FDA.reportPublic FDA data

Dermablend Professional cover creme

Manufacturer
Baxter of California | Beauty Manufacturing Solutions
Effective date
2026-07-31
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
daily-update
Hydrated at
2026-08-04 03:32:55

Label at a glance#

ProductCover Creme
Active ingredientTITANIUM DIOXIDE
Label structure9 sections

Indications and uses

helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Dosage and administration

For sunscreen use, apply liberally 15 minutes before sun exposure; reapply at least every 2 hours; use a water resistant sunscreen if swimming or sweating. Spending time n the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrun SPF value of 15 or higher and other sun protection measures including; limit time in the sun, especially from...

Storage and handling

Protect the product in this container from excessive heat and direct sun

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 5.81%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

For external use only

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin.

When using this product

OTC - WHEN USING SECTION

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Cneter right away.

Directions

DOSAGE & ADMINISTRATION SECTION

For sunscreen use, apply liberally 15 minutes before sun exposure; reapply at least every 2 hours; use a water resistant sunscreen if swimming or sweating.

Sun Protection Measures

OTHER SAFETY INFORMATION

Spending time n the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrun SPF value of 15 or higher and other sun protection measures including; limit time in the sun, especially from 10a.m.-2p.m.; wear long-sleeve shirts, pants, hats and sunglasses. Children under 6 months of age. Ask a doctor.

Other information

STORAGE AND HANDLING SECTION

Protect the product in this container from excessive heat and direct sun

Inactive ingredients

INACTIVE INGREDIENT SECTION

Inactive ingredients

mineral oil (paraffinum liquidum), zea mays (corn) starch, synthetic beeswax, kaolin, barium sulfate, isopropyl plamitate, magnesium carbonate, copernicia cerifera (carnauba) wax, aluminum hydroxide, microcrystalline wax (cera microcristallina), stearic acid, phenoxyethanol, triethoxycaprylylsilane, caprylyl glycol, lauroyl lysine, allantoin, silica silylate, tocopherol. may contain: iron oxides, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

1-800-662-8011

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

cover cremecover creme

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

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84203-00584203-005-01, 84203-005-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
TITANIUM DIOXIDE15FIX9V2JPACTIB
MINERAL OILT5L8T28FGPIACT
KAOLIN24H4NWX5COIACT
BARIUM SULFATE25BB7EKE2EIACT
MAGNESIUM CARBONATE0E53J927NAIACT
CARNAUBA WAXR12CBM0EIZIACT
STEARIC ACID4ELV7Z65APIACT
PHENOXYETHANOLHIE492ZZ3TIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
CAPRYLYL GLYCOL00YIU5438UIACT
LAUROYL LYSINE113171Q70BIACT
ALLANTOIN344S277G0ZIACT
SYNTHETIC BEESWAX08MNR5YE2RIACT
SILICA DIMETHYL SILYLATEEU2PSP0G0WIACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
MICROCRYSTALLINE WAXXOF597Q3KYIACT
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)461P5CJN6TIACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
TOCOPHEROLR0ZB2556P8IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12025-04-04full-release2026-06-01 00:58:41

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cover CremeTITANIUM DIOXIDEBaxter of California31f5e8c4-523f-4596-e063-6294a90a6a122026-07-31WarningsExact identifier
ndc (package): 84203-005-01
ndc (package): 84203-005-02
ndc (product): 84203-005
ndc11 (package): 84203000502
ndc11 (package): 84203000501
spl id: 57f4c026-ee78-8280-e063-6294a90a911b
spl set id: 31f5e8c4-523f-4596-e063-6294a90a6a12

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.