BALANCE DYNAMICS BALANCING LOTION SPF-15

Manufacturer: JAFRA COSMETICS INTERNATIONAL | Jafra Manufacturing, S.A. de C.V.
Effective date: 2012-05-31
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:32:10

Label at a glance#

ProductBALANCE DYNAMICS BALANCING SPF 15

Active ingredientOCTISALATE, OXYBENZONE, OCTINOXATE

Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

SUNSCREEN ACTIVE INGREDIENT (SPF 15):
OCTINOXATE, OCTISALATE, OXYBENZONE/BENZOPHENONE-3

OTC - PURPOSE SECTION

PURPOSE: SUNSCREEN

INACTIVE INGREDIENT SECTION

OTHER INGREDIENTS: WATER/AQUA, TRIBEHENIN PEG-20 ESTERS, IPOMOEA DIGITATA (FINGERLEAF MORNING GLORY) EXTRACT, CENTELLA ASIATICA EXTRACT, WITHANIA SOMNIFERIA EXTRACT, BUTYLENE GLYCOL, DIMETHICONE, DIMETHICONE CROSSPOLYMER, XYLITOL, XYLITAN, XYLITYL POLYGLUCOSIDE, GLYCERYL STEARATE, BIS-DIGLYCERYL POLYACRYLADIPATE-2, IRIS FLORENTINA ROOT EXTRACT, RETINYL PALMITATE, ZINC SULFATE, ALCOHOL, PROPYLENE GLYCOL, BIOSACCHARIDE GUM-1, LAMINARIA SACCHARINA EXTRACT, GLYCERIN, BUTYROSPERMUM PARKII (SHEA BUTTER) FRUIT, DIAZOLIDINYL UREA, IODOPROPYNYL BUTYLCARBAMATE, SILANEDIOL SALICYLATE, ACRYLATES COPOLYMER, CYCLOMETHICONE, TRIETHANOLAMINE, CHONDRUS CRISPUS (CARRAGEENAN) EXTRACT, BIOSACCHARIDE GUM-4, PANTHENOL, TOCOPHERYL ACETATE, CARBOMER, XANTHAN GUM, FRAGRANCE/PARFUM, TRISODIUM EDTA, PENTYLENE GLYCOL, PROPAMIDOBENZOIC ACID, ZINGIBER OFFICINALE (GINGER) EXTRACT, BISABOLOL, YELLOW 6/CI 15985, RED 33/CI 17200 [FRAGRANCE/PARFUM CONTAINS: AMYL CINNAMAL, BENZYL ALCOHOL, BENZYL BENZOATE, LIMONENE, LINALOOL, BUTYLCHEMYL METHYLPROPIONAL (LILLIAL)].

INDICATIONS & USAGE SECTION

BALANCING LOTION SPF 15

DOSAGE & ADMINISTRATION SECTION

TO USE: IN THE MORNING AFTER CLEANSING, SMOOTH OVER FACE AND THROAT.

WARNINGS SECTION

DISCONTINUE USE IF IRRITATION OCCURS.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

JAFRA

BALANCE

DYNAMICS

BALANCING LOTION SPF 15

Balancing Dynamics_ART_BOX-FR_50mLBalancing Dynamics_ART_BOX-BK_50mLBalancing Dynamics_ART_BOX-S1_50mLBalancing Dynamics_ART_BOX-S2_50mLBalancing Dynamics_ART_LBL-FR_50mLBalancing Dynamics_ART_LBL-BK_50mLBalancing Dynamics_ART_LBL-FR_7mLBalancing Dynamics_ART_LBL-BK_7mLBalancing Dynamics_ART_INSERT_7mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68828-150-12	2020-01-31	C162847	48780-1	9d75b9d0-037c-f424-e053-dadaa90a57ce	BALANCE DYNAMICS BALANCING LOTION SPF-15
68828-150-17	2020-01-31	C162847	48780-1	9d75b9d0-037c-f424-e053-dadaa90a57ce	BALANCE DYNAMICS BALANCING LOTION SPF-15

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68828-150-12	BALANCE DYNAMICS BALANCINGSPF 15	1 in 1 BOX	LOTION	1	1
68828-150-17	BALANCE DYNAMICS BALANCINGSPF 15	7 mL in 1 TUBE	LOTION	7	1
68828-150-62	BALANCE DYNAMICS BALANCINGSPF 15	50 mL in 1 BOTTLE	LOTION	50	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68828-150	BALANCE DYNAMICS BALANCING SPF 15 (OCTISALATE OXYBENZONE OCTINOXATE) LOTION [JAFRA COSMETICS INTERNATIONAL]	1	Legacy NDC, 3 package rows	20120601_31066ffd-d8be-4390-bc91-268162945de9.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	1
OCTISALATE	ACTIVE INGREDIENT	4X49Y0596W	1
OXYBENZONE	ACTIVE INGREDIENT	95OOS7VE0Y	1
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	1
OCTISALATE	ACTIVE MOIETY	4X49Y0596W	1
OXYBENZONE	ACTIVE MOIETY	95OOS7VE0Y	1
.ALPHA.-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	1
BENZOIC ACID	INACTIVE INGREDIENT	8SKN0B0MIM	1
BIOSACCHARIDE GUM-1	INACTIVE INGREDIENT	BB4PU4V09H	1
BUTYLENE GLYCOL	INACTIVE INGREDIENT	3XUS85K0RA	1
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)	INACTIVE INGREDIENT	71DD5V995L	1
CARBOMER HOMOPOLYMER (ALLYL SUCROSE CROSSLINKED)	INACTIVE INGREDIENT	Z135WT9208	1
CENTELLA ASIATICA LEAF	INACTIVE INGREDIENT	6810070TYD	1
CHONDRUS CRISPUS	INACTIVE INGREDIENT	OQS23HUA1X	1
CYCLOMETHICONE	INACTIVE INGREDIENT	NMQ347994Z	1
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	1
DIAZOLIDINYL UREA	INACTIVE INGREDIENT	H5RIZ3MPW4	1
DIGLYCERIN	INACTIVE INGREDIENT	3YC120743U	1
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	1
EDETATE TRISODIUM	INACTIVE INGREDIENT	420IP921MB	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	1
GINGER	INACTIVE INGREDIENT	C5529G5JPQ	1
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	1
IODOPROPYNYL BUTYLCARBAMATE	INACTIVE INGREDIENT	603P14DHEB	1
IPOMOEA MAURITIANA TUBER	INACTIVE INGREDIENT	K67Y2SGX79	1
IRIS GERMANICA VAR. FLORENTINA ROOT	INACTIVE INGREDIENT	M30XO5X4XD	1
LEVOMENOL	INACTIVE INGREDIENT	24WE03BX2T	1
PANTHENOL	INACTIVE INGREDIENT	WV9CM0O67Z	1
PENTYLENE GLYCOL	INACTIVE INGREDIENT	50C1307PZG	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	1
SACCHARINA LATISSIMA THALLUS	INACTIVE INGREDIENT	68CMP2MB55	1
SHEA BUTTER	INACTIVE INGREDIENT	K49155WL9Y	1
SILANETRIOL	INACTIVE INGREDIENT	E52D0J3TS5	1
TRIBEHENIN PEG-20 ESTERS	INACTIVE INGREDIENT	84K9EH29Y9	1
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	1
VITAMIN A PALMITATE	INACTIVE INGREDIENT	1D1K0N0VVC	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1
WITHANIA SOMNIFERA FLOWER	INACTIVE INGREDIENT	2HZ95R7082	1
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	1
XYLITOL	INACTIVE INGREDIENT	VCQ006KQ1E	1
XYLITYLGLUCOSIDE	INACTIVE INGREDIENT	O0IEZ166FB	1
ZINC SULFATE	INACTIVE INGREDIENT	89DS0H96TB	1

Products#

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

DailyMed product names page 1 of 2 · 42 matching rows.

BALANCE DYNAMICS BALANCING SPF 15
OCTISALATE OXYBENZONE OCTINOXATE
WATER
TRIBEHENIN PEG-20 ESTERS
IPOMOEA MAURITIANA TUBER
CENTELLA ASIATICA LEAF
WITHANIA SOMNIFERA FLOWER
BUTYLENE GLYCOL
DIMETHICONE
XYLITOL
XYLITYLGLUCOSIDE
GLYCERYL MONOSTEARATE
DIGLYCERIN
IRIS GERMANICA VAR. FLORENTINA ROOT
VITAMIN A PALMITATE
ZINC SULFATE
ALCOHOL
PROPYLENE GLYCOL
BIOSACCHARIDE GUM-1
SACCHARINA LATISSIMA THALLUS
SHEA BUTTER
DIAZOLIDINYL UREA
IODOPROPYNYL BUTYLCARBAMATE
SILANETRIOL
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)
CYCLOMETHICONE
TROLAMINE
CHONDRUS CRISPUS
PANTHENOL
.ALPHA.-TOCOPHEROL ACETATE
CARBOMER HOMOPOLYMER (ALLYL SUCROSE CROSSLINKED)
XANTHAN GUM
EDETATE TRISODIUM
PENTYLENE GLYCOL
BENZOIC ACID
GINGER
LEVOMENOL
FD&C YELLOW NO. 6
D&C RED NO. 33
OCTISALATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
68828-150	68828-150-17, 68828-150-62, 68828-150-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 40 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
WATER	059QF0KO0R	IACT
TRIBEHENIN PEG-20 ESTERS	84K9EH29Y9	IACT
IPOMOEA MAURITIANA TUBER	K67Y2SGX79	IACT
CENTELLA ASIATICA LEAF	6810070TYD	IACT
WITHANIA SOMNIFERA FLOWER	2HZ95R7082	IACT
BUTYLENE GLYCOL	3XUS85K0RA	IACT
DIMETHICONE	92RU3N3Y1O	IACT
XYLITOL	VCQ006KQ1E	IACT
XYLITYLGLUCOSIDE	O0IEZ166FB	IACT
GLYCERYL MONOSTEARATE	230OU9XXE4	IACT
DIGLYCERIN	3YC120743U	IACT
IRIS GERMANICA VAR. FLORENTINA ROOT	M30XO5X4XD	IACT
VITAMIN A PALMITATE	1D1K0N0VVC	IACT
ZINC SULFATE	89DS0H96TB	IACT
ALCOHOL	3K9958V90M	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
BIOSACCHARIDE GUM-1	BB4PU4V09H	IACT
SACCHARINA LATISSIMA THALLUS	68CMP2MB55	IACT
SHEA BUTTER	K49155WL9Y	IACT
DIAZOLIDINYL UREA	H5RIZ3MPW4	IACT
IODOPROPYNYL BUTYLCARBAMATE	603P14DHEB	IACT
SILANETRIOL	E52D0J3TS5	IACT
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)	71DD5V995L	IACT
CYCLOMETHICONE	NMQ347994Z	IACT
TROLAMINE	9O3K93S3TK	IACT
CHONDRUS CRISPUS	OQS23HUA1X	IACT
PANTHENOL	WV9CM0O67Z	IACT
.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	IACT
CARBOMER HOMOPOLYMER (ALLYL SUCROSE CROSSLINKED)	Z135WT9208	IACT
XANTHAN GUM	TTV12P4NEE	IACT
EDETATE TRISODIUM	420IP921MB	IACT
PENTYLENE GLYCOL	50C1307PZG	IACT
BENZOIC ACID	8SKN0B0MIM	IACT
GINGER	C5529G5JPQ	IACT
LEVOMENOL	24WE03BX2T	IACT
FD&C YELLOW NO. 6	H77VEI93A8	IACT
D&C RED NO. 33	9DBA0SBB0L	IACT
OCTISALATE	4X49Y0596W	ACTIB
OXYBENZONE	95OOS7VE0Y	ACTIB
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 6 · 330 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
TROLAMINE	TROLAMINE	9O3K93S3TK	AEROSOL, METERED / RECTAL	ADJ PH		Exact identifier — unii candidate 22 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	CAPSULE, COATED PELLETS / ORAL	NA		Exact identifier — unii candidate 34 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	SUSPENSION / OPHTHALMIC	0.5 %w/v		Exact identifier — unii candidate 21 equally ranked IID candidates
D&C RED NO. 33	D&C RED NO. 33	9DBA0SBB0L	ELIXIR / ORAL	27.5 mg/5ml		Exact identifier — unii candidate 14 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	TABLET, DELAYED RELEASE / ORAL		6 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION, SOLUTION / INTRAVENOUS		4000 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	ELIXIR / ORAL		90 mg	Exact identifier — unii candidate 23 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	LIQUID / INTRAMUSCULAR		400 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CONCENTRATE / ORAL		7000 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
CARBOMER HOMOPOLYMER (ALLYL SUCROSE CROSSLINKED)	CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)	Z135WT9208	CREAM / TOPICAL		600 mg	Exact identifier — unii candidate 14 equally ranked IID candidates
CHONDRUS CRISPUS	CHONDRUS CRISPUS	OQS23HUA1X	LOTION / TOPICAL	NA		Exact identifier — unii candidate
ALCOHOL	ALCOHOL	3K9958V90M	AEROSOL, METERED / NASAL	70 mg		Exact identifier — unii candidate 59 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	TABLET / ORAL	33.34 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	SUSPENSION / RECTAL	0.1 %w/w		Exact identifier — unii candidate 23 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	SUSPENSION / ORAL		11 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CREAM / TOPICAL		76000 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
DIAZOLIDINYL UREA	DIAZOLIDINYL UREA	H5RIZ3MPW4	CREAM / TOPICAL		29 mg	Exact identifier — unii candidate 3 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	SPONGE / TOPICAL	11 %w/w		Exact identifier — unii candidate 22 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	POWDER, FOR SUSPENSION / ORAL	4223 mg		Exact identifier — unii candidate 12 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / INTRAVESICAL		7892 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	SHAMPOO / TOPICAL	3.7 %w/w		Exact identifier — unii candidate 22 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	POWDER / ORAL	275 mg		Exact identifier — unii candidate 29 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	CAPSULE / ORAL		7 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
CARBOMER HOMOPOLYMER (ALLYL SUCROSE CROSSLINKED)	CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)	Z135WT9208	TABLET, EXTENDED RELEASE / ORAL		90 mg	Exact identifier — unii candidate 14 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION, CONCENTRATE / ORAL	150.68 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
D&C RED NO. 33	D&C RED NO. 33	9DBA0SBB0L	TABLET / ORAL	0.24 mg		Exact identifier — unii candidate 14 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SUSPENSION, EXTENDED RELEASE / ORAL	186.8 mg		Exact identifier — unii candidate 29 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	SOLUTION / ORAL		21600 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	TABLET, ORALLY DISINTEGRATING / ORAL	0.15 mg		Exact identifier — unii candidate 29 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SHAMPOO / TOPICAL		714 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	GEL / TOPICAL		9971 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	GEL / RECTAL		11 mg	Exact identifier — unii candidate 23 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
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION / SUBCUTANEOUS	1.4 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	LOTION, AUGMENTED / TOPICAL		2070 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	TABLET, CHEWABLE / ORAL		1 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	EMULSION / ORAL	NA		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
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	INJECTION / INTRAMUSCULAR	5 %w/v		Exact identifier — unii candidate 23 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	GRANULE, FOR SUSPENSION / ORAL		450 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
D&C RED NO. 33	D&C RED NO. 33	9DBA0SBB0L	TABLET, FILM COATED / ORAL	NA		Exact identifier — unii candidate 14 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION, CONCENTRATE / INTRAVENOUS		4000 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / INTRAVENOUS		99 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	EMULSION / TOPICAL	8 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	SYRUP / ORAL		20 mg	Exact identifier — unii candidate 23 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	SOLUTION / ORAL	75.3 mg/15ml		Exact identifier — unii candidate 34 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	TABLET / SUBLINGUAL	1 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	FILM, SOLUBLE / BUCCAL		5 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	ELIXIR / ORAL	5.4 mg/5ml		Exact identifier — unii candidate 34 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SOLUTION / OPHTHALMIC	0.6 %w/v		Exact identifier — unii candidate 29 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	SOLUTION / IRRIGATION	0.02 %w/v		Exact identifier — unii candidate 23 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / ORAL		6624 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	CAPSULE, EXTENDED RELEASE / ORAL	4.59 mg		Exact identifier — unii candidate 34 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
XYLITOL	XYLITOL	VCQ006KQ1E	SUSPENSION, EXTENDED RELEASE / ORAL		9000 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	SUSPENSION, EXTENDED RELEASE / ORAL	0.12 mg/5ml		Exact identifier — unii candidate 34 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	POWDER / ORAL	20 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
CYCLOMETHICONE	CYCLOMETHICONE	NMQ347994Z	CREAM, AUGMENTED / TOPICAL	7.6 %w/w		Exact identifier — unii candidate 5 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	LOTION / TOPICAL		177 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	SUSPENSION / ORAL		1500 mg	Exact identifier — unii candidate 12 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
3a483673-b894-4efe-9021-5c10cdd637ee			31066ffd-d8be-4390-bc91-268162945de9	2012-05-31	Warnings	Exact identifier spl id: 3a483673-b894-4efe-9021-5c10cdd637ee spl set id: 31066ffd-d8be-4390-bc91-268162945de9

Reported adverse events (FAERS/openFDA)#

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