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
2026-12-31
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
2026-12-31

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 166 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
e.l.f Sun Boss Gloss SPF 25 Sunscreen Blush MuchZINC OXIDEe.l.f. Cosmetics, Inc.53d64042-f9ef-494d-a347-490c6a3c49b82025-11-07WarningsExact identifier
application number: M020
e.l.f. Suntouchable Invisi SPF 50OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONEe.l.f cosmetics,Inc.547eac8c-492e-4a6b-ac58-4f0d1e0ccb3d2025-11-07WarningsExact identifier
application number: M020
e.l.f Sun Boss Gloss SPF 25 Sunscreen Thats my JamZINC OXIDEe.l.f. Cosmetics, Inc.b7d56015-4734-4ce4-b40d-64236df810e32025-11-07WarningsExact identifier
application number: M020
elf Sun Boss Gloss SPF 25 Sunscreen Peachy KweenZINC OXIDEe.l.f. Cosmetics, Inc.4d9784b6-c54d-483d-a5ba-c557a05300ec2025-11-07WarningsExact identifier
application number: M020
ITP DAILY BAWSE CLEAN, TINTED SUNSCREEN SERUM SPF 28 ON THE GLOWZINC OXIDEIn The Pynk LLC13badac4-e310-9589-e063-6394a90ab06b2025-11-07WarningsExact identifier
application number: M020
ITP DAILY BAWSE CLEAN, TINTED SUNSCREEN SERUM SPF 28 GOLDEN HOURZINC OXIDEIn The Pynk LLC13bb8426-27cd-fbc9-e063-6294a90a8bf82025-11-07WarningsExact identifier
application number: M020
ITP DAILY BAWSE CLEAN, TINTED SUNSCREEN SERUM SPF 28 DEW YOUZINC OXIDEIn The Pynk LLC1365c6d8-64cb-3cb3-e063-6394a90a9d642025-11-07WarningsExact identifier
application number: M020
Well People Bio Tint SPF 30 Sunscreen 10wZINC OXIDEe.l.f. Cosmetics, Incc8a935e6-f7ac-4e3a-e053-2a95a90a877a2025-11-07WarningsExact identifier
application number: M020
Well People Bio Tint SPF 30 Sunscreen 11wZINC OXIDEe.l.f. Cosmetics, Incc8a94fb4-8752-587c-e053-2995a90a1e9a2025-11-07WarningsExact identifier
application number: M020
Well People Bio Tint SPF 30 Sunscreen 13wZINC OXIDEe.l.f. Cosmetics, Incc8a9bf6c-80cd-5884-e053-2a95a90a4a662025-11-07WarningsExact identifier
application number: M020
Well People Bio Tint SPF 30 Sunscreen 12wZINC OXIDEe.l.f. Cosmetics, Incc8a99278-21e0-c517-e053-2a95a90ade372025-11-07WarningsExact identifier
application number: M020
Well People Bio Tint SPF 30 Sunscreen 1CZINC OXIDEe.l.f. Cosmetics, Incc8a82c8b-e308-15e9-e053-2995a90afa2a2025-11-07WarningsExact identifier
application number: M020
Well People Bio Tint SPF 30 Sunscreen 14wZINC OXIDEe.l.f. Cosmetics, Incc8aa4629-1573-48a7-e053-2995a90aa86c2025-11-07WarningsExact identifier
application number: M020
Well People Bio Tint SPF 30 Sunscreen 2wZINC OXIDEe.l.f. Cosmetics, Inc.c8a82f54-839d-1de0-e053-2a95a90a2a972025-11-07WarningsExact identifier
application number: M020
Well People Bio Tint SPF 30 Sunscreen 4WZINC OXIDEe.l.f. Cosmetics, Incc8a83921-3181-396e-e053-2a95a90a02ee2025-11-07WarningsExact identifier
application number: M020
Well People Bio Tint SPF 30 Sunscreen 3NZINC OXIDEe.l.f. Cosmetics, Incc8aa6047-ce3e-59f7-e053-2a95a90a678e2025-11-07WarningsExact identifier
application number: M020
Well People Bio Tint SPF 30 Sunscreen 5NZINC OXIDEe.l.f. Cosmetics, Incc8aa6047-ce42-59f7-e053-2a95a90a678e2025-11-07WarningsExact identifier
application number: M020
Well People Bio Tint SPF 30 Sunscreen 6wZINC OXIDEe.l.f. Cosmetics, Incc8a8ef6f-4426-a981-e053-2a95a90a94512025-11-07WarningsExact identifier
application number: M020
Well People Lip Butter SPF 15 Sunscreen PEACHZINC OXIDEe.l.f. Cosmetics, Incc8aa931b-a3b4-6804-e053-2995a90a3eab2025-11-07WarningsExact identifier
application number: M020
Well People Bio Tint SPF 30 Sunscreen 7NZINC OXIDEe.l.f. Cosmetics, Incc8aa6047-ce45-59f7-e053-2a95a90a678e2025-11-07WarningsExact 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