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 25 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
O HUI DAY SHIELD PERFECT SUN BLACK BROAD SPECTRUM SPF 50 SUNSCREENOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDELG H&H Co., Ltd.52ba9423-8b9b-38f7-e063-6394a90a95da2026-05-26WarningsExact identifier
application number: M020
Odacite Color Balm - Frosted PetalZINC OXIDEOdacite52ba9423-8b9d-38f7-e063-6394a90a95da2026-05-26WarningsExact identifier
application number: M020
Iris and Romeo Weekend Skin Moisture Lip Balm - DawnZINC OXIDEIris and Romeo52bb700b-ff56-2286-e063-6394a90ac4582026-05-26WarningsExact identifier
application number: M020
Iris and Romeo Weekend Skin Moisture Lip Balm - CamelliaZINC OXIDEIris and Romeo52bb52ec-2cd7-f8cc-e063-6294a90aa61b2026-05-26WarningsExact identifier
application number: M020
Bubble Solar Mate Daily Mineral Sunscreen SPF 40ZINC OXIDEBubble Beauty, Inc.d2eca90f-9463-4d2f-975d-02f2802ded3e2026-05-26WarningsExact identifier
application number: M020
Plexus Sun Shield Hydrating Mineral Sunscreen SPF 30ZINC OXIDEPlexus Worldwide, LLC55c391fa-37c6-47a2-befd-12888eb5fc182026-05-26WarningsExact identifier
application number: M020
Iris and Romeo Weekend Skin Moisture Lip Balm - SuedeZINC OXIDEIris and Romeo52bb7505-a027-2533-e063-6294a90a25202026-05-26WarningsExact identifier
application number: M020
Kiehls Dermatologist Solutions Better Screen UV Serum Broad Spectrum SPF 50 Plus SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENELOreal USA Products Inc9c909ae0-0117-4675-afc2-533d542f36592026-05-26WarningsExact identifier
application number: M020
Iris and Romeo Weekend Skin Moisture Lip Balm - CarobZINC OXIDEIris and Romeo52bbe9da-37f8-b3ba-e063-6394a90a139e2026-05-26WarningsExact identifier
application number: M020
Iris and Romeo Weekend Skin Moisture Lip Balm - CameoZINC OXIDEIris and Romeo52bc0174-872d-445b-e063-6294a90ab3292026-05-26WarningsExact identifier
application number: M020
Iris and Romeo Weekend Skin Moisture Lip Balm - IconicZINC OXIDEIris and Romeo52bbfdfe-dfc9-364f-e063-6294a90a646d2026-05-26WarningsExact identifier
application number: M020
Bloomeffects Tulip Dew BronzeZINC OXIDEBloomeffects52bc7f23-3594-3173-e063-6294a90a81ea2026-05-26WarningsExact identifier
application number: M020
Bloomeffects Tulip DewZINC OXIDEBloomeffects0fcb1b45-c04d-310a-e063-6294a90ab56d2026-05-26WarningsExact identifier
application number: M020
Bloomeffects Tulipscreen Hydrating Lip Oil Mauve MomentZINC OXIDEBloomeffects52bd7522-81b5-6189-e063-6394a90a29b42026-05-26WarningsExact identifier
application number: M020
Bloomeffects Tulipscreen Hydrating Lip Oil BarelyZINC OXIDEBloomeffects52bd8a43-a8c2-897e-e063-6394a90a9f3d2026-05-26WarningsExact identifier
application number: M020
Bloomeffects Tulipscreen Hydrating Lip Oil Fruit PunchZINC OXIDEBloomeffects52bdc0ec-ac5e-4a57-e063-6294a90a0b3b2026-05-26WarningsExact identifier
application number: M020
Bloomeffects Tulipscreen Hydrating Lip Oil Tulipy PinkZINC OXIDEBloomeffects52bdc5cc-9742-4af6-e063-6294a90aba222026-05-26WarningsExact identifier
application number: M020
Alleyoop Sun Serum Lip Oil - DaylightZINC OXIDENewAlley Innovations Inc52be1071-67cb-f2c0-e063-6294a90a368c2026-05-26WarningsExact identifier
application number: M020
Alleyoop Sun Serum Lip Oil - HazyZINC OXIDENewAlley Innovations Inc52be3c9e-a791-5053-e063-6294a90a1b302026-05-26WarningsExact identifier
application number: M020
Alleyoop Sun Serum Lip Oil - WhirlwindZINC OXIDENewAlley Innovations Inc52be633a-fc64-7456-e063-6294a90a8fc02026-05-26WarningsExact 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