celazome

Product NDC: 58466-108
11-digit product format: 584660108
Labeler code: 58466
Product ID: 58466-108_f1bea67c-e6e1-44cf-b088-53a00d157b70
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: 60; 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 · 14 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	58466-108-04	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	58466-108-04	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	58466-108-04	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	58466-108-04	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	58466-108-04	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	58466-108-04	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	58466-108-04	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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 29 Active with DNArescue
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OXYBENZONE	60 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
99fb90ca-6527-459b-8af2-627ea9abe11b	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
58466-108-04	2025-07-25	C162847	48780-1	2cef2736-636a-d83d-e063-dadaa90ab31f	celazome ® Moisturizing SPF 29 Active with DNArescue™
58466-108-04	2025-01-30	C162847	48780-1	2cef2736-636a-d83d-e063-dadaa90ab31f	celazome ® Moisturizing SPF 29 Active with DNArescue™

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
58466-108-04	celazomeMoisturizing SPF 29 Active with DNArescue	113 g in 1 BOTTLE, DISPENSING	CREAM	113		3
58466-108-04	celazomeMoisturizing SPF 29 Active with DNArescue	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 29 ACTIVE WITH DNARESCUE (OXYBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [DERMAZONE SOLUTIONS, INC.]	1
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	CELAZOME MOISTURIZING SPF 29 ACTIVE WITH DNARESCUE (OXYBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [DERMAZONE SOLUTIONS, INC.]	1
OCTISALATE	ACTIVE INGREDIENT	4X49Y0596W	CELAZOME MOISTURIZING SPF 29 ACTIVE WITH DNARESCUE (OXYBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [DERMAZONE SOLUTIONS, INC.]	1
OXYBENZONE	ACTIVE INGREDIENT	95OOS7VE0Y	CELAZOME MOISTURIZING SPF 29 ACTIVE WITH DNARESCUE (OXYBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [DERMAZONE SOLUTIONS, INC.]	1
HOMOSALATE	ACTIVE MOIETY	V06SV4M95S	CELAZOME MOISTURIZING SPF 29 ACTIVE WITH DNARESCUE (OXYBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [DERMAZONE SOLUTIONS, INC.]	1
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	CELAZOME MOISTURIZING SPF 29 ACTIVE WITH DNARESCUE (OXYBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [DERMAZONE SOLUTIONS, INC.]	1
OCTISALATE	ACTIVE MOIETY	4X49Y0596W	CELAZOME MOISTURIZING SPF 29 ACTIVE WITH DNARESCUE (OXYBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [DERMAZONE SOLUTIONS, INC.]	1
OXYBENZONE	ACTIVE MOIETY	95OOS7VE0Y	CELAZOME MOISTURIZING SPF 29 ACTIVE WITH DNARESCUE (OXYBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [DERMAZONE SOLUTIONS, INC.]	1
.alpha.-tocopherol acetate	INACTIVE INGREDIENT	9E8X80D2L0	CELAZOME MOISTURIZING SPF 29 ACTIVE WITH DNARESCUE (OXYBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [DERMAZONE SOLUTIONS, INC.]	1
alcohol	INACTIVE INGREDIENT	3K9958V90M	CELAZOME MOISTURIZING SPF 29 ACTIVE WITH DNARESCUE (OXYBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [DERMAZONE SOLUTIONS, INC.]	1
aloe vera leaf	INACTIVE INGREDIENT	ZY81Z83H0X	CELAZOME MOISTURIZING SPF 29 ACTIVE WITH DNARESCUE (OXYBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [DERMAZONE SOLUTIONS, INC.]	1
cetyl alcohol	INACTIVE INGREDIENT	936JST6JCN	CELAZOME MOISTURIZING SPF 29 ACTIVE WITH DNARESCUE (OXYBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [DERMAZONE SOLUTIONS, INC.]	1
Diethanolamine Cetyl Phosphate	INACTIVE INGREDIENT	4UG0316V9S	CELAZOME MOISTURIZING SPF 29 ACTIVE WITH DNARESCUE (OXYBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [DERMAZONE SOLUTIONS, INC.]	1
dimethicone	INACTIVE INGREDIENT	92RU3N3Y1O	CELAZOME MOISTURIZING SPF 29 ACTIVE WITH DNARESCUE (OXYBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [DERMAZONE SOLUTIONS, INC.]	1
dioctyl maleate	INACTIVE INGREDIENT	OD88G8439L	CELAZOME MOISTURIZING SPF 29 ACTIVE WITH DNARESCUE (OXYBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [DERMAZONE SOLUTIONS, INC.]	1
methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	CELAZOME MOISTURIZING SPF 29 ACTIVE WITH DNARESCUE (OXYBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [DERMAZONE SOLUTIONS, INC.]	1
propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	CELAZOME MOISTURIZING SPF 29 ACTIVE WITH DNARESCUE (OXYBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [DERMAZONE SOLUTIONS, INC.]	1
sorbitol	INACTIVE INGREDIENT	506T60A25R	CELAZOME MOISTURIZING SPF 29 ACTIVE WITH DNARESCUE (OXYBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [DERMAZONE SOLUTIONS, INC.]	1
trolamine	INACTIVE INGREDIENT	9O3K93S3TK	CELAZOME MOISTURIZING SPF 29 ACTIVE WITH DNARESCUE (OXYBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [DERMAZONE SOLUTIONS, INC.]	1
water	INACTIVE INGREDIENT	059QF0KO0R	CELAZOME MOISTURIZING SPF 29 ACTIVE WITH DNARESCUE (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
58466-108	CELAZOME MOISTURIZING SPF 29 ACTIVE WITH DNARESCUE (OXYBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [DERMAZONE SOLUTIONS, INC.]	2	Current NDC, Legacy NDC, 2 package rows	20181117_99fb90ca-6527-459b-8af2-627ea9abe11b.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 18 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
La Roche Posay Laboratoire Dermatologique Anthelios Broad Spectrum SPF 100 Body and Face Melt In Milk Sunscreen Water Resistant 80 Minutes	AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE	L'Oreal USA Products Inc	511f6de9-264a-4cf2-97c3-aa8adbc52a87	2026-06-23	Warnings	Exact identifier application number: M020
fmg Cashmere Lip Glaze Broad Spectrum SPF 30 Sunscreen	ZINC OXIDE	THE AVON COMPANY	54f1b153-c79b-bcf8-e063-6394a90ae426	2026-06-23	Warnings	Exact identifier application number: M020
CVS 70 Daily Clear Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	CVS PHARMACY	54f25934-b4c4-4fc8-e063-6294a90a543a	2026-06-23	Warnings	Exact identifier application number: M020
Soleil Set sunscreen SPF 50	AVABENZONE 3% HOMOSALATE 10% OCTISALATE 5%	The Soleil Group	cc4e4b99-5f42-4a93-a3a0-ea19f57d2783	2026-06-23	Warnings	Exact identifier application number: M020
AVON ANEW SOLAIRE EVERYDAY FACE PROTECTION BROAD SPECTRUM SPF 50 SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	THE AVON COMPANY	54f6d7c1-59d1-0b36-e063-6394a90a17a3	2026-06-23	Warnings	Exact identifier application number: M020
RYDEEN UV CLEAR	SUNSCREEN	Guangzhou Oupeng Cosmetics Co., Ltd.	548000cd-1655-aeb3-e063-6294a90ad004	2026-06-22	Warnings	Exact identifier application number: M020
Good Instincts Proper Sunscreen SPF 50	ZINC OXIDE, TITANIUM DIOXIDE	Inhabit Brands, Inc	82d2af99-7c42-4ce5-94e0-b2ac60b8db1b	2026-06-22	Warnings	Exact identifier application number: M020
Mama and Hapa s - Bulk Sunscreen Extra Sensitive	ZINC OXIDE SUNSCREEN	VEGANIC SKN LIMITED	54e18569-2e51-366a-e063-6394a90af8ec	2026-06-22	Warnings	Exact identifier application number: M020
ESPOIR BE VELVET COVER CUSHION	HOMOSALATE, TITANIUM DIOXIDE	ESPOIR Corporation	54ce2420-4ac0-eb51-e063-6294a90a2de9	2026-06-21	Warnings	Exact identifier application number: M020
BABIES KIDSSUN PROTECTION	MINERAL SUNSCREEN	PANERGYTEK USA INC	3a554118-b71d-a844-e063-6294a90a699f	2026-06-20	Warnings	Exact identifier application number: M020
By the Beach Suncare	SPF 30 SUNCARE COCO LOCO	By the Beach Suncare LLC	549be1ca-df21-a643-e063-6394a90ac026	2026-06-19	Warnings	Exact identifier application number: M020
By the Beach Suncare	SPF 30 FACE AND BODY DRY OIL COCO LOCO	By the Beach Suncare LLC	549bad35-3005-875b-e063-6394a90ad31e	2026-06-19	Warnings	Exact identifier application number: M020
By the Beach Suncare	SPF 30 FACE AND BODY DRY OIL MELON DAZE	By the Beach Suncare LLC	549bbd19-8e22-e420-e063-6294a90a6a98	2026-06-19	Warnings	Exact identifier application number: M020
By the Beach Suncare	SPF 30 FACE AND BODY DRY OIL CANDY CLOUDS	By the Beach Suncare LLC	549bd1b1-a6e2-b35c-e063-6394a90a8d0e	2026-06-19	Warnings	Exact identifier application number: M020
By the Beach Suncare	SPF 30 FACE AND BODY DRY OIL CITRUS CRUSH	By the Beach Suncare LLC	549bd1b1-a6ee-b35c-e063-6394a90a8d0e	2026-06-19	Warnings	Exact identifier application number: M020
FHF Elevated Shade 100% Mineral Sunscreen	SUNSCREEN	Summer Soles, LLC dba Farm House Freash Goods	5488fd8c-7ef2-22c2-e063-6394a90aff3c	2026-06-18	Warnings	Exact identifier application number: M020
Stream2Sea Sport Lip Balm SPF 50	ZINC OXIDE	Stream2Sea, LLC	5489fea5-bc0e-82cf-e063-6294a90aa097	2026-06-18	Warnings	Exact identifier application number: M020
Creamy Beige Perfecting Makeup Broad Spectrum SPF 25	OCTINOXATE, TITANIUM DIOXIDE	Merle Norman Cosmetics, Inc	548b7c90-ef97-38ab-e063-6394a90ac609	2026-06-18	Warnings	Exact identifier application number: M020
UV SOLUTIONS HYDRATING BROAD SPECTRUM SPF 50	AVOBENZONE,HOMOSALATE,OCTISALATE, AND OCTOCRYLENE	CLINIQUE LABORATORIES LLC	4a6f9be3-2a56-8b41-e063-6294a90a30f8	2026-06-18	Warnings	Exact identifier application number: M020
Mineral Sunscreen SPF 50	MINERAL SUNSCREEN	ALAINA HEALTHCARE PRIVATE LIMITED	7e036f9f-b26d-4f11-911c-c1fa854edb0f	2026-06-17	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
58466-108-04	58466010804	1 BOTTLE, DISPENSING in 1 CARTON (58466-108-04) / 113 g in 1 BOTTLE, DISPENSING	2015-10-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
celazome ® Moisturizing SPF 29 Active with DNArescue™	Dermazone LLC	2025-07-25	HUMAN OTC DRUG LABEL	3