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 89 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HAWAIIAN TROPIC	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Edgewell Personal Care Brands LLC	228fab45-e0d2-f219-e063-6294a90a1ef6	2026-01-05	Warnings	Exact identifier application number: M020
HAWAIIAN TROPIC	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Edgewell Personal Care Brands LLC	228055ec-ff59-4412-e063-6394a90abe14	2026-01-05	Warnings	Exact identifier application number: M020
SHISEIDO UV PROTECTIVE FOUNDATION FAIR IVORY	OCTINOXATE AND TITANIUM DIOXIDE	SHISEIDO AMERICAS CORPORATION	236bdb53-d7a5-43a2-8a0c-bce4a5522e26	2026-01-05	Warnings	Exact identifier application number: M020
SHISEIDO BENEFIANCE WRINKLE SMOOTHING DAY	AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE, AND OXYBENZONE	SHISEIDO AMERICAS CORPORATION	4bd99626-690b-49e8-8c42-a2e2dbca09bf	2026-01-05	Warnings	Exact identifier application number: M020
cle de peau BEAUTE LONG-LASTING HYDRATING VEIL	AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE	SHISEIDO AMERICAS CORPORATION	f04ece6c-66b6-48e9-8f6b-e898a538ba00	2026-01-05	Warnings	Exact identifier application number: M020
cle de peau BEAUTE RADIANT FOUNDATION N I10	OCTINOXATE AND TITANIUM DIOXIDE	SHISEIDO AMERICAS CORPORATION	05ffb157-5e28-4e94-866d-9e3371480d84	2026-01-05	Warnings	Exact identifier application number: M020
cle de peau BEAUTE CONCEALER N 1	TITANIUM DIOXIDE	SHISEIDO AMERICAS CORPORATION	eedf8065-8897-4773-9cbb-bab57d2dd04f	2026-01-05	Warnings	Exact identifier application number: M020
cle de peau BEAUTE BRIGHTENING ENHANCER VEIL	OCTINOXATE, OCTOCRYLENE, AND TITANIUM DIOXIDE	SHISEIDO AMERICAS CORPORATION	bb00d6d7-cc51-4fee-a0df-68bbd5bc50d6	2026-01-05	Warnings	Exact identifier application number: M020
cle de peau BEAUTE THE FOUNDATION N I10 VERY LIGHT IVORY	OCTINOXATE AND TITANIUM DIOXIDE	SHISEIDO AMERICAS CORPORATION	beefe840-6f32-483b-8a37-2696adb8eea1	2026-01-05	Warnings	Exact identifier application number: M020
cle de peau BEAUTE PROTECTIVE LIP TREATMENT SPF 25	AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE	SHISEIDO AMERICAS CORPORATION	addd9885-362c-4ce0-9a6e-759e71d8756c	2026-01-05	Warnings	Exact identifier application number: M020
cle de peau BEAUTE PROTECTIVE FORTIFYING n	AVOBENZONE, OCTINOXATE, OCTOCRYLENE, AND OXYBENZONE	SHISEIDO AMERICAS CORPORATION	65ca1240-6ee8-40c0-b62f-3597e0872c6e	2026-01-05	Warnings	Exact identifier application number: M020
cle de peau BEAUTE CORRECTING VEIL n M	ENSULIZOLE, OCTINOXATE, AND ZINC OXIDE	SHISEIDO AMERICAS CORPORATION	15a258a0-61c3-4419-bcdb-a8197d5ae46f	2026-01-05	Warnings	Exact identifier application number: M020
Dominas Dark Spot UV Defense Sunscreen Broad Spectrum SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	LG H&H Co.,Ltd.	098c0a9b-2b96-6be3-e063-6294a90a959a	2026-01-05	Warnings	Exact identifier application number: M020
Poolside Butter Screen SPF 30 Sunscreen Butter	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	I World LLC	ae838725-79ab-4c17-905b-d4138ad6af1f	2026-01-05	Warnings	Exact identifier application number: M020
Poolside Bronze Service Instant Bronzing Sunscreen SPF 30	HOMOSALATE, OCTOCRYLENE, OCTISALATE, OCTINOXATE, AVOBENZONE	I World LLC	b98a9cec-3c48-4614-b091-4e59fa7d196e	2026-01-05	Warnings	Exact identifier application number: M020
Poolside Orange Creme SPF 30 Sunscreen Oil Mist	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	I World LLC	5a9f8888-529d-40d7-9489-baa5ff657cb4	2026-01-05	Warnings	Exact identifier application number: M020
Yon-Ka 50 Mineral Fluid	ZINC OXIDE	Laboratoire MULTALER Yon-Ka	47a8c8b2-30ff-0d40-e063-6294a90ac461	2026-01-05	Warnings	Exact identifier application number: M020
SHISEIDO FUTURE solution LX UNIVERSAL DEFENSE E	OCTISALATE, OCTOCRYLENE, AND ZINC OXIDE	SHISEIDO AMERICAS CORPORATION	6d2f82d5-b3af-44af-b6b0-de96a4cd95fc	2026-01-05	Warnings	Exact identifier application number: M020
SHISEIDO SPORTS BB LIGHT	OCTINOXATE AND TITANIUM DIOXIDE	SHISEIDO AMERICAS CORPORATION	260a3eab-8fe6-4259-8dcc-3706ca1f6881	2026-01-05	Warnings	Exact identifier application number: M020
SHISEIDO VITAL PERFECTION UPLIFTING AND FIRMING DAY	AVOBENZONE, OCTINOXATE, OCTOCRYLENE, AND HOMOSALATE	SHISEIDO AMERICAS CORPORATION	4a16dbb7-e860-4aae-8e8b-67abbe8295bd	2026-01-05	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