CLE DE PEAU BEAUTE REFRESHING PROTECTIVE I

Manufacturer: SHISEIDO AMERICAS CORPORATION | SHISEIDO AMERICA INC. | Davlyn Industries Inc
Effective date: 2013-12-27
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: legacy-cache
Hydrated at: 2026-08-02 01:36:27

Label at a glance#

ProductCLE DE PEAU BEAUTE REFRESHING PROTECTIVE I

Active ingredientAVOBENZONE, OCTINOXATE, OCTOCRYLENE, OXYBENZONE

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.

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
AVOBENZONE 2.5%	Sunscreen
OCTINOXATE 7.4%	Sunscreen
OCTOCRYLENE 2.0%	Sunscreen
OXYBENZONE 1.0%	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, SD ALCOHOL 40-B, DIPROPYLENE GLYCOL, GLYCERIN, XYLITOL, DIMETHICONE, HYDROGENATED POLYDECENE, PPG-8-CETETH-20, PEG/PPG-17/4 DIMETHYL ETHER, PHYTOSTERYL MACADAMIATE, XANTHAN GUM, TOCOPHERYL ACETATE, CRATAEGUS MONOGYNA 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 MA-YUEN SEED EXTRACT, PPG-17, TRIETHANOLAMINE, ISOSTEARIC ACID, CARBOMER, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, DISODIUM EDTA, BUTYLENE GLYCOL, BHT, SODIUM METABISULFITE, ALCOHOL , TOCOPHEROL, PHENOXYETHANOL, FRAGRANCE,

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 - 125 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

clé de peau

BEAUTÉ

refreshing protective emulsion

BROAD SPECTRUM
SPF 22
SUNSCREEN

125mL 4.2 FL. OZ.

Principal Display Panel - 125 mL Bottle Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
58411-143-10	2023-12-14	C162847	48780-1	9d75b9cf-f7bb-f424-e053-dadaa90a57ce	CLÉ DE PEAU BEAUTÉ REFRESHING PROTECTIVE I
58411-143-10	2020-01-31	C162847	48780-1	9d75b9cf-f7bb-f424-e053-dadaa90a57ce	CLÉ DE PEAU BEAUTÉ REFRESHING PROTECTIVE I

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
AVOBENZONE	ACTIVE INGREDIENT	G63QQF2NOX	1
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	1
OCTOCRYLENE	ACTIVE INGREDIENT	5A68WGF6WM	1
OXYBENZONE	ACTIVE INGREDIENT	95OOS7VE0Y	1
AVOBENZONE	ACTIVE MOIETY	G63QQF2NOX	1
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	1
OCTOCRYLENE	ACTIVE MOIETY	5A68WGF6WM	1
OXYBENZONE	ACTIVE MOIETY	95OOS7VE0Y	1
.ALPHA.-TOCOPHEROL	INACTIVE INGREDIENT	H4N855PNZ1	1
.ALPHA.-TOCOPHEROL ACETATE, DL-	INACTIVE INGREDIENT	WR1WPI7EW8	1
2-O-ETHYL ASCORBIC ACID	INACTIVE INGREDIENT	801M14RK9K	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	1
BUPLEURUM FALCATUM ROOT	INACTIVE INGREDIENT	X04E310LUY	1
BUTYLATED HYDROXYTOLUENE	INACTIVE INGREDIENT	1P9D0Z171K	1
BUTYLENE GLYCOL	INACTIVE INGREDIENT	3XUS85K0RA	1
COIX LACRYMA-JOBI VAR. MA-YUEN SEED	INACTIVE INGREDIENT	8DW238I7ZI	1
CRATAEGUS MONOGYNA FLOWER	INACTIVE INGREDIENT	NT52AMP29J	1
DIGLYCINE	INACTIVE INGREDIENT	10525P22U0	1
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	1
DIPROPYLENE GLYCOL	INACTIVE INGREDIENT	E107L85C40	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	1
GINKGO	INACTIVE INGREDIENT	19FUJ2C58T	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	1
HYDROGENATED POLYDECENE (550 MW)	INACTIVE INGREDIENT	U333RI6EB7	1
ISOSTEARIC ACID	INACTIVE INGREDIENT	X33R8U0062	1
PAEONIA SUFFRUTICOSA ROOT	INACTIVE INGREDIENT	7M7E9A2C8J	1
PEG/PPG-17/4 DIMETHYL ETHER	INACTIVE INGREDIENT	4ET18WJG5K	1
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	1
PPG-17	INACTIVE INGREDIENT	OV0Q322E0U	1
ROSA ROXBURGHII FRUIT	INACTIVE INGREDIENT	CVT1AA87FF	1
SAXIFRAGA STOLONIFERA LEAF	INACTIVE INGREDIENT	O3TMV4903H	1
SERINE	INACTIVE INGREDIENT	452VLY9402	1
SODIUM ACETYLATED HYALURONATE	INACTIVE INGREDIENT	WN66R7GL93	1
SODIUM METABISULFITE	INACTIVE INGREDIENT	4VON5FNS3C	1
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	1
XYLITOL	INACTIVE INGREDIENT	VCQ006KQ1E	1

Products#

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

DailyMed product names page 1 of 1 · 36 matching rows.

CLE DE PEAU BEAUTE REFRESHING PROTECTIVE I
AVOBENZONE, OCTINOXATE, OCTOCRYLENE, and OXYBENZONE
AVOBENZONE
OCTINOXATE
OCTOCRYLENE
OXYBENZONE
WATER
DIPROPYLENE GLYCOL
GLYCERIN
XYLITOL
DIMETHICONE
HYDROGENATED POLYDECENE (550 MW)
PEG/PPG-17/4 DIMETHYL ETHER
XANTHAN GUM
.ALPHA.-TOCOPHEROL ACETATE, DL-
CRATAEGUS MONOGYNA FLOWER
SERINE
2-O-ETHYL ASCORBIC ACID
DIGLYCINE
SODIUM ACETYLATED HYALURONATE
SAXIFRAGA STOLONIFERA LEAF
GINKGO
PAEONIA SUFFRUTICOSA ROOT
ROSA ROXBURGHII FRUIT
BUPLEURUM FALCATUM ROOT
COIX LACRYMA-JOBI VAR. MA-YUEN SEED
PPG-17
TROLAMINE
ISOSTEARIC ACID
EDETATE DISODIUM
BUTYLENE GLYCOL
BUTYLATED HYDROXYTOLUENE
SODIUM METABISULFITE
ALCOHOL
.ALPHA.-TOCOPHEROL
PHENOXYETHANOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
58411-143	58411-143-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 34 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
AVOBENZONE	G63QQF2NOX	ACTIB
OCTINOXATE	4Y5P7MUD51	ACTIB
OCTOCRYLENE	5A68WGF6WM	ACTIB
OXYBENZONE	95OOS7VE0Y	ACTIB
WATER	059QF0KO0R	IACT
DIPROPYLENE GLYCOL	E107L85C40	IACT
GLYCERIN	PDC6A3C0OX	IACT
XYLITOL	VCQ006KQ1E	IACT
DIMETHICONE	92RU3N3Y1O	IACT
HYDROGENATED POLYDECENE (550 MW)	U333RI6EB7	IACT
PEG/PPG-17/4 DIMETHYL ETHER	4ET18WJG5K	IACT
XANTHAN GUM	TTV12P4NEE	IACT
.ALPHA.-TOCOPHEROL ACETATE, DL-	WR1WPI7EW8	IACT
CRATAEGUS MONOGYNA FLOWER	NT52AMP29J	IACT
SERINE	452VLY9402	IACT
2-O-ETHYL ASCORBIC ACID	801M14RK9K	IACT
DIGLYCINE	10525P22U0	IACT
SODIUM ACETYLATED HYALURONATE	WN66R7GL93	IACT
SAXIFRAGA STOLONIFERA LEAF	O3TMV4903H	IACT
GINKGO	19FUJ2C58T	IACT
PAEONIA SUFFRUTICOSA ROOT	7M7E9A2C8J	IACT
ROSA ROXBURGHII FRUIT	CVT1AA87FF	IACT
BUPLEURUM FALCATUM ROOT	X04E310LUY	IACT
COIX LACRYMA-JOBI VAR. MA-YUEN SEED	8DW238I7ZI	IACT
PPG-17	OV0Q322E0U	IACT
TROLAMINE	9O3K93S3TK	IACT
ISOSTEARIC ACID	X33R8U0062	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
BUTYLENE GLYCOL	3XUS85K0RA	IACT
BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	IACT
SODIUM METABISULFITE	4VON5FNS3C	IACT
ALCOHOL	3K9958V90M	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	TABLET, FILM COATED / ORAL	4 mg		Exact identifier — unii candidate 77 equally ranked IID candidates
SODIUM METABISULFITE	SODIUM METABISULFITE	4VON5FNS3C	INJECTION, SOLUTION / SUBMUCOSAL	5 %w/v		Exact identifier — unii candidate 43 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	GEL / RECTAL		898 mg	Exact identifier — unii candidate 59 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	GEL / TRANSDERMAL		6 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SUSPENSION / OPHTHALMIC		2 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
SODIUM METABISULFITE	SODIUM METABISULFITE	4VON5FNS3C	INJECTION, SOLUTION / INFILTRATION	0.05 %w/v		Exact identifier — unii candidate 43 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	AEROSOL, FOAM / TOPICAL	0.05 %w/w		Exact identifier — unii candidate 77 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	SPRAY / NASAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	CREAM / TOPICAL		57 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS	0.02 %w/v		Exact identifier — unii candidate 22 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION/ DROPS / OPHTHALMIC	0.13 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	GEL / TOPICAL		58 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRA-ARTICULAR	0.05 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	LOTION / TOPICAL	1 %w/w		Exact identifier — unii candidate 6 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL		2350 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SWAB / TOPICAL		2250 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION / INTRAVENOUS		33750 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CONCENTRATE / ORAL		1800 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		72 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	ELIXIR / ORAL		5621 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	CONCENTRATE / ORAL		20 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SUSPENSION / OPHTHALMIC	0.06 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / RESPIRATORY (INHALATION)	0.08 %w/v		Exact identifier — unii candidate 59 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	LIQUID / ORAL		2400 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
SODIUM METABISULFITE	SODIUM METABISULFITE	4VON5FNS3C	INJECTION / SUBMUCOSAL		5 mg	Exact identifier — unii candidate 43 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	NA		Exact identifier — unii candidate 32 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	SOAP / TOPICAL	0.08 %w/w		Exact identifier — unii candidate 22 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CREAM / VAGINAL		60 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	SUSPENSION, EXTENDED RELEASE / ORAL		9000 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SOLUTION / TOPICAL		3 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
SODIUM METABISULFITE	SODIUM METABISULFITE	4VON5FNS3C	INJECTION, SOLUTION, CONCENTRATE / SUBCUTANEOUS	0.15 %w/v		Exact identifier — unii candidate 43 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	EMULSION / TOPICAL	0.5 %w/w		Exact identifier — unii candidate 22 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	GEL / TOPICAL		8 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SPRAY / TRANSDERMAL	90 %w/v		Exact identifier — unii candidate 59 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SOAP / TOPICAL	0.02 %w/w		Exact identifier — unii candidate 32 equally ranked IID candidates
SODIUM METABISULFITE	SODIUM METABISULFITE	4VON5FNS3C	INJECTION / SUBCUTANEOUS		43 mg	Exact identifier — unii candidate 43 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / DENTAL	15 %w/v		Exact identifier — unii candidate 75 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
SODIUM METABISULFITE	SODIUM METABISULFITE	4VON5FNS3C	SUSPENSION, EXTENDED RELEASE / ORAL		100 mg	Exact identifier — unii candidate 43 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	POWDER, FOR SUSPENSION / ORAL	4223 mg		Exact identifier — unii candidate 12 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, SUSPENSION / INTRAMUSCULAR		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / INTRAVENOUS	0.05 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	TABLET, ORALLY DISINTEGRATING / ORAL		3 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, SOLUTION / SUBCUTANEOUS		2 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, SOLUTION / INTRAMUSCULAR		4 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / TOPICAL		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	ELIXIR / ORAL		13675 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SUSPENSION / RECTAL	0.35 %v/v		Exact identifier — unii candidate 59 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / OPHTHALMIC		4 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	EMULSION / INTRAVENOUS	2.2 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CLOTH / TOPICAL	0.05 mg/mg		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	FILM, EXTENDED RELEASE / BUCCAL		34 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	DROPS / OPHTHALMIC	0.05 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	SOLUTION / NASAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	CREAM / VAGINAL		3 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	TROCHE / ORAL		948 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
SODIUM METABISULFITE	SODIUM METABISULFITE	4VON5FNS3C	INJECTION / INTRAVENOUS	27.5 %w/v		Exact identifier — unii candidate 43 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION, EXTENDED RELEASE / ORAL		2000 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	AEROSOL, FOAM / TOPICAL		4 mg	Exact identifier — unii candidate 32 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
24f65786-e665-4822-8211-ac892bb45efc			cdce6f2c-0833-43e0-be71-e61c9048673d	2023-10-20	Warnings	Exact identifier spl set id: cdce6f2c-0833-43e0-be71-e61c9048673d

Reported adverse events (FAERS/openFDA)#

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