SHISEIDO WHITE LUCENT ONMAKEUP SPOT CORRECTING SERUM

Product NDC: 58411-296
11-digit product format: 584110296
Labeler code: 58411
Product ID: 58411-296_47aab51b-96c9-d1c1-e063-6294a90a738e
Type: HUMAN OTC DRUG
Nonproprietary name: OCTINOXATE and TITANIUM DIOXIDE
Dosage form: CREAM
Route: TOPICAL
Labeler: SHISEIDO AMERICAS CORPORATION
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2017-02-01
Substance: OCTINOXATE; TITANIUM DIOXIDE
Active strength: 138; 123 mg/4mL; mg/4mL
NDC exclude flag: No
Listing certified through: 2027-12-31
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 · 18 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
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	58411-296-10	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	58411-296-10	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
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	58411-296-10	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	58411-296-10	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	58411-296-10	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	58411-296-10	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	58411-296-10	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	58411-296-10	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	58411-296-10	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: SHISEIDO WHITE LUCENT ONMAKEUP SPOT CORRECTING SERUM
Brand name suffix: NATURAL LIGHT
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OCTINOXATE	138 mg/4mL
TITANIUM DIOXIDE	123 mg/4mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
15FIX9V2JP	Internal UNII lookup
4Y5P7MUD51	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
bf736c5b-fc33-4cd5-8d18-03929f739d76	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d1c9d1af-bddd-448d-86f7-69052b7d5b47	Product name	1	20220627
5dbf91a8-ec29-4ffc-807c-e3bae7fb67b1	Product name	1	20201123
85bed648-23ca-4804-98e6-e36aee999cad	Product name	1	20190717
80de93b4-8a94-428d-beb7-d644353ee70b	Product name	1	20180424
eb4f7d5b-1286-40dc-b8bf-ad87ff51c688	Product name	1	20170522
db8eb201-78c7-4590-8a71-fac0a539bd8c	Product name	1	20170404
141092be-5eb5-452e-9f69-2d350aa70a87	Product name	1	20161208
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
58411-296-10	2026-01-06	C162847	48780-1	9d75b9d0-6be3-f424-e053-dadaa90a57ce	SHISEIDO WHITE LUCENT ONMAKEUP SPOT CORRECTING SERUM
58411-296-10	2025-01-31	C162847	48780-1	9d75b9d0-6be3-f424-e053-dadaa90a57ce	SHISEIDO WHITE LUCENT ONMAKEUP SPOT CORRECTING SERUM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
58411-296-10	SHISEIDO WHITE LUCENT ONMAKEUP SPOT CORRECTING SERUMNATURAL LIGHT	4 mL in 1 BOTTLE	CREAM	4		4
58411-296-10	SHISEIDO WHITE LUCENT ONMAKEUP SPOT CORRECTING SERUMNATURAL LIGHT	1 in 1 CARTON	CREAM	1		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58411-296	SHISEIDO WHITE LUCENT ONMAKEUP SPOT CORRECTING SERUM NATURAL LIGHT (OCTINOXATE AND TITANIUM DIOXIDE) CREAM SHISEIDO WHITE LUCENT ONMAKEUP SPOT CORRECTING SERUM NATURAL (OCTINOXATE AND TITANIUM DIOXIDE) CREAM SHISEIDO WHITE LUCENT ONMAKEUP SPOT CORRECTING SERUM MEDIUM (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [SHISEIDO AMERICAS CORPORATION]	3	Current NDC, Legacy NDC, 2 package rows	20231222_bf736c5b-fc33-4cd5-8d18-03929f739d76.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 118 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Eclipse Face Tinted	ZINC OXIDE	DENISE BELL SKIN CARE	396f0151-2d0d-f4da-e063-6394a90a5f7f	2025-12-15		Exact identifier application number: M020
Eclipse Body Non Tinted	ZINC OXIDE	DENISE BELL SKIN CARE	396f56df-d0de-1344-e063-6294a90a46ea	2025-12-15		Exact identifier application number: M020
Solar Shield Tinted	TITANIUM DIOXIDE, ZINC OXIDE	DENISE BELL SKIN CARE	396eb781-5947-3665-e063-6294a90a38dd	2025-12-15		Exact identifier application number: M020
Sun Veil Illuminating Sunscreen SPF30	ZINC OXIDE	Koco Life LLC	46001097-540e-65da-e063-6294a90af299	2025-12-15	Warnings	Exact identifier application number: M020
Mineral Primer tinted SPF40	TITANIUM DIOXIDE, ZINC OXIDE	Oracle Esthetics, LLC	3542d8d3-35a3-7d63-e063-6394a90a6fd1	2025-12-15		Exact identifier application number: M020
Mineral Primer non-tinted SPF40	TITANIUM DIOXIDE, ZINC OXIDE	Oracle Esthetics, LLC	354357de-1a85-3bdb-e063-6294a90aa9a2	2025-12-15		Exact identifier application number: M020
Mineral Primer tinted SPF40	TITANIUM DIOXIDE, ZINC OXIDE	Oracle Esthetics, LLC	35433254-1dc8-a8f3-e063-6394a90a29f0	2025-12-15		Exact identifier application number: M020
Sun Therapy Sunscreen	ZINC OXIDE	Skin Therapy Studio LLC	3544916b-3f63-3a7a-e063-6394a90ae507	2025-12-15		Exact identifier application number: M020
Ultra Zinc Mineral Non Tinted	ZINC OXIDE	Skin Therapy Studio LLC	3545d603-3d01-c51d-e063-6394a90a1599	2025-12-15		Exact identifier application number: M020
Sun Therapy Sunscreen	ZINC OXIDE	Skin Therapy Studio LLC	357efafb-aa1c-0d69-e063-6394a90a5135	2025-12-15		Exact identifier application number: M020
Ultra Zinc Mineral Non Tinted	ZINC OXIDE	Skin Therapy Studio LLC	35806102-6919-116f-e063-6294a90ad922	2025-12-15		Exact identifier application number: M020
Complexion Correction Primer Sunscreen clear	TITANIUM DIOXIDE, ZINC OXIDE	MCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY	357eee3c-1c21-5efb-e063-6294a90a4bb7	2025-12-15		Exact identifier application number: M020
Complexion Correction Tinted Primer Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	MCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY	357e75ec-473e-df76-e063-6294a90a70c7	2025-12-15		Exact identifier application number: M020
Complexion Correction Tinted Primer Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	MCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY	357f2f62-904a-2234-e063-6394a90aee72	2025-12-15		Exact identifier application number: M020
Superscreen Daytime Mineral Sunscreen	ZINC OXIDE	MCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY	357f915a-bd77-350b-e063-6294a90ad27f	2025-12-15		Exact identifier application number: M020
Complexion Correction Primer Sunscreen clear	TITANIUM DIOXIDE, ZINC OXIDE	MCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY	357ff025-84ad-6d77-e063-6394a90aad95	2025-12-15		Exact identifier application number: M020
Complexion Correction Tinted Primer Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	MCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY	358021a2-235b-825b-e063-6394a90a76f5	2025-12-15		Exact identifier application number: M020
Superscreen Daytime Mineral Sunscreen	ZINC OXIDE	MCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY	35805e66-18e6-0e45-e063-6294a90afe58	2025-12-15		Exact identifier application number: M020
Ultra Zinc Physical Defense	ZINC OXIDE	ATLANTA DERMOTOLOGY VEIN & RESEARCH CENTER	35474ac4-8a9d-6a84-e063-6394a90a9bad	2025-12-15		Exact identifier application number: M020
Ultra Zinc Physical Defense	ZINC OXIDE	ATLANTA DERMOTOLOGY VEIN & RESEARCH CENTER	357e315e-8802-ad73-e063-6394a90a2495	2025-12-15		Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4Y5P7MUD51	OCTINOXATE	83834-59-7	OCTINOXATE
15FIX9V2JP	TITANIUM DIOXIDE	13463-67-7	TITANIUM DIOXIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
58411-296-10	58411029610	1 BOTTLE in 1 CARTON (58411-296-10) / 4 mL in 1 BOTTLE	1 bottle	2017-02-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SHISEIDO WHITE LUCENT ONMAKEUP SPOT CORRECTING SERUM	SHISEIDO AMERICAS CORPORATION \| SHISEIDO AMERICA INC.	2026-01-05	HUMAN OTC DRUG LABEL	4