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 102 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DECORTE AQ ABSOLUTE TREATMENT AWAKENING PROTECTIVE DAY	AVOBENZONE, OCTINOXATE, OCTISALATE	KOS America, Inc.	81352963-36ec-4099-af51-3498d89f3077	2025-12-23	Warnings	Exact identifier application number: M020
Poolside Soft Serve Mineral Milk SPF 30 face sunscreen drops	ZINC OXIDE, OCTINOXATE	Longway Technology(Guangzhou)Co.,Ltd.	451b4d37-99e2-8e4f-e063-6294a90a51bb	2025-12-23	Warnings	Exact identifier application number: M020
Reclaim Revolutionary Anti-Aging Day SPF15	OCTINOXATE, OCTISALATE, AND OXYBENZONE	Guthy-Renker LLC	4b735c91-f650-4531-8744-c211d57a3e28	2025-12-23	Warnings	Exact identifier application number: M020
SCINIC ENJOY SUPER MILD SUN ESSENCE EX	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	ELEVEN STREET	35272744-8253-046c-e063-6394a90aabc2	2025-12-22	Warnings	Exact identifier application number: M020
TINTED FACIAL SUNSCREEN	ZINC OXIDE, TITANIUM DIOXIDE	Guangzhou Tata Biotechnology Co., Ltd.	1259035e-9196-97de-e063-6394a90a9dec	2025-12-22	Warnings	Exact identifier application number: M020
SUNSCREEN LIP BALM	ETHYLHEXYL METHOXYCINNAMATE, HOMOSALATE, POLYSILICONE-15, OCTOCRYLENE, BUTYL METHOXYDIBENZOYLMETHANE	Guangzhou Tata Biotechnology Co., Ltd.	0f8e08bf-4b14-bdad-e063-6394a90a34e1	2025-12-22	Warnings	Exact identifier application number: M020
SUNSCREEN LIP PROTECTIONBROAD SPECTRUM SPF 15	ETHYLHEXYL METHOXYCINNAMATE, OCTOCRYLENE	Guangzhou Tata Biotechnology Co., Ltd.	1c32b019-a038-eb61-e063-6394a90a45f2	2025-12-22	Warnings	Exact identifier application number: M020
SPF 50 MINERAL SUNSCREEN LIP	ZINC OXIDE , TITANIUM DIOXIDE	Guangzhou Tata Biotechnology Co., Ltd.	1c6f0964-9bee-1c06-e063-6294a90ac2a4	2025-12-22	Warnings	Exact identifier application number: M020
Absolut Skin SPF 50 Moisturizing Sunscreen	ETHYLHEXYL METHOXYCINNAMATE,ETHYLHEXYL SALICYLATE,METHYLENE BIS-BENZOTRIAZOLYL TETRAMETHYLBUTYLPHENOL,OCTOCRYLENE	Guangzhou Tata Biotechnology Co., Ltd.	3264543c-e8f5-da9a-e063-6394a90ac8c6	2025-12-22	Warnings	Exact identifier application number: M020
Firmarine Moisturizer SPF 30	AVOBENZONE, OCTINOXATE, AND OCTISALATE	Erno Laszlo, Inc.	073f8b95-6f46-4341-817f-22f5b4f32542	2025-12-22	Warnings	Exact identifier application number: M020
G.M. Collin FPS-SPF 50 UVA-UVB TINTED SUNSCREEN	ZINC OXIDE, TITANIUM DIOXIDE	LABORATOIRES DERMO-COSMETIK INC.	468c90d7-3b9e-1641-e063-6394a90a928c	2025-12-22	Warnings	Exact identifier application number: M020
TiZO3	TITANIUM DIOXIDE, ZINC OXIDE	Fallien Cosmeceuticals Ltd.	468d6476-127a-e9f0-e063-6294a90a3df9	2025-12-22	Warnings	Exact identifier application number: M020
YOUR SKIN BUT BETTER FAIR	TITANIUM DIOXIDE AND ZINC OXIDE	IT COSMETICS, LLC	3e65ec1a-0ed9-433d-8da9-a6cb61829911	2025-12-22	Warnings	Exact identifier application number: M020
Sun Shades Sunscreen Sunscreen SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Melaleuca Inc.	1f982f03-9542-29f9-e063-6294a90a959c	2025-12-22	Warnings	Exact identifier application number: M020
SOLARA SUNCARE - GLOW GETTER SPF-30 NATURALLY SCENTED	ZINC OXIDE	SOLARA SUNCARE, INC.	ca99b8c4-6778-43dc-bdd5-ca4a470860a0	2025-12-22	Warnings	Exact identifier application number: M020
SOLARA SUNCARE - GO MINERAL DEFENSE SPORT SUPERFRUIT VITAMIN C PLUS ALOE SHEER SUNSCREEN MIST SPF-30 UNSCENTED	ZINC OXIDE	SOLARA SUNCARE, INC.	f810843b-5a4d-6cbc-e053-6294a90ac9e3	2025-12-22	Warnings	Exact identifier application number: M020
SOLARA SUNCARE - CLEAN FREAK SPF-30 NATURALLY SCENTED	ZINC OXIDE	SOLARA SUNCARE, INC.	7a5644b9-4368-4e9a-aa22-b3307acf43cc	2025-12-22	Warnings	Exact identifier application number: M020
MINERAL DEFENSE SPORT CERAMIDE SPF-30	ZINC OXIDE	SOLARA SUNCARE, INC.	cbf9c715-2d45-4c1b-b58f-42795722821c	2025-12-22	Warnings	Exact identifier application number: M020
SPF 50 Baby Sunscreen Equate	AVOBENZONE, HOMOSALATE, OCTOCRYLENE	Walmart Inc	4690d89b-ae61-2ed5-e063-6294a90a743f	2025-12-22	Warnings	Exact identifier application number: M020
MINERAL DEFENSE SPORT ANTIOXIDANT FACE SUNSCREEN SPF-50	ZINC OXIDE	SOLARA SUNCARE, INC.	f5242c7d-09e1-4141-8de1-a89bd7981ca6	2025-12-22	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