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 86 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ROE WELLNESS SPF 50 MINERAL	SPF 50 MINERAL POWDER	Aopline Biotechnology (Guangzhou) Co., Ltd.	47dc8155-4abb-4bb7-e063-6294a90af1ad	2026-01-08	Warnings	Exact identifier application number: M020
ALOHA MINERAL BLOCK-BRUSH ON MINERAL	SUNSCREEN SPF50	Aopline Biotechnology (Guangzhou) Co., Ltd.	47dd07aa-71b4-5d54-e063-6394a90a4127	2026-01-08	Warnings	Exact identifier application number: M020
SUNSCREEN SETTING SPRITZ, SPF 45	SUNSCREEN SETTING SPRAY	Aopline Biotechnology (Guangzhou) Co., Ltd.	47ddf752-cae2-313f-e063-6294a90a7e3a	2026-01-08	Warnings	Exact identifier application number: M020
St Moriz suncare face sunscreen spf50	OCTOCRYLENE, OCTISALATE , AVOBENZONE , HOMOSALATE	Aopline Biotechnology (Guangzhou) Co., Ltd.	47df072e-151f-eb30-e063-6294a90a4eeb	2026-01-08	Warnings	Exact identifier application number: M020
SUNSCREEN GLOWING	AVOBENZONE ,OCTISALATE ,OCTOCRYLENE , HOMOSALATE	Aopline Biotechnology (Guangzhou) Co., Ltd.	47df0de5-012a-c896-e063-6394a90a9cef	2026-01-08	Warnings	Exact identifier application number: M020
BANANA BOAT	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Edgewell Personal Care Brands LLC	616d35f6-63d2-3d26-e053-2991aa0a5b44	2026-01-08	Warnings	Exact identifier application number: M020
BANANA BOAT	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Edgewell Personal Care Brands LLC	616d35a1-a139-1974-e053-2a91aa0a20b6	2026-01-08	Warnings	Exact identifier application number: M020
PIPA SKIN CARE SUN-SATIONAL Mineral Sunscreen	SPF 30	EVI LABS	258b7b7c-a3f2-172c-e063-6394a90aec6a	2026-01-08	Warnings	Exact identifier application number: M020
DMK Ultrascreen Mineral Sunscreen	ZINC OXIDE	Danne Montague King	3f022275-c1e5-2704-e063-6294a90a4a81	2026-01-08	Warnings	Exact identifier application number: M020
Anhydrous SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	Owen Biosciences, Inc.	0cc8221d-5ec5-4abf-a4f5-ab06e8dcea68	2026-01-08	Warnings	Exact identifier application number: M020
Rejuvaskin Mineral Facial Sunscreen SPF 32 Sheer	REJUVASKIN MINERAL FACIAL SUNSCREEN SPF 32 SHEER	Atlantic Medical Products, LLC	47e5198e-7bf6-72a8-e063-6294a90a7ec5	2026-01-08	Warnings	Exact identifier application number: M020
inde wild SUN DEFENSE SPF 50 SUNSCREEN GLOW DROPS BROAD SPECTRUM	INDE WILD SUN DEFENSE GLOW DROPS	INDE WILD PRIVATE LIMITED	47e57407-2925-09ca-e063-6294a90a49ec	2026-01-08	Warnings	Exact identifier application number: M020
NIDA Invisible Fit Sunscreen	SUNSCREEN	Proso Corp	47ed3b62-45ef-b67a-e063-6294a90a317b	2026-01-08	Warnings	Exact identifier application number: M020
Organic Matters SPF 50 Sunscreen	ZINC OXIDE	Veganic SKN Limited	12f37c8d-07f0-3e75-e063-6294a90a2cdf	2026-01-08	Warnings	Exact identifier application number: M020
Ellegreen Sunscreen Broad Spectrum SPF50	ZINC OXIDE	Veganic SKN Limited	161a7209-10d8-928c-e063-6394a90a4139	2026-01-08	Warnings	Exact identifier application number: M020
Live Sunny Eco-zinc hydrating mineral sunscreen for body and face	ZINC OXIDE	Veganic SKN Limited	1a97169e-67be-3d25-e063-6294a90a3b88	2026-01-08	Warnings	Exact identifier application number: M020
Dr Loretta Universal Glow Daily Defense SPF 40	ZINC OXIDE	Dr. Loretta, LLC	1208d0f8-bb12-4574-b70e-3a76b11a64c7	2026-01-07	Warnings	Exact identifier application number: M020
Neutrogena Ultra Sheer Face Sunscreen SPF 60	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	KDC/One Development Corporation, Inc.	259f3fe3-2967-6c05-e063-6394a90a9e45	2026-01-07	Warnings	Exact identifier application number: M020
Hawaiian Blend Extreme Zinc SPF 30	ZINC OXIDE, TITANIUM DIOXIDE	The Islander Group	4084dd98-357f-4011-b0d4-db6536d2931f	2026-01-07	Warnings	Exact identifier application number: M020
Hawaiian Blend Extreme Zinc SPF 50	ZINC OXIDE, TITANIUM DIOXIDE	The Islander Group	9b4acc5e-fdaf-4fcb-83a9-69e430dd43de	2026-01-07	Warnings	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