BOBBI BROWN EXTRA

Manufacturer: Bobbi Brown Professional Cosmetics Inc. | Estee Lauder Companies Inc. | Whitman Laboratories Ltd. | ESTEE LAUDER COMPANY, THE | Estee Lauder Cosmetics Ltd. | NORTHTEC INC | NORTHTEC PALC | Len-Ron Manufacturing Division of Aramis Inc. | PADC 1 | Estee Lauder N.V.
Effective date: 2021-08-12
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: legacy-cache
Hydrated at: 2026-08-01 22:38:28

Label at a glance#

ProductBOBBI BROWN EXTRA REPAIR FOUNDATION BROAD SPECTRUM SPF 25

Active ingredientOCTINOXATE, HOMOSALATE, OXYBENZONE, AVOBENZONE

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

Avobenzone 2.00%
Homosalate 5.00%
Octinoxate 7.50%
Oxybenzone 5.00%

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 ▪ glycerin ▪ bis-diglyceryl polyacyladipate-2 ▪ butyrospermum parkii (shea butter) ▪ peg-4 diheptanoate ▪ cetearyl alcohol ▪ cetyl alcohol ▪ glyceryl stearate ▪ hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer ▪ epilobium angustifolium extract ▪ rosmarinus officinalis (rosemary) ▪ oenothera biennis (evening primrose) oil ▪ pelargonium graveolens (geranium) flower oil ▪ angelica archangelica seed oil ▪ citrus aurantium amara (bitter orange) oil ▪ astrocaryum murumuru seed butter ▪ anthemis nobilis (chamomile) ▪ acetyl hexapeptide-8 ▪ lecithin ▪ dimethicone ▪ phenyl trimethicone ▪ propylene glycol laurate ▪ sorbitan stearate ▪ peg-40 stearate ▪ squalane ▪ ethylhexylglycerin ▪ butylene glycol ▪ dicetyl phosphate ▪ ceteth-10 phosphate ▪ polysorbate 60 ▪ peg-12 dimethicone ▪ citrus grandis (grapefruit) peel oil ▪ propylene glycol stearate ▪ sodium hyaluronate ▪ sorbitan laurate ▪ polysorbate 20 ▪ citric acid ▪ tocopheryl acetate ▪ xanthan gum ▪ alumina ▪ pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate ▪ tetrasodium edta ▪ limonene ▪ linalool ▪ citral ▪ geraniol ▪ citronellol ▪ potassium sorbate ▪ phenoxyethanol ▪ chlorphenesin ▪ [+/- titanium dioxide (ci 77891) ▪ iron oxides (ci 77491, ci 77492, ci 77499) ▪ mica] <iln38338>

Other information

STORAGE AND HANDLING SECTION

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

PRINCIPAL DISPLAY PANEL - 30 ml Jar Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BOBBI BROWN
EXTRA

Repair Foundation
Broad Spectrum SPF 25

1 FL. OZ./30 ml e

Principal Display Panel - 30 ml Jar Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
64141-015-01	2022-07-29	C162847	48780-1	c7ccaba7-1602-fd44-e053-dadaa90aa01b	BOBBI BROWN EXTRA REPAIR FOUNDATION BROAD SPECTRUM SPF 25
64141-015-01	2021-08-12	C162847	48780-1	c7ccaba7-1602-fd44-e053-dadaa90aa01b	BOBBI BROWN EXTRA REPAIR FOUNDATION BROAD SPECTRUM SPF 25
64141-015-01	2021-07-23	C162847	48780-1	c7ccaba7-1602-fd44-e053-dadaa90aa01b	BOBBI BROWN EXTRA REPAIR FOUNDATION BROAD SPECTRUM SPF 25

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64141-015	BOBBI BROWN EXTRA REPAIR FOUNDATION BROAD SPECTRUM SPF 25 (OCTINOXATE, HOMOSALATE, OXYBENZONE, AND AVOBENZONE) CREAM [BOBBI BROWN PROFESSIONAL COSMETICS INC.]	3	Legacy NDC	20210813_6a1fa3dc-3016-419a-bbfa-118434b22e49.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
AVOBENZONE	ACTIVE INGREDIENT	G63QQF2NOX	1
HOMOSALATE	ACTIVE INGREDIENT	V06SV4M95S	1
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	1
OXYBENZONE	ACTIVE INGREDIENT	95OOS7VE0Y	1
AVOBENZONE	ACTIVE MOIETY	G63QQF2NOX	1
HOMOSALATE	ACTIVE MOIETY	V06SV4M95S	1
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	1
OXYBENZONE	ACTIVE MOIETY	95OOS7VE0Y	1
.alpha.-tocopherol acetate	INACTIVE INGREDIENT	9E8X80D2L0	1
.beta.-citronellol, (r)-	INACTIVE INGREDIENT	P01OUT964K	1
acetyl hexapeptide-8	INACTIVE INGREDIENT	L4EL31FWIL	1
aluminum oxide	INACTIVE INGREDIENT	LMI26O6933	1
angelica seed oil	INACTIVE INGREDIENT	67IO7RRV7A	1
astrocaryum murumuru seed butter	INACTIVE INGREDIENT	12V64UPU6R	1
butylene glycol	INACTIVE INGREDIENT	3XUS85K0RA	1
ceteth-10 phosphate	INACTIVE INGREDIENT	4E05O5N49G	1
cetostearyl alcohol	INACTIVE INGREDIENT	2DMT128M1S	1
cetyl alcohol	INACTIVE INGREDIENT	936JST6JCN	1
chamomile	INACTIVE INGREDIENT	FGL3685T2X	1
chlorphenesin	INACTIVE INGREDIENT	I670DAL4SZ	1
citral	INACTIVE INGREDIENT	T7EU0O9VPP	1
citric acid monohydrate	INACTIVE INGREDIENT	2968PHW8QP	1
citrus aurantium fruit	INACTIVE INGREDIENT	DQD16J2B5O	1
citrus maxima fruit rind oil	INACTIVE INGREDIENT	8U3877WD44	1
dihexadecyl phosphate	INACTIVE INGREDIENT	2V6E5WN99N	1
dimethicone	INACTIVE INGREDIENT	92RU3N3Y1O	1
edetate sodium	INACTIVE INGREDIENT	MP1J8420LU	1
ethylhexylglycerin	INACTIVE INGREDIENT	147D247K3P	1
evening primrose oil	INACTIVE INGREDIENT	3Q9L08K71N	1
ferric oxide red	INACTIVE INGREDIENT	1K09F3G675	1
ferric oxide yellow	INACTIVE INGREDIENT	EX438O2MRT	1
ferrosoferric oxide	INACTIVE INGREDIENT	XM0M87F357	1
geraniol	INACTIVE INGREDIENT	L837108USY	1
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	1
glyceryl monostearate	INACTIVE INGREDIENT	230OU9XXE4	1
hyaluronate sodium	INACTIVE INGREDIENT	YSE9PPT4TH	1
linalool, (+/-)-	INACTIVE INGREDIENT	D81QY6I88E	1
mica	INACTIVE INGREDIENT	V8A1AW0880	1
peg-4 diheptanoate	INACTIVE INGREDIENT	2DQ7O61VHJ	1
peg-40 stearate	INACTIVE INGREDIENT	ECU18C66Q7	1
pelargonium graveolens flower oil	INACTIVE INGREDIENT	3K0J1S7QGC	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
polysorbate 20	INACTIVE INGREDIENT	7T1F30V5YH	1
polysorbate 60	INACTIVE INGREDIENT	CAL22UVI4M	1
potassium sorbate	INACTIVE INGREDIENT	1VPU26JZZ4	1
propylene glycol monolaurate	INACTIVE INGREDIENT	668Z5835Z3	1
propylene glycol stearate	INACTIVE INGREDIENT	MZM1I680W0	1
rosemary	INACTIVE INGREDIENT	IJ67X351P9	1
shea butter	INACTIVE INGREDIENT	K49155WL9Y	1
sorbitan monolaurate	INACTIVE INGREDIENT	6W9PS8B71J	1
sorbitan monostearate	INACTIVE INGREDIENT	NVZ4I0H58X	1
squalane	INACTIVE INGREDIENT	GW89575KF9	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	1
water	INACTIVE INGREDIENT	059QF0KO0R	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 · 55 matching rows.

BOBBI BROWN EXTRA REPAIR FOUNDATION BROAD SPECTRUM SPF 25
OCTINOXATE, HOMOSALATE, OXYBENZONE, and AVOBENZONE
OCTINOXATE
HOMOSALATE
OXYBENZONE
AVOBENZONE
WATER
GLYCERIN
SHEA BUTTER
PEG-4 DIHEPTANOATE
CETOSTEARYL ALCOHOL
CETYL ALCOHOL
GLYCERYL MONOSTEARATE
ROSEMARY
EVENING PRIMROSE OIL
PELARGONIUM GRAVEOLENS FLOWER OIL
ANGELICA SEED OIL
CITRUS AURANTIUM FRUIT
ASTROCARYUM MURUMURU SEED BUTTER
CHAMOMILE
ACETYL HEXAPEPTIDE-8
DIMETHICONE
PHENYL TRIMETHICONE
PROPYLENE GLYCOL MONOLAURATE
SORBITAN MONOSTEARATE
PEG-40 STEARATE
SQUALANE
ETHYLHEXYLGLYCERIN
BUTYLENE GLYCOL
DIHEXADECYL PHOSPHATE
CETETH-10 PHOSPHATE
POLYSORBATE 60
CITRUS MAXIMA FRUIT RIND OIL
PROPYLENE GLYCOL MONOSTEARATE
HYALURONATE SODIUM
SORBITAN MONOLAURATE
POLYSORBATE 20
CITRIC ACID MONOHYDRATE
.ALPHA.-TOCOPHEROL ACETATE
XANTHAN GUM

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
64141-015	64141-015-01

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 53 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
OCTINOXATE	4Y5P7MUD51	ACTIB
HOMOSALATE	V06SV4M95S	ACTIB
OXYBENZONE	95OOS7VE0Y	ACTIB
AVOBENZONE	G63QQF2NOX	ACTIB
WATER	059QF0KO0R	IACT
GLYCERIN	PDC6A3C0OX	IACT
SHEA BUTTER	K49155WL9Y	IACT
PEG-4 DIHEPTANOATE	2DQ7O61VHJ	IACT
CETOSTEARYL ALCOHOL	2DMT128M1S	IACT
CETYL ALCOHOL	936JST6JCN	IACT
GLYCERYL MONOSTEARATE	230OU9XXE4	IACT
ROSEMARY	IJ67X351P9	IACT
EVENING PRIMROSE OIL	3Q9L08K71N	IACT
PELARGONIUM GRAVEOLENS FLOWER OIL	3K0J1S7QGC	IACT
ANGELICA SEED OIL	67IO7RRV7A	IACT
CITRUS AURANTIUM FRUIT	DQD16J2B5O	IACT
ASTROCARYUM MURUMURU SEED BUTTER	12V64UPU6R	IACT
CHAMOMILE	FGL3685T2X	IACT
ACETYL HEXAPEPTIDE-8	L4EL31FWIL	IACT
DIMETHICONE	92RU3N3Y1O	IACT
PHENYL TRIMETHICONE	DR0K5NOJ4R	IACT
PROPYLENE GLYCOL MONOLAURATE	668Z5835Z3	IACT
SORBITAN MONOSTEARATE	NVZ4I0H58X	IACT
PEG-40 STEARATE	ECU18C66Q7	IACT
SQUALANE	GW89575KF9	IACT
ETHYLHEXYLGLYCERIN	147D247K3P	IACT
BUTYLENE GLYCOL	3XUS85K0RA	IACT
DIHEXADECYL PHOSPHATE	2V6E5WN99N	IACT
CETETH-10 PHOSPHATE	4E05O5N49G	IACT
POLYSORBATE 60	CAL22UVI4M	IACT
CITRUS MAXIMA FRUIT RIND OIL	8U3877WD44	IACT
PROPYLENE GLYCOL MONOSTEARATE	MZM1I680W0	IACT
HYALURONATE SODIUM	YSE9PPT4TH	IACT
SORBITAN MONOLAURATE	6W9PS8B71J	IACT
POLYSORBATE 20	7T1F30V5YH	IACT
CITRIC ACID MONOHYDRATE	2968PHW8QP	IACT
.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	IACT
XANTHAN GUM	TTV12P4NEE	IACT
ALUMINUM OXIDE	LMI26O6933	IACT
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE)	255PIF62MS	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 · 461 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
xanthan gum	XANTHAN GUM	TTV12P4NEE	GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL		2350 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	SPRAY / NASAL		9 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
aluminum oxide	ALUMINUM OXIDE	LMI26O6933	TABLET / ORAL	NA		Exact identifier — unii candidate 2 equally ranked IID candidates
xanthan gum	XANTHAN GUM	TTV12P4NEE	TABLET / ORAL		56 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	SYSTEM / IONTOPHORESIS	168.1 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
polysorbate 20	POLYSORBATE 20	7T1F30V5YH	CAPSULE / ORAL		563 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION / OPHTHALMIC	6 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
polysorbate 20	POLYSORBATE 20	7T1F30V5YH	TABLET, EXTENDED RELEASE / ORAL	4.2 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
xanthan gum	XANTHAN GUM	TTV12P4NEE	GRANULE, FOR SUSPENSION / ORAL		450 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	FILM, EXTENDED RELEASE / TRANSDERMAL	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
polysorbate 20	POLYSORBATE 20	7T1F30V5YH	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
glyceryl monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	CAPSULE, EXTENDED RELEASE / ORAL	32.4 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
sorbitan monolaurate	SORBITAN MONOLAURATE	6W9PS8B71J	SPRAY, METERED / NASAL		1 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
ferrosoferric oxide	FERROSOFERRIC OXIDE	XM0M87F357	POWDER, FOR SUSPENSION / ORAL	NA		Exact identifier — unii candidate 10 equally ranked IID candidates
citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	CAPSULE, EXTENDED RELEASE / ORAL		101 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
squalane	SQUALANE	GW89575KF9	SOLUTION / TOPICAL	1 %w/w		Exact identifier — unii candidate 5 equally ranked IID candidates
citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	CREAM / VAGINAL	0.49 %w/w		Exact identifier — unii candidate 88 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE / ORAL		72 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	SHAMPOO, SUSPENSION / TOPICAL	3 %w/v		Exact identifier — unii candidate 40 equally ranked IID candidates
cetyl alcohol	CETYL ALCOHOL	936JST6JCN	AEROSOL / TOPICAL	1.16 %w/w		Exact identifier — unii candidate 20 equally ranked IID candidates
ferric oxide red	FERRIC OXIDE RED	1K09F3G675	CAPSULE, COATED / ORAL	0.12 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
edetate sodium	EDETATE SODIUM	MP1J8420LU	SHAMPOO / TOPICAL	1.33 %w/w		Exact identifier — unii candidate 12 equally ranked IID candidates
citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / INTRAVENOUS	2068 mg		Exact identifier — unii candidate 88 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	FILM, SOLUBLE / BUCCAL		11 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
cetyl alcohol	CETYL ALCOHOL	936JST6JCN	TABLET, FILM COATED / ORAL	NA		Exact identifier — unii candidate 20 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
citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		38 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
sorbitan monostearate	SORBITAN MONOSTEARATE	NVZ4I0H58X	TABLET / ORAL		4 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
polysorbate 20	POLYSORBATE 20	7T1F30V5YH	SOLUTION / TOPICAL	15 %w/w		Exact identifier — unii candidate 28 equally ranked IID candidates
potassium sorbate	POTASSIUM SORBATE	1VPU26JZZ4	TABLET / ORAL		6 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
glyceryl monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	GRANULE, FOR SUSPENSION / ORAL		4 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
polysorbate 20	POLYSORBATE 20	7T1F30V5YH	INJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		60 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET, ORALLY DISINTEGRATING / ORAL		83 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
hyaluronate sodium	HYALURONATE SODIUM	YSE9PPT4TH	LOTION / TOPICAL	0.01 %w/w		Exact identifier — unii candidate 5 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		42 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	POWDER, FOR SOLUTION / TOPICAL	NA		Exact identifier — unii candidate 88 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	FILM, EXTENDED RELEASE / BUCCAL		34 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / INTRAMUSCULAR		28 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	TABLET, COATED / ORAL	1 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
ferric oxide yellow	FERRIC OXIDE YELLOW	EX438O2MRT	TABLET / BUCCAL		1 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
polysorbate 20	POLYSORBATE 20	7T1F30V5YH	LOTION / TOPICAL		2000 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	DROPS / ORAL	NA		Exact identifier — unii candidate 88 equally ranked IID candidates
polysorbate 20	POLYSORBATE 20	7T1F30V5YH	POWDER, FOR SUSPENSION / ORAL	1.3 mg/5ml		Exact identifier — unii candidate 28 equally ranked IID candidates
ferrosoferric oxide	FERROSOFERRIC OXIDE	XM0M87F357	CAPSULE, DELAYED RELEASE / ORAL		6 mg	Exact identifier — unii candidate 10 equally ranked IID candidates
cetyl alcohol	CETYL ALCOHOL	936JST6JCN	CREAM / VAGINAL		200 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
sorbitan monostearate	SORBITAN MONOSTEARATE	NVZ4I0H58X	CREAM / TOPICAL		177 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
ferric oxide yellow	FERRIC OXIDE YELLOW	EX438O2MRT	GRANULE, FOR SUSPENSION / ORAL		11 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
ferric oxide red	FERRIC OXIDE RED	1K09F3G675	TABLET, FILM COATED / ORAL		3 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
ferric oxide yellow	FERRIC OXIDE YELLOW	EX438O2MRT	CAPSULE, EXTENDED RELEASE / ORAL		7 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
polysorbate 60	POLYSORBATE 60	CAL22UVI4M	SUSPENSION / ORAL		125 mg	Exact identifier — unii candidate 13 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	SYSTEM / TOPICAL		18144 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
polysorbate 20	POLYSORBATE 20	7T1F30V5YH	INJECTION, SOLUTION / INTRAVENOUS		30 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	DOUCHE / VAGINAL	1 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
sorbitan monostearate	SORBITAN MONOSTEARATE	NVZ4I0H58X	AEROSOL, FOAM / TOPICAL	0.55 %w/w		Exact identifier — unii candidate 11 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED / ORAL		36 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
glyceryl monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	TABLET / SUBLINGUAL	1.23 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
xanthan gum	XANTHAN GUM	TTV12P4NEE	SOLUTION / OPHTHALMIC	0.6 %w/v		Exact identifier — unii candidate 29 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	INJECTION, SOLUTION / INTRAVENOUS	15 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
xanthan gum	XANTHAN GUM	TTV12P4NEE	SUSPENSION/ DROPS / ORAL		22 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, DELAYED RELEASE / ORAL		66 mg	Exact identifier — unii candidate 40 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
4dcdf8b4-859d-533d-e063-6294a90a299a			6a1fa3dc-3016-419a-bbfa-118434b22e49	2026-03-24	Warnings	Exact identifier spl set id: 6a1fa3dc-3016-419a-bbfa-118434b22e49

Reported adverse events (FAERS/openFDA)#

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