Sei Bella Skin Refining Tinted Moisturizer

Manufacturer: Melaleuca Inc.
Effective date: 2014-04-30
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 22:39:08

Label at a glance#

ProductSei Bella Skin Refining Tinted Moisturizer Tan

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
54473-251-01	2019-11-27	C162847	48780-1	9855e2a2-4ad3-60a7-e053-dbdaa90a05bd	Sei Bella Skin-Refining Tinted Moisturizer - Broadspectrum SPF 20 - Tan

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
54473-251-01	Sei Bella Skin Refining Tinted MoisturizerTan	1 in 1 BOX	LOTION	1		2
54473-251-01	Sei Bella Skin Refining Tinted MoisturizerTan	44.4 mL in 1 TUBE	LOTION	44.4		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54473-251	SEI BELLA SKIN REFINING TINTED MOISTURIZER TAN (TITANIUM DIOXIDE) LOTION [MELALEUCA INC.]	2	Legacy NDC, 2 package rows	20140430_5b46cd56-723e-4744-869f-450e6a5c4510.zip

DailyMed Socrata Ingredients#

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

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 Tan
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
54473-251	54473-251-01

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
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	CAPSULE, COATED / ORAL	0.12 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SUSPENSION / SUBCUTANEOUS	0.3 %w/v		Exact identifier — unii candidate 78 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDES	MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	SUSPENSION / ORAL		10170 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	AEROSOL, FOAM / VAGINAL	4 %w/w		Exact identifier — unii candidate 26 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDES	MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	LOTION / TOPICAL	7 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	SPRAY / TOPICAL	1 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / NASAL	100 mg/100ml		Exact identifier — unii candidate 77 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	SUSPENSION / OPHTHALMIC		58 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	SUSPENSION / ORAL		26208 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	TABLET, CHEWABLE / ORAL		84 mg	Exact identifier — unii candidate 78 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
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, SOLUTION / INTRAMUSCULAR	5 %w/v		Exact identifier — unii candidate 78 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, EXTENDED RELEASE / ORAL		200 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / RESPIRATORY (INHALATION)		43 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	GEL / TOPICAL		500 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	LOTION / TOPICAL	15 %w/w		Exact identifier — unii candidate 78 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	TABLET, FILM COATED / ORAL	1.55 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	LOTION / TOPICAL	0.3 %w/v		Exact identifier — unii candidate 29 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	AEROSOL / TOPICAL	3 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, SUSPENSION / INTRA-ARTICULAR		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	OINTMENT / TOPICAL	1.2 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	LOTION / TOPICAL		22 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SUSPENSION/ DROPS / ORAL		4 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
CETYL PALMITATE	CETYL PALMITATE	5ZA2S6B08X	CREAM / TOPICAL	0.32 %w/w		Exact identifier — unii candidate 4 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
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET / BUCCAL	6 mg		Exact identifier — unii candidate 26 equally ranked IID candidates
LECITHIN, SOYBEAN	SOYBEAN LECITHIN	1DI56QDM62	TABLET, FILM COATED / ORAL	0.33 mg		Exact identifier — unii candidate 7 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	TABLET / SUBLINGUAL	0.08 mg		Exact identifier — unii candidate 78 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	TABLET, EXTENDED RELEASE / ORAL		7 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	TABLET / BUCCAL	0.4 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SUSPENSION, EXTENDED RELEASE / ORAL		40 mg	Exact identifier — unii candidate 77 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
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, SUSPENSION / INTRAVENOUS	0.5 %w/v		Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CREAM / VAGINAL	0.4 %w/w		Exact identifier — unii candidate 78 equally ranked IID candidates
HYDROGENATED COTTONSEED OIL	HYDROGENATED COTTONSEED OIL	Z82Y2C65EA	TABLET / SUBLINGUAL	2 mg		Exact identifier — unii candidate 7 equally ranked IID candidates
SOYBEAN OIL	SOYBEAN OIL	241ATL177A	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS	10 %w/v		Exact identifier — unii candidate 7 equally ranked IID candidates
CETYL PALMITATE	CETYL PALMITATE	5ZA2S6B08X	CREAM / VAGINAL		165 mg	Exact identifier — unii candidate 4 equally ranked IID candidates
POLYSORBATE 60	POLYSORBATE 60	CAL22UVI4M	CREAM / TOPICAL		225 mg	Exact identifier — unii candidate 13 equally ranked IID candidates
CETYL PALMITATE	CETYL PALMITATE	5ZA2S6B08X	SOLUTION / TOPICAL	0.05 %w/w		Exact identifier — unii candidate 4 equally ranked IID candidates
HIGH DENSITY POLYETHYLENE	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	TABLET / ORAL	50 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
glycerin	GLYCERIN	PDC6A3C0OX	CAPSULE / ORAL		3487 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	CREAM / TOPICAL		190 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	INJECTION / INTRAVENOUS		33750 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 75 equally ranked IID candidates
FERROSOFERRIC OXIDE	FERROSOFERRIC OXIDE	XM0M87F357	CAPSULE, EXTENDED RELEASE / ORAL	1.49 mg		Exact identifier — unii candidate 10 equally ranked IID candidates
SOYBEAN OIL	SOYBEAN OIL	241ATL177A	CAPSULE / ORAL		1318 mg	Exact identifier — unii candidate 7 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	CAPSULE, DELAYED RELEASE / ORAL		3 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	GUM, CHEWING / BUCCAL		230 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	CAPSULE, EXTENDED RELEASE / ORAL		265 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	JELLY / TOPICAL	NA		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
FERROSOFERRIC OXIDE	FERROSOFERRIC OXIDE	XM0M87F357	TABLET, FILM COATED / ORAL	0.2 mg		Exact identifier — unii candidate 10 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	PELLET / SUBCUTANEOUS	0.97 mg		Exact identifier — unii candidate 26 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SUSPENSION, EXTENDED RELEASE / ORAL		40 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	DROPS / OPHTHALMIC	0.05 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	INJECTION, SOLUTION / INTRAMUSCULAR	15 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	LIQUID / INTRAVENOUS		720 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
SOYBEAN OIL	SOYBEAN OIL	241ATL177A	INJECTION, SOLUTION, CONCENTRATE / INTRAVENOUS		223 mg	Exact identifier — unii candidate 7 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, SUSPENSION / INTRA-ARTICULAR		4 mg	Exact identifier — unii candidate 78 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
3b019caa-1834-4f15-bd75-234851e86fdc			5b46cd56-723e-4744-869f-450e6a5c4510	2014-04-30	Warnings	Exact identifier spl id: 3b019caa-1834-4f15-bd75-234851e86fdc spl set id: 5b46cd56-723e-4744-869f-450e6a5c4510

Reported adverse events (FAERS/openFDA)#

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