FDA.reportPublic FDA data

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 169 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Indie Lee Daily PrimerZINC OXIDEAmerica Exchange38e5232b-7daf-7e61-e063-6394a90aa5b02025-11-06WarningsExact identifier
application number: M020
Duette UntintedZINC OXIDESkin Theory Studios3ce24b39-8bb1-1246-e063-6294a90a32d42025-11-06WarningsExact identifier
application number: M020
Duette TintedZINC OXIDESkin Theory Studios3ce1d7cb-b37d-fb9f-e063-6394a90aaef32025-11-06WarningsExact identifier
application number: M020
Truskin Broad Spectrum Mineral Sunscreen Facial Serum with Vitamin C and AloeZINC OXIDEAllure Labs42f3999f-4163-fadc-e063-6294a90aacf32025-11-06WarningsExact identifier
application number: M020
Melan RXZINC OXIDEMelan RXf4bdf20c-b6bc-55f1-e053-2995a90ac3082025-11-06WarningsExact identifier
application number: M020
ESIKA HYDRACOLOR 2 IN 1 SPF 25 (FUCSIA CAUTIVANTE EXOTIC) - PINKOCTINOXATE AND OXYBENZONEVentura Corporation LTDe1eb77f1-d65c-4af8-a7d9-90f10570960f2025-11-06WarningsExact identifier
application number: M020
Ultraceuticals Ultra UV Protective Daily MoisturisingZINC OXIDEUltraceuticalsfc8a5c02-23b4-b4d8-e053-6294a90a55ea2025-11-06WarningsExact identifier
application number: M020
Vaihea Protect Clean SPF DropsZINC OXIDEVaihea Skincare LLCfe7e3145-a8e2-d14f-e053-6394a90abb5e2025-11-06WarningsExact identifier
application number: M020
Refy Skin TrioZINC OXIDERefy3029a690-dbb0-ff15-e063-6394a90abdbe2025-11-06WarningsExact identifier
application number: M020
Stream2Sea Broad Spectrum 20TITANIUM DIOXIDEStream2Sea, LLC1775d07d-6914-6928-e054-00144ff88e882025-11-06WarningsExact identifier
application number: M020
PHYSICAL TINTED MOISTURIZER SPF44ZINC OXIDE, TITANIUM DIOXIDEDrmtlgy, LLC483d0d28-56f3-4b37-af03-0331e1653d732025-11-06WarningsExact identifier
application number: M020
Neutrogena Rapid Wrinkle Repair Retinol Moisturizer Sunscreen Broad Spectrum SPF 30 DayAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLCd3ebe2a9-434e-497c-8fed-b5c73c70a58b2025-11-05WarningsExact identifier
application number: M020
Clear Smart Shine Control Sunscreen Broad Spectrum SPF 25AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEDistribuidora Comercial Jafra, S.A. de C.V.a57bcf44-580d-520e-e053-2a95a90a69232025-11-05WarningsExact identifier
application number: M020
Spa Niacinamide And Vitamin E Hand Cream Broad Spectrum SPF 15AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEDistribuidora Comercial Jafra, S.A. de C.V.865057ce-f617-4232-a60e-e23c120b0a732025-11-05WarningsExact identifier
application number: M020
Revitalize Solar Protection Fluid Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEDistribuidora Comercial Jafra, S.A. de C.V.29b3ee35-e849-4427-a455-37d92c4b995c2025-11-05WarningsExact identifier
application number: M020
Sarah Creal Brilliant Repair ShieldZINC OXIDESarah Creal LLC258ab6f2-f1a7-2d0d-e063-6294a90af34a2025-11-05WarningsExact identifier
application number: M020
Perricone MD Cold Plasma Plus Neck and Chest Broad Spectrum SPF 25TITANIUM DIOXIDETHG Beauty USA LLC23a55301-2277-6e4f-e063-6394a90af1712025-11-05WarningsExact identifier
application number: M020
Sun Bum Face and Body Stick 40AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC20d9d60d-e0ce-a177-e063-6394a90a162e2025-11-05WarningsExact identifier
application number: M020
Obagi Nu-Derm Fx System Normal-Dry Skin Transformation Complexion Brightening SystemTITANIUM DIOXIDE, ZINC OXIDEObagi Cosmeceuticals LLC4cbf1dc6-78b3-4e51-a53f-2018ac88136a2025-11-04WarningsExact identifier
application number: M020
SUNBEAT PROCARE FPS 50 KIDSHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE, ENSULIZOLETecnoglobal, PH7 S.A. DE C.V.42c74ddf-70a3-f2b1-e063-6294a90a91a92025-11-04WarningsExact 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