AGE DEFENSE BB BROAD SPECTRUM SPF 30 ALL SKIN TYPES

Manufacturer: CLINIQUE LABORATORIES LLC | Estee Lauder Companies Inc. | PALC | Estee Lauder N.V. | The Estee Lauder Inc | Northtec LLC
Effective date: 2025-12-29
Label type: HUMAN OTC DRUG LABEL
Version: 12
Source: monthly-update
Hydrated at: 2026-06-03 17:46:50

Label at a glance#

ProductAGE DEFENSE BB BROAD SPECTRUM SPF 30 ALL SKIN TYPES

Active ingredientOCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE

Label structure9 sections

Dosage and administration

For sunscreen use: apply liberally 15 minutes before sun exposure reapply at least every two hours use a water resistant sunscreen if swimming or sweating 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...

Storage and handling

protect the product in this container from excessive heat and direct sun

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 7.5%
Octisalate 4.4%
Titanium dioxide 3.5%
Zinc oxide 2.2%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Use

INDICATIONS & USAGE SECTION

helps prevent sunburn

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
reapply at least every two hours
use a water resistant sunscreen if swimming or sweating
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 10 a.m. – 2 p.m.
- wear long-sleeved shirts, pants, hats and sunglasses
children under 6 months of age: ask a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

water\aqua\eau • octyldodecyl neopentanoate • butylene glycol • dimethicone • propanediol • glyceryl stearate • behenyl alcohol • peg-40 stearate • polyglyceryl-10 pentastearate • phenyl trimethicone • polymethylsilsesquioxane • hordeum vulgare (barley) extract\extrait d'orge • triticum vulgare (wheat) germ extract • laminaria saccharina extract • linoleic acid • oryzanol • squalane • caffeine • hydrogenated lecithin • sucrose • glycerin • polyquaternium-51 • lecithin • sodium stearoyl lactylate • polyglyceryl-6 polyricinoleate • sodium pca • isopropyl titanium triisostearate • trehalose • urea • tocopheryl acetate • sodium hyaluronate • ammonium acryloyldimethyltaurate/vp copolymer • xanthan gum • glycyrrhetinic acid • stearic acid • alumina • silica • pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate • disodium edta • chlorphenesin • sodium dehydroacetate • phenoxyethanol • [+/- titanium dioxide (ci 77891) • iron oxides (ci 77491, ci 77492, ci 77499) • mica] [iln39837]

Other information

STORAGE AND HANDLING SECTION

protect the product in this container from excessive heat and direct sun

PRINCIPAL DISPLAY PANEL - 40 ml Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

C

CLINIQUE

age defense

BB

cream

broad spectrum

SPF 30

ALL SKIN TYPES

1.4 FL.OZ.LIQ./40 ml e

Principal Display Panel

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
7dea7767-9f52-b60a-5435-33cb9cc28bae	Product name	4	20250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4	Product name	7	20250116
0ca83774-3f79-b837-5d6f-c210102f3bc8	Product name	6	20250114
41b814f3-0166-1c53-c9ef-a0794c7daf9d	Product name	3	20221110
a590be26-846c-8659-a5a1-fb25907965dc	Product name	2	20221110
2dc76302-91c0-4c35-ad78-99adfb049c4b	Product name	1	20200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2b	Product name	2	20180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6	Product name	2	20161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550	Product name	2	20151105
332e86c3-7875-ca6e-f934-2206d2b31996	Product name	1	20140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21	Product name	1	20140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092	Product name	1	20140508
96c2be53-8e44-452d-56a2-d255b2f1af2d	Product name	1	20140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44	Product name	1	20140508
d223c173-c39b-d764-47d4-d671d3088815	Product name	1	20140508
e01133ad-4dcd-c7f3-454b-2ff569ee160a	Product name	1	20140508

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	1
OCTISALATE	ACTIVE INGREDIENT	4X49Y0596W	1
TITANIUM DIOXIDE	ACTIVE INGREDIENT	15FIX9V2JP	1
ZINC OXIDE	ACTIVE INGREDIENT	SOI2LOH54Z	1
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	1
OCTISALATE	ACTIVE MOIETY	4X49Y0596W	1
TITANIUM DIOXIDE	ACTIVE MOIETY	15FIX9V2JP	1
ZINC OXIDE	ACTIVE MOIETY	SOI2LOH54Z	1
.alpha.-tocopherol acetate	INACTIVE INGREDIENT	9E8X80D2L0	1
aluminum oxide	INACTIVE INGREDIENT	LMI26O6933	1
ammonium acryloyldimethyltaurate/vp copolymer	INACTIVE INGREDIENT	W59H9296ZG	1
butylene glycol	INACTIVE INGREDIENT	3XUS85K0RA	1
caffeine	INACTIVE INGREDIENT	3G6A5W338E	1
chlorphenesin	INACTIVE INGREDIENT	I670DAL4SZ	1
dimethicone	INACTIVE INGREDIENT	92RU3N3Y1O	1
docosanol	INACTIVE INGREDIENT	9G1OE216XY	1
edetate disodium	INACTIVE INGREDIENT	7FLD91C86K	1
enoxolone	INACTIVE INGREDIENT	P540XA09DR	1
ferric oxide red	INACTIVE INGREDIENT	1K09F3G675	1
ferric oxide yellow	INACTIVE INGREDIENT	EX438O2MRT	1
ferrosoferric oxide	INACTIVE INGREDIENT	XM0M87F357	1
gamma oryzanol	INACTIVE INGREDIENT	SST9XCL51M	1
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	1
glyceryl monostearate	INACTIVE INGREDIENT	230OU9XXE4	1
hyaluronate sodium	INACTIVE INGREDIENT	YSE9PPT4TH	1
isopropyl titanium triisostearate	INACTIVE INGREDIENT	949E3KBJ1I	1
linoleic acid	INACTIVE INGREDIENT	9KJL21T0QJ	1
mica	INACTIVE INGREDIENT	V8A1AW0880	1
octyldodecyl neopentanoate	INACTIVE INGREDIENT	X8725R883T	1
peg-40 stearate	INACTIVE INGREDIENT	ECU18C66Q7	1
pentaerythritol tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate)	INACTIVE INGREDIENT	255PIF62MS	1
phenoxyethanol	INACTIVE INGREDIENT	HIE492ZZ3T	1
phenyl trimethicone	INACTIVE INGREDIENT	DR0K5NOJ4R	1
propanediol	INACTIVE INGREDIENT	5965N8W85T	1
saccharina latissima	INACTIVE INGREDIENT	68CMP2MB55	1
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	1
sodium dehydroacetate	INACTIVE INGREDIENT	8W46YN971G	1
sodium pyrrolidone carboxylate	INACTIVE INGREDIENT	469OTG57A2	1
sodium stearoyl lactylate	INACTIVE INGREDIENT	IN99IT31LN	1
squalane	INACTIVE INGREDIENT	GW89575KF9	1
stearic acid	INACTIVE INGREDIENT	4ELV7Z65AP	1
sucrose	INACTIVE INGREDIENT	C151H8M554	1
trehalose	INACTIVE INGREDIENT	B8WCK70T7I	1
urea	INACTIVE INGREDIENT	8W8T17847W	1
water	INACTIVE INGREDIENT	059QF0KO0R	1
wheat germ	INACTIVE INGREDIENT	YR3G369F5A	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 · 45 matching rows.

AGE DEFENSE BB BROAD SPECTRUM SPF 30 ALL SKIN TYPES
OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, and ZINC OXIDE
OCTYLDODECYL NEOPENTANOATE
BUTYLENE GLYCOL
DIMETHICONE
PROPANEDIOL
GLYCERYL MONOSTEARATE
DOCOSANOL
PEG-40 STEARATE
PHENYL TRIMETHICONE
WHEAT GERM
SACCHARINA LATISSIMA
LINOLEIC ACID
ORYZANOL
SQUALANE
CAFFEINE
SUCROSE
GLYCERIN
SODIUM STEAROYL LACTYLATE
SODIUM PYRROLIDONE CARBOXYLATE
ISOPROPYL TITANIUM TRIISOSTEARATE
TREHALOSE
UREA
WATER
.ALPHA.-TOCOPHEROL ACETATE
HYALURONATE SODIUM
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER
XANTHAN GUM
ENOXOLONE
STEARIC ACID
ALUMINUM OXIDE
SILICON DIOXIDE
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE)
EDETATE DISODIUM
CHLORPHENESIN
SODIUM DEHYDROACETATE
PHENOXYETHANOL
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
49527-030	49527-030-01

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 43 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
OCTYLDODECYL NEOPENTANOATE	X8725R883T	IACT
BUTYLENE GLYCOL	3XUS85K0RA	IACT
DIMETHICONE	92RU3N3Y1O	IACT
PROPANEDIOL	5965N8W85T	IACT
GLYCERYL MONOSTEARATE	230OU9XXE4	IACT
DOCOSANOL	9G1OE216XY	IACT
PEG-40 STEARATE	ECU18C66Q7	IACT
PHENYL TRIMETHICONE	DR0K5NOJ4R	IACT
WHEAT GERM	YR3G369F5A	IACT
SACCHARINA LATISSIMA	68CMP2MB55	IACT
LINOLEIC ACID	9KJL21T0QJ	IACT
ORYZANOL	SST9XCL51M	IACT
SQUALANE	GW89575KF9	IACT
CAFFEINE	3G6A5W338E	IACT
SUCROSE	C151H8M554	IACT
GLYCERIN	PDC6A3C0OX	IACT
SODIUM STEAROYL LACTYLATE	IN99IT31LN	IACT
SODIUM PYRROLIDONE CARBOXYLATE	469OTG57A2	IACT
ISOPROPYL TITANIUM TRIISOSTEARATE	949E3KBJ1I	IACT
TREHALOSE	B8WCK70T7I	IACT
UREA	8W8T17847W	IACT
WATER	059QF0KO0R	IACT
.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	IACT
HYALURONATE SODIUM	YSE9PPT4TH	IACT
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER	W59H9296ZG	IACT
XANTHAN GUM	TTV12P4NEE	IACT
ENOXOLONE	P540XA09DR	IACT
STEARIC ACID	4ELV7Z65AP	IACT
ALUMINUM OXIDE	LMI26O6933	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE)	255PIF62MS	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
CHLORPHENESIN	I670DAL4SZ	IACT
SODIUM DEHYDROACETATE	8W46YN971G	IACT
PHENOXYETHANOL	HIE492ZZ3T	IACT
FERRIC OXIDE RED	1K09F3G675	IACT
FERRIC OXIDE YELLOW	EX438O2MRT	IACT
FERROSOFERRIC OXIDE	XM0M87F357	IACT
MICA	V8A1AW0880	IACT
OCTINOXATE	4Y5P7MUD51	ACTIB

Source Document#

Source XML · Source PDF

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 · 412 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
sodium pyrrolidone carboxylate	SODIUM PYRROLIDONE CARBOXYLATE	469OTG57A2	LOTION / TOPICAL		42 mg	Exact identifier — unii candidate
glycerin	GLYCERIN	PDC6A3C0OX	SYRUP / ORAL		16734 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	PASTE / DENTAL	20 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
stearic acid	STEARIC ACID	4ELV7Z65AP	TABLET / BUCCAL	6 mg		Exact identifier — unii candidate 26 equally ranked IID candidates
sucrose	SUCROSE	C151H8M554	SUSPENSION / ORAL		48209 mg	Exact identifier — unii candidate 48 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
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / SUBLINGUAL		10 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
stearic acid	STEARIC ACID	4ELV7Z65AP	IMPLANT / SUBCUTANEOUS	1.04 mg		Exact identifier — unii candidate 26 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	SUSPENSION / AURICULAR (OTIC)	0.01 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
glyceryl monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		23 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
stearic acid	STEARIC ACID	4ELV7Z65AP	SHAMPOO / TOPICAL	9.7 %w/w		Exact identifier — unii candidate 26 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	LOTION / TOPICAL		22 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	TABLET, EXTENDED RELEASE / ORAL		7 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
sucrose	SUCROSE	C151H8M554	LOZENGE / BUCCAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	SUSPENSION / AURICULAR (OTIC)	0.05 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	SPONGE / TOPICAL	2 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	SHAMPOO / TOPICAL	1 %w/w		Exact identifier — unii candidate 77 equally ranked IID candidates
xanthan gum	XANTHAN GUM	TTV12P4NEE	AEROSOL, FOAM / TOPICAL	0.27 %w/w		Exact identifier — unii candidate 29 equally ranked IID candidates
sucrose	SUCROSE	C151H8M554	TABLET, COATED / ORAL	516.42 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	SOLUTION / INTRAVENOUS	0.05 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
ferric oxide red	FERRIC OXIDE RED	1K09F3G675	TABLET / SUBLINGUAL	1 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
xanthan gum	XANTHAN GUM	TTV12P4NEE	SUSPENSION / ORAL		360 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
sucrose	SUCROSE	C151H8M554	SUSPENSION, EXTENDED RELEASE / ORAL		5400 mg	Exact identifier — unii candidate 48 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
edetate disodium	EDETATE DISODIUM	7FLD91C86K	SUSPENSION / OPHTHALMIC	0.06 %w/v		Exact identifier — unii candidate 77 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
stearic acid	STEARIC ACID	4ELV7Z65AP	LOTION / TOPICAL		80 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
sucrose	SUCROSE	C151H8M554	TABLET, CHEWABLE / ORAL		7258 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / NASAL		20 mg	Exact identifier — unii candidate 49 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
glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION / AURICULAR (OTIC)	63.64 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	TABLET, CHEWABLE / ORAL		12 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	INJECTION / INTRAMUSCULAR		450 mg	Exact identifier — unii candidate 75 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	TABLET / PERIODONTAL	0.53 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
xanthan gum	XANTHAN GUM	TTV12P4NEE	GEL / TOPICAL		58 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
aluminum oxide	ALUMINUM OXIDE	LMI26O6933	TABLET / ORAL	NA		Exact identifier — unii candidate 2 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	GEL / TRANSDERMAL		500 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE, FOR SOLUTION / ORAL	1.8 mg/120ml		Exact identifier — unii candidate 49 equally ranked IID candidates
glyceryl monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	AEROSOL, FOAM / TOPICAL	3.27 %w/w		Exact identifier — unii candidate 21 equally ranked IID candidates
sucrose	SUCROSE	C151H8M554	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	119.12 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION/ DROPS / AURICULAR (OTIC)		25 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
xanthan gum	XANTHAN GUM	TTV12P4NEE	PASTE / ORAL		1050 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
sucrose	SUCROSE	C151H8M554	CAPSULE, COATED PELLETS / ORAL	59.8 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	TABLET, COATED / ORAL	0.21 mg		Exact identifier — unii candidate 77 equally ranked IID candidates
xanthan gum	XANTHAN GUM	TTV12P4NEE	FILM, SOLUBLE / ORAL		1 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	JELLY / VAGINAL	NA		Exact identifier — unii candidate 75 equally ranked IID candidates
hyaluronate sodium	HYALURONATE SODIUM	YSE9PPT4TH	GEL / TOPICAL		463 mg	Exact identifier — unii candidate 5 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	INJECTION / SUBCUTANEOUS		6 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
stearic acid	STEARIC ACID	4ELV7Z65AP	EMULSION / ORAL	NA		Exact identifier — unii candidate 26 equally ranked IID candidates
glyceryl monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	SUSPENSION / AURICULAR (OTIC)	0.5 %w/v		Exact identifier — unii candidate 21 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	ENEMA / RECTAL		60 mg	Exact identifier — unii candidate 77 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
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, COATED PELLETS / ORAL		69 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	TABLET, EXTENDED RELEASE / ORAL		10 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
stearic acid	STEARIC ACID	4ELV7Z65AP	TABLET, FILM COATED / ORAL		176 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
xanthan gum	XANTHAN GUM	TTV12P4NEE	LOZENGE / ORAL		1264 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
ferric oxide yellow	FERRIC OXIDE YELLOW	EX438O2MRT	FILM / BUCCAL	0.27 mg		Exact identifier — unii candidate 20 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	POWDER / ORAL		602 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
glyceryl monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	CREAM / TOPICAL		836 mg	Exact identifier — unii candidate 21 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
471e2cda-b7c7-087e-e063-6394a90a25b1			e31dab08-08ee-4a90-b6ff-6e632c836c65	2025-12-29	Warnings	Exact identifier spl id: 471e2cda-b7c7-087e-e063-6394a90a25b1 spl set id: e31dab08-08ee-4a90-b6ff-6e632c836c65

Reported adverse events (FAERS/openFDA)#

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