CoTZ Baby

Product NDC
58892-618
11-digit product format
588920618
Labeler code
58892
Product ID
58892-618_15704611-83f8-4ccf-890b-7e67486c9a04
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
2019-01-02
Substance
ZINC OXIDE
Active strength
200 mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
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 productproduct58892-618UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage58892-61858892-618-01UExcluded 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 Baby
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE200 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
17cc12c7-5af8-413f-b205-31ac150583e2Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58892-618-01CoTZ Baby1 in 1 CARTONCREAM13
58892-618-01CoTZ Baby100 g in 1 TUBECREAM1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58892-618COTZ BABY (ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD]3Current NDC, Legacy NDC, 2 package rows20250112_17cc12c7-5af8-413f-b205-31ac150583e2.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 222 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SHISEIDO REVITALESSENCE SKIN GLOW FOUNDATION 110OCTINOXATESHISEIDO AMERICAS CORPORATION393ce1fa-f188-45d0-a23e-2818de9749952025-03-13WarningsExact identifier
application number: M020
SHISEIDO FUTURE solution LX TOTAL PROTECTIVE SAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENESHISEIDO AMERICAS CORPORATION1a304bf0-dcda-4887-9738-54ce35ca503b2025-03-13WarningsExact identifier
application number: M020
SHISEIDO REVITALESSENCE SKIN GLOW PRIMERAVOBENZONE, OCTINOXATE, AND OCTOCRYLENESHISEIDO AMERICAS CORPORATION805fd75e-3c53-4ddd-afdc-a65f921822d42025-03-13WarningsExact identifier
application number: M020
Visor Clear Body Oil-Free Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEVISOR SKINCARE LLC10abc330-7d45-4049-b80a-dbf58374187e2025-03-12WarningsExact identifier
application number: M020
Visor Clear Face Oil-Free Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEVISOR SKINCARE LLC462acd16-b9c0-4f02-b297-d9b54036b5312025-03-12WarningsExact identifier
application number: M020
HAWAIIAN TROPICHOMOSALATE,OCTOCRYLENE,OCTISALATE,AVOBENZONEEdgewell Personal Care Brands LLC302982a3-e3f9-ef46-e063-6394a90abaf82025-03-12WarningsExact identifier
application number: M020
Neutrogena Pure And Free Sunscreen Broad Spectrum SPF 50ZINC OXIDEKenvue Brands LLC41ff1a98-69ff-4d7a-bc89-d986a803cee32025-03-10WarningsExact identifier
application number: M020
Sheer Mineral Antioxidant Sunscreen SPF50ZINC OXIDETopiderm, Inc.1af53e89-debe-4f4c-b0ef-eec2073228df2025-03-07WarningsExact identifier
application number: M020
COOLA Firming Face Serum Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE SUNSCREEN SERUMCOOLA LLC85fd7ef4-ed08-4a69-8293-5f3f3d264c042025-03-06WarningsExact identifier
application number: M020
GOLDEN HOUR HYDRATING SPF 30OCTOCRYLENE, OCTISALATE, AND AVOBENZONEDermalogica, LLC.090b5861-20f5-43c6-aff6-d17d61e8568e2025-03-04WarningsExact identifier
application number: M020
Aveeno Baby continuous protection sensitive skin Sunscreen Broad Spectrum SPF50ZINC OXIDEKenvue Brands LLCbbd6710f-a665-437e-b86b-437f732984d12025-03-04WarningsExact identifier
application number: M020
LBEL DIVINE DOUBLE USE LONGWEAR 36H SPF 15 CREME 110OCTINOXATE, ZINC OXIDEBELSTAR S.A.2f8607c5-b5ab-ed81-e063-6394a90a34532025-03-04WarningsExact identifier
application number: M020
ADVANCED PROTECTION SUNSCREEN SPF-30OCTINOXATE, OCTISALATE, ZINC OXIDEBOTANICAL SCIENCE, INC.2f8bbd08-d199-03bd-e063-6294a90adfac2025-03-04WarningsExact identifier
application number: M020
MINERAL TINTED SPF 30TITANIUM DIOXIDE, ZINC OXIDEBOTANICAL SCIENCE, INC.2f9e2252-fb54-363f-e063-6294a90aa7c92025-03-04WarningsExact identifier
application number: M020
LBEL LUMI-AGE ANTI-AGING HYDRATING DAY FACIAL SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENEBEL STAR S.A.2f717492-347d-5bf8-e063-6294a90a4b5f2025-03-03WarningsExact identifier
application number: M020
CoTZ Kids Mineral Sun StickTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD2f7225d0-ddfa-e19a-e063-6294a90a52a82025-03-03WarningsExact identifier
application number: M020
Sum 37 Micro Active Daily Moisture SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENELG HOUSEHOLD & HEALTH CARE LTD.2eea94e1-2409-8ad6-e063-6294a90a5df82025-03-03WarningsExact identifier
application number: M020
Sun Defense Minerals (Fair)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2e21c9f9-acf8-997b-e063-6394a90ada3f2025-03-01WarningsExact identifier
application number: M020
Sun Defense Minerals (Medium)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2e232e8d-4274-68bc-e063-6394a90a942b2025-03-01WarningsExact identifier
application number: M020
Sun Defense Minerals (Deep)ZINC OXIDEEminence Organic Skin Care2e23d463-fbc1-5718-e063-6294a90a72722025-03-01WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58892-618-01588920618011 TUBE in 1 CARTON (58892-618-01) / 100 g in 1 TUBE1 tube2019-01-020000-00-00NoNoCurrent