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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct45634-167IInactivated by FDA2026-11-06
excluded packagepackage45634-16745634-167-31IInactivated by FDA2026-11-06

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 dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage45634-167-31IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage45634-167-31IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage45634-167-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage45634-167-31IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage45634-167-31IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage45634-167-31IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage45634-167-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage45634-167-31UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage45634-167-31UExcluded because listing certification expired0efc9e666f02…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
NDCEffectiveActionDocumentIndexing SPLRelated label
45634-167-312025-01-30C16284748780-12cef2736-aa5e-d83d-e063-dadaa90ab31fdb954edf-f530-3bbd-e053-2995a90a8ebe

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45634-167-31Cold Plasma Plus Neck and Chest SPF258 g in 1 BOTTLE, GLASSCREAM84

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45634-167COLD PLASMA PLUS NECK AND CHEST SPF25 (TITANIUM DIOXIDE) CREAM [NV PERRICONE LLC]4Legacy NDC, 1 package rows20230906_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 342 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sheer Tint Mineral Sunscreen Broad Spectrum SPF 50 - Light/Medium ShadeSPF 50 SUNSCREEN BROAD SPECTRUM - LIGHT/MEDIUM SHADEAutumn Harpfd6807e1-c8c0-b361-e053-6294a90aea0c2023-06-05WarningsExact identifier
application number: M020
Thinksport Clear Zinc SPF 50ZINC OXIDEthinkOperations,LLCb5ce523f-eee8-f1a8-da19-b3dc14f8a58e2023-05-31WarningsExact identifier
application number: M020
Thinksport Mineral SPF 50ZINC OXIDE AND TITANIUM DIOXIDEthinkOperations,LLC77b63c0b-353b-4f5f-95c7-6f7eeab814712023-05-30WarningsExact identifier
application number: M020
Think Kids Mineral SPF 50ZINC OXIDE AND TITANIUM DIOXIDEthinkOperations,LLC25c59820-a08d-4abe-87ae-a787ac8b2ac22023-05-30WarningsExact identifier
application number: M020
Topix Mineral Mattifying Tinted Sunscreeninted SPF 50ZINC OXIDETopiderm, Inc.46c6f20f-4bb6-47c6-9eac-17ca97bb14a72023-03-20WarningsExact identifier
application number: M020
Replenix Sunscreen SPF 50ZINC OXIDETopiderm, Inc.9223ffa8-7af3-4407-9170-482afec536d82023-02-24WarningsExact identifier
application number: M020
Bath and Body Works SPF20 Coconut Lip BalmSPF20 LIP BALMAutumn Harpf5744a48-2b39-4949-e053-2a95a90ab15d2023-02-24WarningsExact identifier
application number: M020
Replenix Tinted Sunscreen SPF 50ZINC OXIDE AND OCTINOXATETopiderm, Inc.1fda4a54-e323-4f3c-b659-bded4b1b3dd02023-02-22WarningsExact identifier
application number: M020
Topix Mineral Mattifying Tinted Sunscreen SPF 50ZINC OXIDETopiderm, Inc.ac5bbf3f-e1e0-4e03-bc5a-d6029dfb4e912023-02-22WarningsExact identifier
application number: M020
Mineral Sunscreen SPF 50ZINC OXIDE TITANIUM DIOXIDETopiderm, Inc.3a637542-0f79-47ae-815d-84d0036c737a2023-02-13WarningsExact identifier
application number: M020
Essential Moisturizing SunscreenZINC OXIDE, OCTINOXATETopiderm, Inc.450d916e-4c77-489e-86b1-78b6863554762023-02-09WarningsExact identifier
application number: M020
Mineral Repair SPF 45ZINC OXIDETopiderm, Inc.84580f10-3119-4253-87a6-53d24a1f22272023-02-07WarningsExact identifier
application number: M020
Think Aloe and Tea Leaves Zinc oxideZINC OXIDEthinkOperations,LLC9965ccd1-821d-4d9d-8a56-e87440b809ee2023-02-02WarningsExact identifier
application number: M020
Replenix Lip Therapy homosalateHOMOSALATETopiderm, Inc.b60dc004-d713-47bc-a6e9-ea4783aa70192023-02-02WarningsExact identifier
application number: M020
Josie Maran Argan Daily Moisturizer SPF47ZINC OXIDE, TITANIUM DIOXIDEAutumn Harp, Inc.027821e6-db7d-4c03-956a-00313488ebc72023-01-14Boxed warning, WarningsExact identifier
application number: M020
Tinted Lip Balm SPF30 Wild PeonySPF30 LIP BALMAutumn Harpd0604720-623a-e8a9-e053-2995a90ab0e62023-01-10WarningsExact identifier
application number: M020
Basin French Pear SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENERetail Concepts of Minnesota, Inc.3a39d91c-2dcf-71d6-e063-6394a90a54742022-02-10WarningsExact identifier
application number: M020
Basin Mexican Vanilla SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENERetail Concepts of Minnesota, Inc.3a3a63d3-c7e0-bf03-e063-6394a90a16622022-02-10WarningsExact identifier
application number: M020
Basin Norwegian Berry SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENERetail Concepts of Minnesota, Inc.3a3c0aa0-7501-7ef0-e063-6294a90a9f942022-02-10WarningsExact identifier
application number: M020
Marcelle CC Cream Complete Correction Sunscreen Broad Spectrum SPF 35OCTINOXATE AND OXYBENZONEGroupe Marcelle Inc.c24ac3ad-b2e2-4381-bd80-a499da0e06702021-12-14WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45634-167-31456340167318 g in 1 BOTTLE, GLASS (45634-167-31) 8 g2022-04-010000-00-00NoNoCurrent