CoTZ Face Prime and Protect SPF 40 (Non-Tinted)

Product NDC
58892-348
11-digit product format
588920348
Labeler code
58892
Product ID
58892-348_9498c109-3155-481c-a847-975cb655f6bc
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide, Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
Fallien Cosmeceuticals, LTD
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-11-15
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
80; 38 mg/g; 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 productproduct58892-348UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage58892-34858892-348-45UExcluded 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 Prime and Protect SPF 40 (Non-Tinted)
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE80 mg/g
ZINC OXIDE38 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
15FIX9V2JPInternal UNII lookup
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
f106f52b-2157-46c7-9f7c-50f43a649050Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58892-348-45CoTZ Face Prime and Protect SPF 40 (Non-Tinted)42.5 g in 1 TUBECREAM42.52
58892-348-45CoTZ Face Prime and Protect SPF 40 (Non-Tinted)1 in 1 CARTONCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58892-348COTZ FACE PRIME AND PROTECT SPF 40 (NON-TINTED) (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD]2Current NDC, Legacy NDC, 2 package rows20250112_f106f52b-2157-46c7-9f7c-50f43a649050.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 183 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Vertra Mick Fanning Signature Foundation Sunscreen Face Stick SPF 35 Coolangatta BeigeTITANIUM DIOXIDEToshiki Pigment Co., Ltd.b9eba15f-493a-43c9-e053-2995a90a04512025-10-06WarningsExact identifier
application number: M020
Apple Lip Balm with Aloe VeraBROAD SPECTRUM SPF 15 SUNSCREEN LIP BALMDurvet, Inc.6dcbb2cd-e690-4970-8cf1-08ca539d36022025-10-06WarningsExact identifier
application number: M020
PURE SOL SPF 50 Daily MoisturizerZINC OXIDEBrand 2022b LLC4051506c-fc13-cd22-e063-6394a90a977e2025-10-04WarningsExact identifier
application number: M020
PURE SOL SPF 30 Mineral Whipped Sunscreen (Shimmer)ZINC OXIDEBrand 2022b LLC4051ced5-85cf-6211-e063-6394a90a09fc2025-10-04WarningsExact identifier
application number: M020
PURE SOL SPF 30 Mineral Whipped SunscreenZINC OXIDEBrand 2022b LLC4051d241-6890-2b06-e063-6294a90aa09d2025-10-04WarningsExact identifier
application number: M020
PURE SOL SPF 37 Tinted MoisturizerZINC OXIDE TITANIUM DIOXIDEBrand 2022b LLC4052c4e4-2105-80c0-e063-6294a90af41d2025-10-04WarningsExact identifier
application number: M020
PLAY Antioxidant Body Mist SPF 50 - Vanilla OrchidAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESupergoop LLC3f7a9722-d211-e861-e063-6294a90a6cdc2025-10-02WarningsExact identifier
application number: M020
Kids Mineral Sunscreen SPF50SUNSCREENHello Bello01cc554b-9241-d891-e063-6394a90a84502025-10-02WarningsExact identifier
application number: M020
HydroGlow Daily Sunscreen BROAD SPECTRUM SPF 50 UVA and UVBSUNSCREEN SPF 50IHerb, LLC3cab1598-5ef3-df73-e063-6394a90ab1e22025-10-01WarningsExact identifier
application number: M020
Moisturizing Rich Sunscreen SPF 30ZINC OXIDEGood Molecules, LLC36c3ba26-ca25-7498-e063-6294a90a47fc2025-10-01WarningsExact identifier
application number: M020
Wonderscreen Broad Spectrum SPF 30 Shade 1ZINC OXIDEDime Beauty Co, LLC07104cbf-0446-a053-e063-6394a90ab41f2025-10-01WarningsExact identifier
application number: M020
Wonderscreen Tinted Broad Spectrum SPF 30 Shade 3ZINC OXIDEDime Beauty Co, LLC07503a1f-d530-e3bb-e063-6294a90a8ae32025-10-01WarningsExact identifier
application number: M020
Wonderscreen Broad Spectrum SPF 30ZINC OXIDEDime Beauty Co, LLCe38deed3-e1e2-0b1d-e053-2a95a90a547f2025-10-01WarningsExact identifier
application number: M020
Wonderscreen Tinted Broad Spectrum SPF 30ZINC OXIDEDime Beauty Co, LLCf2a59fa4-f19c-a15f-e053-2a95a90a6ace2025-10-01WarningsExact identifier
application number: M020
Bronzing Blendrops Broad Spectrum SPF 46HOMOSALATE, OCTISALATE, ZINC OXIDEWasatch Product Development, LLC414b88ca-a3df-5e42-e063-6294a90a69ba2025-10-01WarningsExact identifier
application number: M020
FENTY SKIN HYDRA VIZOR BROAD SPECTRUM MINERAL SPF 30 SUNSCREEN MOISTURIZER FRAGRANCE-FREEZINC OXIDEKENDO HOLDINGS INC19120c3f-8fc0-62c3-e063-6394a90a30f32025-09-30WarningsExact identifier
application number: M020
FENTY SKIN HYDRA VIZOR SPF 30AVOBENZONE, HOMOSALATE, OCTISALATEKENDO HOLDINGS INC1d26bfb0-3c05-4a0c-9d4b-8103592227302025-09-30WarningsExact identifier
application number: M020
FENTY SKIN HYDRA VIZOR BROAD SPECTRUM MINERAL SPF 30 SUNSCREEN MOISTURIZERZINC OXIDEKENDO HOLDINGS INCfd16def1-4c88-3ad0-e053-6294a90ab0882025-09-30WarningsExact identifier
application number: M020
FENTY SKIN HYDRA VIZOR BROAD SPECTRUM MINERAL SPF 15 SUNSCREEN HANDZINC OXIDEKENDO HOLDINGS INCf92b75bd-c5b7-0320-e053-6394a90ab4c32025-09-30WarningsExact identifier
application number: M020
OLE HENRIKSEN BANANA BRIGHT MINERAL SUNSCREEN SPF 30ZINC OXIDEKENDO HOLDINGS INCf92ae08e-0bca-4775-e053-6394a90ab3d62025-09-30WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58892-348-45588920348451 TUBE in 1 CARTON (58892-348-45) / 42.5 g in 1 TUBE1 tube2018-11-150000-00-00NoNoCurrent