AVOBENZONE, OCTINOXATE, OCTISALATE

Manufacturer: Burberry Limited
Effective date: 2017-12-28
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-05-31 22:53:44

Label at a glance#

ProductBurberry Cashmere Long-Lasting Flawless Soft-Matte Foundation Sunscreen Broad Spectrum SPF 20 Ochre Nude No.12

Active ingredientAVOBENZONE, OCTINOXATE, OCTISALATE

Label structure7 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

Apply liberally 15 mins before sun exposure. Reapply at least every 2 hrs. Use a water resistant sunscreen if swiming 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...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3.0%

Octinoxate 3.5%

Octisalate 4%

Purpose

OTC - PURPOSE SECTION

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.

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin.

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor

OTC - STOP USE SECTION

if rash occurs.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply liberally 15 mins before sun exposure.
Reapply at least every 2 hrs.
Use a water resistant sunscreen if swiming 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 doctor.

Other information

SPL UNCLASSIFIED SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, methyl trimethicone, isododecane, cyclopentasiloxane, butylene glycol, diphenyl dimethicone/vinyl diphenyl dimethicone/vinyl diphenyl dimethicone/silsesquioxane cross polymer, methyl methacrylate crosspolymer, PEG-10 dimethicone, phenyl trimethicone, lauryl PEG-9 polydimethylsiloxyethyl dimethicone, glycerin, PEG/PPG-18/18 dimethicone, caprylyl methicone, sodium chloride, octyldodecanol, alcohol, acrylates/dimethicone copolymer, VP/VA copolymer, phenoxyethanol, disteardimonium hectorite, caprylyl glycol, tocopheryl acetate, triethoxycaprylylsilane, propylene carbonate, disodium EDTA, gum arabic tree (acacia senegal) gum, xanthan gum, sodium hyaluronate, dog rose (rosa canina) fruit extract, BHT, tea (camellia sinensis) leaf extract, citric acid, tocopherol, sodium benzoate, potassium sorbate, spanish lavender (lavandula stoechas) extract. May contain: Titanium dioxide, iron oxides, bismuth oxycholride.

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

OchreNude_InnerOchreNude_Outer

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7792dadb-52b6-46b6-8fdf-80b1171065b5	Product name	1	20180810
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
69038-027-00	2020-01-31	C162847	48780-1	9d75b9d0-1825-f424-e053-dadaa90a57ce	Burberry Cashmere Long-Lasting Flawless Soft-Matte Foundation Sunscreen Broad Spectrum SPF 20 Ochre Nude No.12

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69038-027-00	Burberry Cashmere Long-Lasting Flawless Soft-Matte Foundation Sunscreen Broad Spectrum SPF 20 Ochre Nude No.12	1 in 1 CARTON	CREAM	1		3
69038-027-00	Burberry Cashmere Long-Lasting Flawless Soft-Matte Foundation Sunscreen Broad Spectrum SPF 20 Ochre Nude No.12	30 mL in 1 PACKAGE	CREAM	30		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69038-027	BURBERRY CASHMERE LONG-LASTING FLAWLESS SOFT-MATTE FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 20 OCHRE NUDE NO.12 (AVOBENZONE, OCTINOXATE, OCTISALATE) CREAM [BURBERRY LIMITED]	3	Legacy NDC, 2 package rows	20171228_1271830f-15fe-4e2b-aac1-0b068119553b.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
AVOBENZONE	ACTIVE INGREDIENT	G63QQF2NOX	2
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	2
OCTISALATE	ACTIVE INGREDIENT	4X49Y0596W	2
AVOBENZONE	ACTIVE MOIETY	G63QQF2NOX	2
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	2
OCTISALATE	ACTIVE MOIETY	4X49Y0596W	2
.ALPHA.-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	2
ACACIA	INACTIVE INGREDIENT	5C5403N26O	2
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	2
BISMUTH OXYCHLORIDE	INACTIVE INGREDIENT	4ZR792I587	2
BUTYLENE GLYCOL	INACTIVE INGREDIENT	3XUS85K0RA	2
CAPRYLYL GLYCOL	INACTIVE INGREDIENT	00YIU5438U	2
CAPRYLYL TRISILOXANE	INACTIVE INGREDIENT	Q95M2P1KJL	2
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	2
COPOVIDONE K25-31	INACTIVE INGREDIENT	D9C330MD8B	2
CYCLOMETHICONE 5	INACTIVE INGREDIENT	0THT5PCI0R	2
DISTEARDIMONIUM HECTORITE	INACTIVE INGREDIENT	X687XDK09L	2
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	2
HYALURONATE SODIUM	INACTIVE INGREDIENT	YSE9PPT4TH	2
ISODODECANE	INACTIVE INGREDIENT	A8289P68Y2	2
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE	INACTIVE INGREDIENT	25G622K2RA	2
LAVANDULA STOECHAS FLOWERING TOP	INACTIVE INGREDIENT	70759G2U6A	2
METHYL TRIMETHICONE	INACTIVE INGREDIENT	S73ZQI0GXM	2
OCTYLDODECANOL	INACTIVE INGREDIENT	461N1O614Y	2
PEG/PPG-18/18 DIMETHICONE	INACTIVE INGREDIENT	9H0AO7T794	2
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	2
PHENYL TRIMETHICONE	INACTIVE INGREDIENT	DR0K5NOJ4R	2
POTASSIUM SORBATE	INACTIVE INGREDIENT	1VPU26JZZ4	2
PROPYLENE CARBONATE	INACTIVE INGREDIENT	8D08K3S51E	2
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	2
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	2
TEA LEAF	INACTIVE INGREDIENT	GH42T47V24	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	2
TOCOPHEROL	INACTIVE INGREDIENT	R0ZB2556P8	2
TRIETHOXYCAPRYLYLSILANE	INACTIVE INGREDIENT	LDC331P08E	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	2
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	2

Products#

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

DailyMed product names page 1 of 1 · 38 matching rows.

Burberry Cashmere Long-Lasting Flawless Soft-Matte Foundation Sunscreen Broad Spectrum SPF 20 Ochre Nude No.12
AVOBENZONE, OCTINOXATE, OCTISALATE
WATER
METHYL TRIMETHICONE
ISODODECANE
CYCLOMETHICONE 5
BUTYLENE GLYCOL
PHENYL TRIMETHICONE
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE
GLYCERIN
PEG/PPG-18/18 DIMETHICONE
CAPRYLYL TRISILOXANE
SODIUM CHLORIDE
OCTYLDODECANOL
ALCOHOL
COPOVIDONE K25-31
PHENOXYETHANOL
DISTEARDIMONIUM HECTORITE
CAPRYLYL GLYCOL
.ALPHA.-TOCOPHEROL ACETATE
TRIETHOXYCAPRYLYLSILANE
PROPYLENE CARBONATE
EDETATE DISODIUM
ACACIA
XANTHAN GUM
HYALURONATE SODIUM
TEA LEAF
CITRIC ACID MONOHYDRATE
TOCOPHEROL
SODIUM BENZOATE
POTASSIUM SORBATE
LAVANDULA STOECHAS FLOWERING TOP
TITANIUM DIOXIDE
FERRIC OXIDE RED
BISMUTH OXYCHLORIDE
AVOBENZONE
OCTINOXATE
OCTISALATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
69038-027	69038-027-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 36 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
WATER	059QF0KO0R	IACT
METHYL TRIMETHICONE	S73ZQI0GXM	IACT
ISODODECANE	A8289P68Y2	IACT
CYCLOMETHICONE 5	0THT5PCI0R	IACT
BUTYLENE GLYCOL	3XUS85K0RA	IACT
PHENYL TRIMETHICONE	DR0K5NOJ4R	IACT
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE	25G622K2RA	IACT
GLYCERIN	PDC6A3C0OX	IACT
PEG/PPG-18/18 DIMETHICONE	9H0AO7T794	IACT
CAPRYLYL TRISILOXANE	Q95M2P1KJL	IACT
SODIUM CHLORIDE	451W47IQ8X	IACT
OCTYLDODECANOL	461N1O614Y	IACT
ALCOHOL	3K9958V90M	IACT
COPOVIDONE K25-31	D9C330MD8B	IACT
PHENOXYETHANOL	HIE492ZZ3T	IACT
DISTEARDIMONIUM HECTORITE	X687XDK09L	IACT
CAPRYLYL GLYCOL	00YIU5438U	IACT
.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	IACT
TRIETHOXYCAPRYLYLSILANE	LDC331P08E	IACT
PROPYLENE CARBONATE	8D08K3S51E	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
ACACIA	5C5403N26O	IACT
XANTHAN GUM	TTV12P4NEE	IACT
HYALURONATE SODIUM	YSE9PPT4TH	IACT
TEA LEAF	GH42T47V24	IACT
CITRIC ACID MONOHYDRATE	2968PHW8QP	IACT
TOCOPHEROL	R0ZB2556P8	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
POTASSIUM SORBATE	1VPU26JZZ4	IACT
LAVANDULA STOECHAS FLOWERING TOP	70759G2U6A	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
FERRIC OXIDE RED	1K09F3G675	IACT
BISMUTH OXYCHLORIDE	4ZR792I587	IACT
AVOBENZONE	G63QQF2NOX	ACTIB
OCTINOXATE	4Y5P7MUD51	ACTIB
OCTISALATE	4X49Y0596W	ACTIB

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 11 · 648 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	INJECTION, SOLUTION / INTRAMUSCULAR	4.8 %w/v		Exact identifier — unii candidate 35 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	DOUCHE / VAGINAL	0.07 %w/w		Exact identifier — unii candidate 88 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		36 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SYRUP / ORAL	722 mg/5ml		Exact identifier — unii candidate 88 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SUSPENSION / INTRA-ARTICULAR		26 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	GRANULE, FOR SUSPENSION / ORAL		450 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / INTRAMUSCULAR		28 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SUSPENSION/ DROPS / ORAL		22 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	NA		Exact identifier — unii candidate 88 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	GRANULE, EFFERVESCENT / ORAL	60 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
COPOVIDONE K25-31	COPOVIDONE K25-31	D9C330MD8B	CAPSULE, COATED PELLETS / ORAL		88 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SPRAY, METERED / NASAL		36 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	TABLET / SUBLINGUAL	1 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION, CONCENTRATE / INTRAOCULAR	0.86 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, POWDER, FOR SUSPENSION / INTRA-ARTICULAR		45 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, LIQUID FILLED / ORAL		12 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	TABLET, FILM COATED / ORAL	0.08 mg		Exact identifier — unii candidate 29 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	AEROSOL, FOAM / TOPICAL		4504 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	ELIXIR / ORAL		5621 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	DROPS / NASAL	NA		Exact identifier — unii candidate 134 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	DROPS / NASAL	10 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, SOLUTION / INTRAVENOUS		7 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / INTRAMUSCULAR		1486 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / NASAL	2.8 mg/1ml		Exact identifier — unii candidate 88 equally ranked IID candidates
COPOVIDONE K25-31	COPOVIDONE K25-31	D9C330MD8B	CAPSULE / ORAL		1346 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	TABLET, EXTENDED RELEASE / ORAL	34.4 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, DELAYED RELEASE PELLETS / ORAL		24 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	LOTION / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 19 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	LIQUID / INTRAMUSCULAR		400 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / SOFT TISSUE	ADJ PH		Exact identifier — unii candidate 88 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SUSPENSION / ORAL		113 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	TABLET, CHEWABLE / ORAL		20 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	MOUTHWASH / BUCCAL	100 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	OINTMENT / TOPICAL	5 %w/w		Exact identifier — unii candidate 40 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SOLUTION / ORAL		660 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SUSPENSION / INTRAMUSCULAR		26 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	CAPSULE, DELAYED RELEASE / ORAL		14 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		24 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	0.2 mg		Exact identifier — unii candidate 19 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
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
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	PASTE, DENTIFRICE / DENTAL	0.5 %w/w		Exact identifier — unii candidate 35 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / SUBCUTANEOUS	0.8 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SWAB / TOPICAL	0.05 %w/w		Exact identifier — unii candidate 88 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SOLUTION / ORAL		84 mg	Exact identifier — unii candidate 29 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
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / OPHTHALMIC	0.5 %w/v		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	CAPSULE / ORAL		882 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, EXTENDED RELEASE / ORAL		90 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SHAMPOO / TOPICAL	1 %w/w		Exact identifier — unii candidate 77 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	CAPSULE, COATED PELLETS / ORAL	2 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / NASAL	100 mg/100ml		Exact identifier — unii candidate 77 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	MOUTHWASH / BUCCAL	200 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	DROPS / ORAL	NA		Exact identifier — unii candidate 134 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION, SOLUTION / SUBCUTANEOUS	6.1 %v/v		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / TRANSDERMAL	49.37 %w/v		Exact identifier — unii candidate 59 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION, SOLUTION / SUBCUTANEOUS		26 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	CREAM / VAGINAL		3 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INHALANT / RESPIRATORY (INHALATION)	3 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	POWDER, FOR SOLUTION / ORAL	10 mg/5ml		Exact identifier — unii candidate 29 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
616a5f3a-9e18-4834-e053-2a91aa0a2406			1271830f-15fe-4e2b-aac1-0b068119553b	2017-12-28	Warnings	Exact identifier spl id: 616a5f3a-9e18-4834-e053-2a91aa0a2406 spl set id: 1271830f-15fe-4e2b-aac1-0b068119553b

Reported adverse events (FAERS/openFDA)#

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