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 338 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Strawberry Limoncello SPF 15 Broad Spectrum Lip BalmSTRAWBERRY LIMONCELLO SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Incc222bd6e-59b0-394a-e053-2995a90ae4292023-10-18WarningsExact identifier
application number: M020
Raspberry Lime Margarita SPF 15 Broad Spectrum Lip BalmRASPBERRY LIME MARGARITA SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Incc2150247-ff7d-9863-e053-2995a90a3f012023-10-18WarningsExact identifier
application number: M020
Key Lime Pie Shake SPF 15 Broad Spectrum Lip BalmKEY LIME PIE SHAKE SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Incc214e5c2-53ea-31bd-e053-2995a90a886a2023-10-18WarningsExact identifier
application number: M020
Summer Sangria SPF 15 Broad Spectrum Lip BalmSUMMER SANGRIA SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Incc222cc2d-232c-0f3d-e053-2995a90af79b2023-10-18WarningsExact identifier
application number: M020
Broad Spectrum SPF 30 Mineral Sun StickBROAD SPECTRUM SPF 30 MINERAL SUN STICKRaining Rosec2261a55-12e4-9a75-e053-2a95a90a82112023-10-18WarningsExact identifier
application number: M020
Broad Spectrum SPF 30 SunscreenBROAD SPECTRUM SPF 30 SUNSCREENRaining Rosec238ce45-91d9-e9fa-e053-2a95a90a7d652023-10-18WarningsExact identifier
application number: M020
Broad Spectrum SPF 30 SunscreenBROAD SPECTRUM SPF 30 SUNSCREENRaining Rosec23d49bd-8447-4920-e053-2a95a90a0a062023-10-18WarningsExact identifier
application number: M020
Tropical Mint Broad Spectrum SPF 15 Lip MoisturizerTROPICAL MINT SPF 15 BROAD SPECTRUM LIP MOISTURIZERRaining Rose, Incaef6b419-efac-4e37-e053-2995a90a0d2f2023-10-18WarningsExact identifier
application number: M020
Broad Spectrum SPF 15 Sunscreen Cherry Lip BalmBROAD SPECTRUM SPF 15 SUNSCREEN CHERRY LIP BALMRaining Roseefbd2179-5f6d-a8c6-e053-2a95a90a17e72023-10-18WarningsExact identifier
application number: M020
Vanilla Mint Broad Spectrum SPF 15 Lip MoisturizerVANILLA MINT SPF 15 BROAD SPECTRUM LIP MOISTURIZERRaining Rose, Incaf10a007-6597-2231-e053-2995a90a87172023-10-18WarningsExact identifier
application number: M020
Mint Broad Spectrum SPF 15 Lip MoisturizerMINT SPF 15 BROAD SPECTRUM LIP MOISTURIZERRaining Rose, Incaf471721-54e4-0738-e053-2a95a90a7e122023-10-18WarningsExact identifier
application number: M020
Spearmint SPF 15 Broad Spectrum Lip BalmSPEARMINT SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inca9029e6d-7443-efe2-e053-2995a90a81252023-10-18WarningsExact identifier
application number: M020
Watermelon Twist SPF 15 Broad Spectrum Lip BalmWATERMELON TWIST SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inca903a7cc-0de5-5adc-e053-2a95a90aa9612023-10-18WarningsExact identifier
application number: M020
Vanilla Mint SPF 15 Broad Spectrum Lip BalmVANILLA MINT SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inca9031b15-d2b0-d248-e053-2a95a90a65ff2023-10-18WarningsExact identifier
application number: M020
Cherry SPF 15 Broad Spectrum Lip BalmCHERRY SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inca75a7326-aaa4-767b-e053-2995a90adf162023-10-18WarningsExact identifier
application number: M020
Wildberry SPF 15 Broad Spectrum Lip BalmWILDBERRY SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inca903c855-867b-4f14-e053-2a95a90a53332023-10-18WarningsExact identifier
application number: M020
Tropical SPF 15 Broad Spectrum Lip BalmTROPICAL SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inca903202b-1dc6-85ad-e053-2995a90a4ab82023-10-18WarningsExact identifier
application number: M020
Pomegranate SPF 15 Broad Spectrum Lip BalmPOMEGRANATE SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inca901e45d-2ea6-bae8-e053-2a95a90afc982023-10-18WarningsExact identifier
application number: M020
Vanilla SPF 15 Broad Spectrum Lip BalmVANILLA SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inca903a7cc-0dd5-5adc-e053-2a95a90aa9612023-10-18WarningsExact identifier
application number: M020
Raspberry SPF 15 Broad Spectrum Lip BalmRASPBERRY SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inca902917c-b8fb-b2d0-e053-2995a90a42db2023-10-18WarningsExact 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