78 x 36 SPF 30 Active

Product NDC: 58466-109
11-digit product format: 584660109
Labeler code: 58466
Product ID: 58466-109_1c2b73fd-1c52-4db3-982e-d937c04ceeac
Type: HUMAN OTC DRUG
Nonproprietary name: ZINC OXIDE
Dosage form: CREAM
Route: TOPICAL
Labeler: Dermazone LLC
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2023-10-01
Substance: ZINC OXIDE
Active strength: .2 g/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	58466-109-03	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	58466-109-03	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	58466-109-03	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	58466-109-03	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	58466-109-03	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	58466-109-03	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	58466-109-03	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: 78 x 36 SPF 30 Active
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ZINC OXIDE	.2 g/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
SOI2LOH54Z	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
96a8aacc-5c2f-410a-8fb4-8b3bc0f81e55	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
124351b2-6dbf-42d0-9ea7-f0e299215f9a	Product name	1	20210115

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
58466-109-03	2025-07-25	C162847	48780-1	2cef2736-9a18-d83d-e063-dadaa90ab31f	78 x 36 SPF 30 Active
58466-109-03	2025-01-30	C162847	48780-1	2cef2736-9a18-d83d-e063-dadaa90ab31f	78 x 36 SPF 30 Active

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
58466-109-03	78 x 36 SPF 30 Active	96 g in 1 TUBE	CREAM	96		2
58466-109-03	78 x 36 SPF 30 Active	1 in 1 CARTON	CREAM	1		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58466-109	78 X 36 SPF 30 ACTIVE (ZINC OXIDE) CREAM [DERMAZONE SOLUTIONS, INC.]	1	Current NDC, 2 package rows	20231001_96a8aacc-5c2f-410a-8fb4-8b3bc0f81e55.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 59 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Avebonzone, Homosalate, Octisalate	AVEBONZONE, HOMOSALATE, OCTISALATE	Amazon.com Services LLC	4ab66c16-5f4c-6987-e063-6294a90add86	2026-02-26	Warnings, Adverse reactions	Exact identifier application number: M020
Seonglow Daily Moisturizing Sunscreen SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	SeonGlow Inc.	01f3479f-3a0d-420b-bbf8-62a0a225bc9b	2026-02-26	Warnings	Exact identifier application number: M020
Avebonzone, Homosalate, Octisalate	AVEBONZONE, HOMOSALATE, OCTISALATE	Amazon.com Services LLC	4ab5d5ca-26bf-1c5f-e063-6394a90a00ca	2026-02-26	Warnings, Adverse reactions	Exact identifier application number: M020
SPF50 Moisturizer with Aloe, Green Tea and Shea Butter	ZINC OXIDE	Audrey Morris Cosmetics International, LLC	92960e14-9845-49aa-b3ce-c8023aa109b6	2026-02-26	Warnings	Exact identifier application number: M020
Naturalessa SPF50 Moisturizer	ZINC OXIDE	Audrey Morris Cosmetics International, LLC	816ddfa1-cb55-4591-a90b-71631cb17626	2026-02-26	Warnings	Exact identifier application number: M020
UV DEFENSE FACE MINERAL SPF 50	ZINC OXIDE	BETTER INVENTION LTD	4b9a9efe-9aba-0ed0-e063-6394a90a2c6b	2026-02-26	Warnings	Exact identifier application number: M020
MISTINE UV DEFENSE FACE SUNSCREEN SPF50	AVOBENZONE, HOMOSOLATE, OCTISALATE, OCTOCRYLENE	BETTER INVENTION LTD	4b9a8f28-9043-8fb7-e063-6294a90a34d3	2026-02-26	Warnings	Exact identifier application number: M020
MISTINE UV INVISIBLE FACE SHEER SUNSCREEN SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	BETTER INVENTION LTD	4b9a8f28-9041-8fb7-e063-6294a90a34d3	2026-02-26	Warnings	Exact identifier application number: M020
Rationale The Discovery Travel Kit	ZINC OXIDE	RATIONALE GROUP PTY LTD	0c919aea-4bd4-427e-97e7-9c153b42f491	2026-02-25	Warnings	Exact identifier application number: M020
Kiss My Face Purely Mineral Daily 50 Sunscreen SPF 50	ZINC OXIDE	Windmill Health Products, LLC	ebfb149c-0371-4492-b03a-5fdcb7821753	2026-02-25	Warnings	Exact identifier application number: M020
SHISEIDO UV PROTECTIVE COMPACT (REFILL) FAIR IVORY	OCTINOXATE, OCTOCRYLENE, AND TITANIUM DIOXIDE	SHISEIDO AMERICAS CORPORATION	c05cef12-a6a7-4682-9357-6d77f4ca3267	2026-02-25	Warnings	Exact identifier application number: M020
cle de peau BEAUTE Protective Day	AVOBENZONE, OCTINOXATE, OCTOCRYLENE	Shiseido Americas Corporation	dea8e4c1-6a9c-44c6-abc8-6cdd50f35f49	2026-02-25	Warnings	Exact identifier application number: M020
Aura Defense	ZINC OXIDE	Grace and Glow MD LLC	4ba75eff-74ef-278b-e063-6394a90a8ef0	2026-02-25	Warnings	Exact identifier application number: M020
AM Shield plus	ZINC OXIDE	Grace and Glow MD LLC	4ba7c282-c68e-8719-e063-6394a90a3814	2026-02-25	Warnings	Exact identifier application number: M020
cle de peau BEAUTE RADIANT FOUNDATION N M I10	OCTINOXATE AND TITANIUM DIOXIDE	Shiseido Americas Corporation	3be1fe06-bd3b-4078-bee9-d3caf8d068ff	2026-02-25	Warnings	Exact identifier application number: M020
Jack Black	AVOBENZONE/HOMOSALATE/OCTISALATE/PETROLATUM	Jack Black L.L.C.	4babe2ab-c5da-9a83-e063-6294a90aee4c	2026-02-25	Warnings	Exact identifier application number: M020
Daily Facial Moisturizer SPF 25	SUNSCREEN	Person and Covey	6b9258e4-c7c6-765e-e053-2991aa0a9f4e	2026-02-25	Warnings	Exact identifier application number: M020
Jack Black	AVOBENZONE/HOMOSALATE/OCTISALATE/PETROLATUM	Jack Black L.L.C.	4bac1c33-36fe-8d29-e063-6394a90a32a5	2026-02-25	Warnings	Exact identifier application number: M020
Jack Black	AVOBENZONE/HOMOSALATE/OCTISALATE/PETROLATUM	Jack Black L.L.C.	4bac5550-c45f-a738-e063-6394a90ae5c8	2026-02-25	Warnings	Exact identifier application number: M020
Jack Black	AVOBENZONE/HOMOSALATE/OCTISALATE/PETROLATUM	Jack Black L.L.C.	4baca374-7aaa-8d1d-e063-6394a90a5a55	2026-02-25	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
58466-109-03	58466010903	1 TUBE in 1 CARTON (58466-109-03) / 96 g in 1 TUBE	1 tube	2023-10-01	No	No	Current