Cold Plasma Plus Neck and Chest SPF25

Product NDC: 45634-167
11-digit product format: 456340167
Labeler code: 45634
Product ID: 45634-167_dbd71b03-b2f6-2a75-e053-2a95a90ad3eb
Type: HUMAN OTC DRUG
Nonproprietary name: titanium dioxide
Dosage form: CREAM
Route: TOPICAL
Labeler: NV Perricone LLC
Application: M020
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2022-04-01
Marketing end: 0000-00-00
Substance: TITANIUM DIOXIDE
Active strength: 1 g/30g
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	45634-167		I	Inactivated by FDA		2026-11-02
excluded package	package	45634-167	45634-167-31	I	Inactivated by FDA		2026-11-02

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	45634-167-31	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	45634-167-31	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	45634-167-31	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	45634-167-31	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	45634-167-31	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	45634-167-31	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	45634-167-31	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	45634-167-31	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	45634-167-31	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
45634-167-31	2025-01-30	C162847	48780-1	2cef2736-aa5e-d83d-e063-dadaa90ab31f	db954edf-f530-3bbd-e053-2995a90a8ebe

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
45634-167-31	Cold Plasma Plus Neck and Chest SPF25	8 g in 1 BOTTLE, GLASS	CREAM	8		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
45634-167	COLD PLASMA PLUS NECK AND CHEST SPF25 (TITANIUM DIOXIDE) CREAM [NV PERRICONE LLC]	4	Legacy NDC, 1 package rows	20230906_db954edf-f530-3bbd-e053-2995a90a8ebe.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 205 of 352 · 7,030 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Vine Vera Resveratrol Cabernet Replenishing Moisture	OCTINOXATE, HOMOSALATE, OCTISILATE, OXYBENZONE AND AVOBENZONE	Innovation Brands Inc.	c48a7346-3971-4946-b527-a5549a98e246	2025-07-07	Warnings	Exact identifier application number: M020
Lavelier Divine Day Defense Broad Spectrum SPF 30	OCTINOXATE, HOMOSALATE, OCTISILATE, OXYBENZONE AND AVOBENZONE	Innovation Brands Inc.	1f33a93f-ae3f-4024-9d23-26b01eed1764	2025-07-03	Warnings	Exact identifier application number: M020
HIGHHEAT Sunscreen SPF 50 Performance For Athletes	AVOBENZONE, OCTISALATE, OCTOCRYLENE	DUGOUT ESSENTIALS LLC	3b7cddb5-00d2-4998-8eec-5e5a7c5a6097	2025-07-03	Warnings	Exact identifier application number: M020
Mineral Lip Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	CAPE COD SKIN CARE CO. INC.	39093b2d-3fbb-8378-e063-6294a90ac6d8	2025-07-03		Exact identifier application number: M020
Neutrogena Clear Face Serum Sunscreen Broad Spectrum SPF 60	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Kenvue Brands LLC	09ccb37b-78ee-b510-e063-6294a90a48d5	2025-07-01	Warnings	Exact identifier application number: M020
First Aid Beauty FAB Ultra Light Mineral Sunscreen Broad Spectrum SPF 30	ZINC OXIDE	Port Jervis Laboratories, Inc.	4b442fdf-a9cf-7e5a-e063-6394a90a9e1e	2025-07-01	Warnings	Exact identifier application number: M020
Sincerely Yours Sunny Side Up Mineral Sunscreen Broad Spectrum SPF 30	ZINC OXIDE	Sincerely Yours Inc.	4c9dfa22-70f7-83f6-e063-6394a90aa8c5	2025-07-01	Warnings	Exact identifier application number: M020
Nova Bright Skin SPF 30	OCTINOXATE, HOMOSALATE, OCTISALATE, OXYBENZONE, AVOBENZONE	Innovation Brands Inc.	1c201147-7a54-41b5-bdf0-394e3d7efc0c	2025-07-01	Warnings	Exact identifier application number: M020
Introstem Vitiscell Facial Shield	OCTINOXATE, HOMOSALATE, OCTISALATE, OXYBENZONE AND AVOBENZONE	Innovation Brands Inc.	65c28ed6-649d-41d9-b214-aab6ccb02dd5	2025-07-01	Warnings	Exact identifier application number: M020
Bath and Body Works SPF Tahiti Isle	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Bath & Body Works, Inc.	38d049b4-557f-724a-e063-6394a90a19b3	2025-06-30	Warnings	Exact identifier application number: M020
Bath and Body Works SPF Tahiti Isle	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Bath & Body Works, Inc.	2f74965f-3c84-0590-e063-6294a90af267	2025-06-30	Warnings	Exact identifier application number: M020
Bath and Body Works SPF Tahiti Isle	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Bath & Body Works, Inc.	38d0d165-e981-284a-e063-6294a90acace	2025-06-30	Warnings	Exact identifier application number: M020
LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE TOLERAINE DOUBLE REPAIR MATTE MOISTURIZER UV BROAD SPECTRUM SPF 30 FOR OILY, COMBINATION SKIN	AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE	LOreal USA Products Inc	a3dc6195-3011-4e7f-b1b0-0c815b11ba8d	2025-06-30	Warnings	Exact identifier application number: M020
Youth to the People Youthscreen Sunscreen Broad Spectrum SPF 60	AVOBENZONE, HOMOSALATE AND OCTISALATE	LOreal USA Products Inc	5712df74-5201-474b-bbfd-703f3117bd9c	2025-06-30	Warnings	Exact identifier application number: M020
BINDA Vitamin C and hyaluronic acid Sunscreen SPF50	ZINC OXIDE SUNSCREEN	VEGANIC SKN LIMITED	38bff6d0-5690-3ee5-e063-6294a90a9faa	2025-06-29	Warnings	Exact identifier application number: M020
Vertra S Dorian Kona Gold Signature Face Stick SPF 38	TITANIUM DIOXIDE	Toshiki Pigment Co., ltd.	b7162a2f-07f1-6188-e053-2995a90a8a9c	2025-06-27	Warnings	Exact identifier application number: M020
Orchidee Double Defense Skin Shield	OCTINOXATE, HOMOSALATE, OCTISALATE, OXYBENZONE AND AVOBENZONE	Innovation Brands Inc.	74b3c33f-5db5-460d-97be-fa495b625249	2025-06-27	Warnings	Exact identifier application number: M020
GHOSTED	ZINC OXIDE	Spooge	a5b611c3-d4d3-461e-84d8-d04a29c74902	2025-06-26	Warnings	Exact identifier application number: M020
Dew Me	ZINC OXIDE	Spooge	0c4b429b-7dd5-4929-95af-d02b6770f121	2025-06-26	Warnings	Exact identifier application number: M020
Zinc FIVE-0 baby and kids mineral sunscreen SPF50	ZINC OXIDE SUNSCREEN	VEGANIC SKN LIMITED	38744f77-4845-eac4-e063-6294a90af648	2025-06-26	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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
45634-167-31	45634016731	8 g in 1 BOTTLE, GLASS (45634-167-31)	8 g	2022-04-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cold Plasma Plus Neck and Chest SPF25 - NV Perricone LLC	NV Perricone LLC	2023-09-05	HUMAN OTC DRUG LABEL	4