CoTZ Face Prime and Protect SPF 40 (Non-Tinted)

Product NDC
58892-348
11-digit product format
588920348
Labeler code
58892
Product ID
58892-348_9498c109-3155-481c-a847-975cb655f6bc
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
2018-11-15
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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct58892-348UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage58892-34858892-348-45UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…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 (Non-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
f106f52b-2157-46c7-9f7c-50f43a649050Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58892-348-45CoTZ Face Prime and Protect SPF 40 (Non-Tinted)42.5 g in 1 TUBECREAM42.52
58892-348-45CoTZ Face Prime and Protect SPF 40 (Non-Tinted)1 in 1 CARTONCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58892-348COTZ FACE PRIME AND PROTECT SPF 40 (NON-TINTED) (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD]2Current NDC, Legacy NDC, 2 package rows20250112_f106f52b-2157-46c7-9f7c-50f43a649050.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 162 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pipette Diaper RashZINC OXIDEPipette LLC2a93998c-1855-9207-e063-6294a90ab0e92025-11-14WarningsExact identifier
application number: M020
Ware Sonny UniversalTITANIUM DIOXIDE, ZINC OXIDEWare Cosmeticsfe2b9d16-9215-e21e-e053-6394a90a51562025-11-14WarningsExact identifier
application number: M020
YAY NOVELTY ALL-IN-ONETITANIUM DIOXIDE, ZINC OXIDEYAY Noveltyfb833158-d0d8-de7f-e053-6294a90adc5a2025-11-14WarningsExact identifier
application number: M020
Thu Brule Free Spirit Correct and ProtectTITANIUM DIOXIDE, ZINC OXIDELaughing Buddha LLC258a4f97-d811-0521-e063-6394a90aaf3b2025-11-14WarningsExact identifier
application number: M020
Alpha-H Total EclipseTITANIUM DIOXIDE, ZINC OXIDEAlpha-Hfc8a4efe-7d5e-5f44-e053-6394a90a80aa2025-11-14WarningsExact identifier
application number: M020
Svens Everyday Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESvens, Inc912170ae-124c-5eb9-e053-2995a90a0ba32025-11-14WarningsExact identifier
application number: M020
Wander Beauty Pack Up and Glow PrimingTITANIUM DIOXIDE, ZINC OXIDEWander Beauty3d844efc-091c-9a9b-e063-6294a90aee7c2025-11-14WarningsExact identifier
application number: M020
Baby Bare Republic Mineral SunscreenZINC OXIDECOOLA, LLCb292d1a9-7ff8-0faf-e053-2995a90ae3422025-11-14WarningsExact identifier
application number: M020
Aspen Islanders Sheer Mineral SportZINC OXIDEAspen Islanders LLC0fcb2adf-71c9-3369-e063-6294a90aa8062025-11-14WarningsExact identifier
application number: M020
By the Beach SuncareSPF 30 SUNCARE MALON DAZEBy the Beach Suncare LLC4391728b-dfe7-3ffb-e063-6394a90a240e2025-11-14WarningsExact identifier
application number: M020
By the Beach SuncareSPF 30 SUNCARE CITRUS CRUSHBy the Beach Suncare LLC43918d25-e947-5e17-e063-6394a90ada7c2025-11-14WarningsExact identifier
application number: M020
By the Beach SuncareSPF 30 SUNCARE CANDY CLOUDSBy the Beach Suncare LLC4391728b-dfe8-3ffb-e063-6394a90a240e2025-11-14WarningsExact identifier
application number: M020
Sunsolve MD Balance and ClearZINC OXIDESunsolve MD Inc26f3595d-adef-a8a5-e063-6394a90adfd42025-11-14WarningsExact identifier
application number: M020
Sunsolve MD Detox and ShieldZINC OXIDESunsolve MD Inc26f3886b-a3a5-c9b7-e063-6394a90af6c32025-11-14WarningsExact identifier
application number: M020
Sunsolve MD Mineral Shade Amber 002ZINC OXIDESunsolve MD Inc26e00001-9c68-0734-e063-6394a90a17872025-11-14WarningsExact identifier
application number: M020
Sunsolve MD Mineral Shade Agate 003ZINC OXIDESunsolve MD Inc26e00001-9c6f-0734-e063-6394a90a17872025-11-14WarningsExact identifier
application number: M020
Sunsolve MD Mineral Shade Bronzite 004ZINC OXIDESunsolve MD Inc26e13356-9ab5-246a-e063-6394a90a2a702025-11-14WarningsExact identifier
application number: M020
Sunsolve MD Mineral Shade Onyx 006ZINC OXIDESunsolve MD Inc26e16b5e-dd2e-6fb8-e063-6394a90a6a7f2025-11-14WarningsExact identifier
application number: M020
Sunsolve MD Calm and RevitalizeZINC OXIDESunsolve MD Inc26f3f534-a305-3530-e063-6394a90a75e12025-11-14WarningsExact identifier
application number: M020
Sunsolve MD Mineral Shade Garnet 005ZINC OXIDESunsolve MD Inc26e1508f-d386-329b-e063-6394a90a0a982025-11-14WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58892-348-45588920348451 TUBE in 1 CARTON (58892-348-45) / 42.5 g in 1 TUBE1 tube2018-11-150000-00-00NoNoCurrent