Sebastian Sun Smacker SPF 24 Calypso Berry Beat

Manufacturer: Bonne Bell LLC
Effective date: 2012-09-06
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 22:32:56

Label at a glance#

ProductSebastian Sun Smacker SPF 24 Calypso Berry Beat

Active ingredientOCTINOXATE, OXYBENZONE, PADIMATE O

Label structure14 sections

Dosage and administration

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.

Storage and handling

Protect this product from excessive heat and direct sun

Contacts and useful links#

PhoneLabel contact1-866-984-1433

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 7.5 percent w per w

Oxybenzone 6.0 percent w per w

Padimate 0 8.0 percent w per w

PURPOSES

OTC - PURPOSE SECTION

Sunscreen

USE

INDICATIONS & USAGE SECTION

HELPS PREVENT SUNBURN.

WARNINGS

WARNINGS SECTION

Skin Cancer Skin Aging Alert. Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

For external use only

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin

Stop use and ask a doctor

OTC - STOP USE SECTION

if rash occurs

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove

Keep out of the 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 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.

Storage and Handling

STORAGE AND HANDLING SECTION

Protect this product from excessive heat and direct sun

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

RICINUS COMMUNIS (CASTOR) SEED OIL, CETYL ACETATE, BEESWAX (CERA ALBA), EUPHORBIA CERIFERA (CANDELILLA) WAX, FLAVOR/AROMA, POLYBUTENE, COPERNICIA CERIFERA (CARNAUBA) WAX, OZOKERITE, ACETYLATED LANOLIN ALCOHOL, SESAMUM INDICUM (SESAME) SEED OIL, ISOPROPYL MYRISTATE, BENZYL BENZOATE, PARAFFIN, POLYESTER-3, TRITICUM VULGARE (WHEAT) GERM OIL, MICA, PROPYLENE GLYCOL, STEARIC ACID, HYDROGENATED SOY GLYCERIDES, PROPYL GALLATE, CITRIC ACID, NEOTAME, CITRAL, LINALOOL, BENZYL ALCOHOL, GERANIOL, METHYL 2-OCTYNOATE, CINNAMAL, EUGENOL, FARNESOL, LIMONENE. MAY CONTAIN (PLUS OR MINUS) TITANIUM DIOXIDE (CI 77891), BLUE 1 LAKE (CI 42090), RED 28 (CI 45410), RED 6 LAKE (CI 15850), RED 22 (CI 45380), YELLOW 5 LAKE (CI 19140), CARMINE (CI 75470).

Questions or Comments

OTC - QUESTIONS SECTION

Call 1-866-984-1433

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SUNSCREEN LIP BALM SPF 24
SUN SMACKER
Calypso Berry Beat

(c) Disney
DIST. ASPIRE BRANDS/BONNE BELL (R)
SANTA MONICA CA 90404 N-1703 SARPSBORG NORWAY
Made in U.S.A. net wt 0.14 oz 4.0 g

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
9869efd7-d6dd-0665-5b67-53adbe6ef15e	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50051-0003-4	2019-11-13	C162847	48780-1	97449f38-d45a-f6ea-e053-dbdaa90aa703	Sebastian Sun Smacker SPF 24 Calypso Berry Beat

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50051-0003-4	Sebastian Sun Smacker SPF 24 Calypso Berry Beat	4 g in 1 CYLINDER	LIPSTICK	4		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50051-0003	SEBASTIAN SUN SMACKER SPF 24 CALYPSO BERRY BEAT (OCTINOXATE, OXYBENZONE, PADIMATE O) LIPSTICK [BONNE BELL LLC]	2	Legacy NDC, 1 package rows	20120907_0951e5e0-2015-4687-bcee-605621fb5186.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	2
OXYBENZONE	ACTIVE INGREDIENT	95OOS7VE0Y	2
PADIMATE O	ACTIVE INGREDIENT	Z11006CMUZ	2
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	2
OXYBENZONE	ACTIVE MOIETY	95OOS7VE0Y	2
PADIMATE O	ACTIVE MOIETY	Z11006CMUZ	2
ACETYLATED LANOLIN ALCOHOLS	INACTIVE INGREDIENT	SNN716810P	2
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	2
BENZYL BENZOATE	INACTIVE INGREDIENT	N863NB338G	2
CANDELILLA WAX	INACTIVE INGREDIENT	WL0328HX19	2
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	2
CASTOR OIL	INACTIVE INGREDIENT	D5340Y2I9G	2
CETYL ACETATE	INACTIVE INGREDIENT	4Q43814HXS	2
CINNAMALDEHYDE	INACTIVE INGREDIENT	SR60A3XG0F	2
CITRAL	INACTIVE INGREDIENT	T7EU0O9VPP	2
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	2
D&C RED NO. 22	INACTIVE INGREDIENT	1678RKX8RT	2
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	2
D&C RED NO. 6	INACTIVE INGREDIENT	481744AI4O	2
EUGENOL	INACTIVE INGREDIENT	3T8H1794QW	2
FARNESOL	INACTIVE INGREDIENT	EB41QIU6JL	2
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	2
GERANIOL	INACTIVE INGREDIENT	L837108USY	2
ISOPROPYL MYRISTATE	INACTIVE INGREDIENT	0RE8K4LNJS	2
LINALOOL, (+/-)-	INACTIVE INGREDIENT	D81QY6I88E	2
METHYL HEPTINE CARBONATE	INACTIVE INGREDIENT	0TTP6YT2T3	2
MICA	INACTIVE INGREDIENT	V8A1AW0880	2
NEOTAME	INACTIVE INGREDIENT	VJ597D52EX	2
PARAFFIN	INACTIVE INGREDIENT	I9O0E3H2ZE	2
PROPYL GALLATE	INACTIVE INGREDIENT	8D4SNN7V92	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	2
SESAME OIL	INACTIVE INGREDIENT	QX10HYY4QV	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	2
WHEAT GERM OIL	INACTIVE INGREDIENT	14C97E680P	2
YELLOW WAX	INACTIVE INGREDIENT	2ZA36H0S2V	2

Products#

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

DailyMed product names page 1 of 1 · 35 matching rows.

Sebastian Sun Smacker SPF 24 Calypso Berry Beat
OCTINOXATE, OXYBENZONE, PADIMATE O
OCTINOXATE
OXYBENZONE
PADIMATE O
CASTOR OIL
CETYL ACETATE
YELLOW WAX
CANDELILLA WAX
CARNAUBA WAX
ACETYLATED LANOLIN ALCOHOLS
SESAME OIL
ISOPROPYL MYRISTATE
BENZYL BENZOATE
PARAFFIN
WHEAT GERM OIL
MICA
PROPYLENE GLYCOL
STEARIC ACID
PROPYL GALLATE
CITRIC ACID MONOHYDRATE
NEOTAME
CITRAL
LINALOOL, (+/-)-
BENZYL ALCOHOL
GERANIOL
METHYL HEPTINE CARBONATE
CINNAMALDEHYDE
EUGENOL
FARNESOL
TITANIUM DIOXIDE
D&C RED NO. 28
D&C RED NO. 22
D&C RED NO. 6
FD&C YELLOW NO. 5

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
50051-0003	50051-0003-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 33 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
OCTINOXATE	4Y5P7MUD51	ACTIB
OXYBENZONE	95OOS7VE0Y	ACTIB
PADIMATE O	Z11006CMUZ	ACTIB
CASTOR OIL	D5340Y2I9G	IACT
CETYL ACETATE	4Q43814HXS	IACT
YELLOW WAX	2ZA36H0S2V	IACT
CANDELILLA WAX	WL0328HX19	IACT
CARNAUBA WAX	R12CBM0EIZ	IACT
ACETYLATED LANOLIN ALCOHOLS	SNN716810P	IACT
SESAME OIL	QX10HYY4QV	IACT
ISOPROPYL MYRISTATE	0RE8K4LNJS	IACT
BENZYL BENZOATE	N863NB338G	IACT
PARAFFIN	I9O0E3H2ZE	IACT
WHEAT GERM OIL	14C97E680P	IACT
MICA	V8A1AW0880	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
STEARIC ACID	4ELV7Z65AP	IACT
PROPYL GALLATE	8D4SNN7V92	IACT
CITRIC ACID MONOHYDRATE	2968PHW8QP	IACT
NEOTAME	VJ597D52EX	IACT
CITRAL	T7EU0O9VPP	IACT
LINALOOL, (+/-)-	D81QY6I88E	IACT
BENZYL ALCOHOL	LKG8494WBH	IACT
GERANIOL	L837108USY	IACT
METHYL HEPTINE CARBONATE	0TTP6YT2T3	IACT
CINNAMALDEHYDE	SR60A3XG0F	IACT
EUGENOL	3T8H1794QW	IACT
FARNESOL	EB41QIU6JL	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
D&C RED NO. 28	767IP0Y5NH	IACT
D&C RED NO. 22	1678RKX8RT	IACT
D&C RED NO. 6	481744AI4O	IACT
FD&C YELLOW NO. 5	I753WB2F1M	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 7 · 410 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION, SOLUTION / SUBCUTANEOUS	0.95 %w/v		Exact identifier — unii candidate 50 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	AEROSOL, METERED / RECTAL	NA		Exact identifier — unii candidate 81 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / ORAL		446 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CINNAMALDEHYDE	CINNAMALDEHYDE	SR60A3XG0F	SUSPENSION / ORAL	NA		Exact identifier — unii candidate 2 equally ranked IID candidates
PARAFFIN	PARAFFIN	I9O0E3H2ZE	OINTMENT / TOPICAL		2860 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	OINTMENT, AUGMENTED / TOPICAL		714 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	GEL / TOPICAL		185 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, COATED / ORAL		49 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION / INTRAVENOUS		1620 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
PROPYL GALLATE	PROPYL GALLATE	8D4SNN7V92	GEL / TOPICAL	0.05 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	TABLET, COATED / ORAL	213.7 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	CONCENTRATE / BUCCAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
D&C RED NO. 22	D&C RED NO. 22	1678RKX8RT	TABLET, DELAYED RELEASE / ORAL	0.38 mg		Exact identifier — unii candidate 5 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	POWDER, FOR SUSPENSION / ORAL		297 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SWAB / TOPICAL	34.6 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	OINTMENT / TOPICAL	20 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	CREAM / VAGINAL	1 %w/w		Exact identifier — unii candidate 50 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE, DELAYED RELEASE / ORAL	1.7 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	TABLET, DELAYED RELEASE / ORAL	0.1 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION / INTRA-ARTERIAL	0.9 %w/v		Exact identifier — unii candidate 50 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SHAMPOO, SUSPENSION / TOPICAL	3 %w/v		Exact identifier — unii candidate 40 equally ranked IID candidates
CASTOR OIL	CASTOR OIL	D5340Y2I9G	EMULSION / OPHTHALMIC		32 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
PARAFFIN	PARAFFIN	I9O0E3H2ZE	TABLET, DELAYED RELEASE / ORAL	0.2 mg		Exact identifier — unii candidate 11 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS		608 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	CREAM / VAGINAL		50 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	OINTMENT / TOPICAL		5148 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL / TRANSDERMAL		500 mg	Exact identifier — unii candidate 81 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
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	TABLET, EXTENDED RELEASE / ORAL	0.01 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / PERIDURAL	NA		Exact identifier — unii candidate 88 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE, EXTENDED RELEASE / ORAL		8 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	AEROSOL, SPRAY / TOPICAL	6.89 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
PARAFFIN	PARAFFIN	I9O0E3H2ZE	SUSPENSION / TOPICAL		11726 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / TOPICAL	5.28 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / AURICULAR (OTIC)	56.55 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 50 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	TABLET, CHEWABLE / ORAL	4.5 mg		Exact identifier — unii candidate 22 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE, COATED / ORAL	25 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
CASTOR OIL	CASTOR OIL	D5340Y2I9G	INJECTION, SOLUTION / INTRAMUSCULAR		525 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	EMULSION / TOPICAL	0.11 %w/w		Exact identifier — unii candidate 88 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION/ DROPS / TOPICAL	0.75 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / ORAL		27120 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
CINNAMALDEHYDE	CINNAMALDEHYDE	SR60A3XG0F	TABLET, CHEWABLE / ORAL		34 mg	Exact identifier — unii candidate 2 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	SOLUTION / TOPICAL	2 %w/w		Exact identifier — unii candidate 50 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS	63.4 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / INTRACARDIAC	1.05 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	TABLET / BUCCAL	0.11 mg		Exact identifier — unii candidate 22 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	CREAM / TOPICAL		190 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	FILM, SOLUBLE / BUCCAL		11 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, COATED / ORAL	42.4 mg		Exact identifier — unii candidate 26 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	CAPSULE, EXTENDED RELEASE / ORAL	0.26 mg		Exact identifier — unii candidate 22 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	OINTMENT / TOPICAL	15 %w/w		Exact identifier — unii candidate 26 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, EXTENDED RELEASE / ORAL		200 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET / ORAL		64 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	SUSPENSION / AURICULAR (OTIC)	0.9 %w/v		Exact identifier — unii candidate 50 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SUSPENSION/ DROPS / ORAL		19 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION/ DROPS / OPHTHALMIC	0.75 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 9 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION, EMULSION / SUBCUTANEOUS		225 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 22 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
61de5d4d-47d0-45bb-9129-608221978b92			0951e5e0-2015-4687-bcee-605621fb5186	2012-09-06	Warnings	Exact identifier spl id: 61de5d4d-47d0-45bb-9129-608221978b92 spl set id: 0951e5e0-2015-4687-bcee-605621fb5186

Reported adverse events (FAERS/openFDA)#

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