CLE DE PEAU BEAUTE FOUNDATION L

Manufacturer
SHISEIDO AMERICAS CORPORATION | SHISEIDO AMERICA INC.
Effective date
2018-12-13
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:42:32

Label at a glance#

ProductCLE DE PEAU BEAUTE FOUNDATION L BF20
Active ingredientTITANIUM DIOXIDE
Label structure17 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 use a water resistant sunscreen if swimming or sweating reapply at least every 2 hours Sun Protection Measures . Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: limit time in the su...

Storage and handling

protect this product in this container from excessive heat and direct sun.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

TITANIUM DIOXIDE 2.1%

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

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

For sunscreen use:

  • apply liberally 15 minutes before sun exposure
  • use a water resistant sunscreen if swimming or sweating
  • reapply at least every 2 hours
  • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
    • limit time in the sun, especially from 10 a.m. – 2 p.m.
    • wear long-sleeve shirts, pants, hats, and sunglasses
  • children under 6 months: Ask a doctor

Inactive Ingredients

INACTIVE INGREDIENT SECTION

WATER, CYCLOMETHICONE, TALC, BUTYLENE GLYCOL, NYLON-12, DIMETHICONE, GLYCERIN, PEG-10 DIMETHICONE, DEXTRIN PALMITATE, BARIUM SULFATE, POLYMETHYL METHACRYLATE, TOCOPHERYL ACETATE, GINKGO BILOBA LEAF EXTRACT, SODIUM ACETYLATED HYALURONATE, ROSA ROXBURGHII FRUIT EXTRACT, LILIUM CANDIDUM BULB EXTRACT, ALUMINUM HYDROXIDE, PALMITIC ACID, STEARIC ACID, TRISODIUM EDTA, DISTEARYLDIMONIUM CHLORIDE, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, POLYSILICONE-2, ISOPROPYL ALCOHOL, SYNTHETIC FLUORPHLOGOPITE, TOCOPHEROL, TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL DIMETHICONE, PHENOXYETHANOL, FRAGRANCE, TITANIUM DIOXIDE, IRON OXIDES, MICA,

Other information

STORAGE AND HANDLING SECTION

  • protect this product in this container from excessive heat and direct sun.

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-800-906-7503

PRINCIPAL DISPLAY PANEL - 25 mL Tube Carton BF20

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

clé de peau

BEAUTÉ

cream foundation

BROAD SPECTRUM SPF 29
SUNSCREEN

25mL NET WT. 1.1 OZ.

Principal Display Panel - 25 mL Tube Carton BF20
Principal Display Panel - 25 mL Tube Carton BF20

PRINCIPAL DISPLAY PANEL - 25 mL Tube Carton I10

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

clé de peau

BEAUTÉ

cream foundation

BROAD SPECTRUM SPF 29
SUNSCREEN

25mL NET WT. 1.1 OZ.

Principal Display Panel - 25 mL Tube Carton I10
Principal Display Panel - 25 mL Tube Carton I10

PRINCIPAL DISPLAY PANEL - 25 mL Tube Carton O10

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

clé de peau

BEAUTÉ

cream foundation

BROAD SPECTRUM SPF 29
SUNSCREEN

25mL NET WT. 1.1 OZ.

Principal Display Panel - 25 mL Tube Carton O10
Principal Display Panel - 25 mL Tube Carton O10

PRINCIPAL DISPLAY PANEL - 25 mL Tube Carton O20

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

clé de peau

BEAUTÉ

cream foundation

BROAD SPECTRUM SPF 29
SUNSCREEN

25mL NET WT. 1.1 OZ.

Principal Display Panel - 25 mL Tube Carton O20
Principal Display Panel - 25 mL Tube Carton O20

PRINCIPAL DISPLAY PANEL - 25 mL Tube Carton O30

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

clé de peau

BEAUTÉ

cream foundation

BROAD SPECTRUM SPF 29
SUNSCREEN

25mL NET WT. 1.1 OZ.

Principal Display Panel - 25 mL Tube Carton O30
Principal Display Panel - 25 mL Tube Carton O30

PRINCIPAL DISPLAY PANEL - 25 mL Tube Carton B10

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

clé de peau

BEAUTÉ

cream foundation

BROAD SPECTRUM SPF 29
SUNSCREEN

25mL NET WT. 1.1 OZ.

Principal Display Panel - 25 mL Tube Carton B10
Principal Display Panel - 25 mL Tube Carton B10

PRINCIPAL DISPLAY PANEL - 25 mL Tube Carton B20

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

clé de peau

BEAUTÉ

cream foundation

BROAD SPECTRUM SPF 29
SUNSCREEN

25mL NET WT. 1.1 OZ.

Principal Display Panel - 25 mL Tube Carton B20
Principal Display Panel - 25 mL Tube Carton B20

PRINCIPAL DISPLAY PANEL - 25 mL Tube Carton B30

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

clé de peau

BEAUTÉ

cream foundation

BROAD SPECTRUM SPF 29
SUNSCREEN

25mL NET WT. 1.1 OZ.

Principal Display Panel - 25 mL Tube Carton B30
Principal Display Panel - 25 mL Tube Carton B30

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58411-145-602023-12-14C16284748780-19d75b9cf-e88b-f424-e053-dadaa90a57ceCLÉ DE PEAU BEAUTÉ FOUNDATION L
58411-146-602023-12-14C16284748780-19d75b9cf-e88b-f424-e053-dadaa90a57ceCLÉ DE PEAU BEAUTÉ FOUNDATION L
58411-147-602023-12-14C16284748780-19d75b9cf-e88b-f424-e053-dadaa90a57ceCLÉ DE PEAU BEAUTÉ FOUNDATION L
58411-148-602023-12-14C16284748780-19d75b9cf-e88b-f424-e053-dadaa90a57ceCLÉ DE PEAU BEAUTÉ FOUNDATION L
58411-149-602023-12-14C16284748780-19d75b9cf-e88b-f424-e053-dadaa90a57ceCLÉ DE PEAU BEAUTÉ FOUNDATION L
58411-150-602023-12-14C16284748780-19d75b9cf-e88b-f424-e053-dadaa90a57ceCLÉ DE PEAU BEAUTÉ FOUNDATION L
58411-151-602023-12-14C16284748780-19d75b9cf-e88b-f424-e053-dadaa90a57ceCLÉ DE PEAU BEAUTÉ FOUNDATION L
58411-152-602023-12-14C16284748780-19d75b9cf-e88b-f424-e053-dadaa90a57ceCLÉ DE PEAU BEAUTÉ FOUNDATION L
58411-145-602020-01-31C16284748780-19d75b9cf-e88b-f424-e053-dadaa90a57ceCLÉ DE PEAU BEAUTÉ FOUNDATION L
58411-146-602020-01-31C16284748780-19d75b9cf-e88b-f424-e053-dadaa90a57ceCLÉ DE PEAU BEAUTÉ FOUNDATION L
58411-147-602020-01-31C16284748780-19d75b9cf-e88b-f424-e053-dadaa90a57ceCLÉ DE PEAU BEAUTÉ FOUNDATION L
58411-148-602020-01-31C16284748780-19d75b9cf-e88b-f424-e053-dadaa90a57ceCLÉ DE PEAU BEAUTÉ FOUNDATION L
58411-149-602020-01-31C16284748780-19d75b9cf-e88b-f424-e053-dadaa90a57ceCLÉ DE PEAU BEAUTÉ FOUNDATION L
58411-150-602020-01-31C16284748780-19d75b9cf-e88b-f424-e053-dadaa90a57ceCLÉ DE PEAU BEAUTÉ FOUNDATION L
58411-151-602020-01-31C16284748780-19d75b9cf-e88b-f424-e053-dadaa90a57ceCLÉ DE PEAU BEAUTÉ FOUNDATION L
58411-152-602020-01-31C16284748780-19d75b9cf-e88b-f424-e053-dadaa90a57ceCLÉ DE PEAU BEAUTÉ FOUNDATION L

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Titanium dioxideACTIVE INGREDIENT15FIX9V2JP1
Titanium dioxideACTIVE MOIETY15FIX9V2JP1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L01
ALUMINUM HYDROXIDEINACTIVE INGREDIENT5QB0T2IUN01
BARIUM SULFATEINACTIVE INGREDIENT25BB7EKE2E1
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RA1
CYCLOMETHICONEINACTIVE INGREDIENTNMQ347994Z1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1O1
DISTEARYLDIMONIUM CHLORIDEINACTIVE INGREDIENTOM9573ZX3X1
EDETATE TRISODIUMINACTIVE INGREDIENT420IP921MB1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G6751
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRT1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F3571
GINKGOINACTIVE INGREDIENT19FUJ2C58T1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M4163021
LILIUM CANDIDUM BULBINACTIVE INGREDIENTAHG15J8AM01
MICAINACTIVE INGREDIENTV8A1AW08801
NYLON-12INACTIVE INGREDIENT446U8J075B1
PALMITIC ACIDINACTIVE INGREDIENT2V16EO95H11
PEG-10 DIMETHICONE (600 CST)INACTIVE INGREDIENT8PR7V1SVM01
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T1
ROSA ROXBURGHII FRUITINACTIVE INGREDIENTCVT1AA87FF1
SODIUM ACETYLATED HYALURONATEINACTIVE INGREDIENTWN66R7GL931
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP1
TALCINACTIVE INGREDIENT7SEV7J4R1U1
TOCOPHEROLINACTIVE INGREDIENTR0ZB2556P81
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 35 matching rows.

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 6 · 216 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 4 · 226 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
GLYCERINGLYCERINPDC6A3C0OXOINTMENT / TOPICALNAExact identifier — unii candidate
75 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTPOWDER / RESPIRATORY (INHALATION)0.04 mgExact identifier — unii candidate
20 equally ranked IID candidates
FERROSOFERRIC OXIDEFERROSOFERRIC OXIDEXM0M87F357CAPSULE, DELAYED RELEASE / ORAL6 mgExact identifier — unii candidate
10 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET / ORAL42 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSHAMPOO / TOPICAL5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXPASTE / ORAL3822 mgExact identifier — unii candidate
75 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APCAPSULE / ORAL90 mgExact identifier — unii candidate
26 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDROPS / NASAL10 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTCAPSULE, EXTENDED RELEASE / ORAL7 mgExact identifier — unii candidate
20 equally ranked IID candidates
FERROSOFERRIC OXIDEFERROSOFERRIC OXIDEXM0M87F357TABLET / ORAL2 mgExact identifier — unii candidate
10 equally ranked IID candidates
FERROSOFERRIC OXIDEFERROSOFERRIC OXIDEXM0M87F357CAPSULE, EXTENDED RELEASE / ORAL1.49 mgExact identifier — unii candidate
10 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCLOTH / TOPICAL0.05 mg/mgExact identifier — unii candidate
75 equally ranked IID candidates
ALUMINUM HYDROXIDEALUMINUM HYDROXIDE5QB0T2IUN0CREAM / TOPICAL5 %w/wExact identifier — unii candidate
4 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, EXTENDED RELEASE / ORAL200 mgExact identifier — unii candidate
26 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET, FILM COATED / ORAL3 mgExact identifier — unii candidate
21 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675CAPSULE, DELAYED RELEASE / ORAL14 mgExact identifier — unii candidate
21 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675LOTION / TOPICALNAExact identifier — unii candidate
21 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675SUSPENSION, EXTENDED RELEASE / ORAL2.7 mgExact identifier — unii candidate
21 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTCAPSULE, COATED / ORAL0.01 mgExact identifier — unii candidate
20 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, ORALLY DISINTEGRATING / ORAL10 mgExact identifier — unii candidate
26 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTTABLET, ORALLY DISINTEGRATING / ORAL2 mgExact identifier — unii candidate
20 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM, AUGMENTED / TOPICAL10 mgExact identifier — unii candidate
6 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302GEL / TOPICAL75 mgExact identifier — unii candidate
9 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET / ORAL336 mgExact identifier — unii candidate
26 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, CHEWABLE / ORAL12 mgExact identifier — unii candidate
75 equally ranked IID candidates
TALCTALC7SEV7J4R1UPELLET / ORAL69 mgExact identifier — unii candidate
35 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPONGE / TOPICAL2 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPRAY, METERED / NASAL13 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / ORAL750 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXJELLY / TOPICALNAExact identifier — unii candidate
75 equally ranked IID candidates
TALCTALC7SEV7J4R1ULOZENGE / ORAL50 mgExact identifier — unii candidate
35 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET / SUBLINGUAL32.4 mgExact identifier — unii candidate
35 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTTABLET / SUBLINGUAL1 mgExact identifier — unii candidate
20 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302GEL, METERED / TOPICAL525 mgExact identifier — unii candidate
9 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, COATED / ORAL320.75 mgExact identifier — unii candidate
35 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET / BUCCAL15 mgExact identifier — unii candidate
35 equally ranked IID candidates
CYCLOMETHICONECYCLOMETHICONENMQ347994ZAEROSOL, FOAM / TOPICAL5.26 %w/wExact identifier — unii candidate
5 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET, COATED / ORAL1 mgExact identifier — unii candidate
21 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXEMULSION / INTRAVENOUS2.2 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
BUTYLENE GLYCOLBUTYLENE GLYCOL3XUS85K0RASYSTEM / TOPICAL1400 mgExact identifier — unii candidate
2 equally ranked IID candidates
FERROSOFERRIC OXIDEFERROSOFERRIC OXIDEXM0M87F357POWDER, FOR SUSPENSION / ORALNAExact identifier — unii candidate
10 equally ranked IID candidates
ALUMINUM HYDROXIDEALUMINUM HYDROXIDE5QB0T2IUN0CAPSULE / ORALNAExact identifier — unii candidate
4 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TRANSDERMAL500 mgExact identifier — unii candidate
75 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, CHEWABLE / ORAL202 mgExact identifier — unii candidate
35 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APEMULSION / ORALNAExact identifier — unii candidate
26 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET / PERIODONTAL0.53 mgExact identifier — unii candidate
75 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0TABLET / ORAL0.5 mgExact identifier — unii candidate
3 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TAEROSOL, FOAM / TOPICAL72 mgExact identifier — unii candidate
6 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTGRANULE, FOR SUSPENSION / ORAL11 mgExact identifier — unii candidate
20 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SPONGE / TOPICAL4 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL2 mgExact identifier — unii candidate
20 equally ranked IID candidates
TOCOPHEROLTOCOPHEROLR0ZB2556P8CREAM / TOPICALNAExact identifier — unii candidate
5 equally ranked IID candidates
PALMITIC ACIDPALMITIC ACID2V16EO95H1INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUSNAExact identifier — unii candidate
2 equally ranked IID candidates
TALCTALC7SEV7J4R1USUSPENSION, EXTENDED RELEASE / ORAL46 mgExact identifier — unii candidate
35 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / ORAL26208 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXMOUTHWASH / BUCCAL100 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / ORAL32400 mgExact identifier — unii candidate
75 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675CAPSULE, COATED / ORAL0.12 mgExact identifier — unii candidate
21 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPRAY / NASAL22.3 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTCAPSULE, DELAYED RELEASE / ORAL3 mgExact identifier — unii candidate
20 equally ranked IID candidates

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
ed8fcb61-e95b-4f2e-ac49-a71230bb015221cf1472-452c-42db-9556-7d3576e415922023-10-19WarningsExact identifier
spl set id: 21cf1472-452c-42db-9556-7d3576e41592

Reported adverse events (FAERS/openFDA)#

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