COTZ FACE MOISTURE

Product NDC
58892-360
11-digit product format
588920360
Labeler code
58892
Product ID
58892-360_509d9a74-bc8e-c9c1-e063-6394a90a403d
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
Fallien Cosmeceuticals Ltd.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-02-04
Substance
ZINC OXIDE
Active strength
160 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 · 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 productproduct58892-360UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage58892-36058892-360-42UExcluded 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 MOISTURE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE160 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
509d9a74-bc8d-c9c1-e063-6394a90a403dAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58892-360-42CoTZ Face Moisture1 in 1 CARTONCREAM13
58892-360-42CoTZ Face Moisture42.5 g in 1 TUBECREAM42.53
58892-360-18COTZ FACE MOISTURE5 g in 1 TUBECREAM51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58892-360COTZ FACE MOISTURE (ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD]3Current NDC, Legacy NDC, 2 package rows20250112_db682516-6c8f-4009-a9ec-e21dfc64ce15.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 110 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mattifying Mineral SPF40 TintedTITANIUM DIOXIDE, ZINC OXIDEELIZA ARAKELIAN36d4f6a7-1115-1efa-e063-6294a90a20c42025-12-17Exact identifier
application number: M020
Replenish SPF 40ZINC OXIDEELIZA ARAKELIAN36d69eb5-597d-14a0-e063-6394a90a0a492025-12-17Exact identifier
application number: M020
Mattifying Mineral SPF 40 TintedTITANIUM DIOXIDE, ZINC OXIDEELIZA ARAKELIAN36d45700-fc41-ef54-e063-6394a90abcc32025-12-17Exact identifier
application number: M020
Gentle Mineral SPF 40 TintedZINC OXIDEELIZA ARAKELIAN36d66cde-1f90-32b5-e063-6294a90acb342025-12-17Exact identifier
application number: M020
Replenish SPF 40ZINC OXIDEELIZA ARAKELIAN36d7148b-b1c4-a6a9-e063-6294a90af92f2025-12-17Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEHSC MIAMI, INC36d85902-fbd2-ba74-e063-6294a90acfc32025-12-17Exact identifier
application number: M020
DAY DEFENSETITANIUM DIOXIDE, ZINC OXIDETHE SKIN CARE SOURCE, INC.36ad1330-a8bf-e8f8-e063-6394a90acb022025-12-17Exact identifier
application number: M020
Non-Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEHSC MIAMI, INC36d9a8f3-7760-57f3-e063-6394a90a1a1e2025-12-17Exact identifier
application number: M020
Non-Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEHSC MIAMI, INC36d7a18b-5a12-84a9-e063-6394a90a7e382025-12-17Exact identifier
application number: M020
DAY DEFENSE TINTEDTITANIUM DIOXIDE, ZINC OXIDETHE SKIN CARE SOURCE, INC.36ad4442-e45f-90e2-e063-6294a90aeef52025-12-17Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEHSC MIAMI, INC36d8b849-cf73-e008-e063-6394a90a410a2025-12-17Exact identifier
application number: M020
TINTED RESTORATIVE MOISTURIZERZINC OXIDESKINERGIX LLC3636adf0-c3bd-7422-e063-6394a90aaccc2025-12-17Exact identifier
application number: M020
Premier ZincZINC OXIDEENSO SKINCARE & WELLNESS LLC3bb378c8-14b0-aa13-e063-6294a90a4db32025-12-17WarningsExact identifier
application number: M020
Protect and RenewZINC OXIDEENSO SKINCARE & WELLNESS LLC3bb479ed-1153-8e80-e063-6294a90a29372025-12-17WarningsExact identifier
application number: M020
Flawless FinishTITANIUM DIOXIDE, ZINC OXIDEENSO SKINCARE & WELLNESS LLC3b8df7ce-e5ce-aaf8-e063-6394a90afdae2025-12-17WarningsExact identifier
application number: M020
Shield Mineral Sunscreen TintedZINC OXIDESMOOTHE LLC369b9d76-f6c3-e25f-e063-6294a90adaf32025-12-17Exact identifier
application number: M020
Shield Mineral Sunscreen Non TintedZINC OXIDESMOOTHE LLC369bc20d-7192-7c0a-e063-6294a90a3dfe2025-12-17Exact identifier
application number: M020
Lip BalmTITANIUM DIOXIDE, ZINC OXIDEPATRICIA SOLIS MAKEUP ARTIST, LLC369d63a9-b9a9-9530-e063-6394a90ac8ef2025-12-17Exact identifier
application number: M020
Matte TintTITANIUM DIOXIDE, ZINC OXIDEPATRICIA SOLIS MAKEUP ARTIST, LLC369ced69-59b4-0f3c-e063-6294a90a582f2025-12-17Exact identifier
application number: M020
Hydra TintZINC OXIDEPATRICIA SOLIS MAKEUP ARTIST, LLC369d4e7a-8356-8f15-e063-6394a90acca82025-12-17Exact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58892-360-18588920360185 g in 1 TUBE (58892-360-18) 5 g2019-02-04NoNoCurrent
58892-360-42588920360421 TUBE in 1 CARTON (58892-360-42) / 42.5 g in 1 TUBE1 tube2019-02-040000-00-00NoNoCurrent