FDA.reportPublic FDA data

CLE DE PEAU BEAUTE SMOOTHING BASE FOR LINES

Manufacturer
SHISEIDO CO., LTD.
Effective date
2012-04-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:47:40

Label at a glance#

ProductCLE DE PEAU BEAUTE SMOOTHING BASE FOR LINES
Active ingredientTitanium dioxide
Label structure11 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 9.9%

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 • GLYCERIN • DIMETHICONE • POLYMETHYL METHACRYLATE • DIPROPYLENE GLYCOL • PEG-10 DIMETHICONE • XYLITOL • BUTYLENE GLYCOL • ERYTHRITOL • PEG-150 • ALUMINUM HYDROXIDE • ALUMINUM DISTEARATE • CETYL ETHYLHEXANOATE • BARIUM SULFATE • DISTEARDIMONIUM HECTORITE • OLEA EUROPAEA (OLIVE) FRUIT OIL • PHENOXYETHANOL • TRIMETHYLSILOXYSILICATE • ISOSTEARIC ACID • TRISODIUM EDTA • FRAGRANCE • IRON OXIDES • TOCOPHEROL • SYNTHETIC FLUORPHLOGOPITE • ALCOHOL • MICA • TALC • SODIUM ACETYLATED HYALURONATE • ROSA ROXBURGHII FRUIT EXTRACT • TRIETHOXYCAPRYLYLSILANE • CAMELLIA SINENSIS LEAF EXTRACT • TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL DIMETHICONE • PRUNUS SPECIOSA LEAF EXTRACT • DIMETHICONE/METHICONE COPOLYMER • TITANIUM DIOXIDE

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

SPL UNCLASSIFIED SECTION

Manufactured by SHISEIDO CO., LTD.
7-5-5 GINZA TOKYO

PRINCIPAL DISPLAY PANEL - 34 mL Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

clé de peau
BEAUTÉ

smoothing base for lines

BROAD SPECTRUM SPF 26
SUNSCREEN

34mL NET WT. 1.3 OZ.

PRINCIPAL DISPLAY PANEL - 34 mL Tube Carton
PRINCIPAL DISPLAY PANEL - 34 mL Tube Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52685-192-602023-09-12C16284748780-197449f38-c239-f6ea-e053-dbdaa90aa703CLE DE PEAU BEAUTE SMOOTHING BASE FOR LINES
52685-192-602019-11-13C16284748780-197449f38-c239-f6ea-e053-dbdaa90aa703CLE DE PEAU BEAUTE SMOOTHING BASE FOR LINES

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Titanium dioxideACTIVE INGREDIENT15FIX9V2JP1
Titanium dioxideACTIVE MOIETY15FIX9V2JP1
.ALPHA.-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ11
ALCOHOLINACTIVE INGREDIENT3K9958V90M1
ALUMINUM DISTEARATEINACTIVE INGREDIENT7P1HP1B9UI1
ALUMINUM HYDROXIDEINACTIVE INGREDIENT5QB0T2IUN01
BARIUM SULFATEINACTIVE INGREDIENT25BB7EKE2E1
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RA1
CETYL ETHYLHEXANOATEINACTIVE INGREDIENT134647WMX41
CYCLOMETHICONEINACTIVE INGREDIENTNMQ347994Z1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1O1
DIPROPYLENE GLYCOLINACTIVE INGREDIENTE107L85C401
EDETATE TRISODIUMINACTIVE INGREDIENT420IP921MB1
ERYTHRITOLINACTIVE INGREDIENTRA96B954X61
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G6751
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRT1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
GREEN TEA LEAFINACTIVE INGREDIENTW2ZU1RY8B01
ISOSTEARIC ACIDINACTIVE INGREDIENTX33R8U00621
MICAINACTIVE INGREDIENTV8A1AW08801
OLIVE OILINACTIVE INGREDIENT6UYK2W1W1E1
PEG-10 DIMETHICONE (600 CST)INACTIVE INGREDIENT8PR7V1SVM01
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T1
POLYETHYLENE GLYCOL 7000INACTIVE INGREDIENTQ0JET65GEL1
PRUNUS SPECIOSA LEAFINACTIVE INGREDIENTQ71D900FVU1
ROSA ROXBURGHII FRUITINACTIVE INGREDIENTCVT1AA87FF1
TALCINACTIVE INGREDIENT7SEV7J4R1U1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP1
TRIETHOXYCAPRYLYLSILANEINACTIVE INGREDIENTLDC331P08E1
TRIMETHYLSILOXYSILICATE (M/Q 0.66)INACTIVE INGREDIENT5041RX63GN1
WATERINACTIVE INGREDIENT059QF0KO0R1
XYLITOLINACTIVE INGREDIENTVCQ006KQ1E1

Products#

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

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52685-19252685-192-60

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 31 matching rows.

Name, UNII, Kind table
NameUNIIKind
Titanium dioxide15FIX9V2JPACTIB
WATER059QF0KO0RIACT
CYCLOMETHICONENMQ347994ZIACT
GLYCERINPDC6A3C0OXIACT
DIMETHICONE92RU3N3Y1OIACT
DIPROPYLENE GLYCOLE107L85C40IACT
PEG-10 DIMETHICONE (600 CST)8PR7V1SVM0IACT
XYLITOLVCQ006KQ1EIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
ERYTHRITOLRA96B954X6IACT
POLYETHYLENE GLYCOL 7000Q0JET65GELIACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
ALUMINUM DISTEARATE7P1HP1B9UIIACT
CETYL ETHYLHEXANOATE134647WMX4IACT
BARIUM SULFATE25BB7EKE2EIACT
OLIVE OIL6UYK2W1W1EIACT
PHENOXYETHANOLHIE492ZZ3TIACT
TRIMETHYLSILOXYSILICATE (M/Q 0.66)5041RX63GNIACT
ISOSTEARIC ACIDX33R8U0062IACT
EDETATE TRISODIUM420IP921MBIACT
FERRIC OXIDE RED1K09F3G675IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
ALCOHOL3K9958V90MIACT
MICAV8A1AW0880IACT
TALC7SEV7J4R1UIACT
ROSA ROXBURGHII FRUITCVT1AA87FFIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
PRUNUS SPECIOSA LEAFQ71D900FVUIACT
TITANIUM DIOXIDE15FIX9V2JPIACT

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 6 · 303 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
TALCTALC7SEV7J4R1UPOWDER / TOPICAL9235 mgExact identifier — unii candidate
35 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675POWDER, FOR SUSPENSION / ORAL1 mgExact identifier — unii candidate
21 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii candidate
59 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE, COATED PELLETS / ORAL4.4 mgExact identifier — unii candidate
40 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPONGE / TOPICAL2 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / TRANSDERMAL306.2 mgExact identifier — unii candidate
75 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPLOTION / TOPICALNAExact identifier — unii candidate
40 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / OPHTHALMIC0.88 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / SUBCUTANEOUS450 mgExact identifier — unii candidate
75 equally ranked IID candidates
ISOSTEARIC ACIDISOSTEARIC ACIDX33R8U0062CREAM / TOPICAL100 mgExact identifier — unii candidate
3 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MJELLY / VAGINALNAExact identifier — unii candidate
59 equally ranked IID candidates
ISOSTEARIC ACIDISOSTEARIC ACIDX33R8U0062GEL / TOPICAL20 mgExact identifier — unii candidate
3 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPRAY / NASAL22.3 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, EXTENDED RELEASE / ORAL300 mgExact identifier — unii candidate
35 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION/ DROPS / OPHTHALMIC12 mgExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALUMINUM HYDROXIDEALUMINUM HYDROXIDE5QB0T2IUN0CREAM / TOPICAL5 %w/wExact identifier — unii candidate
4 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXPASTE / DENTAL20 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLIQUID / ORAL2400 mgExact identifier — unii candidate
75 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, FILM COATED / ORAL36 mgExact identifier — unii candidate
40 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCONCENTRATE / BUCCAL679 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDROPS / NASAL10 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPPOWDER / ORAL2 mgExact identifier — unii candidate
40 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SOLUTION / INTRAMUSCULAR15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii candidate
59 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTTABLET / SUBLINGUAL1 mgExact identifier — unii candidate
20 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPPOWDER / RESPIRATORY (INHALATION)2 mgExact identifier — unii candidate
40 equally ranked IID candidates
XYLITOLXYLITOLVCQ006KQ1ESUSPENSION / ORAL1500 mgExact identifier — unii candidate
12 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675CAPSULE, DELAYED RELEASE / ORAL14 mgExact identifier — unii candidate
21 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii candidate
59 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET, EXTENDED RELEASE / ORAL7 mgExact identifier — unii candidate
21 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii candidate
59 equally ranked IID candidates
TALCTALC7SEV7J4R1UCAPSULE, COATED, EXTENDED RELEASE / ORAL20 mgExact identifier — unii candidate
35 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, CHEWABLE / ORAL12 mgExact identifier — unii candidate
75 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675DROPS / ORALNAExact identifier — unii candidate
21 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1SOLUTION / ORAL1.05 mg/1mlExact identifier — unii candidate
10 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL42 mgExact identifier — unii candidate
40 equally ranked IID candidates
XYLITOLXYLITOLVCQ006KQ1ESOLUTION / ORAL21600 mgExact identifier — unii candidate
12 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXOINTMENT / TOPICALNAExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii candidate
59 equally ranked IID candidates
TALCTALC7SEV7J4R1UPELLET / ORAL69 mgExact identifier — unii candidate
35 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPFILM, EXTENDED RELEASE / TRANSDERMALNAExact identifier — unii candidate
40 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTFILM / BUCCAL0.27 mgExact identifier — unii candidate
20 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, COATED / ORAL320.75 mgExact identifier — unii candidate
35 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / OPHTHALMIC6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
TALCTALC7SEV7J4R1UCAPSULE, COATED PELLETS / ORAL14 mgExact identifier — unii candidate
35 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1TABLET, EXTENDED RELEASE / ORAL4 mgExact identifier — unii candidate
10 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPPASTE, DENTIFRICE / DENTAL0.4 %w/wExact identifier — unii candidate
40 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION, CONCENTRATE / INTRAVENOUS4000 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / INTRAVENOUS99 mgExact identifier — unii candidate
59 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPGUM, CHEWING / BUCCAL182 mgExact identifier — unii candidate
40 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, SUGAR COATED / ORALNAExact identifier — unii candidate
35 equally ranked IID candidates
TALCTALC7SEV7J4R1UCAPSULE, EXTENDED RELEASE / ORAL5119 mgExact identifier — unii candidate
35 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / SUBCUTANEOUS149 mgExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SOLUTION / SUBCUTANEOUS15 %w/vExact identifier — unii candidate
75 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
ce3495e4-942a-4f72-8153-4afd7307bab2699579bb-61d4-4167-94cb-3b173ab2f6942023-09-12WarningsExact identifier
spl set id: 699579bb-61d4-4167-94cb-3b173ab2f694

Reported adverse events (FAERS/openFDA)#

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