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 17 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ivory Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc552f25ba-61d5-6a94-e063-6394a90a46e92026-06-26WarningsExact identifier
application number: M020
Simply Beige Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc552f4799-9122-8db5-e063-6394a90a51322026-06-26WarningsExact identifier
application number: M020
Vanilla Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc552f6d2c-9b8c-aa52-e063-6294a90a787e2026-06-26WarningsExact identifier
application number: M020
Bath and Body Works SPF Pink Pineapple SunriseAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEBath & Body Works, Inc.1c30a422-b22a-ca79-e063-6294a90a19a92026-06-26WarningsExact identifier
application number: M020
Bath and Body Works SPF Pink Pineapple SunriseAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEBath & Body Works, Inc.1c37a994-79dd-9720-e063-6294a90a7f342026-06-26WarningsExact identifier
application number: M020
Bath and Body Works SPF Waikiki Beach CoconutAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEBath & Body Works, Inc.1c37b8d7-de72-f534-e063-6294a90aeab72026-06-26WarningsExact identifier
application number: M020
UV Daily Hydration TintedOCTISALAT AND ZINC OXIDE SUNSCREENCP Skin Health Group, Inc02e71602-13e1-43b3-9cba-a75e46cccacc2026-06-25WarningsExact identifier
application number: M020
Coral Isle SPF 50 Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDERocky Mountain5515f562-62d9-c6ee-e063-6294a90a9ea62026-06-25WarningsExact identifier
application number: M020
SPF30 SunscreenAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEZhejiang Ayan Biotech Co.,Ltd.6759b9f7-296a-4c06-9198-b4e824e0bdc92026-06-25WarningsExact identifier
application number: M020
Delicate Beige Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc551928b4-74bb-3f6c-e063-6294a90a6b832026-06-25WarningsExact identifier
application number: M020
Alabaster Beige Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc5519290c-b040-6a37-e063-6394a90a8a1d2026-06-25WarningsExact identifier
application number: M020
Soft Bisque Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc551ab7d1-dd2f-c6d8-e063-6394a90aff652026-06-25WarningsExact identifier
application number: M020
Alabaster Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc551b8c21-3afc-c804-e063-6294a90a51562026-06-25WarningsExact identifier
application number: M020
Scalp and Face Sunscreen Broad Spectrum SPF 30ZINC OXIDEOnly Balds LLC551bf10e-598c-1400-e063-6294a90a4af12026-06-25WarningsExact identifier
application number: M020
Bare Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc552f20b2-9a2e-70f3-e063-6394a90a93372026-06-25WarningsExact identifier
application number: M020
MORANDIPARK PANTHENOL ULTRA LIGHT SUNSCREENHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEBRAND GENOME CO., Ltd.51c07375-e81d-8572-e063-6394a90ab5b02026-06-24WarningsExact identifier
application number: M020
BROAD SPECTRUM SPF 50 UNIVERSAL TINTED SUNSCREENTITANIUM DIOXIDEShantou Woodsleep Biotechnology Co., Ltd.54fc80b7-8f6c-e2be-e063-6394a90a4b592026-06-24WarningsExact identifier
application number: M020
Neutrogena Collagen Bank SPF Moisturizer Sunscreen Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKenvue Brands LLC365613b6-36ec-0512-e063-6294a90a95322026-06-24WarningsExact identifier
application number: M020
BANANA BOATAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC235a9430-b445-8d5c-e063-6394a90a93542026-06-24WarningsExact identifier
application number: M020
Cerave Developed with Dermatologists Hydrating Sunscreen SPF 30 Body Lightweight, non-greasy feel 3 essential ceramides Mineral SunscreenTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc54ecaea7-dafe-9694-e063-6394a90ae3b52026-06-23WarningsExact 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