celazome

Product NDC: 58466-901
11-digit product format: 584660901
Labeler code: 58466
Product ID: 58466-901_586f453e-4b57-49b8-8139-91fa03099f92
Type: HUMAN OTC DRUG
Nonproprietary name: OXYBENZONE, OCTINOXATE, OCTISALATE, and HOMOSALATE
Dosage form: CREAM
Route: TOPICAL
Labeler: Dermazone LLC
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2015-10-01
Substance: OXYBENZONE; OCTINOXATE; OCTISALATE; HOMOSALATE
Active strength: 50; 75; 50; 50 mg/g; mg/g; mg/g; mg/g
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 26 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
2025-04-01 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	58466-901-04	`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	58466-901-04	`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	58466-901-04	`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	58466-901-04	`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	58466-901-04	`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	58466-901-04	`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	58466-901-04	`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	58466-901-04	`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	58466-901-04	`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	58466-901-04	`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	58466-901-04	`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	58466-901-04	`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	58466-901-04	`1332a3947898…`	`d4bfe170f9cd…`

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: celazome
Brand name suffix: Moisturizing SPF 30 Active
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OXYBENZONE	50 mg/g
OCTINOXATE	75 mg/g
OCTISALATE	50 mg/g
HOMOSALATE	50 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
95OOS7VE0Y	Internal UNII lookup
4Y5P7MUD51	Internal UNII lookup
4X49Y0596W	Internal UNII lookup
V06SV4M95S	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
5ec1510d-1465-4849-9e23-f16e11ff0e65	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
58466-901-04	2025-07-25	C162847	48780-1	1030e365-0eac-111a-e063-dadaa90a10e2	celazome ® Moisturizing SPF 30 Active
58466-901-04	2024-01-30	C162847	48780-1	1030e365-0eac-111a-e063-dadaa90a10e2	celazome ® Moisturizing SPF 30 Active

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
58466-901-04	celazomeMoisturizing SPF 30 Active	113 g in 1 BOTTLE, DISPENSING	CREAM	113		3
58466-901-04	celazomeMoisturizing SPF 30 Active	1 in 1 CARTON	CREAM	1		3

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HOMOSALATE	ACTIVE INGREDIENT	V06SV4M95S	CELAZOME MOISTURIZING SPF 30 ACTIVE (OXYBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [DERMAZONE SOLUTIONS, INC.]	1
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	CELAZOME MOISTURIZING SPF 30 ACTIVE (OXYBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [DERMAZONE SOLUTIONS, INC.]	1
OCTISALATE	ACTIVE INGREDIENT	4X49Y0596W	CELAZOME MOISTURIZING SPF 30 ACTIVE (OXYBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [DERMAZONE SOLUTIONS, INC.]	1
OXYBENZONE	ACTIVE INGREDIENT	95OOS7VE0Y	CELAZOME MOISTURIZING SPF 30 ACTIVE (OXYBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [DERMAZONE SOLUTIONS, INC.]	1
HOMOSALATE	ACTIVE MOIETY	V06SV4M95S	CELAZOME MOISTURIZING SPF 30 ACTIVE (OXYBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [DERMAZONE SOLUTIONS, INC.]	1
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	CELAZOME MOISTURIZING SPF 30 ACTIVE (OXYBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [DERMAZONE SOLUTIONS, INC.]	1
OCTISALATE	ACTIVE MOIETY	4X49Y0596W	CELAZOME MOISTURIZING SPF 30 ACTIVE (OXYBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [DERMAZONE SOLUTIONS, INC.]	1
OXYBENZONE	ACTIVE MOIETY	95OOS7VE0Y	CELAZOME MOISTURIZING SPF 30 ACTIVE (OXYBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [DERMAZONE SOLUTIONS, INC.]	1
.alpha.-tocopherol acetate	INACTIVE INGREDIENT	9E8X80D2L0	CELAZOME MOISTURIZING SPF 30 ACTIVE (OXYBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [DERMAZONE SOLUTIONS, INC.]	1
alcohol	INACTIVE INGREDIENT	3K9958V90M	CELAZOME MOISTURIZING SPF 30 ACTIVE (OXYBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [DERMAZONE SOLUTIONS, INC.]	1
aloe vera leaf	INACTIVE INGREDIENT	ZY81Z83H0X	CELAZOME MOISTURIZING SPF 30 ACTIVE (OXYBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [DERMAZONE SOLUTIONS, INC.]	1
cetyl alcohol	INACTIVE INGREDIENT	936JST6JCN	CELAZOME MOISTURIZING SPF 30 ACTIVE (OXYBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [DERMAZONE SOLUTIONS, INC.]	1
Diethanolamine Cetyl Phosphate	INACTIVE INGREDIENT	4UG0316V9S	CELAZOME MOISTURIZING SPF 30 ACTIVE (OXYBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [DERMAZONE SOLUTIONS, INC.]	1
dimethicone	INACTIVE INGREDIENT	92RU3N3Y1O	CELAZOME MOISTURIZING SPF 30 ACTIVE (OXYBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [DERMAZONE SOLUTIONS, INC.]	1
dioctyl maleate	INACTIVE INGREDIENT	OD88G8439L	CELAZOME MOISTURIZING SPF 30 ACTIVE (OXYBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [DERMAZONE SOLUTIONS, INC.]	1
methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	CELAZOME MOISTURIZING SPF 30 ACTIVE (OXYBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [DERMAZONE SOLUTIONS, INC.]	1
propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	CELAZOME MOISTURIZING SPF 30 ACTIVE (OXYBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [DERMAZONE SOLUTIONS, INC.]	1
sorbitol	INACTIVE INGREDIENT	506T60A25R	CELAZOME MOISTURIZING SPF 30 ACTIVE (OXYBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [DERMAZONE SOLUTIONS, INC.]	1
trolamine	INACTIVE INGREDIENT	9O3K93S3TK	CELAZOME MOISTURIZING SPF 30 ACTIVE (OXYBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [DERMAZONE SOLUTIONS, INC.]	1
water	INACTIVE INGREDIENT	059QF0KO0R	CELAZOME MOISTURIZING SPF 30 ACTIVE (OXYBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [DERMAZONE SOLUTIONS, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58466-901	CELAZOME MOISTURIZING SPF 30 ACTIVE (OXYBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [DERMAZONE SOLUTIONS, INC.]	2	Current NDC, Legacy NDC, 2 package rows	20181120_5ec1510d-1465-4849-9e23-f16e11ff0e65.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 15 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bath and Body Works SPF Coconut	AVOBENZONE,HOMOSALATE,OCTISALATE	Bath & Body Works, Inc.	56078491-f7d6-97f7-e063-6394a90a6deb	2026-07-07	Warnings	Exact identifier application number: M020
Natu Botanicals DAILY NATURAL SUNSCREEN SPF 35 Reef safe mineral sunscreen with non-nano zinc oxide	ZINC OXIDE	Surprise Enterprise LLC	38cf4325-9720-f511-e063-6394a90ad628	2026-07-07	Warnings	Exact identifier application number: M020
Sun Bum Road Tripper - Amazon - Coconut Lip Balm SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Bum, LLC	560c0f35-2132-52a6-e063-6394a90a2d24	2026-07-07	Warnings	Exact identifier application number: M020
Ciele lip and PROTECT lipstick SPF 60 Bonnie	CIELE LIP AND PROTECT LIPSTICK SPF 60 BONNIE	Delicate Cosmetics Inc	560d1d19-87a6-179b-e063-6294a90ada5e	2026-07-07	Warnings	Exact identifier application number: M020
Ciele lip and PROTECT lipstick SPF 60 Kelly	CIELE LIP AND PROTECT LIPSTICK SPF 60 KELLY	Delicate Cosmetics Inc	560df34a-e6da-0792-e063-6394a90a7e71	2026-07-07	Warnings	Exact identifier application number: M020
Ciele lip and PROTECT lipstick SPF 60 LouLou	CIELE LIP AND PROTECT LIPSTICK SPF 60 LOULOU	Delicate Cosmetics Inc	560e37ae-87c0-39d2-e063-6394a90a2af4	2026-07-07	Warnings	Exact identifier application number: M020
Ciele lip and PROTECT lipstick SPF 60 Cassette	CIELE LIP AND PROTECT LIPSTICK SPF 60 CASSETTE	Delicate Cosmetics Inc	560e4198-b07c-3d48-e063-6394a90a7be3	2026-07-07	Warnings	Exact identifier application number: M020
Ciele lip and PROTECT lipstick SPF 60 Margaux	CIELE LIP AND PROTECT LIPSTICK SPF 60 MARGAUX	Delicate Cosmetics Inc	560e47d5-c881-438c-e063-6394a90a3091	2026-07-07	Warnings	Exact identifier application number: M020
Ciele lip and PROTECT lipstick SPF 60 Saddle	CIELE LIP AND PROTECT LIPSTICK SPF 60 SADDLE	Delicate Cosmetics Inc	560e5de5-1350-4046-e063-6394a90abffa	2026-07-07	Warnings	Exact identifier application number: M020
Ciele lip and PROTECT lipstick SPF 60 Puzzle	CIELE LIP AND PROTECT LIPSTICK SPF 60 PUZZLE	Delicate Cosmetics Inc	560e5558-8e46-7736-e063-6294a90acb05	2026-07-07	Warnings	Exact identifier application number: M020
EELHOE Body Coverage Perfector	TITANIUM DIOXIDE	Shantou Eelhoe Daily Chemical Technology Co., Ltd.	5610c3b7-456b-3bc1-e063-6394a90a3fa8	2026-07-07	Warnings	Exact identifier application number: M020
Sunscreen SPF 50	AVOBENZONE 3% HOMOSALATE 10% OCTOCRYLENE 5%	Worthy Promotional Products	1d4be26a-4695-491c-85d1-86824e1cd029	2026-07-06	Warnings	Exact identifier application number: M020
SPF 30 Sunscreen	HOMOSALATE 10% OCTISALATE 5% AVOBENZONE 3%	Coconut Caliente Costa Rica LLC	71856cb3-9386-4569-80e4-92826342e386	2026-07-06	Warnings	Exact identifier application number: M020
Stay Ageless Sunscreen	BROAD SPECTRUM SPF 30	TOXFAIRY, LLC	55f7e07e-1689-6d38-e063-6294a90a9119	2026-07-06	Warnings	Exact identifier application number: M020
Premier Tinted Mineral Sunscreen	BROAD SPECTRUM SPF30	Emerald Aesthetics LLC	55f88dd1-346c-22a5-e063-6294a90a711f	2026-07-06	Warnings	Exact identifier application number: M020
RR Sun	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE	Undefined Inc	87244432-2967-4145-89cd-11a7567083a3	2026-07-06	Warnings	Exact identifier application number: M020
TOCOBO Cotton Airy Sun Stick	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	PICTON CO., Ltd.	35af90d3-dfe1-30dc-e063-6294a90a10a5	2026-07-05	Warnings	Exact identifier application number: M020
MDP PEPTIDE 9 BIO SUN PRO	HOMOSALATE, OCTOCRYLENE, ETHYLHEXYL SALICYLATE, BUTYL METHOXYDIBENZOYLMETHANE	SKINIDEA CO., LTD	26db53cd-dd82-8790-e063-6394a90a92b1	2026-07-03	Warnings	Exact identifier application number: M020
SPF 50 plus Sunscreen	TITANIUM DIOXIDE AND ZINC OXIDE	Theravita LLC	d8e276cc-0292-499d-9075-a83a2d3fafcc	2026-07-02	Warnings	Exact identifier application number: M020
Sport Sunscreen SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE	The Kroger Co.	5880b275-91fc-4589-a076-0e55409425d8	2026-07-02	Warnings, Adverse reactions	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
95OOS7VE0Y	OXYBENZONE	131-57-7	OXYBENZONE
4Y5P7MUD51	OCTINOXATE	83834-59-7	OCTINOXATE
4X49Y0596W	OCTISALATE	118-60-5	OCTISALATE
V06SV4M95S	HOMOSALATE	118-56-9	HOMOSALATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
58466-901-04	58466090104	1 BOTTLE, DISPENSING in 1 CARTON (58466-901-04) / 113 g in 1 BOTTLE, DISPENSING	2015-10-01	0000-00-00	No	No	Current