powder

Product NDC: 61354-061
11-digit product format: 613540061
Labeler code: 61354
Product ID: 61354-061_bc059598-5988-3d4c-e053-2995a90a0e28
Type: HUMAN OTC DRUG
Nonproprietary name: Zinc Oxide, Titanium Dioxide
Dosage form: POWDER
Route: TOPICAL
Labeler: Oxygen Development
Application: part352
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2021-02-23
Marketing end: 0000-00-00
Substance: TITANIUM DIOXIDE; ZINC OXIDE
Active strength: 15 g/100g; g/100g
NDC exclude flag: No
Listing certified through: 2022-12-31
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 · 8 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	61354-061		I	Inactivated by FDA	2026-10-05
excluded product	product	61354-061		I	Inactivated by FDA	2026-10-05
excluded product	product	61354-061		I	Inactivated by FDA	2026-10-05
excluded product	product	61354-061		I	Inactivated by FDA	2026-10-05
excluded package	package	61354-061	61354-061-04	D	Discontinued by firm	2026-10-05
excluded package	package	61354-061	61354-061-03	D	Discontinued by firm	2026-10-05
excluded package	package	61354-061	61354-061-02	D	Discontinued by firm	2026-10-05
excluded package	package	61354-061	61354-061-01	D	Discontinued by firm	2026-10-05

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 2 · 84 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 product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
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 product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61354-061-03	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61354-061-01	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61354-061-04	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61354-061-02	D	Discontinued by firm	`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 product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
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 product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61354-061-03	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61354-061-01	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61354-061-04	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61354-061-02	D	Discontinued by firm	`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 product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
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 product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61354-061-03	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61354-061-01	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61354-061-04	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61354-061-02	D	Discontinued by firm	`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 product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
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 product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61354-061-03	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61354-061-01	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61354-061-04	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61354-061-02	D	Discontinued by firm	`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 product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
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 product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61354-061-03	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61354-061-01	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61354-061-04	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61354-061-02	D	Discontinued by firm	`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 product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
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 product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61354-061-03	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61354-061-01	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61354-061-04	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61354-061-02	D	Discontinued by firm	`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 product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
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 product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61354-061-03	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61354-061-01	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61354-061-04	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61354-061-02	D	Discontinued by firm	`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 product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
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 product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Indexing SPL table
NDC	Effective	Indexing SPL	Related label
61354-061-01	2025-01-30	f386c64a-1cce-0266-e053-dadaa90a7c1a	Touch Behold SPF FINISHING POWDER BROAD SPECTRUM SPF 25
61354-061-02	2025-01-30	f386c649-d614-0266-e053-dadaa90a7c1a	Touch Behold SPF FINISHING POWDER BROAD SPECTRUM SPF 25
61354-061-03	2025-01-30	f386c649-c25b-0266-e053-dadaa90a7c1a	Touch Behold SPF FINISHING POWDER BROAD SPECTRUM SPF 25
61354-061-04	2025-01-30	f386c64a-08ea-0266-e053-dadaa90a7c1a	Touch Behold SPF FINISHING POWDER BROAD SPECTRUM SPF 25
61354-061-01	2023-02-10	f386c64a-1cce-0266-e053-dadaa90a7c1a	Touch Behold SPF FINISHING POWDER BROAD SPECTRUM SPF 25
61354-061-02	2023-02-10	f386c649-d614-0266-e053-dadaa90a7c1a	Touch Behold SPF FINISHING POWDER BROAD SPECTRUM SPF 25
61354-061-03	2023-02-10	f386c649-c25b-0266-e053-dadaa90a7c1a	Touch Behold SPF FINISHING POWDER BROAD SPECTRUM SPF 25
61354-061-04	2023-02-10	f386c64a-08ea-0266-e053-dadaa90a7c1a	Touch Behold SPF FINISHING POWDER BROAD SPECTRUM SPF 25
61354-061-01	2023-01-30	f386c64a-1cce-0266-e053-dadaa90a7c1a	Touch Behold SPF FINISHING POWDER BROAD SPECTRUM SPF 25
61354-061-02	2023-01-30	f386c649-d614-0266-e053-dadaa90a7c1a	Touch Behold SPF FINISHING POWDER BROAD SPECTRUM SPF 25
61354-061-03	2023-01-30	f386c649-c25b-0266-e053-dadaa90a7c1a	Touch Behold SPF FINISHING POWDER BROAD SPECTRUM SPF 25
61354-061-04	2023-01-30	f386c64a-08ea-0266-e053-dadaa90a7c1a	Touch Behold SPF FINISHING POWDER BROAD SPECTRUM SPF 25

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
61354-061-01	powder	4 g in 1 BOTTLE, PLASTIC	POWDER	4	2
61354-061-01	powder	1 in 1 CARTON	POWDER	1	2
61354-061-02	powder	1 in 1 CARTON	POWDER	1	2
61354-061-02	powder	4 g in 1 BOTTLE, PLASTIC	POWDER	4	2
61354-061-03	powder	4 g in 1 BOTTLE, PLASTIC	POWDER	4	2
61354-061-03	powder	1 in 1 CARTON	POWDER	1	2
61354-061-04	powder	1 in 1 CARTON	POWDER	1	2
61354-061-04	powder	4 g in 1 BOTTLE, PLASTIC	POWDER	4	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61354-061	POWDER (ZINC OXIDE, TITANIUM DIOXIDE) POWDER [OXYGEN DEVELOPMENT]	2	Legacy NDC, 2 package rows	20230211_bc058d19-4ec8-d727-e053-2a95a90afee0.zip
61354-061	POWDER (ZINC OXIDE, TITANIUM DIOXIDE) POWDER [OXYGEN DEVELOPMENT]	2	Legacy NDC, 2 package rows	20230211_bc05d708-7eae-c871-e053-2995a90afead.zip
61354-061	POWDER (ZINC OXIDE, TITANIUM DIOXIDE) POWDER [OXYGEN DEVELOPMENT]	2	Legacy NDC, 2 package rows	20230211_bc032168-a5e8-0868-e053-2a95a90abc61.zip
61354-061	POWDER (ZINC OXIDE, TITANIUM DIOXIDE) POWDER [OXYGEN DEVELOPMENT]	2	Legacy NDC, 2 package rows	20230211_bc04e6fa-2705-68b2-e053-2995a90a1c13.zip

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	Marketing start	Marketing end	Sample	Exclude flag	Status
61354-061-01	61354006101	1 BOTTLE, PLASTIC in 1 CARTON (61354-061-01) > 4 g in 1 BOTTLE, PLASTIC	2021-02-23	0000-00-00	No	No	Current
61354-061-02	61354006102	1 BOTTLE, PLASTIC in 1 CARTON (61354-061-02) > 4 g in 1 BOTTLE, PLASTIC	2021-02-23	0000-00-00	No	No	Current
61354-061-03	61354006103	1 BOTTLE, PLASTIC in 1 CARTON (61354-061-03) > 4 g in 1 BOTTLE, PLASTIC	2021-02-23	0000-00-00	No	No	Current
61354-061-04	61354006104	1 BOTTLE, PLASTIC in 1 CARTON (61354-061-04) > 4 g in 1 BOTTLE, PLASTIC	2021-02-23	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Touch Behold SPF FINISHING POWDER BROAD SPECTRUM SPF 25	Oxygen Development	2023-02-10	HUMAN OTC DRUG LABEL	2
Touch Behold SPF FINISHING POWDER BROAD SPECTRUM SPF 25	Oxygen Development	2023-02-10	HUMAN OTC DRUG LABEL	2
Touch Behold SPF FINISHING POWDER BROAD SPECTRUM SPF 25	Oxygen Development	2023-02-10	HUMAN OTC DRUG LABEL	2
Touch Behold SPF FINISHING POWDER BROAD SPECTRUM SPF 25	Oxygen Development	2023-02-10	HUMAN OTC DRUG LABEL	2