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 35 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
THANKYOU FARMER Sun Project Soothing SunOCTISALATE, OCTINOXATE, OCTOCRYLENE, AVOBENZONE, HOMOSALATETHANK YOU FARMER CO., LTD300ab1bc-9c11-c2f0-e063-6394a90aa8532026-05-06WarningsExact identifier
application number: M020
Sheer Defense Tinted Broad Spectrum Sunscreen SPF 50ZINC OXIDE, OCTINOXATEPrivate Label Skin Care9eb7f287-cb61-4f9d-968e-16b195dbbc9a2026-05-06WarningsExact identifier
application number: M020
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 1W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior53a79ee7-312b-49a2-8a9b-c50794fcd1712026-05-05WarningsExact identifier
application number: M020
SPF 50 Dry Tropix with fragranceHOMOSALATE 10.00% OCTISALATE 5.00% AVOBENZONE 3.00%Surface Products Corp2c95f5c0-7ff6-4eac-b2d6-49e7da7e7bec2026-05-05WarningsExact identifier
application number: M020
SURFACE SUN SPF30 DRY TOUCH Fragrance FreeHOMOSALATE 10.00% OCTOCRYLENE 6.00% AVOBENZONE 3.00%Surface Products Corp9592835a-7c07-487e-a955-04fdea0708092026-05-05WarningsExact identifier
application number: M020
SURFACE SUN SPF 50 DRY TOUCH Fragrance FreeHOMOSALATE 10.00% OCTOCRYLENE 6.00% AVOBENZONE 3.00%Surface Products Corp65f52fc8-8ddb-4282-9bc0-92a7d0e0c0f22026-05-05WarningsExact identifier
application number: M020
Knesko Skin The SunscreenZINC OXIDEKnesko, LLC5114dc75-a865-326e-e063-6294a90a89112026-05-05WarningsExact identifier
application number: M020
SURFACE SUN SPF 50 DRY TOUCH Fragrance FreeHOMOSALATE 10.00% OCTOCRYLENE 6.00% AVOBENZONE 3.00%Surface Products Corp683cb489-e4e1-44ab-9543-614d42b08edd2026-05-05WarningsExact identifier
application number: M020
Neutrogena MINERAL UV TINT FACE DEEP SPF 30TITANIUM DIOXIDE, ZINC OXIDEPort Jervis Laboratories, Inc51169bed-2091-ad2b-e063-6294a90a84b62026-05-05WarningsExact identifier
application number: M020
Surface Sun SPF 50 Mineral SunscreenZINC OXIDE 24%Surface Products Corp6f95de43-cb71-4ddd-b438-a35ee2e14fae2026-05-05WarningsExact identifier
application number: M020
Neutrogena Ultra Sheer Dry Touch Sunscreen Broad Spectrum SPF 70AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEPort Jervis Laboratories, Inc5118a0a4-728b-6884-e063-6394a90a02b32026-05-05WarningsExact identifier
application number: M020
Carmex Daily Care Moisturizing Lip Balm Strawberry SPF 15OCTINOXATE, OXYBENZONECarma Laboratories, Inc.baed7205-2e0d-c6aa-e053-2995a90a8e292026-05-05WarningsExact identifier
application number: M020
Carmex Daily Care Moisturizing Lip Balm Strawberry SPF 15OCTINOXATE, OXYBENZONECarma Laboratories, Inc.baee366f-c1a0-5e21-e053-2a95a90a66872026-05-05WarningsExact identifier
application number: M020
Carmex Sun and Soothe Moisturizing Lip Balm SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENECarma Laboratories, Inc.fc4d2387-ce6a-4105-bab4-7d371b61f7702026-05-05WarningsExact identifier
application number: M020
THANKYOU FARMER Sun Project Soothing SunHOMOSALATE, OCTISALATE. AVOBENZONETHANK YOU FARMER CO., LTD3009df84-4ca7-e170-e063-6294a90a15782026-05-05WarningsExact identifier
application number: M020
THANKYOU FARMER Sun Project Moisture SunHOMOSALATE, OCTOCRYLENE, OCTISALATE, OCTINOXATE, AVOBENZONETHANK YOU FARMER CO., LTD300d8526-0daf-2255-e063-6394a90a21b12026-05-05WarningsExact identifier
application number: M020
LUMINOUS EYE CORRECTOR SPF 41 - FAIRTITANIUM DIOXIDE, ZINC OXIDEDrmtlgy, LLC8cfb1f8c-1bd7-4983-ab82-1c9bd8925afa2026-05-04WarningsExact identifier
application number: M020
LUMINOUS EYE CORRECTOR SPF 41 - DEEPTITANIUM DIOXIDE, ZINC OXIDEDrmtlgy, LLC930bd1de-5a0e-4607-8d3c-b1ca918f890b2026-05-04WarningsExact identifier
application number: M020
THANKYOU FARMER Sun Project Rice Tinted Mineral SunscreenZINC OXIDETHANK YOU FARMER CO., LTD30086b1e-d876-2528-e063-6294a90a4e9f2026-05-04WarningsExact identifier
application number: M020
Blue Berry SPF 15 Broad Spectrum Lip BalmBLUE BERRY SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inc50ff6ecb-c8b3-02fc-e063-6394a90a68de2026-05-04WarningsExact 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