celazome

Product NDC: 58466-901
Requested package NDC: 58466-901-04
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 · 13 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`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 1 of 361 · 7,213 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ultra Violette Sheen Screen Broad Spectrum Hydrating Lip Balm Dusk	SPF50	Grace And Fire USA Inc.	2735ab0f-5eec-04c5-e063-6394a90aa60e	2026-10-01	Warnings	Exact identifier application number: M020
Ultra Violette Sheen Screen Broad Spectrum Hydrating Lip Balm Bejewelled	SPF50	Grace And Fire USA Inc.	274a0544-6c71-4d91-e063-6394a90a2247	2026-10-01	Warnings	Exact identifier application number: M020
TRILIPIDERM All-Body Moisture Retention SPF-30	AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE	Trilipid Research Institute, LLC	7f34de0a-eeb3-4b71-9abd-53d03266d993	2026-09-10	Warnings	Exact identifier application number: M020
Neutrogena Ultra Sheer Dry Touch Sunscreen Broad Spectrum SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Kenvue Brands LLC	6a43173f-41f9-4207-a0db-53bc8db6f4a4	2026-09-10	Warnings	Exact identifier application number: M020
Neutrogena Ultra Sheer Body Mist Sunscreen Broad Spectrum SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Kenvue Brands LLC	d69b4992-d7e6-4bd7-b144-0485e35818a6	2026-09-10	Warnings	Exact identifier application number: M020
Hydra Finish SPF 15	HOMOSALATE, OCTINOXATE	Guinot	4047e8ec-834a-41e6-a144-5649a7718de4	2026-09-10	Warnings	Exact identifier application number: M020
HYDRA BEAUTE SPF 15	AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	Guinot	806d1e18-a3fc-43df-a52a-a640902d0887	2026-09-10	Warnings	Exact identifier application number: M020
Pur Confort SPF 15	AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	Guinot	2fe0656f-f924-48da-91bf-d6f3d98e8fd9	2026-09-10	Warnings	Exact identifier application number: M020
Neutrogena Ultra Sheer Body Mist Sunscreen Broad Spectrum SPF 45	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Kenvue Brands LLC	51f3d6ca-3189-4380-9afb-4259ba878274	2026-09-10	Warnings	Exact identifier application number: M020
Sun Logic Creme Solaire Visage et corps SPF 30	AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	Guinot	b0a95379-998a-4cda-bae7-63faf3d6f3c8	2026-09-10	Warnings	Exact identifier application number: M020
Sun Logic Lait Solaire Corps SPF 20	AVOBENZONE, HOMOSALATE, OCTOCRYLENE	Guinot	d9d2cee0-9189-42d0-b1ab-78b97141b128	2026-09-10	Warnings	Exact identifier application number: M020
Sunscreen	BROAD SPECTRUM SPF 30	1226 W AESTHETICS	5b0ef395-a7dd-378e-e063-6394a90a5dce	2026-09-09	Warnings	Exact identifier application number: M020
Stay Ageless Tinted Mineral Sunscreen	BROAD SPECTRUM SPF30	W Aesthetics	5b0f2c8f-d6fa-5e25-e063-6394a90a084d	2026-09-09	Warnings	Exact identifier application number: M020
Baloom 2% Panthenol Hydro Airy Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE. OCTOCRYLENE	ARSN KOREA	5148b638-f8a4-fa8b-e063-6294a90ac208	2026-09-08	Warnings	Exact identifier application number: M020
Double-Duty Face Moisturizer	MOSITURIZING SUNSCREEN	Jack Black, LLC	672be406-e3a1-47b4-8ef6-ee2b62baae96	2026-09-08	Warnings	Exact identifier application number: M020
Intense Therapy Lip Balm Pineapple Mint	SUNSCREEN SKIN PROTECTANT LIP BALM	Jack Black, LLC	0862534c-5f48-4f67-a3b8-0876a667556f	2026-09-08	Warnings	Exact identifier application number: M020
Intense Therapy Lip Balm SPF25, Shea Butter and Vitamin E	LIP BALM SPF25	Jack Black, LLC	88e8752d-1fbf-4e28-b79d-7c05ecdce842	2026-09-08	Warnings	Exact identifier application number: M020
Jack Black Intense Lip Therapy SPF25, Natural Mint and Shea Butter	LIP BALM SUNSCREEN	Jack Black, LLC	e8730127-2d8d-4b80-ab90-d2f136d9e516	2026-09-08	Warnings	Exact identifier application number: M020
Jack Black Intense Therapy Lip Balm SPF25, Grapefruit and Ginger	LIP BALM SUNSCREEN	Jack Black, LLC	d961d22a-2125-41e9-94a3-5b53d12b320f	2026-09-08	Warnings	Exact identifier application number: M020
Intense Therapy Lip Balm Asian Pear	SUNSCREEN SKIN PROTECTANT LIP BALM	Jack Black, LLC	acace707-6671-4818-86f2-d9813792157a	2026-09-08	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