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 182 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
EquateDaytimeFaceLotion	EQUATE DAYTIME FACE LOTION WITH SUNSCREEN, SPF 30, 3 OZ	Walmart Inc.	2efc7087-f4ad-2f2e-e063-6394a90a1302	2025-09-18	Warnings	Exact identifier application number: M020
ERBORIAN CC RED CORRECT	ERBORIAN CC RED CORRECT SPF 25- OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE CREAM	Kolmask Co., Ld.	09ca2d4b-e0c2-9961-e063-6394a90aa82e	2025-09-18		Exact identifier application number: M020
ELROEL Pang Pang Sun Cushion Plus	ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE	MONOGLOT HOLDINGS Inc.	5ffaad65-f0b2-416a-b0a3-b92e880641e4	2025-09-18	Warnings	Exact identifier application number: M020
e.l.f. Camo CC Cream SPF 30 Fair 125 C	HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE	e.l.f. Cosmetics, Inc.	407f9c0d-31c6-f5bb-e063-6394a90a4db4	2025-09-18	Warnings	Exact identifier application number: M020
Neutrogena Collagen Bank SPF Moisturizer Sunscreen Broad Spectrum SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Kenvue Brands LLC	1630feee-7e0d-c6f4-e063-6294a90a7b1c	2025-09-17	Warnings	Exact identifier application number: M020
Guise Tinted Drops	ZINC OXIDE	Donis Men LLC	3f039049-5004-2888-e063-6294a90a5150	2025-09-17	Warnings	Exact identifier application number: M020
ONE SIZE ON TIL DAWN	ONE SIZE ON TIL DAWN	Pogi Beauty LLC	3f05d90b-9274-4d21-e063-6294a90a8485	2025-09-17	Warnings	Exact identifier application number: M020
PUR 4-in-1 Skin Tint DP3	ZINC OXIDE	PUR Minerals	3f073413-b314-e5da-e063-6394a90a9ab4	2025-09-17	Warnings	Exact identifier application number: M020
e.l.f. Hydrating Camo CC Cream SPF30 Fair 100 W	HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE	e.l.f. Cosmetics, Inc.	3fa7ef54-2c4d-9883-e063-6294a90a8d88	2025-09-17	Warnings	Exact identifier application number: M020
CVS SPF 50 Face Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	CVS	26a69a47-947a-a478-e063-6394a90aa468	2025-09-16	Warnings	Exact identifier application number: M020
SkinSuit TM 3 in 1 Moisturizer SPF 50	ZINC OXIDE	Skin Authority LLC	5eb27be9-9e80-4f4a-b193-b918d831555d	2025-09-15	Warnings	Exact identifier application number: M020
Sun and Honey Tallow Sunscreen SPF 30	ZINC OXIDE	Amara Ventures	3eda8a70-7c9e-e920-e063-6394a90a85a2	2025-09-15	Warnings	Exact identifier application number: M020
Klein Tools Sunscreen SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	KLEIN TOOLS, INC.	3edcc26a-d960-3fa8-e063-6394a90ab703	2025-09-15	Warnings	Exact identifier application number: M020
Klein Tools Sunscreen SPF 50	AVOBENZONE, HOMOSALATE, OCTOCRYLENE	KLEIN TOOLS, INC.	3ede5e54-4c9f-02f7-e063-6294a90a9df6	2025-09-15	Warnings	Exact identifier application number: M020
I.C. Industrial Sunscreen	ZINC OXIDE, OCTINOXATE, OXYBENZONE, AND OCTISALATE	R & R Lotion, Inc	b89d687a-7b36-4643-9817-765d4710ca60	2025-09-15	Warnings	Exact identifier application number: M020
Neutrogena Ultra Sheer Body Mist Sunscreen Broad Spectrum SPF 70	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Kenvue Brands LLC	97795f0e-d867-4e17-b7c9-ede08e7df70c	2025-09-12	Warnings	Exact identifier application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 36N Deep	ZINC OXIDE	DOLCE & GABBANA BEAUTY S.R.L.	2d05659c-57d2-4faf-ab67-1b8d68945aed	2025-09-12	Warnings	Exact identifier application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 37W Deep	ZINC OXIDE	DOLCE & GABBANA BEAUTY S.R.L.	5ff2b9e4-a778-4667-8c3c-3561317b374a	2025-09-12	Warnings	Exact identifier application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 39N Deep	ZINC OXIDE	DOLCE & GABBANA BEAUTY S.R.L.	bc4f909f-3e2c-4fd7-a129-3c2fac8259f0	2025-09-12	Warnings	Exact identifier application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 40C Deep	ZINC OXIDE	DOLCE & GABBANA BEAUTY S.R.L.	2dd9a30a-2cde-44c0-9350-3aeab9f7091b	2025-09-12	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