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 110 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	HSC MIAMI, INC	36d8b849-cf73-e008-e063-6394a90a410a	2025-12-17		Exact identifier application number: M020
TINTED RESTORATIVE MOISTURIZER	ZINC OXIDE	SKINERGIX LLC	3636adf0-c3bd-7422-e063-6394a90aaccc	2025-12-17		Exact identifier application number: M020
Premier Zinc	ZINC OXIDE	ENSO SKINCARE & WELLNESS LLC	3bb378c8-14b0-aa13-e063-6294a90a4db3	2025-12-17	Warnings	Exact identifier application number: M020
Protect and Renew	ZINC OXIDE	ENSO SKINCARE & WELLNESS LLC	3bb479ed-1153-8e80-e063-6294a90a2937	2025-12-17	Warnings	Exact identifier application number: M020
Flawless Finish	TITANIUM DIOXIDE, ZINC OXIDE	ENSO SKINCARE & WELLNESS LLC	3b8df7ce-e5ce-aaf8-e063-6394a90afdae	2025-12-17	Warnings	Exact identifier application number: M020
Shield Mineral Sunscreen Tinted	ZINC OXIDE	SMOOTHE LLC	369b9d76-f6c3-e25f-e063-6294a90adaf3	2025-12-17		Exact identifier application number: M020
Shield Mineral Sunscreen Non Tinted	ZINC OXIDE	SMOOTHE LLC	369bc20d-7192-7c0a-e063-6294a90a3dfe	2025-12-17		Exact identifier application number: M020
Lip Balm	TITANIUM DIOXIDE, ZINC OXIDE	PATRICIA SOLIS MAKEUP ARTIST, LLC	369d63a9-b9a9-9530-e063-6394a90ac8ef	2025-12-17		Exact identifier application number: M020
Matte Tint	TITANIUM DIOXIDE, ZINC OXIDE	PATRICIA SOLIS MAKEUP ARTIST, LLC	369ced69-59b4-0f3c-e063-6294a90a582f	2025-12-17		Exact identifier application number: M020
Hydra Tint	ZINC OXIDE	PATRICIA SOLIS MAKEUP ARTIST, LLC	369d4e7a-8356-8f15-e063-6394a90acca8	2025-12-17		Exact identifier application number: M020
Mineral Sunscreen Tinted	TITANIUM DIOXIDE, ZINC OXIDE	LOTUS SKINCARE AND MAKE-UP STUDIO	36b0ac77-13d8-4259-e063-6394a90a893b	2025-12-17		Exact identifier application number: M020
Mineral Sunscreen Non-Tinted	TITANIUM DIOXIDE, ZINC OXIDE	LOTUS SKINCARE AND MAKE-UP STUDIO	36b000e3-2516-932c-e063-6294a90a0e41	2025-12-17		Exact identifier application number: M020
Moisturizing Mineral Sunscreen Tinted	ZINC OXIDE	LOTUS SKINCARE AND MAKE-UP STUDIO	36b12dbc-5edc-aad1-e063-6394a90a42ea	2025-12-17		Exact identifier application number: M020
Mineral Lip Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	LOTUS SKINCARE AND MAKE-UP STUDIO	36b1a6c8-b4ff-089a-e063-6394a90a2469	2025-12-17		Exact identifier application number: M020
Badger SPF 40 Tinted Mineral Face	ZINC OXIDE	W.S. Badger Company, Inc.	4628c04f-b7a6-b3fe-e063-6294a90a1675	2025-12-17	Warnings	Exact identifier application number: M020
Coppertone Kids Sunscreen SPF 50	(TO DELIVER) AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5%	Beiersdorf Inc	0a5a4d0e-8ab2-3d79-e063-6394a90a7006	2025-12-17	Warnings	Exact identifier application number: M020
Coppertone Kids Sunscreen SPF 50	(TO DELIVER) AVOBENZONE 3%, HOMOSALATE 5%, OCTISALATE 10%, OCTOCRYLENE 5%	Beiersdorf Inc	0a5a42a3-6fe4-2980-e063-6394a90a54fe	2025-12-17	Warnings	Exact identifier application number: M020
Coppertone Glow Suncreen SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Beiersdord Inc	b65c117d-f200-bb22-e053-2995a90ab71d	2025-12-17	Warnings	Exact identifier application number: M020
Covergirl Clean Fresh Tinted Lip Balm Glowing Protection SPF 15 Mineral Sunscreen - All shades	ZINC OXIDE AND TITANIUM DIOXIDE	Noxell	2cdbeb73-b805-f144-e063-6294a90a088d	2025-12-17	Warnings	Exact identifier application number: M020
Covergirl Clean Fresh Blurring Skintint SPF 30 Mineral Sunscreen Liquid Foundation- All shades	ZINC OXIDE	Noxell	3fa58ac5-f45c-369a-e063-6294a90a46e4	2025-12-17	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