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 4 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Round Lab Holiday Heroes Gift Set	AVOBENZONE, HOMOSALATE, OCTISALATE	SEORIN COMPANY Co., Ltd.	5a0d3a85-caff-a90d-e063-6394a90ad045	2026-08-27	Warnings	Exact identifier application number: M020
MELAO Hydrating Lightweight Sunscreen	AVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDE	Guangdong Aimu Biological Technology Co., Ltd	59eeaea1-d726-99f3-e063-6394a90aeea3	2026-08-26	Warnings	Exact identifier application number: M020
Hero Force Shield Superlight Sunscreen SPF 30	ZINC OXIDE	Church & Dwight Co., Inc.	140268a9-adb9-4574-ad82-4a2e924dc808	2026-08-26	Warnings	Exact identifier application number: M020
Juyasuyon Sport Ultra Sunscreen Cream	OCTOCRYLENE,OXYBENZONE,AVOBENZONE,BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE	Guangdong Aimu Biological Technology Co., Ltd	598cfe9e-6ebe-ad18-e063-6294a90ace22	2026-08-25	Warnings	Exact identifier application number: M020
NeoStrata Sheer Hydration Sunscreen Broad Spectrum SPF 40	OCTINOXATE, OCTISALATE, AND AVOBENZONE	NeoStrata Company Inc.	e8cdf9f7-d968-42b3-bcb8-02dee7717fd8	2026-08-25	Warnings	Exact identifier application number: M020
JUYASUYON Sport Ultra Sunscreen	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Guangdong Aimu Biological Technology Co., Ltd	59d97ee0-e416-53e7-e063-6294a90a9153	2026-08-25	Warnings	Exact identifier application number: M020
NeoStrata Enlighten Skin Brightener with Sunscreen Broad Spectrum SPF 35	OCTINOXATE, OCTISALATE, AND AVOBENZONE	NeoStrata Company Inc.	ed495f18-2f8e-4991-b797-82e9f6fc7acb	2026-08-25	Warnings	Exact identifier application number: M020
Q Skin Science	SUNSCREEN	International Cosmeceuticals, Inc	59e4c3d0-ee4c-2350-e063-6394a90ac9d2	2026-08-25	Warnings	Exact identifier application number: M020
ISNTREE HYALURONIC ACID WATERY SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	ISNTREE Inc.	59e9279a-2427-d6bc-e063-6394a90ae86e	2026-08-25	Warnings	Exact identifier application number: M020
Exuviance Age Reverse Day Repair with Sunscreen Broad Spectrum SPF 30	AVOBENZONE, OCTINOXATE, AND OCTISALATE	NeoStrata Company Inc.	4739e678-ce51-4863-bb74-2275879e1b47	2026-08-24	Warnings	Exact identifier application number: M020
MELAO zinc stick(YELLOW)	TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENE	Guangzhou Haishi Biological Technology Co., Ltd.	59c3009b-ae16-52e1-e063-6394a90a69ee	2026-08-24	Warnings	Exact identifier application number: M020
MELAO zinc stick(PINK)	TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENE	Guangzhou Haishi Biological Technology Co., Ltd.	59c68d9b-9aa9-4996-e063-6394a90a48d4	2026-08-24	Warnings	Exact identifier application number: M020
MELAO zinc stick(GREEN)	TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENE	Guangzhou Haishi Biological Technology Co., Ltd.	59c70c82-f7ff-9a04-e063-6294a90a7b3d	2026-08-24	Warnings	Exact identifier application number: M020
MELAO zinc stick(BLUE)	TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENE	Guangzhou Haishi Biological Technology Co., Ltd.	59c78929-9df7-5212-e063-6394a90a3766	2026-08-24	Warnings	Exact identifier application number: M020
Dr Marvel COLOR CHANGING FOUNDATION SPF30	ETHYLHEXYL METHOXYCINNAMATE	Guangzhou Liyan Cosmetics Technology Co., Ltd.	59c8865f-ccee-dd50-e063-6294a90aa185	2026-08-24	Warnings	Exact identifier application number: M020
Exuviance Daily Corrector with Sunsreen Broad Spectrum SPF 35	OCTINOXATE, OCTISALATE, AND AVOBENZONE	NeoStrata Company Inc.	74a998e2-8ebf-436c-aac1-b456cd2e072d	2026-08-24	Warnings	Exact identifier application number: M020
Homosalate, Octisalate, Zinc oxide	HOMOSALATE, OCTISALATE, ZINC OXIDE	Aldi Inc	59cbfb14-d9b1-ce93-e063-6394a90ac312	2026-08-24	Warnings, Adverse reactions	Exact identifier application number: M020
SKIN-INFUSED FOUNDATION SPF 25/ Mineral sunscreen broad Spectrum SPF 25 01	ZINC OXIDE, TITANIUM DIOXIDE	Cosmuses Cosmetics (Ningbo) Co., Ltd.	59d74e3f-e3fa-a7a9-e063-6294a90a76e5	2026-08-24	Warnings	Exact identifier application number: M020
ISNTREE HYALURONIC ACID WATERY SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	ISNTREE Inc.	59ac747a-f9c7-2c18-e063-6394a90a2306	2026-08-23	Warnings	Exact identifier application number: M020
Sunski Sol Power Daily Face Sunscreen SPF 50	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	Stewart Charley Ventures, LLC	b6c3d6b1-3d8a-43c0-aac5-07fe60afbd8c	2026-08-21	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