Cream

Product NDC: 61354-084
11-digit product format: 613540084
Labeler code: 61354
Product ID: 61354-084_e7763ac1-d05c-7f8f-e053-2995a90a6c15
Type: HUMAN OTC DRUG
Nonproprietary name: Zinc Oxide, Titanium Dioxide
Dosage form: CREAM
Route: TOPICAL
Labeler: Oxygen Development LLC
Application: M020
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2022-08-30
Marketing end: 0000-00-00
Substance: TITANIUM DIOXIDE; ZINC OXIDE
Active strength: 5 mg/100mg; mg/100mg
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

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	61354-084-01	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	61354-084-01	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	61354-084-01	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	61354-084-01	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	61354-084-01	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	61354-084-01	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	61354-084-01	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	61354-084-01	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	61354-084-01	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
61354-084-01	2025-01-30	C162847	48780-1	2cef2736-62bf-d83d-e063-dadaa90ab31f	TARTE high-performance naturals BB tinted treatment primer Broad Spectrum SPF 30 Sunscreen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61354-084-01	Cream	100 mg in 1 TUBE	CREAM	100		1
61354-084-01	Cream	1 in 1 CARTON	CREAM	1		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61354-084	CREAM (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [OXYGEN DEVELOPMENT LLC]	1	Legacy NDC, 2 package rows	20220831_e7760899-8b4a-9a2a-e053-2995a90a2fd5.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 329 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dr.C.Tuna Sun Body SPF50	AVOBENZONE, OCTINOXATE, HOMOSALATE, OCTOCRYLENE	Tan Alize Kozmetik ve Temizlik Urunleri Sanayi ve Ticaret Anonim Sirketi	250d8b0c-729b-4a0d-b6b0-2c9fdbc66197	2023-11-05	Warnings	Exact identifier application number: M020
Farmasi BB	AVOBENZONE, OCTINOXATE, HOMOSALATE, OCTOCRYLENE	TAN ALIZE KOZMETIK VE TEMIZLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI	042817f9-675e-056a-e063-6394a90a2d97	2023-11-05	Warnings	Exact identifier application number: M020
JACKET SPF 50	ZINC OXIDE, OCTINOXATE, OCTISALATE, OCTISALATE	Balshi MD Dermaceuticals	b82b8a46-8009-416e-8718-296a23106914	2023-11-05	Warnings	Exact identifier application number: M020
SEA STAR SPARKLE SPF 50 Glitter Sunscreen Cotton Candy	HOMOSALATE, OCTOCRYLENE, OCTISALATE, ZINC OXIDE	MJ Products Association, LLC	6ccd648f-ec3b-4325-8d89-b5dd10c2fff7	2023-11-05	Warnings	Exact identifier application number: M020
SEA STAR SPARKLE SPF 50 Glitter Sunscreen Cotton Candy	HOMOSALATE, OCTOCRYLENE, OCTISALATE, ZINC OXIDE	MJ Products Association, LLC	43c84cab-e35b-4808-bcc5-399573aef3b4	2023-11-05	Warnings	Exact identifier application number: M020
NO BS Moisturizer SPF20	OCTINOXATE, OCTISALATE, AVOBENZONE	Product Management, LLC	142f3610-85da-408d-8fa5-3773167ffc9f	2023-11-05	Warnings	Exact identifier application number: M020
SEA STAR SPARKLE SPF 50 Glitter Sunscreen Coco Lime	HOMOSALATE, OCTOCRYLENE, OCTISALATE, ZINC OXIDE	MJ Products Association, LLC	63b252c4-7d02-475b-97aa-57ef9c2e52ad	2023-11-05	Warnings	Exact identifier application number: M020
SEA STAR SPARKLE SPF 50 Glitter Sunscreen Coco Lime	HOMOSALATE, OCTOCRYLENE, OCTISALATE, ZINC OXIDE	MJ Products Association, LLC	533b6106-7f6f-49b9-9670-e2050bfcb932	2023-11-05	Warnings	Exact identifier application number: M020
VERTRA Premium Suncare SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	Eai-Jr286, Inc.	720ca725-24ca-4b59-b640-afa983238692	2023-11-05	Warnings	Exact identifier application number: M020
BEACH GYPSY Glitter Sunscreen SPF 30	OCTINOXATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	MJ Products Association, LLC	1d224ecf-d356-424e-b181-ad8692f82b03	2023-11-05	Warnings	Exact identifier application number: M020
BEAST HYDRATING FACE SPF-20	OCTOCRYLENE, OCTISALATE, AVOBENZONE	Small Batch Beauty, LLC	37941628-9f4f-474e-a8d9-080f4c663112	2023-11-05	Warnings	Exact identifier application number: M020
NAELI Day Moisturizer SPF 30	OCTISALATE, OCTOCRYLENE, AVOBENZONE	Alli LLC	9fe2f5c4-cf20-207e-e053-2a95a90ac54f	2023-11-05	Warnings	Exact identifier application number: M020
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 1C	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	4c9ffd30-4799-475d-94cb-07ce3d5b3660	2023-11-04	Warnings	Exact identifier application number: M020
enfuselle BODY SUNSCREEN BROAD SPECTRUM SPF 30	HOMOSALATE, OCTISALATE, AVOBENZONE, AND OCTOCRYLENE	Shaklee Corporation	c57bfab7-f67c-435b-8703-e2051cfd097e	2023-11-03	Warnings	Exact identifier application number: M020
Youth 2 Activating BB Cream SPF 30 Light Medium	ZINC OXIDE, TITANIUM DIOXIDE	Shaklee Corporation	e51e38c9-cc9b-4af3-842d-41d0162f17ff	2023-11-03	Warnings	Exact identifier application number: M020
Youth 4 Activating BB Cream SPF 30 Dark	ZINC OXIDE, TITANIUM DIOXIDE	Shaklee Corporation	63f7f8bd-02f0-4a13-bb1e-298754b24fce	2023-11-03	Warnings	Exact identifier application number: M020
Youth 1 Activating BB Cream SPF 30 Light	ZINC OXIDE, TITANIUM DIOXIDE	Shaklee Corporation	c9e05055-48ea-405d-b1d4-50b263d0dbf9	2023-11-03	Warnings	Exact identifier application number: M020
CAPTURE DREAMSKIN FRESH and PERFECT CUSHION WITH SUNSCREEN BROAD SPECTRUM SPF 50 020	OCTINOXATE,TITANIUM DIOXIDE,ZINC OXIDE	Parfums Christian Dior	fe03fc14-4132-4dab-b013-d490764be0d4	2023-11-03	Warnings	Exact identifier application number: M020
CAPTURE DREAMSKIN FRESH and PERFECT CUSHION WITH SUNSCREEN BROAD SPECTRUM SPF 50 000	OCTINOXATE,TITANIUM DIOXIDE,ZINC OXIDE	Parfums Christian Dior	968cfae7-89b6-4ef3-ab60-1c675b90c151	2023-11-03	Warnings	Exact identifier application number: M020
CAPTURE TOTALE C.E.L.L. ENERGY SUPER POTENT SERUM FOUNDATION BROAD SPECTRUM SPF 20 1N	ENSULIZOLE, OCTISALATE	Parfums Christian Dior	d2ca01ad-68b2-4312-a9d0-04d3e992bb13	2023-11-03	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
15FIX9V2JP	TITANIUM DIOXIDE	13463-67-7	TITANIUM DIOXIDE
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	Marketing end	Sample	Exclude flag	Status
61354-084-01	61354008401	1 TUBE in 1 CARTON (61354-084-01) > 100 mg in 1 TUBE	1 tube	2022-08-30	0000-00-00	No	No	Current