Cream

Product NDC: 61354-082
Requested package NDC: 61354-082-01
11-digit product format: 613540082
Labeler code: 61354
Product ID: 61354-082_e724e10c-4f05-b03d-e053-2a95a90a754c
Type: HUMAN OTC DRUG
Nonproprietary name: Zinc Oxide, Titanium Dioxide
Dosage form: LOTION
Route: TOPICAL
Labeler: Oxygen Development LLC
Application: M020
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2022-08-26
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	61354-082	61354-082-01	I	Inactivated by FDA		2026-10-28

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 · 9 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
61354-082-01	2025-01-30	C162847	48780-1	2cef2736-b0b7-d83d-e063-dadaa90ab31f	SKIN TREAT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61354-082-01	Cream	1 in 1 CARTON	LOTION	1		1
61354-082-01	Cream	100 mg in 1 TUBE	LOTION	100		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61354-082	CREAM (ZINC OXIDE, TITANIUM DIOXIDE) LOTION [OXYGEN DEVELOPMENT LLC]	1	Legacy NDC, 2 package rows	20220827_e724e098-f5c9-262a-e053-2995a90a2a02.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 203 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Basin Juicy Watermelon SPF 15 Broad Spectrum Sunscreen Lip Balm	AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	Retail Concepts of Minnesota, Inc.	3a8a093b-cc9c-26fc-e063-6394a90a2028	2025-07-22	Warnings	Exact identifier application number: M020
Basin Coconut SPF 15 Broad Spectrum Sunscreen Lip Balm	AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	Retail Concepts of Minnesota, Inc.	3a8a87d6-ef86-60c2-e063-6394a90a0706	2025-07-22	Warnings	Exact identifier application number: M020
Basin Eucalyptus Mint SPF 15 Broad Spectrum Sunscreen Lip Balm	AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	Retail Concepts of Minnesota, Inc.	3a8b773c-f456-836a-e063-6294a90a0d46	2025-07-22	Warnings	Exact identifier application number: M020
Basin Strawberry SPF 15 Broad Spectrum Sunscreen Lip Balm	AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	Retail Concepts of Minnesota, Inc.	3a8bc90d-350f-98c8-e063-6294a90abd9c	2025-07-22	Warnings	Exact identifier application number: M020
Basin Peach Apricot SPF 15 Broad Spectrum Sunscreen Lip Balm	AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	Retail Concepts of Minnesota, Inc.	3a8bd5d8-1c4c-0407-e063-6394a90a138f	2025-07-22	Warnings	Exact identifier application number: M020
CLEAR GLOW RADIANT SUN SERUM SPF50	AVOBENZONE 15MG/G, HOMOSALATE 5MG/G, OCTOCRYLENE 25MG/G, (SUNSCREEN)	NAKED SUNDAYS PTY LTD	d748e291-3a29-663c-e053-2995a90a8d92	2025-07-22	Warnings	Exact identifier application number: M020
La Defense Broad Spectrum SPF 30 Mineral Sunscreen	ZINC OXIDE, TITANIUM DIOXIDE	Luzern Laboratories, Inc	3f00befa-415d-415d-89e1-6ba8770ba51e	2025-07-21	Warnings	Exact identifier application number: M020
PREDIRE PARIS skin shield protector mineral defense cream	PREDIRE PARIS SKIN SHIELD PROTECTOR MINERAL DEFENSE CREAM	Guangzhou Fantesy Biotechnology Co.,Ltd	3a7c1345-532f-b38f-e063-6394a90a5245	2025-07-21	Warnings	Exact identifier application number: M020
Medicated Peppermint Lip Balm	DIMETHICONE, UNSPECIFIED, OCTINOXATE, AND OCTISALATE	Blistex Inc	5d48a6fa-ddce-47c3-9b09-1f3abb695017	2025-07-18	Warnings	Exact identifier application number: M020
ICD Moisture Layer Sunscreen	HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE	ICD Moisture Layer Sunscreen	3a2a74f2-9fed-808f-e063-6294a90a410c	2025-07-18	Warnings	Exact identifier application number: M020
Counter Beauty Dew Skin Tinted Moisturizer No. 2	ZINC OXIDE	G2G Ventures, PBC	3a35c95b-10eb-689f-e063-6394a90ae1d4	2025-07-18	Warnings	Exact identifier application number: M020
Counter Beauty Dew Skin Tinted Moisturizer No. 3	ZINC OXIDE	G2G Ventures, PBC	3a35bbb2-a1eb-346b-e063-6294a90a9078	2025-07-18	Warnings	Exact identifier application number: M020
Counter Beauty Dew Skin Tinted Moisturizer No. 4	ZINC OXIDE	G2G Ventures, PBC	3a35f23b-3732-db3c-e063-6294a90ae00c	2025-07-18	Warnings	Exact identifier application number: M020
Counter Beauty Dew Skin Tinted Moisturizer No. 5	ZINC OXIDE	G2G Ventures, PBC	3a35fd79-f4d3-5ccf-e063-6294a90a9798	2025-07-18	Warnings	Exact identifier application number: M020
Counter Beauty Dew Skin Tinted Moisturizer No. 6	ZINC OXIDE	G2G Ventures, PBC	3a360053-5863-95fe-e063-6394a90a45c5	2025-07-18	Warnings	Exact identifier application number: M020
Counter Beauty Dew Skin Tinted Moisturizer No. 8	ZINC OXIDE	G2G Ventures, PBC	3a362e05-3a1e-8059-e063-6294a90ad525	2025-07-18	Warnings	Exact identifier application number: M020
Counter Beauty Dew Skin Tinted Moisturizer No. 7	ZINC OXIDE	G2G Ventures, PBC	3a3621c2-709a-82fd-e063-6294a90a7a7e	2025-07-18	Warnings	Exact identifier application number: M020
Basin Pina Colada SPF 15 Broad Spectrum Sunscreen Lip Balm	AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	Retail Concepts of Minnesota, Inc	3a39ac31-85c9-5e04-e063-6394a90aa537	2025-07-18	Warnings	Exact identifier application number: M020
Basin American Pink Lemonade SPF 15 Broad Spectrum Sunscreen Lip Balm	AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	Retail Concepts of Minnesota, Inc.	3a3afeda-f235-eac2-e063-6294a90a5a93	2025-07-18	Warnings	Exact identifier application number: M020
Basin Chinese Mandarin SPF 15 Broad Spectrum Sunscreen Lip Balm	AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	Retail Concepts of Minnesota, Inc.	3a3b5f56-aa36-01c7-e063-6294a90a6d62	2025-07-18	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
61354-082-01	61354008201	1 TUBE in 1 CARTON (61354-082-01) > 100 mg in 1 TUBE	1 tube	2022-08-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SKIN TREAT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN	Oxygen Development LLC	2022-08-27	HUMAN OTC DRUG LABEL	1