Sei Bella Skin Refining Tinted Moisturizer

Manufacturer: Melaleuca Inc.
Effective date: 2014-04-28
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:39:07

Label at a glance#

ProductSei Bella Skin Refining Tinted Moisturizer Classic Beige

Active ingredientTITANIUM DIOXIDE

Label structure12 sections

Indications and uses

helps prevent sunburn is 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

apply smoothly on cleased skin apply liberally 15 minutes before sun exposure use a water-resistant sunscreen if swimming or sweating reapply at least every 2 hours children under 6 months of age: ask a doctor 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 value of 15 or higher and...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 6.5%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

helps prevent sunburn
is 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 AND PRECAUTIONS 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 the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

apply smoothly on cleased skin
apply liberally 15 minutes before sun exposure
use a water-resistant sunscreen if swimming or sweating
reapply at least every 2 hours
children under 6 months of age: ask a doctor
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 value of 15 or higher and other sun protection measures including:
limit time in the sun, especially from 10a.m.-2p.m.
wear long-sleeve shirts, pants, hats, and sunglasses

Other Information

GENERAL PRECAUTIONS SECTION

for normal-to-oily skin

CLINICAL STUDIES SECTION

dermatologist and allergy tested

STORAGE AND HANDLING SECTION

may stain some fabrics
protect this product from excessive heat and direct sun
do not store at temperatures below 32^oF (0^oC) or above 120^oF (49^oC)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

1,2-hexandiol, aloe barbadensis leaf juice, alumina, aminomethyl propanol, aqua (water/eau), beta-glucan, butylene glycol, butyrospermum parkii (shea butter), caprylic/capric tryglyceride, caprylyl glycol, carnosine, cetearyl alcohol, ceteth-10 phosphate, cetyl palmitate, cucumis sativus (cucumber) fruit extract, cyclopentasilloxane, dicetyl phosphate, disodium EDTA, ethylhexylglycerin, glycerin, glycine soja (soybean) oil, hydrogenated cottonseed oil, hydrogenated palm glycerides, iron oxides (CI77491, CI77492, CI77499), isostearic acid, lecithin, octyldodecyl neopentanoate, PEG/PPG-20/15 dimethicone, pentylene glycol, phenyl methicone, polyethylene, polyglyceryl-3, polyricinoleate, polyhydroxystearic acid, polymethylsilsesquioxane, polysorbate 60, polysorbate 80, potassium cetyl phosphate, propylheptyl caprylate, simethicone, stearic acid, tetrahexyldecyl ascorbate, tetrapeptide-21, titanium dioxide (CI77891), tocopheryl acetate, tremella fuciformis sporocarp extract, vitis vinifera (grape) leaf extract, xanthan gum

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tint Moist Box

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
baf7f49c-75b6-496b-a00e-8e766a8e4f03	Product name	1	20210127
ebc62596-fc97-4d03-9483-7ba095d25db7	Product name	1	20151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
54473-248-01	2019-11-27	C162847	48780-1	9855e2a2-3a17-60a7-e053-dbdaa90a05bd	Sei Bella Skin-Refining Tinted Moisturizer - Broadspectrum SPF 20 - Classic Beige

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
54473-248-01	Sei Bella Skin Refining Tinted MoisturizerClassic Beige	1 in 1 BOX	LOTION	1		1
54473-248-01	Sei Bella Skin Refining Tinted MoisturizerClassic Beige	44.4 mL in 1 TUBE	LOTION	44.4		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54473-248	SEI BELLA SKIN REFINING TINTED MOISTURIZER CLASSIC BEIGE (TITANIUM DIOXIDE) LOTION [MELALEUCA INC.]	1	Legacy NDC, 2 package rows	20140429_a332d270-d57c-42bb-8c85-f259727cfc2e.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
TITANIUM DIOXIDE	ACTIVE INGREDIENT	15FIX9V2JP	1
TITANIUM DIOXIDE	ACTIVE MOIETY	15FIX9V2JP	1
1,2-HEXANEDIOL	INACTIVE INGREDIENT	TR046Y3K1G	1
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	1
ALPHA-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	1
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	1
AMINOMETHYLPROPANOL	INACTIVE INGREDIENT	LU49E6626Q	1
BUTYLENE GLYCOL	INACTIVE INGREDIENT	3XUS85K0RA	1
CAPRYLYL GLYCOL	INACTIVE INGREDIENT	00YIU5438U	1
CARNOSINE	INACTIVE INGREDIENT	8HO6PVN24W	1
CETETH-10 PHOSPHATE	INACTIVE INGREDIENT	4E05O5N49G	1
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	1
CETYL PALMITATE	INACTIVE INGREDIENT	5ZA2S6B08X	1
CUCUMBER	INACTIVE INGREDIENT	YY7C30VXJT	1
CYCLOMETHICONE 5	INACTIVE INGREDIENT	0THT5PCI0R	1
DIHEXADECYL PHOSPHATE	INACTIVE INGREDIENT	2V6E5WN99N	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	1
ETHYLHEXYLGLYCERIN	INACTIVE INGREDIENT	147D247K3P	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	1
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	1
HIGH DENSITY POLYETHYLENE	INACTIVE INGREDIENT	UG00KM4WR7	1
HYDROGENATED COTTONSEED OIL	INACTIVE INGREDIENT	Z82Y2C65EA	1
HYDROGENATED PALM GLYCERIDES	INACTIVE INGREDIENT	YCZ8EM144Q	1
ISOSTEARIC ACID	INACTIVE INGREDIENT	X33R8U0062	1
LECITHIN, SOYBEAN	INACTIVE INGREDIENT	1DI56QDM62	1
MEDIUM-CHAIN TRIGLYCERIDES	INACTIVE INGREDIENT	C9H2L21V7U	1
OCTYLDODECYL NEOPENTANOATE	INACTIVE INGREDIENT	X8725R883T	1
PEG/PPG-20/15 DIMETHICONE	INACTIVE INGREDIENT	06R6X77P9C	1
PENTYLENE GLYCOL	INACTIVE INGREDIENT	50C1307PZG	1
POLYGLYCERYL-3 RICINOLEATE	INACTIVE INGREDIENT	MZQ63P0N0W	1
POLYHYDROXYSTEARIC ACID (2300 MW)	INACTIVE INGREDIENT	YXH47AOU0F	1
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)	INACTIVE INGREDIENT	59Z907ZB69	1
POLYSORBATE 60	INACTIVE INGREDIENT	CAL22UVI4M	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	1
POTASSIUM CETYL PHOSPHATE	INACTIVE INGREDIENT	03KCY6P7UT	1
PROPYLHEPTYL CAPRYLATE	INACTIVE INGREDIENT	991Z19V2OD	1
SHEA BUTTER	INACTIVE INGREDIENT	K49155WL9Y	1
SOYBEAN OIL	INACTIVE INGREDIENT	241ATL177A	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	1
TETRAHEXYLDECYL ASCORBATE	INACTIVE INGREDIENT	9LBV3F07AZ	1
TETRAPEPTIDE-21	INACTIVE INGREDIENT	179JUC43HU	1
TREMELLA FUCIFORMIS FRUITING BODY	INACTIVE INGREDIENT	GG8N28393G	1
VITIS VINIFERA LEAF	INACTIVE INGREDIENT	R1H893D80E	1
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	1

Products#

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

DailyMed product names page 1 of 2 · 46 matching rows.

Sei Bella Skin Refining Tinted Moisturizer Classic Beige
Titanium Dioxide
1,2-HEXANEDIOL
ALOE VERA LEAF
ALUMINUM OXIDE
AMINOMETHYLPROPANOL
BUTYLENE GLYCOL
SHEA BUTTER
MEDIUM-CHAIN TRIGLYCERIDES
CAPRYLYL GLYCOL
CARNOSINE
CETOSTEARYL ALCOHOL
CETETH-10 PHOSPHATE
CETYL PALMITATE
CUCUMBER
CYCLOMETHICONE 5
DIHEXADECYL PHOSPHATE
EDETATE DISODIUM
ETHYLHEXYLGLYCERIN
glycerin
SOYBEAN OIL
HYDROGENATED COTTONSEED OIL
HYDROGENATED PALM GLYCERIDES
ISOSTEARIC ACID
LECITHIN, SOYBEAN
OCTYLDODECYL NEOPENTANOATE
PEG/PPG-20/15 DIMETHICONE
PENTYLENE GLYCOL
HIGH DENSITY POLYETHYLENE
POLYGLYCERYL-3 RICINOLEATE
POLYHYDROXYSTEARIC ACID (2300 MW)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)
POLYSORBATE 60
POLYSORBATE 80
POTASSIUM CETYL PHOSPHATE
PROPYLHEPTYL CAPRYLATE
STEARIC ACID
TETRAHEXYLDECYL ASCORBATE
TETRAPEPTIDE-21
ALPHA-TOCOPHEROL ACETATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
54473-248	54473-248-01

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 45 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
TITANIUM DIOXIDE	15FIX9V2JP	ACTIB
1,2-HEXANEDIOL	TR046Y3K1G	IACT
ALOE VERA LEAF	ZY81Z83H0X	IACT
ALUMINUM OXIDE	LMI26O6933	IACT
AMINOMETHYLPROPANOL	LU49E6626Q	IACT
BUTYLENE GLYCOL	3XUS85K0RA	IACT
SHEA BUTTER	K49155WL9Y	IACT
MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	IACT
CAPRYLYL GLYCOL	00YIU5438U	IACT
CARNOSINE	8HO6PVN24W	IACT
CETOSTEARYL ALCOHOL	2DMT128M1S	IACT
CETETH-10 PHOSPHATE	4E05O5N49G	IACT
CETYL PALMITATE	5ZA2S6B08X	IACT
CUCUMBER	YY7C30VXJT	IACT
CYCLOMETHICONE 5	0THT5PCI0R	IACT
DIHEXADECYL PHOSPHATE	2V6E5WN99N	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
ETHYLHEXYLGLYCERIN	147D247K3P	IACT
glycerin	PDC6A3C0OX	IACT
SOYBEAN OIL	241ATL177A	IACT
HYDROGENATED COTTONSEED OIL	Z82Y2C65EA	IACT
HYDROGENATED PALM GLYCERIDES	YCZ8EM144Q	IACT
ISOSTEARIC ACID	X33R8U0062	IACT
LECITHIN, SOYBEAN	1DI56QDM62	IACT
OCTYLDODECYL NEOPENTANOATE	X8725R883T	IACT
PEG/PPG-20/15 DIMETHICONE	06R6X77P9C	IACT
PENTYLENE GLYCOL	50C1307PZG	IACT
HIGH DENSITY POLYETHYLENE	UG00KM4WR7	IACT
POLYGLYCERYL-3 RICINOLEATE	MZQ63P0N0W	IACT
POLYHYDROXYSTEARIC ACID (2300 MW)	YXH47AOU0F	IACT
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)	59Z907ZB69	IACT
POLYSORBATE 60	CAL22UVI4M	IACT
POLYSORBATE 80	6OZP39ZG8H	IACT
POTASSIUM CETYL PHOSPHATE	03KCY6P7UT	IACT
PROPYLHEPTYL CAPRYLATE	991Z19V2OD	IACT
STEARIC ACID	4ELV7Z65AP	IACT
TETRAHEXYLDECYL ASCORBATE	9LBV3F07AZ	IACT
TETRAPEPTIDE-21	179JUC43HU	IACT
ALPHA-TOCOPHEROL ACETATE	9E8X80D2L0	IACT
TREMELLA FUCIFORMIS FRUITING BODY	GG8N28393G	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 8 · 435 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	SHAMPOO / TOPICAL	1 %w/w		Exact identifier — unii candidate 77 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION / ORAL		32400 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDES	MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	INJECTION, SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	990.3 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CAPSULE / ORAL	418.37 mg		Exact identifier — unii candidate 78 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	3.6 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	ELIXIR / ORAL	1.3 mg/5ml		Exact identifier — unii candidate 77 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CREAM / TOPICAL		20 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRAMUSCULAR	10 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
SOYBEAN OIL	SOYBEAN OIL	241ATL177A	SOLUTION / TOPICAL	5.82 %w/w		Exact identifier — unii candidate 7 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, SUSPENSION / INTRALESIONAL		4 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS	0.4 mg		Exact identifier — unii candidate 77 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION / NASAL	25 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	TABLET, ORALLY DISINTEGRATING / ORAL		2 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	LOTION / TOPICAL	NA		Exact identifier — unii candidate 21 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	CREAM, AUGMENTED / TOPICAL		55 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		2 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, EMULSION / INTRAVENOUS		59 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CAPSULE, COATED PELLETS / ORAL	2 mg		Exact identifier — unii candidate 78 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, DELAYED RELEASE / ORAL		80 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	TABLET / SUBLINGUAL	0.08 mg		Exact identifier — unii candidate 78 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, ORALLY DISINTEGRATING / ORAL		10 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
HIGH DENSITY POLYETHYLENE	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	PASTE / DENTAL		60 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	SPONGE / TOPICAL	2 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SOLUTION / INTRAVENOUS		900 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	SUPPOSITORY / RECTAL		440 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
ISOSTEARIC ACID	ISOSTEARIC ACID	X33R8U0062	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 3 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	TABLET, EXTENDED RELEASE / ORAL		7 mg	Exact identifier — unii candidate 75 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
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	TABLET, EXTENDED RELEASE / ORAL		15 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	TABLET / PERIODONTAL	0.53 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SUSPENSION / TOPICAL	0.11 %w/v		Exact identifier — unii candidate 29 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	TABLET, FILM COATED / ORAL	1.55 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
POLYSORBATE 60	POLYSORBATE 60	CAL22UVI4M	OINTMENT / TOPICAL	2 %w/w		Exact identifier — unii candidate 13 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	EMULSION / OPHTHALMIC	0.3 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	POWDER / ORAL	275 mg		Exact identifier — unii candidate 29 equally ranked IID candidates
FERROSOFERRIC OXIDE	FERROSOFERRIC OXIDE	XM0M87F357	CAPSULE, DELAYED RELEASE / ORAL		6 mg	Exact identifier — unii candidate 10 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
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	LOTION / TOPICAL	0.3 %w/v		Exact identifier — unii candidate 29 equally ranked IID candidates
HIGH DENSITY POLYETHYLENE	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	OINTMENT / TOPICAL	94 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
HIGH DENSITY POLYETHYLENE	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	GEL / TOPICAL	26 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	POWDER, FOR SUSPENSION / ORAL		3 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	INJECTION / INTRAVENOUS		33750 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	DROPS / AURICULAR (OTIC)	0.05 %w/w		Exact identifier — unii candidate 77 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	JELLY / TOPICAL	NA		Exact identifier — unii candidate 75 equally ranked IID candidates
FERROSOFERRIC OXIDE	FERROSOFERRIC OXIDE	XM0M87F357	CAPSULE / ORAL		11 mg	Exact identifier — unii candidate 10 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	CAPSULE, COATED / ORAL	0.01 mg		Exact identifier — unii candidate 20 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	POWDER / ORAL	66 mg		Exact identifier — unii candidate 78 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	INJECTION / SUBCUTANEOUS		450 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION / INTRAMUSCULAR	4 %w/v		Exact identifier — unii candidate 78 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION / OPHTHALMIC	6 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	SPRAY / TOPICAL	1 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	FILM, EXTENDED RELEASE / TRANSDERMAL	306.2 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	TABLET, CHEWABLE / ORAL		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRABURSAL	0.01 %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
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	SUSPENSION, EXTENDED RELEASE / ORAL	2.7 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	GRANULE, FOR SUSPENSION / ORAL		240 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	CAPSULE, COATED / ORAL	14.21 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SYSTEM / TOPICAL		126 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	CAPSULE / ORAL		90 mg	Exact identifier — unii candidate 26 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
e99547a1-a44b-45e5-ada9-90321c09d4d8			a332d270-d57c-42bb-8c85-f259727cfc2e	2014-04-28	Warnings	Exact identifier spl id: e99547a1-a44b-45e5-ada9-90321c09d4d8 spl set id: a332d270-d57c-42bb-8c85-f259727cfc2e

Reported adverse events (FAERS/openFDA)#

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