CLE DE PEAU BEAUTE REFRESHING PROTECTIVE I

Manufacturer: SHISEIDO CO., LTD.
Effective date: 2012-04-03
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: legacy-cache
Hydrated at: 2026-08-02 01:47:52

Label at a glance#

ProductCLE DE PEAU BEAUTE REFRESHING PROTECTIVE I

Active ingredientEnsulizole, Octinoxate, Octocrylene, Oxybenzone

Label structure9 sections

Indications and uses

helps prevent sunburn higher SPF gives more sunburn protection

Dosage and administration

apply evenly before sun exposure and as needed. children under 6 months of age: ask a doctor.

Contacts and useful links#

PhoneLabel contact1-800-906-7503

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients	Purpose
ENSULIZOLE 1.5%	Sunscreen
OCTINOXATE 4.9%	Sunscreen
OCTOCRYLENE 5.0%	Sunscreen
OXYBENZONE 1.0%	Sunscreen

Uses

INDICATIONS & USAGE SECTION

helps prevent sunburn
higher SPF gives more sunburn protection

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

OTC - STOP USE SECTION

rash or irritation develops and lasts.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

apply evenly before sun exposure and as needed.
children under 6 months of age: ask a doctor.

Inactive ingredients

INACTIVE INGREDIENT SECTION

WATER, ALCOHOL, DIPROPYLENE GLYCOL, GLYCERIN, XYLITOL, DIMETHICONE, HYDROGENATED POLYDECENE, TRIETHANOLAMINE, PPG-8 CETETH-20, PEG/PPG-17/4 DIMETHYL ETHER, PHYTOSTERYL MACADAMIATE, XANTHAN GUM, TOCOPHERYL ACETATE, CRATAEGUS MONOGINA FLOWER EXTRACT, SERINE, 2-O-ETHYL ASCORBIC ACID, GLYCYL GLYCINE, SODIUM ACETYLATED HYALURONATE, POLYQUATERNIUM-51, SAXIFRAGA SARMENTOSA EXTRACT, UNCARIA GAMBIR EXTRACT, GINKGO BILOBA LEAF EXTRACT, PAEONIA SUFFRUTICOSA ROOT EXTRACT, ROSA ROXBURGHII FRUIT EXTRACT, HYDROLYZED CONCHIOLIN PROTEIN, HYPERICUM ERECTUM EXTRACT, HYDROLYZED SILK, BUPLEURUM FALCATUM ROOT EXTRACT, COIX LACRYMA-JOBI (JOB'S TEARS) SEED EXTRACT, CARBOMER, ISOSTEARIC ACID, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, DISODIUM EDTA, BUTYLENE GLYCOL, BHT, SODIUM METABISULFITE, TOCOPHEROL, PHENOXYETHANOL, FRAGRANCE

Questions?

OTC - QUESTIONS SECTION

1-800-906-7503

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 125mL Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

clé de peau
BEAUTÉ

refreshing protective emulsion

SPF 20
sunscreen

125mL 4.2 FL. OZ.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
52685-346-10	2023-09-20	C162847	48780-1	97449f38-b603-f6ea-e053-dbdaa90aa703	cle de peau BEAUTE REFRESHING PROTECTIVE EMULSION I
52685-346-10	2019-11-13	C162847	48780-1	97449f38-b603-f6ea-e053-dbdaa90aa703	cle de peau BEAUTE REFRESHING PROTECTIVE EMULSION I

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Ensulizole	ACTIVE INGREDIENT	9YQ9DI1W42	3
Octinoxate	ACTIVE INGREDIENT	4Y5P7MUD51	3
Octocrylene	ACTIVE INGREDIENT	5A68WGF6WM	3
Oxybenzone	ACTIVE INGREDIENT	95OOS7VE0Y	3
Ensulizole	ACTIVE MOIETY	9YQ9DI1W42	3
Octinoxate	ACTIVE MOIETY	4Y5P7MUD51	3
Octocrylene	ACTIVE MOIETY	5A68WGF6WM	3
Oxybenzone	ACTIVE MOIETY	95OOS7VE0Y	3
.ALPHA.-TOCOPHEROL ACETATE, DL-	INACTIVE INGREDIENT	WR1WPI7EW8	3
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	3
ALPHA-TOCOPHEROL	INACTIVE INGREDIENT	H4N855PNZ1	3
BUPLEURUM FALCATUM ROOT	INACTIVE INGREDIENT	X04E310LUY	3
BUTYLATED HYDROXYTOLUENE	INACTIVE INGREDIENT	1P9D0Z171K	3
BUTYLENE GLYCOL	INACTIVE INGREDIENT	3XUS85K0RA	3
COIX LACRYMA-JOBI SEED	INACTIVE INGREDIENT	4Q4V6NTZ1F	3
DIGLYCINE	INACTIVE INGREDIENT	10525P22U0	3
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	3
DIPROPYLENE GLYCOL	INACTIVE INGREDIENT	E107L85C40	3
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	3
GINKGO	INACTIVE INGREDIENT	19FUJ2C58T	3
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	3
HYPERICUM ERECTUM FLOWERING TOP	INACTIVE INGREDIENT	IT0296HQDC	3
ISOSTEARIC ACID	INACTIVE INGREDIENT	X33R8U0062	3
PAEONIA SUFFRUTICOSA ROOT	INACTIVE INGREDIENT	7M7E9A2C8J	3
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	3
SAXIFRAGA STOLONIFERA LEAF	INACTIVE INGREDIENT	O3TMV4903H	3
SERINE	INACTIVE INGREDIENT	452VLY9402	3
SODIUM METABISULFITE	INACTIVE INGREDIENT	4VON5FNS3C	3
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	3
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	3
XYLITOL	INACTIVE INGREDIENT	VCQ006KQ1E	3

Products#

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

DailyMed product names page 1 of 1 · 30 matching rows.

CLE DE PEAU BEAUTE REFRESHING PROTECTIVE I
Ensulizole, Octinoxate, Octocrylene, and Oxybenzone
Ensulizole
Octinoxate
Octocrylene
Oxybenzone
WATER
ALCOHOL
DIPROPYLENE GLYCOL
GLYCERIN
XYLITOL
DIMETHICONE
TROLAMINE
XANTHAN GUM
.ALPHA.-TOCOPHEROL ACETATE, DL-
SERINE
DIGLYCINE
SAXIFRAGA STOLONIFERA LEAF
GINKGO
PAEONIA SUFFRUTICOSA ROOT
HYPERICUM ERECTUM FLOWERING TOP
BUPLEURUM FALCATUM ROOT
COIX LACRYMA-JOBI SEED
ISOSTEARIC ACID
EDETATE DISODIUM
BUTYLENE GLYCOL
BUTYLATED HYDROXYTOLUENE
SODIUM METABISULFITE
ALPHA-TOCOPHEROL
PHENOXYETHANOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
52685-346	52685-346-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Ensulizole	9YQ9DI1W42	ACTIB
Octinoxate	4Y5P7MUD51	ACTIB
Octocrylene	5A68WGF6WM	ACTIB
Oxybenzone	95OOS7VE0Y	ACTIB
WATER	059QF0KO0R	IACT
ALCOHOL	3K9958V90M	IACT
DIPROPYLENE GLYCOL	E107L85C40	IACT
GLYCERIN	PDC6A3C0OX	IACT
XYLITOL	VCQ006KQ1E	IACT
DIMETHICONE	92RU3N3Y1O	IACT
TROLAMINE	9O3K93S3TK	IACT
XANTHAN GUM	TTV12P4NEE	IACT
.ALPHA.-TOCOPHEROL ACETATE, DL-	WR1WPI7EW8	IACT
SERINE	452VLY9402	IACT
DIGLYCINE	10525P22U0	IACT
SAXIFRAGA STOLONIFERA LEAF	O3TMV4903H	IACT
GINKGO	19FUJ2C58T	IACT
PAEONIA SUFFRUTICOSA ROOT	7M7E9A2C8J	IACT
HYPERICUM ERECTUM FLOWERING TOP	IT0296HQDC	IACT
BUPLEURUM FALCATUM ROOT	X04E310LUY	IACT
COIX LACRYMA-JOBI SEED	4Q4V6NTZ1F	IACT
ISOSTEARIC ACID	X33R8U0062	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
BUTYLENE GLYCOL	3XUS85K0RA	IACT
BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	IACT
SODIUM METABISULFITE	4VON5FNS3C	IACT
ALPHA-TOCOPHEROL	H4N855PNZ1	IACT
PHENOXYETHANOL	HIE492ZZ3T	IACT

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 7 · 377 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	DROPS / OPHTHALMIC	0.05 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SOLUTION / OPHTHALMIC	0.6 %w/v		Exact identifier — unii candidate 29 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / TOPICAL		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	GEL / OPHTHALMIC	0.88 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION, EMULSION / INTRAVENOUS		520 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
DIPROPYLENE GLYCOL	DIPROPYLENE GLYCOL	E107L85C40	FILM, EXTENDED RELEASE / BUCCAL		30 mg	Exact identifier — unii candidate 3 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	TABLET, ORALLY DISINTEGRATING / ORAL		360 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / DENTAL	12.8 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION/ DROPS / OPHTHALMIC	2.5 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	JELLY / VAGINAL	NA		Exact identifier — unii candidate 59 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	FILM, SOLUBLE / ORAL		1 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	GEL, METERED / TRANSDERMAL		14 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CREAM / TOPICAL		1720 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	PASTE / ORAL		180 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	POWDER, FOR SOLUTION / TOPICAL	40 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SOLUTION / ORAL		84 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	CREAM, AUGMENTED / TOPICAL		10 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
ALPHA-TOCOPHEROL	.ALPHA.-TOCOPHEROL	H4N855PNZ1	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 10 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	FILM, EXTENDED RELEASE / BUCCAL		34 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
SODIUM METABISULFITE	SODIUM METABISULFITE	4VON5FNS3C	INJECTION / INTRACARDIAC	0.09 %w/v		Exact identifier — unii candidate 43 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	GEL, METERED / TRANSDERMAL		3675 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	DROPS / ORAL	210 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, SOLUTION / INTRAMUSCULAR		4 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	SOLUTION / TOPICAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	LOTION / TOPICAL		3990 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRAVASCULAR	0.48 mg		Exact identifier — unii candidate 77 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	PASTE, DENTIFRICE / DENTAL	18 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CREAM / VAGINAL		60 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
SODIUM METABISULFITE	SODIUM METABISULFITE	4VON5FNS3C	INJECTION / INTRAPERITONEAL	0.33 %w/v		Exact identifier — unii candidate 43 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SUSPENSION / RESPIRATORY (INHALATION)	0.01 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SOAP / TOPICAL	0.02 %w/w		Exact identifier — unii candidate 32 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	GEL / TRANSDERMAL		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
SODIUM METABISULFITE	SODIUM METABISULFITE	4VON5FNS3C	INJECTION, SOLUTION, CONCENTRATE / INTRAOCULAR	0.15 %w/v		Exact identifier — unii candidate 43 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / SOFT TISSUE	0.05 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS		19 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	SHAMPOO / TOPICAL	3.7 %w/w		Exact identifier — unii candidate 22 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	AEROSOL, METERED / NASAL	70 mg		Exact identifier — unii candidate 59 equally ranked IID candidates
SODIUM METABISULFITE	SODIUM METABISULFITE	4VON5FNS3C	CREAM / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 43 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION, SOLUTION / INTRAMUSCULAR		1000 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS	0.02 mg		Exact identifier — unii candidate 32 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SYSTEM / IONTOPHORESIS	0.1 mg		Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	EMULSION / OPHTHALMIC	0.3 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	LIQUID / ORAL		2400 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / TOPICAL		2445 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION / INTRAMUSCULAR		450 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	CREAM / TOPICAL		57 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	AEROSOL / TOPICAL	3 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
ALPHA-TOCOPHEROL	.ALPHA.-TOCOPHEROL	H4N855PNZ1	TABLET, FILM COATED / ORAL		246 mg	Exact identifier — unii candidate 10 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	SUSPENSION, EXTENDED RELEASE / ORAL		9000 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SUSPENSION / OPHTHALMIC		2 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	TABLET, ORALLY DISINTEGRATING / ORAL		3 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
SODIUM METABISULFITE	SODIUM METABISULFITE	4VON5FNS3C	INJECTION, SOLUTION, CONCENTRATE / INTRAMUSCULAR	0.15 %w/v		Exact identifier — unii candidate 43 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / AURICULAR (OTIC)	0.1 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, SUSPENSION / INTRAMUSCULAR		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SUSPENSION, EXTENDED RELEASE / ORAL	186.8 mg		Exact identifier — unii candidate 29 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	AEROSOL, FOAM / TOPICAL		4504 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	INJECTION / INTRAVENOUS	NA		Exact identifier — unii candidate 32 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	GEL, METERED / TOPICAL		20 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	POWDER, FOR SOLUTION / ORAL	10 mg/5ml		Exact identifier — unii candidate 29 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SPRAY / RESPIRATORY (INHALATION)	0.05 %w/w		Exact identifier — unii candidate 77 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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
cbf263e9-f299-493a-ba29-95b1a2a8089d			b98d0003-8583-429a-a6f1-cbdefd797e8a	2023-09-20	Warnings	Exact identifier spl set id: b98d0003-8583-429a-a6f1-cbdefd797e8a

Reported adverse events (FAERS/openFDA)#

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