FDA.reportPublic FDA data

Cover Creme

Product NDC
84203-005
11-digit product format
842030005
Labeler code
84203
Product ID
84203-005_57f4c026-ee78-8280-e063-6294a90a911b
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide
Dosage form
CREAM
Route
TOPICAL
Labeler
Baxter of California
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-04-07
Substance
TITANIUM DIOXIDE
Active strength
30 mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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
Cover Creme
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE30 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
15FIX9V2JPInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
31f5e8c4-523f-4596-e063-6294a90a6a12Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5dbf91a8-ec29-4ffc-807c-e3bae7fb67b1Product name120201123
85bed648-23ca-4804-98e6-e36aee999cadProduct name120190717
80de93b4-8a94-428d-beb7-d644353ee70bProduct name120180424
eb4f7d5b-1286-40dc-b8bf-ad87ff51c688Product name120170522
db8eb201-78c7-4590-8a71-fac0a539bd8cProduct name120170404
141092be-5eb5-452e-9f69-2d350aa70a87Product name120161208

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84203-005-01Cover Creme28 g in 1 JARCREAM281
84203-005-02Cover Creme1 in 1 BOXCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84203-005COVER CREME (TITANIUM DIOXIDE) CREAM [BAXTER OF CALIFORNIA]1Current NDC, 2 package rows20250408_31f5e8c4-523f-4596-e063-6294a90a6a12.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 129 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Age Defying SunscreenZINC OXIDEGINAMARIE Products35837cf7-91e5-f9ec-e063-6394a90aa91e2025-12-12Exact identifier
application number: M020
Mineral Sunscreen Face plus BodyZINC OXIDEKS Esthetics, LLC390a4d8d-b47f-0d9a-e063-6394a90a9b532025-12-12Exact identifier
application number: M020
Mineral Sunscreen Tinted Zinc OxideZINC OXIDEKS Esthetics, LLC3909e657-97a5-dd3c-e063-6394a90a10eb2025-12-12Exact identifier
application number: M020
Prime Protection Sunscreen non tintedTITANIUM DIOXIDE, ZINC OXIDEKRISTI REDD ESTHETICS36608832-22d8-bc76-e063-6394a90abac62025-12-12Exact identifier
application number: M020
Prime Protection Sunscreen, tintedTITANIUM DIOXIDE, ZINC OXIDEKRISTI REDD ESTHETICS3660af9e-d60f-c33e-e063-6394a90a3a052025-12-12Exact identifier
application number: M020
Hydrating Antioxidant Sunscreen tintedZINC OXIDEKRISTI REDD ESTHETICS366149e2-b03c-e798-e063-6394a90a6a1d2025-12-12Exact identifier
application number: M020
Prime Protection Sunscreen, tintedTITANIUM DIOXIDE, ZINC OXIDEKRISTI REDD ESTHETICS3660e701-1373-eef4-e063-6394a90a61402025-12-12Exact identifier
application number: M020
Hydrating Antioxidant Sunscreen tintedZINC OXIDEKRISTI REDD ESTHETICS3661251d-b907-8df6-e063-6294a90a1c732025-12-12Exact identifier
application number: M020
sheer tinted sunscreenTITANIUM DIOXIDE, ZINC OXIDESARA ELIZABETH SKINCARE3b177c49-ed8c-42b9-e063-6294a90a82c62025-12-12WarningsExact identifier
application number: M020
Canopy UntintedZINC OXIDEBORREGO SPRINGS SKINCARE LLC35824cd5-0036-7886-e063-6394a90ae6782025-12-12Exact identifier
application number: M020
Canopy SPF 40 TintedZINC OXIDEBORREGO SPRINGS SKINCARE LLC358319c5-ae35-cb3b-e063-6394a90ad77f2025-12-12Exact identifier
application number: M020
Non-Tinted Matte Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESkin Philosophy by Kelly3581ab49-ef55-3743-e063-6394a90a3bd52025-12-12Exact identifier
application number: M020
Matte Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESkin Philosophy by Kelly3581cf33-3520-42f7-e063-6394a90a6f932025-12-12Exact identifier
application number: M020
Mineral Sunscreen For Face and BodyZINC OXIDESkin Philosophy by Kelly358248e6-16cf-6f9b-e063-6394a90a55d72025-12-12Exact identifier
application number: M020
Replenishing Mineral SunscreenZINC OXIDESkin Philosophy by Kelly35828e76-66db-49de-e063-6294a90a2b992025-12-12Exact identifier
application number: M020
Matte Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESkin Philosophy by Kelly3592b2c7-295a-7c60-e063-6394a90a387b2025-12-12Exact identifier
application number: M020
Mineral Sunscreen For Face and BodyZINC OXIDESkin Philosophy by Kelly3592fd5f-13d1-9aec-e063-6394a90abd672025-12-12Exact identifier
application number: M020
Replenishing Mineral SunscreenZINC OXIDESkin Philosophy by Kelly359371f2-2407-e1a1-e063-6294a90a21652025-12-12Exact identifier
application number: M020
Non Tinted Sheer Mineral Zinc SunscreenZINC OXIDESKIN THERAPY PLLC397fc3c9-9d30-adcf-e063-6394a90ac7612025-12-12Exact identifier
application number: M020
Non Tinted Sheer Mineral Zinc SunscreenZINC OXIDESKIN THERAPY PLLC39800bf1-e01a-e1c8-e063-6294a90a53bf2025-12-12Exact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84203-005-018420300050128 g in 1 JAR28 gHistorical
84203-005-02842030005021 JAR in 1 BOX (84203-005-02) / 28 g in 1 JAR (84203-005-01) 1 jar2025-04-07NoNoCurrent