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 265 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Covergirl Advanced Radiance Age Defying Makeup plus Sunscreen SPF 10 (All shades)OCTINOXATE AND TITANIUM DIOXIDENoxell356af30e-82c7-4e28-94bb-b536e74d01e12024-11-19WarningsExact identifier
application number: M020
Covergirl plus Olay Simply Ageless Foundation plus Titanium Dioxide Sunscreen Broad Spectrum SPF 28 (All shades)TITANIUM DIOXIDENoxell Corporationfab59bd6-4ef6-4626-9f75-edcd4088e6432024-11-19WarningsExact identifier
application number: M020
Coral Care SPF 30 SunscreenTITANIUM DIOXIDE 8.8%Stream2Sea2749fa0e-aed5-6c9a-e063-6294a90a2bf12024-11-19WarningsExact identifier
application number: M020
FULL SPECTRUM MATTE AMBITION SKIN PRIMER SPF 20ENSULIZOLENoxell Corporation82f7bff9-718e-19ea-e053-2991aa0a35602024-11-19WarningsExact identifier
application number: M020
Rimmel London Lasting Finish 25 HR Foundation SPF 20OCTINOXATERimmelcfd041e9-ed40-dc93-e053-2995a90a96992024-11-19WarningsExact identifier
application number: M020
ultimate miracle worker multi-rejuvenating spf 30AVOBENZONE, OCTINOXATE, OCTOCRYLENEPhilosophy, Inc.4387abab-ee1c-4e93-bea9-01624e8b48322024-11-19WarningsExact identifier
application number: M020
Sun Voyage KitAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEKoco Life LLC2732a8d2-6f56-c088-e063-6294a90af3082024-11-18WarningsExact identifier
application number: M020
Eminence Radiant Protection SPF FluidZINC OXIDEEminence Organic Skin Care002a4766-0c7e-4ec7-e063-6294a90a78d82024-11-18WarningsExact identifier
application number: M020
Eryfotona Actinica Ultralight EmulsionSUNSCREENISDIN Corp1d4b88d3-bee9-102c-e054-00144ff8d46c2024-11-18WarningsExact identifier
application number: M020
Rodan and Fields Plumping Lip SPF 28 SunscreenOCTINOXATE, ZINC OXIDERodan & Fieldsedf05ccc-4299-48d5-8f8e-01255eca11c22024-11-15WarningsExact identifier
application number: M020
Melan Mineral Antioxidant Body Mist Mineral Sunscreen SPF 30ZINC OXIDEMELAN INC.210823a0-94f9-4833-b279-fc26b90611952024-11-14WarningsExact identifier
application number: M020
Luminous Sunscreen SPF 50ZINC OXIDE, TITANIUM DIOXIDECLINICAL SKIN LLC26e2b82c-8d7a-7261-e063-6394a90a7c0d2024-11-14WarningsExact identifier
application number: M020
CoTZ Flawless ComplexionZINC OXIDEFallien Cosmeceuticals, LTD0973223b-e75f-4eb8-bcf1-7931b30b7b512024-11-14WarningsExact identifier
application number: M020
TiZO Photoceutical Environmental Skin ProtectantDIMETHICONEFallien Cosmeceuticals, LTD84a3299d-9b98-492e-a83f-ebd72ec58f8d2024-11-14WarningsExact identifier
application number: M020
TiZO Photoceutical AM Replenish Non-TintedZINC OXIDEFallien Cosmeceuticals, LTDc52a1e04-f3ca-47a1-a26e-d6f5e77b47d62024-11-14WarningsExact identifier
application number: M020
Neutrogena MINERAL UV TINT FACE LIGHT SPF 30TITANIUM DIOXIDE, ZINC OXIDEKenvue Brands LLCe7af4f58-90c8-2987-e053-2995a90a416b2024-11-13WarningsExact identifier
application number: M020
Neutrogena Healthy Skin Liquid Makeup Broad Spectrum SPF 20 - Classic Ivory 10TITANIUM DIOXIDEKenvue Brands LLC143e0a1d-305f-9015-e063-6294a90aa0252024-11-13WarningsExact identifier
application number: M020
BANANA BOATAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC05cb5a91-205f-b652-e063-6294a90a06642024-11-13WarningsExact identifier
application number: M020
Neutrogena Ultra Sheer Dry-Touch Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE, ZINC OXIDEKenvue Brands LLC18e40353-5c95-4d64-e063-6394a90a017c2024-11-12WarningsExact identifier
application number: M020
Neutrogena Healthy Skin Liquid Makeup SPF 20 - Classic Ivory 10TITANIUM DIOXIDEKenvue Brands LLCe0ed4537-8146-45e8-e053-2995a90ac51b2024-11-12WarningsExact 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