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 63 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Poolside Golden Hour SPF 15 Sunscreen Lip	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	I World LLC	7d0f8319-f0fa-4ea7-bb66-427c5a78145a	2026-02-10	Warnings	Exact identifier application number: M020
Tanri Broad Spectrum SPF 30	SUNSCREEN	I. Shay Cosmetics	26d5b9d1-d669-3430-e063-6394a90ad7f2	2026-02-10	Warnings	Exact identifier application number: M020
DAILY SUNSCREEN BROAD SPECTRUM SPF 30	ZINC OXIDE	S+	9d6ffe56-debc-4ad2-837b-fd7bb091a56f	2026-02-09	Warnings	Exact identifier application number: M020
Alumier MD Clear Shield Broad Spectrum SPF 42 Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Alumier Labs	a9c970c8-b6e3-b0a1-e053-2a95a90a89c7	2026-02-09	Warnings	Exact identifier application number: M020
Solavida Broad Spectrum Mineral Sunscreen SPF 30 - Face	ZINC OXIDE	Solavida, LLC	4a694cdf-496b-3bc0-e063-6294a90af0d1	2026-02-09	Warnings	Exact identifier application number: M020
numbuzin 9 NAD BIO Super Defense Glow Sunscreen Broad Spectrum SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	BENOW BEAUTY INC	32bfb17c-5535-c016-e063-6394a90a1814	2026-02-09	Warnings	Exact identifier application number: M020
TRADER JOES SHIMMER SUNSCREEN BROAD SPECTRUM SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Trader Joe's Company	4a6b69ed-2739-d22a-e063-6294a90a1e52	2026-02-09	Warnings	Exact identifier application number: M020
SUNPLUS LIP LIFE	SUNSCREEN	I. Shay Cosmetics	26d28286-e812-0fb3-e063-6394a90a338d	2026-02-09	Warnings	Exact identifier application number: M020
NUDESCREEN DEWY ILLUMINATING GLOW SPF 30 - Goddess Glow	ZINC OXIDE SUNSCREEN	Bentley Laboratories, LLC	bb86322d-ff30-4a54-97b5-1be275067146	2026-02-06	Warnings	Exact identifier application number: M020
Hampton Sun SPF 50 Mineral	ZINC OXIDE 19.5% TITANIUM DIOXIDE 4.00%	S&C Hampton Sun LLC	d6c33436-042e-44e8-8b55-98be6e246879	2026-02-06	Warnings	Exact identifier application number: M020
SHISEIDO WASO COLOR-SMART DAY MOISTURIZER	OCTINOXATE, TITANIUM DIOXIDE	Shiseido Americas Corporation	f291f077-1c72-48fc-bb19-c20bdeaaa596	2026-02-06	Warnings	Exact identifier application number: M020
SHISEIDO WASO SHIKULIME COLOR CONTROL	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE,	Shiseido Americas Corporation	f225a736-2ff7-4084-88a4-a8df5b043cce	2026-02-06	Warnings	Exact identifier application number: M020
Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	American Sales Company	79dff6ec-d958-4bba-999b-da4aa67519f5	2026-02-06	Warnings, Adverse reactions	Exact identifier application number: M020
Avobenzone, Homosalate, Octisalate, Octocrylene	SUNSCREEN	Retail Business Services, LLC	1dc325bb-d520-4897-b8f8-3f0ecba2274c	2026-02-06	Warnings, Adverse reactions	Exact identifier application number: M020
Sheer Touch Sunscreen SPF 70	AVOBENZONE, HOMOSALATE, OCTISALATE	Retail Business Services, LLC	d8a55217-ae50-4c7f-a440-f4de079d08ae	2026-02-06	Warnings, Adverse reactions	Exact identifier application number: M020
Sheer Touch Sunscreen SPF 100	AVOBENZONE, HOMOSALATE, OCTISALATE	Retail Business Services, LLC	f2a4b432-118e-42a4-baeb-90614dccbd06	2026-02-06	Warnings, Adverse reactions	Exact identifier application number: M020
Sport Sunscreen SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE	Retail Business Services, LLC	232ab407-1903-45d8-a2b2-6992ffd30d00	2026-02-06	Warnings, Adverse reactions	Exact identifier application number: M020
Sport Sunscreen SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE	Retail Business Services, LLC	0ccef180-0eb1-cf2b-e063-6394a90adf0c	2026-02-06	Warnings, Adverse reactions	Exact identifier application number: M020
Sunscreen for Kids SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE	Retail Business Services, LLC	6a455f1a-4285-44c3-820a-85a50d1bbc5b	2026-02-06	Warnings	Exact identifier application number: M020
Sport Sunscreen SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE	Retail Business Services, LLC	15bf22f5-a8f5-44bb-b787-2b762b330d61	2026-02-06	Warnings, Adverse reactions	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