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 101 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mine Line Coconut Sunscreen SPF 50	ZINC OXIDE	Spa de Soleil	4642b1cc-43b1-6997-e063-6394a90ac764	2025-12-29	Warnings	Exact identifier application number: M020
SnugZ SPF 30 Broad Spectrum Sunscreen	SPF 30 BROAD SPECTRUM SUNSCREEN	SnugZ/USA, LLC	69ac1218-76e6-04ff-e053-2a91aa0a4080	2025-12-29	Warnings	Exact identifier application number: M020
SnugZ SPF 50 Sunscreen Spry	SPF 50 SUNSCREEN SPRAY	SnugZ USA	9390ea21-9f9f-14e2-e053-2a95a90ac577	2025-12-29	Warnings	Exact identifier application number: M020
SnugZ SPF 15 Flavored Beeswax Lip Balm	SPF 15 FLAVORED BEESWAX LIP BALM	SnugZ/USA, LLC	69bdfaaf-d49e-bf31-e053-2a91aa0affd3	2025-12-29	Warnings	Exact identifier application number: M020
SnugZ SPF 50 Broad Spectrum Sunscreen	SPF 50 BROAD SPECTRUM SUNSCREEN	SnugZ/USA, LLC	b7a3eed5-c8ca-ffda-e053-2a95a90a73bb	2025-12-29	Warnings	Exact identifier application number: M020
SnugZ SPF 15 Beeswax Lip Balm	SPF 15 BEESWAX LIP BALM	SnugZ/USA, LLC	68816d3a-dbe9-7ce3-e053-2a91aa0a395e	2025-12-29	Warnings	Exact identifier application number: M020
SnugZ SPF 30 Soy Lip Balm	SPF 30 SOY LIP BALM	SnugZ/USA, LLC	687ff49d-2d0e-2534-e053-2991aa0a2864	2025-12-29	Warnings	Exact identifier application number: M020
SnugZ SPF 50 Sunscreen Stick	SPF 50 SUNSTICK	SnugZ/USA, LLC	6e1179cf-5bfb-1156-e053-2991aa0a5b46	2025-12-29	Warnings	Exact identifier application number: M020
OUHOE Face Body Sunscreen	TITANIUM DIOXIDE	Shantou Ouhoe Technology Co., Ltd.	46d36f60-2a5d-816e-e063-6294a90a2ddc	2025-12-26	Warnings	Exact identifier application number: M020
OUHOE Bean Sunscreen	TITANIUM DIOXIDE	Shantou Ouhoe Technology Co., Ltd.	46d3b11f-93d9-0e38-e063-6294a90a41c3	2025-12-26	Warnings	Exact identifier application number: M020
Cream	ZINC OXIDE	MONAT GLOBAL CORP	e922d89c-4232-77d8-e053-2995a90a85e5	2025-12-26	Warnings	Exact identifier application number: M020
Cream	ZINC OXIDE	MONAT GLOBAL CORP	e9231470-9292-0e70-e053-2a95a90a767a	2025-12-26	Warnings	Exact identifier application number: M020
Cream	ZINC OXIDE	MONAT GLOBAL CORP	e92288bb-739a-2f73-e053-2995a90ac01f	2025-12-26	Warnings	Exact identifier application number: M020
StriVectin-SH NIA-114 UVA UVB Shields SPF 30	HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE, OXYBENZONE	StriVectin Operating Company Inc.	232cbde4-d8ea-4831-9b44-c2e93203260a	2025-12-26	Warnings	Exact identifier application number: M020
Cardon	AVOBENZONE, HOMOSALATE, OCTYL SALICYLATE	Cardon, Inc	72ee2c06-242e-29a2-e053-2991aa0ad8dc	2025-12-26	Warnings	Exact identifier application number: M020
OUHOE Water-Permeable Sunscreen	TITANIUM DIOXIDE	Shantou Ouhoe Technology Co., Ltd.	46e63e1e-7851-ca26-e063-6394a90a9b53	2025-12-26	Warnings	Exact identifier application number: M020
OUHOE Sun Milk	TITANIUM DIOXIDE	Shantou Ouhoe Technology Co., Ltd.	46e678dd-13c5-b317-e063-6294a90aa989	2025-12-26	Warnings	Exact identifier application number: M020
Dermatone Sport SPF 50	AVOBENZONE 3%, HOMOSALATE 10%, OCTOCRYLENE 6%	Dermatone Labs LLC	0e60e5bb-b941-4114-933a-29480bff5960	2025-12-24	Warnings	Exact identifier application number: M020
Intelligent Elixirs Tinted Broad Spectrum SPF 30 - Natural	AVOBENZONE, OCTISALATE, OCTINOXATE	Intelligent Elixirs, LLC	287a61d8-0056-6211-e063-6394a90aa3da	2025-12-24	Warnings	Exact identifier application number: M020
Sugargirl Glowy SPF 30 Face Screen Sunlight Shimmer Sunscreen for the face	HOMOSALATE,OCTOCRYLENE, OCTISALATE,OCTINOXATE, AVOBENZONE	Longway Technology(Guangzhou)Co.,Ltd.	452b5997-d229-60ee-e063-6394a90a68db	2025-12-23	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