CoTZ Face Prime and Protect SPF 40 (Tinted)

Product NDC
58892-354
11-digit product format
588920354
Labeler code
58892
Product ID
58892-354_87f5edec-e860-418b-99d8-317d57624d1b
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide, Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
Fallien Cosmeceuticals, LTD
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-06-26
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
80; 38 mg/g; mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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 · 4 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage58892-354-45ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage58892-354-450efc9e666f02…f202fb6c5f17…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
CoTZ Face Prime and Protect SPF 40 (Tinted)
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE80 mg/g
ZINC OXIDE38 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
15FIX9V2JPInternal UNII lookup
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1088fbf6-5790-490d-b272-ec281b4b76faAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58892-354-45CoTZ Face Prime and Protect SPF 40 (Tinted)1 in 1 CARTONCREAM12
58892-354-45CoTZ Face Prime and Protect SPF 40 (Tinted)42.5 g in 1 TUBECREAM42.52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58892-354COTZ FACE PRIME AND PROTECT SPF 40 (TINTED) (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD]2Current NDC, Legacy NDC, 2 package rows20250124_1088fbf6-5790-490d-b272-ec281b4b76fa.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 191 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cica Redness Solution SunscreenZINC OXIDEMeebak Beauty, Inc15eea1eb-9468-4611-915d-e43112c4a4f52025-08-18WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE/OCTOCRYLENEEdgewell Personal Care Brands LLC3c936ed0-ab7a-ccec-e063-6294a90afd932025-08-17WarningsExact identifier
application number: M020
Banana BoatAVOBENZONE OCTOCRYLENE OXYBENZONEEdgewell Personal Care Brands LLC0f772b91-e67b-46cf-e054-00144ff8d46c2025-08-17WarningsExact identifier
application number: M020
BANANA BOATAVOBENZONE, OCTOCRYLENE, OXYBENZONEEdgewellPersonal Care Brands LLC353353b9-54f8-4300-9632-7615de3940762025-08-17WarningsExact identifier
application number: M020
BANANA BOATAVOBENZONE, HOMOSALATE, OCTOCRYLENEEdgewell Personal Care Brands LLC0c6aeadb-f61d-29e3-e063-6294a90a74732025-08-17WarningsExact identifier
application number: M020
MOISTURE SURGE SPFAVOBENZONE,HOMOSALATE,OCTINOXATE,OCTISALATECLINIQUE LABORATORIES LLCec921e21-db68-db77-e053-2a95a90a57812025-08-15WarningsExact identifier
application number: M020
Olay Invisible Sunscreen Facial Primer plus Sunscreen Broad Spectrum SPF 35AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEThe Procter & Gamble Manufacturing Company3c69f096-1575-309b-e063-6394a90a72292025-08-15WarningsExact identifier
application number: M020
MOISTURE SURGE CC BROAD SPECTRUM SPF 30 HYDRATING COLOUR CORRECTOROCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, AND ZINC OXIDECLINIQUE LABORATORIES LLCea4d564f-ac64-abac-e053-2a95a90a8abb2025-08-15WarningsExact identifier
application number: M020
Sun Bum Tinted Sunscreen Lip Balm Broad Spectrum SPF 15 - Sunset Cove CardedHOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDESun Bum, LLC3ac67c26-d56e-32a9-e063-6294a90a10482025-08-15WarningsExact identifier
application number: M020
Sun Bum Signature High Performance Mineral Sunscreen Broad Spectrum SPF 50ZINC OXIDESun Bum, LLC3aa13423-045a-7227-e063-6294a90ae49b2025-08-15WarningsExact identifier
application number: M020
Sun Bum Daily Sunscreen Mist Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3a796a0b-8021-9a9f-e063-6294a90a6eb22025-08-15WarningsExact identifier
application number: M020
SOLARA SUNCARE - DAY DREAMER SPF 30ZINC OXIDESOLARA SUNCARE, INC.3c6c9266-a7ff-19f4-e063-6294a90a60962025-08-15WarningsExact identifier
application number: M020
Sun Bum Mineral 30 Sheer Sunscreen FaceZINC OXIDESun Bum, LLC3b00c2d6-a55d-0a56-e063-6294a90ac4b82025-08-15WarningsExact identifier
application number: M020
Sun Bum Mineral 30 Sunscreen 3 OZZINC OXIDESun Bum, LLC3b014bd6-ba40-9003-e063-6394a90ab4512025-08-15WarningsExact identifier
application number: M020
Ocean Potion Suncare Mineral 30 Zinc Oxide SunscreenZINC OXIDEGNL BRANDS INTERNATIONAL, LLC3c6e7e62-4313-cbce-e063-6394a90ac3822025-08-15WarningsExact identifier
application number: M020
Ocean Potion Face with Clear Zinc Oxide Broad Spectrum SPF 50 SunscreenOCTOCRYLENE, ZINC OXIDEGNL BRANDS INTERNATIONAL, LLC3c6f3e0b-2dff-6dc3-e063-6394a90abb0e2025-08-15WarningsExact identifier
application number: M020
EltaMD UV Daily HydrationOCTISALATE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc.bfdb266b-9920-4225-84c7-bcbad81fd1c72025-08-15WarningsExact identifier
application number: M020
Sun Bum 70 Premium Moisturizing Sunscreen 8 OZAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC39fb5e66-5172-3b83-e063-6394a90aab2d2025-08-14WarningsExact identifier
application number: M020
Sun Bum Face Cream 50 Premium SunscreenHOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDESun Bum, LLC3c57fcf7-7816-8197-e063-6394a90af80a2025-08-14WarningsExact identifier
application number: M020
Sun Bum 50 Premium Moisturizing Sunscreen Roll-OnAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3c58c9c7-ca9e-d012-e063-6394a90a5aa92025-08-14WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58892-354-45588920354451 TUBE in 1 CARTON (58892-354-45) / 42.5 g in 1 TUBE1 tube2021-05-010000-00-00NoNoCurrent