATORIES INC.]	2
BELLIS PERENNIS	INACTIVE INGREDIENT	2HU33I03UY	DAY HYDRATOR SPF-15 (OCTINOXATE AND OCTISALATE AND OXYBENZONE) LOTION [220 LABORATORIES INC.]	2
BUTYLENE GLYCOL	INACTIVE INGREDIENT	3XUS85K0RA	DAY HYDRATOR SPF-15 (OCTINOXATE AND OCTISALATE AND OXYBENZONE) LOTION [220 LABORATORIES INC.]	2
CALENDULA OFFICINALIS FLOWER	INACTIVE INGREDIENT	P0M7O4Y7YD	DAY HYDRATOR SPF-15 (OCTINOXATE AND OCTISALATE AND OXYBENZONE) LOTION [220 LABORATORIES INC.]	2
CAPRYLYL GLYCOL	INACTIVE INGREDIENT	00YIU5438U	DAY HYDRATOR SPF-15 (OCTINOXATE AND OCTISALATE AND OXYBENZONE) LOTION [220 LABORATORIES INC.]	2
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	DAY HYDRATOR SPF-15 (OCTINOXATE AND OCTISALATE AND OXYBENZONE) LOTION [220 LABORATORIES INC.]	2
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	DAY HYDRATOR SPF-15 (OCTINOXATE AND OCTISALATE AND OXYBENZONE) LOTION [220 LABORATORIES INC.]	2
EDETATE SODIUM	INACTIVE INGREDIENT	MP1J8420LU	DAY HYDRATOR SPF-15 (OCTINOXATE AND OCTISALATE AND OXYBENZONE) LOTION [220 LABORATORIES INC.]	2
ETHYLHEXYL PALMITATE	INACTIVE INGREDIENT	2865993309	DAY HYDRATOR SPF-15 (OCTINOXATE AND OCTISALATE AND OXYBENZONE) LOTION [220 LABORATORIES INC.]	2
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	DAY HYDRATOR SPF-15 (OCTINOXATE AND OCTISALATE AND OXYBENZONE) LOTION [220 LABORATORIES INC.]	2
GREEN TEA LEAF	INACTIVE INGREDIENT	W2ZU1RY8B0	DAY HYDRATOR SPF-15 (OCTINOXATE AND OCTISALATE AND OXYBENZONE) LOTION [220 LABORATORIES INC.]	2
HELIANTHUS ANNUUS	INACTIVE INGREDIENT	BKJ0J3D1BP	DAY HYDRATOR SPF-15 (OCTINOXATE AND OCTISALATE AND OXYBENZONE) LOTION [220 LABORATORIES INC.]	2
HEXYLENE GLYCOL	INACTIVE INGREDIENT	KEH0A3F75J	DAY HYDRATOR SPF-15 (OCTINOXATE AND OCTISALATE AND OXYBENZONE) LOTION [220 LABORATORIES INC.]	2
HIBISCUS SABDARIFFA CALYX	INACTIVE INGREDIENT	584J2XT260	DAY HYDRATOR SPF-15 (OCTINOXATE AND OCTISALATE AND OXYBENZONE) LOTION [220 LABORATORIES INC.]	2
HONEY	INACTIVE INGREDIENT	Y9H1V576FH	DAY HYDRATOR SPF-15 (OCTINOXATE AND OCTISALATE AND OXYBENZONE) LOTION [220 LABORATORIES INC.]	2
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)	INACTIVE INGREDIENT	S38J6RZN16	DAY HYDRATOR SPF-15 (OCTINOXATE AND OCTISALATE AND OXYBENZONE) LOTION [220 LABORATORIES INC.]	2
JASMINE	INACTIVE INGREDIENT	0Q8K841432	DAY HYDRATOR SPF-15 (OCTINOXATE AND OCTISALATE AND OXYBENZONE) LOTION [220 LABORATORIES INC.]	2
LAVENDER	INACTIVE INGREDIENT	9YT4B71U8P	DAY HYDRATOR SPF-15 (OCTINOXATE AND OCTISALATE AND OXYBENZONE) LOTION [220 LABORATORIES INC.]	2
MYRISTYL LAURATE	INACTIVE INGREDIENT	58U0NZN2BT	DAY HYDRATOR SPF-15 (OCTINOXATE AND OCTISALATE AND OXYBENZONE) LOTION [220 LABORATORIES INC.]	2
MYRISTYL MYRISTATE	INACTIVE INGREDIENT	4042ZC00DY	DAY HYDRATOR SPF-15 (OCTINOXATE AND OCTISALATE AND OXYBENZONE) LOTION [220 LABORATORIES INC.]	2
ORANGE OIL	INACTIVE INGREDIENT	AKN3KSD11B	DAY HYDRATOR SPF-15 (OCTINOXATE AND OCTISALATE AND OXYBENZONE) LOTION [220 LABORATORIES INC.]	2
PANTHENOL	INACTIVE INGREDIENT	WV9CM0O67Z	DAY HYDRATOR SPF-15 (OCTINOXATE AND OCTISALATE AND OXYBENZONE) LOTION [220 LABORATORIES INC.]	2
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	DAY HYDRATOR SPF-15 (OCTINOXATE AND OCTISALATE AND OXYBENZONE) LOTION [220 LABORATORIES INC.]	2
POLYOXYL 100 STEARATE	INACTIVE INGREDIENT	YD01N1999R	DAY HYDRATOR SPF-15 (OCTINOXATE AND OCTISALATE AND OXYBENZONE) LOTION [220 LABORATORIES INC.]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	DAY HYDRATOR SPF-15 (OCTINOXATE AND OCTISALATE AND OXYBENZONE) LOTION [220 LABORATORIES INC.]	2
ROSA CANINA FRUIT	INACTIVE INGREDIENT	3TNW8D08V3	DAY HYDRATOR SPF-15 (OCTINOXATE AND OCTISALATE AND OXYBENZONE) LOTION [220 LABORATORIES INC.]	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	DAY HYDRATOR SPF-15 (OCTINOXATE AND OCTISALATE AND OXYBENZONE) LOTION [220 LABORATORIES INC.]	2
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	DAY HYDRATOR SPF-15 (OCTINOXATE AND OCTISALATE AND OXYBENZONE) LOTION [220 LABORATORIES INC.]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	DAY HYDRATOR SPF-15 (OCTINOXATE AND OCTISALATE AND OXYBENZONE) LOTION [220 LABORATORIES INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57367-027	DAY HYDRATOR SPF-15 (OCTINOXATE AND OCTISALATE AND OXYBENZONE) LOTION [220 LABORATORIES INC.]	2	Legacy NDC, 2 package rows	20100511_23a8e7af-802b-48a0-93b9-a3665a12254b.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4Y5P7MUD51	OCTINOXATE	83834-59-7	OCTINOXATE
4X49Y0596W	OCTISALATE	118-60-5	OCTISALATE
95OOS7VE0Y	OXYBENZONE	131-57-7	OXYBENZONE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
57367-027-18	57367002718	56 g in 1 TUBE	56 g	Historical
57367-027-19	57367002719	1 in 1 CARTON		Historical