Cream

Product NDC: 61354-083
Requested package NDC: 61354-083-01
11-digit product format: 613540083
Labeler code: 61354
Product ID: 61354-083_e7757228-2748-0ae5-e053-2a95a90ac31c
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

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	61354-083	61354-083-01	I	Inactivated by FDA		2026-10-21

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
61354-083-01	2025-01-30	C162847	48780-1	2cef2736-615a-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
61354-083-01	Cream	100 mg in 1 TUBE	CREAM	100		1
61354-083-01	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
61354-083	CREAM (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [OXYGEN DEVELOPMENT LLC]	1	Legacy NDC, 2 package rows	20220831_e7757228-2747-0ae5-e053-2a95a90ac31c.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 79 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
THE ENERGIST Multi-Defense Broad Spectrum Sunscreen SPF 50	ZINC OXIDE	Noble Panacea Labs, Inc.	aed57f81-4b7d-42dc-993e-6bb10f93b02a	2026-01-16	Warnings	Exact identifier application number: M020
BRUSH and GO SPF 50 ALL SKIN TYPES BROAD SPECTRUM	TITANIUM DIOXIDE, OCTINOXATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE, AND OXYBENZONE	Noon Aesthetics M.R. Ltd	0d9f132c-7630-4261-a0f8-fc7a4377731f	2026-01-16	Warnings	Exact identifier application number: M020
BRUSH and GO SPF 50 OILY/PROBLEMATIC SKIN BROAD SPECTRUM	TITANIUM DIOXIDE, OCTINOXATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE, AND OXYBENZONE	Noon Aesthetics M.R. Ltd	f292da7d-ffd2-41c3-9a64-619aab19ff18	2026-01-15	Warnings	Exact identifier application number: M020
Multivit Sun Protector	TITANIUM DIOXIDE, OCTOCRYLENE, AND AVOBENZONE	Noon Aesthetics M.R. Ltd	abdb560d-29be-41dc-ad23-54ea571acb14	2026-01-15	Warnings	Exact identifier application number: M020
BeautyBarrier	ZINC OXIDE	NAKED SUNDAYS PTY LTD	45740afa-230d-4dd5-e063-6394a90a102f	2026-01-15	Warnings	Exact identifier application number: M020
Glow This Way	OCTISALATE, OCTOCRYLENE, ZINC OXIDE, AVOBENZONE, HOMOSALATE	Koco Life LLC	4619cf96-987a-3e88-e063-6294a90afbe9	2026-01-15	Warnings	Exact identifier application number: M020
Reef safe lip balm 01	AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE	Cosmuses Cosmetics (Ningbo) Co., Ltd.	486930f2-026b-14b4-e063-6394a90aa031	2026-01-15	Warnings	Exact identifier application number: M020
DRAMATICALLY DIFFERENT MOISTURIZING LTN BROAD SPECTRUM SPF35	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	CLINIQUE LABORATORIES LLC	316bf6f8-7d30-2560-e063-6294a90afb8a	2026-01-15	Warnings	Exact identifier application number: M020
Wellcare Sunstick Lip Balm	AVOBENZONE, OCTINOXATE, OCTOCRYLENE, OCTISALATE	BAMKO, LLC	ef977575-7ef0-fc09-e053-2a95a90a8993	2026-01-15	Warnings	Exact identifier application number: M020
Bali Body Sheer Glow Sunscreen SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Bali Body Pty Ltd	4872793c-a7c0-1b65-e063-6394a90a8b3a	2026-01-15	Warnings	Exact identifier application number: M020
Getaway Glow SPF 30 Radiant Sunscreen Broad Spectrum SPF 30 Sunscreen	ZINC OXIDE	Volition Beauty	2631de4b-66e3-0547-e063-6394a90a822c	2026-01-15	Warnings	Exact identifier application number: M020
AGE RESET Restore Plus Protect Day Cream Broad Spectrum SPF 30	ZINC OXIDE	SKINN COSMETICS, LLC	350ed168-ab3b-f314-e063-6394a90a8bbf	2026-01-15	Warnings	Exact identifier application number: M020
StriVectin TL Advanced Tightening Neck and Chest Broad Spectrum SPF 35 Sunscreen	OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONE	StriVectin Operating Company, Inc.	4873a262-a19b-555e-e063-6394a90a182a	2026-01-15	Warnings	Exact identifier application number: M020
PINK BEACH SUNSCREEN BODY BROAD SPECTRUM SPF 50	SUNSCREEN	The Center Brands, LLC	e843bb6b-257f-4425-95bc-41774e032a09	2026-01-15	Warnings	Exact identifier application number: M020
SANTAL BLOOM SUNSCREEN BODY BROAD SPECTRUM SPF 50	SUNSCREEN	The Center Brands, LLC	1e18f1dd-a4e4-455a-9699-5634b9559678	2026-01-15	Warnings	Exact identifier application number: M020
First Aid Beauty Ultra Repair Hydrating Sunscreen Milk Broad Spectrum SPF 45	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	The Procter & Gamble Manufacturing Company	485c345f-0928-fa1a-e063-6294a90aa856	2026-01-14	Warnings	Exact identifier application number: M020
NELLY DEVUYST BIOSOLAR COLORLIFT 3 TINTED SUNSCREEN SPF30	ZINC OXIDE	LABORATOIRES DRUIDE INC	19af4441-31b2-72db-e063-6394a90a813c	2026-01-14	Warnings	Exact identifier application number: M020
Sqween Paint-On Sun Protection for Independent Kids Mineral Sunscreen SPF 30	ZINC OXIDE	Sqween LLC	9c3cf35b-4bde-46e3-8abd-5f4d1ad6e486	2026-01-14	Warnings	Exact identifier application number: M020
SCENTUAL AROMA BEAUTY SUN VEIL SPF30	TITANIUM DIOXIDE, ZINC OXIDE	LABORATOIRES DRUIDE INC	0799ac38-9a41-6579-e063-6394a90ac4b6	2026-01-14	Warnings	Exact identifier application number: M020
NUDA CANADA SOLARGLOW MINERAL SERUM SUNSCREEN SPF30	ZINC OXIDE	LABORATOIRES DRUIDE INC	0b412e24-baf6-e68e-e063-6394a90a5f49	2026-01-14	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
61354-083-01	61354008301	1 TUBE in 1 CARTON (61354-083-01) > 100 mg in 1 TUBE	1 tube	2022-08-30	0000-00-00	No	No	Current