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 330 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CAPTURE TOTALE C.E.L.L. ENERGY SUPER POTENT SERUM FOUNDATION BROAD SPECTRUM SPF 20 2NENSULIZOLE, OCTISALATEParfums Christian Diorc790b9e4-6925-4796-9945-1c5484116a232023-11-03WarningsExact identifier
application number: M020
CAPTURE TOTALE C.E.L.L. ENERGY SUPER POTENT SERUM FOUNDATION BROAD SPECTRUM SPF 20 2WENSULIZOLE, OCTISALATEParfums Christian Diorf551db8d-7447-41b9-9249-5ee8f76be98a2023-11-03WarningsExact identifier
application number: M020
CAPTURE DREAMSKIN FRESH and PERFECT CUSHION WITH SUNSCREEN BROAD SPECTRUM SPF 50 010OCTINOXATE,TITANIUM DIOXIDE,ZINC OXIDEParfums Christian Dior775f4009-9fc2-475b-a141-b4b5e55421802023-11-03WarningsExact identifier
application number: M020
CAPTURE DREAMSKIN FRESH and PERFECT CUSHION WITH SUNSCREEN BROAD SPECTRUM SPF 50 030OCTINOXATE,TITANIUM DIOXIDE,ZINC OXIDEParfums Christian Dior189f8767-f463-4c83-8a38-975ce8672b2a2023-11-03WarningsExact identifier
application number: M020
CAPTURE TOTALE C.E.L.L. ENERGY SUPER POTENT SERUM FOUNDATION BROAD SPECTRUM SPF 20 1,5NENSULIZOLE, OCTISALATEParfums Christian Diord9c6e0e0-f88e-48ba-94db-0cb198f8dbbe2023-11-03WarningsExact identifier
application number: M020
CAPTURE TOTALE C.E.L.L. ENERGY SUPER POTENT SERUM FOUNDATION BROAD SPECTRUM SPF 20 3NENSULIZOLE, OCTISALATEParfums Christian Diora1e5e9cf-3f59-4e1d-98d6-f17ed1ad8e512023-11-03WarningsExact identifier
application number: M020
CAPTURE TOTALE C.E.L.L. ENERGY SUPER POTENT SERUM FOUNDATION BROAD SPECTRUM SPF 20 2CRENSULIZOLE, OCTISALATEParfums Christian Dior2345d277-3d46-4dfc-9c5d-db7887165ea62023-11-03WarningsExact identifier
application number: M020
CAPTURE TOTALE C.E.L.L. ENERGY SUPER POTENT SERUM FOUNDATION BROAD SPECTRUM SPF 20 5NENSULIZOLE, OCTISALATEParfums Christian Diorcfd207af-d650-4333-a79a-c8f4878e8f9a2023-11-03WarningsExact identifier
application number: M020
CAPTURE TOTALE C.E.L.L. ENERGY SUPER POTENT SERUM FOUNDATION BROAD SPECTRUM SPF 20 7NENSULIZOLE, OCTISALATEParfums Christian Dior5f5e61e3-ea93-401b-b55c-1eb0a711e7382023-11-03WarningsExact identifier
application number: M020
FOREVER SKIN VEIL Extreme Wear and Moisturizing Primer Correction, Protection, Illumination With Sunscreen Floral Extract-Enriched Broad Spectrum SPF20OCTISALATE, TITANIUM DIOXIDEParfums Christian Diorc59b4ece-0534-4072-afe8-2142a43c6bb22023-11-03WarningsExact identifier
application number: M020
CAPTURE TOTALE C.E.L.L. ENERGY SUPER POTENT SERUM FOUNDATION BROAD SPECTRUM SPF 20 4NENSULIZOLE, OCTISALATEParfums Christian Diorcfeb19b9-6597-4bd7-a635-d4024e291c5c2023-11-03WarningsExact identifier
application number: M020
CAPTURE TOTALE C.E.L.L. ENERGY SUPER POTENT SERUM FOUNDATION BROAD SPECTRUM SPF 20 6NENSULIZOLE, OCTISALATEParfums Christian Diorc044849f-94ab-4d91-aac5-e3e9631bc8b12023-11-03WarningsExact identifier
application number: M020
CAPTURE DREAMSKIN FRESH AND PERFECT CUSHION WITH SUNSCREEN BROAD SPECTRUM SPF 50 030OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEParfums Christian Diorcdc2a156-5ccd-4d40-98af-c529f0911a9e2023-11-03WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h Wear Radiant Perfection Skin Caring Foundation With Sunscreen BROAD SPECTRUM SPF 35 Lasting Hydration 2WPOCTINOXATE, TITANIUM DIOXIDEPARFUMS CHRISTIAN DIOR6ee0284e-739d-4aad-9352-9ea9c106efa42023-11-03WarningsExact identifier
application number: M020
Broad Spectrum SPF 15 Coconut Lip BalmZINC OXIDERaining Rose, Inc.2a03abc4-824b-438d-acc5-4698530576792023-11-03WarningsExact identifier
application number: M020
BEAUTY BEFORE AGE AHAVA UPLIFT DAY broad spectrum SPF 20HOMOSALATE, OCTISALATE, AND AVOBENZONEAHAVA Dead Sea Laboratories Ltdbf872bbe-a2d1-4188-b331-e62e339b13e72023-11-03WarningsExact identifier
application number: M020
All Good Broad Spectrum SPF 15 Spearmint Lip BalmBROAD SPECTRUM SPF 15 SPEARMINT LIP BALMRaining Rose, Inc.77370d4e-6888-4cb7-b6b9-1011a71dbf7a2023-11-03WarningsExact identifier
application number: M020
365 Everyday ValueSPORT LOTION MINERAL SUNSCREEN SPF 30Whole Foods Market, Inc.8f15b988-c009-4ca7-bb46-c0fb0aa626432023-11-03WarningsExact identifier
application number: M020
365 Everyday ValueSPORT LOTION MINERAL SUNSCREEN SPF 30Whole Foods Market, Inc.706ed90d-fd98-44bf-99b8-f8c12eec68572023-11-03WarningsExact identifier
application number: M020
THE SOF FLUID LONG WEAR FOUNDATION BROAD SPECTRUM SPF 20OCTINOXATE AND TITANIUM DIOXIDEMAX HUBER RESEARCH LAB INC97787725-9175-46a7-8e3a-af5d06e21d7f2023-10-30WarningsExact 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