FDA.reportPublic FDA data

CLE DE PEAU BEAUTE UV PROTECTION CREAM

Manufacturer
SHISEIDO AMERICA INC. | Davlyn Industries Inc
Effective date
2012-06-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:47:08

Label at a glance#

ProductCLE DE PEAU BEAUTE UV PROTECTION
Active ingredientOCTINOXATE, OCTOCRYLENE, ZINC OXIDE
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 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

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

ACTIVE INGREDIENTS:Purpose
OCTINOXATE 7.4%Sunscreen
OCTOCRYLENE 3.0%Sunscreen
ZINC OXIDE 16.4%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, DIPROPYLENE GLYCOL, ISOHEXADECANE, DIMETHICONE, ISOPROPYL MYRISTATE, GLYCERIN, SD ALCOHOL 40-B, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, POLYMETHYL METHACRYLATE, POLYMETHYLSILSESQUIOXANE, POLYBUTYLENE GLYCOL/PPG-9/1 COPOLYMER, DISTEARDIMONIUM HECTORITE, PEG-6, PEG-32, SILICA, XYLITOL, SODIUM HYALURONATE, TOCOPHERYL ACETATE, LACTOBACILLUS/HIBISCUS SABDARIFFA FLOWER FERMENT FILTRATE, CRATAEGUS MONOGYNA FLOWER EXTRACT, THIOTAURINE, DIPOTASSIUM GLYCYRRHIZATE, 2-O-ETHYL ASCORBIC ACID, SODIUM ACETYLATED HYALURONATE, POLYQUATERNIUM-51, SAXIFRAGA SARMENTOSA EXTRACT, UNCARIA GAMBIR EXTRACT, GINKGO BILOBA LEAF EXTRACT, THYMUS SERPILLUM EXTRACT, ROSA ROXBURGHII FRUIT EXTRACT, HYDROLYZED CONCHIOLIN PROTEIN, CURCUMA LONGA (TURMERIC) ROOT EXTRACT, HYPERICUM ERECTUM EXTRACT, HYDROLYZED SILK, BUPLEURUM FALCATUM ROOT EXTRACT, HYDROGENATED POLYDECENE, HYDROGEN DIMETHICONE, ISOSTEARIC ACID, TRISODIUM EDTA, BUTYLENE GLYCOL, BHT, ALCOHOL, TOCOPHEROL, PHENOXYETHANOL, FRAGRANCE, TITANIUM DIOXIDE, 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 - 50 mL Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

clé de peau
BEAUTÉ

50+

UV protection cream

BROAD SPECTRUM
SPF 50+
SUNSCREEN

50mL NET WT. 2.0 OZ.

Principal Display Panel - 50 mL Tube Carton
Principal Display Panel - 50 mL Tube Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52686-275-602023-11-07C16284748780-19d75b9cf-e831-f424-e053-dadaa90a57ceCLE DE PEAU BEAUTE UV PROTECTION CREAM
52686-275-602020-01-31C16284748780-19d75b9cf-e831-f424-e053-dadaa90a57ceCLE DE PEAU BEAUTE UV PROTECTION CREAM

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD511
OCTOCRYLENEACTIVE INGREDIENT5A68WGF6WM1
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54Z1
OCTINOXATEACTIVE MOIETY4Y5P7MUD511
OCTOCRYLENEACTIVE MOIETY5A68WGF6WM1
ZINC OXIDEACTIVE MOIETYSOI2LOH54Z1
.ALPHA.-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ11
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L01
2-O-ETHYL ASCORBIC ACIDINACTIVE INGREDIENT801M14RK9K1
ALCOHOLINACTIVE INGREDIENT3K9958V90M1
BUPLEURUM FALCATUM ROOTINACTIVE INGREDIENTX04E310LUY1
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171K1
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RA1
CRATAEGUS MONOGYNA FLOWERINACTIVE INGREDIENTNT52AMP29J1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1O1
DIPROPYLENE GLYCOLINACTIVE INGREDIENTE107L85C401
EDETATE TRISODIUMINACTIVE INGREDIENT420IP921MB1
GINKGOINACTIVE INGREDIENT19FUJ2C58T1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
GLYCYRRHIZINATE DIPOTASSIUMINACTIVE INGREDIENTCA2Y0FE3FX1
HYALURONATE SODIUMINACTIVE INGREDIENTYSE9PPT4TH1
HYDROGENATED POLYDECENE (550 MW)INACTIVE INGREDIENTU333RI6EB71
ISOHEXADECANEINACTIVE INGREDIENT918X1OUF1E1
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJS1
ISOSTEARIC ACIDINACTIVE INGREDIENTX33R8U00621
MICAINACTIVE INGREDIENTV8A1AW08801
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T1
POLYETHYLENE GLYCOL 1500INACTIVE INGREDIENT1212Z7S33A1
POLYETHYLENE GLYCOL 300INACTIVE INGREDIENT5655G9Y8AQ1
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)INACTIVE INGREDIENT59Z907ZB691
ROSA ROXBURGHII FRUITINACTIVE INGREDIENTCVT1AA87FF1
SAXIFRAGA STOLONIFERA LEAFINACTIVE INGREDIENTO3TMV4903H1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU41
THIOTAURINEINACTIVE INGREDIENTNQZ2D7AO621
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP1
TURMERICINACTIVE INGREDIENT856YO1Z64F1
WATERINACTIVE INGREDIENT059QF0KO0R1
XYLITOLINACTIVE INGREDIENTVCQ006KQ1E1

Products#

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

DailyMed product names page 1 of 1 · 37 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52686-27552686-275-60

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 35 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTINOXATE4Y5P7MUD51ACTIB
OCTOCRYLENE5A68WGF6WMACTIB
ZINC OXIDESOI2LOH54ZACTIB
WATER059QF0KO0RIACT
DIPROPYLENE GLYCOLE107L85C40IACT
ISOHEXADECANE918X1OUF1EIACT
DIMETHICONE92RU3N3Y1OIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
GLYCERINPDC6A3C0OXIACT
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)59Z907ZB69IACT
POLYETHYLENE GLYCOL 3005655G9Y8AQIACT
POLYETHYLENE GLYCOL 15001212Z7S33AIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
XYLITOLVCQ006KQ1EIACT
HYDROGENATED POLYDECENE (550 MW)U333RI6EB7IACT
ISOSTEARIC ACIDX33R8U0062IACT
PHENOXYETHANOLHIE492ZZ3TIACT
EDETATE TRISODIUM420IP921MBIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
HYALURONATE SODIUMYSE9PPT4THIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
MICAV8A1AW0880IACT
ALCOHOL3K9958V90MIACT
CRATAEGUS MONOGYNA FLOWERNT52AMP29JIACT
GLYCYRRHIZINATE DIPOTASSIUMCA2Y0FE3FXIACT
THIOTAURINENQZ2D7AO62IACT
2-O-ETHYL ASCORBIC ACID801M14RK9KIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
SAXIFRAGA STOLONIFERA LEAFO3TMV4903HIACT
GINKGO19FUJ2C58TIACT
ROSA ROXBURGHII FRUITCVT1AA87FFIACT
TURMERIC856YO1Z64FIACT
BUPLEURUM FALCATUM ROOTX04E310LUYIACT

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 · 337 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
GLYCERINGLYCERINPDC6A3C0OXPASTE / DENTAL20 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
HYALURONATE SODIUMHYALURONATE SODIUMYSE9PPT4THINJECTION, SUSPENSION / INTRA-ARTICULAR23 mgExact identifier — unii candidate
5 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1CAPSULE / ORAL16 mgExact identifier — unii candidate
10 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GRANULE, FOR SOLUTION / ORAL1.8 mg/120mlExact identifier — unii candidate
49 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPONGE / TOPICAL2 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM / TOPICAL57 mgExact identifier — unii candidate
6 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, FOR SUSPENSION / ORAL220 mgExact identifier — unii candidate
49 equally ranked IID candidates
XYLITOLXYLITOLVCQ006KQ1EPOWDER, FOR SUSPENSION / ORAL4223 mgExact identifier — unii candidate
12 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / BUCCAL34 mgExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / INTRAMUSCULAR1491 mgExact identifier — unii candidate
59 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, DELAYED RELEASE / ORAL66 mgExact identifier — unii candidate
40 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1SYSTEM / TOPICAL0.1 mgExact identifier — unii candidate
10 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1FILM, SOLUBLE / BUCCAL0.07 mgExact identifier — unii candidate
10 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRADERMAL1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
POLYETHYLENE GLYCOL 300POLYETHYLENE GLYCOL 3005655G9Y8AQSOLUTION / TOPICAL29.7 %w/wExact identifier — unii candidate
13 equally ranked IID candidates
ISOPROPYL MYRISTATEISOPROPYL MYRISTATE0RE8K4LNJSAEROSOL, FOAM / TOPICAL144 mgExact identifier — unii candidate
18 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1TABLET, EXTENDED RELEASE / ORAL4 mgExact identifier — unii candidate
10 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM, AUGMENTED / TOPICAL10 mgExact identifier — unii candidate
6 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET / ORAL750 mgExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, DELAYED RELEASE PARTICLES / ORAL170 mgExact identifier — unii candidate
49 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii candidate
59 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET / BUCCAL3 mgExact identifier — unii candidate
49 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KAEROSOL, FOAM / TOPICAL4 mgExact identifier — unii candidate
32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KGEL / TOPICAL8 mgExact identifier — unii candidate
32 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GRANULE, FOR SUSPENSION / ORAL200 mgExact identifier — unii candidate
49 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDROPS / ORAL300 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, COATED / ORAL1 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SOLUTION / SUBCUTANEOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
ISOPROPYL MYRISTATEISOPROPYL MYRISTATE0RE8K4LNJSAEROSOL, SPRAY / TOPICAL6.89 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SOLUTION / INTRAVENOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1TABLET, FILM COATED / ORAL246 mgExact identifier — unii candidate
10 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPINSERT, EXTENDED RELEASE / OPHTHALMIC0.4 mgExact identifier — unii candidate
40 equally ranked IID candidates
ISOPROPYL MYRISTATEISOPROPYL MYRISTATE0RE8K4LNJSLOTION / TOPICAL50 mgExact identifier — unii candidate
18 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS225 mgExact identifier — unii candidate
75 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL42 mgExact identifier — unii candidate
40 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / INTRAVASCULAR100 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
ISOPROPYL MYRISTATEISOPROPYL MYRISTATE0RE8K4LNJSAEROSOL / TOPICAL9.3 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPPOWDER / RESPIRATORY (INHALATION)2 mgExact identifier — unii candidate
40 equally ranked IID candidates
POLYETHYLENE GLYCOL 300POLYETHYLENE GLYCOL 3005655G9Y8AQINJECTION, SOLUTION, CONCENTRATE / INTRAVENOUS44.22 %w/vExact identifier — unii candidate
13 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, EMULSION / INTRAVENOUS520 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4LOZENGE / ORAL120 mgExact identifier — unii candidate
49 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, COATED / ORAL14.21 mgExact identifier — unii candidate
75 equally ranked IID candidates
POLYETHYLENE GLYCOL 1500POLYETHYLENE GLYCOL 16001212Z7S33ATABLET, COATED / ORALNAExact identifier — unii candidate
6 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION/ DROPS / AURICULAR (OTIC)25 mgExact identifier — unii candidate
75 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPPASTE / DENTAL0.5 %w/wExact identifier — unii candidate
40 equally ranked IID candidates
POLYETHYLENE GLYCOL 1500POLYETHYLENE GLYCOL 16001212Z7S33APASTE / DENTAL4.96 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KSOAP / TOPICAL0.02 %w/wExact identifier — unii candidate
32 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYRUP / ORAL16734 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYSTEM / TOPICAL18144 mgExact identifier — unii candidate
75 equally ranked IID candidates
XYLITOLXYLITOLVCQ006KQ1ETABLET / ORAL15.04 mgExact identifier — unii candidate
12 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE / ORAL72 mgExact identifier — unii candidate
40 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / AURICULAR (OTIC)0.05 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE, DELAYED RELEASE PELLETS / ORAL24 mgExact identifier — unii candidate
40 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPFILM, EXTENDED RELEASE / TRANSDERMALNAExact identifier — unii candidate
40 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / OPHTHALMIC2.5 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GEL / VAGINAL8 %w/wExact identifier — unii candidate
49 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / OPHTHALMIC58 mgExact identifier — unii candidate
75 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, EXTENDED RELEASE / ORAL90 mgExact identifier — unii candidate
40 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii candidate
59 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
fb37940a-22b3-47b3-9f57-026dfe6170c9d00e4b86-a97e-4204-8f7f-1fc94671b3cb2023-10-17WarningsExact identifier
spl set id: d00e4b86-a97e-4204-8f7f-1fc94671b3cb

Reported adverse events (FAERS/openFDA)#

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