ESIKA

Manufacturer: Ventura Corporation (San Juan, P.R) | Bel Star S.A. (Colombia)
Effective date: 2011-09-20
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: legacy-cache
Hydrated at: 2026-08-02 01:50:41

Label at a glance#

ProductESIKA Ultra Softening SPF 15

Active ingredientOctinoxate, Oxybenzone

Label structure17 sections

Dosage and administration

Apply evenly before sun exposure and as needed. Apply lipstick following the curves of natural lip line.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 6.5%, Oxybenzone 1.82%

Use

INDICATIONS & USAGE SECTION

Helps prevent sunburn.

Warnings

WARNINGS SECTION

For external use only.

OTC - STOP USE SECTION

Stop use if skin rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply evenly before sun exposure and as needed. Apply lipstick following the curves of natural lip line.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Ricinus communis seed oil (ricinus communis (castor) seed oil), ethylhexyl palmitate, caprylic/capric triglyceride, polyethylene, candelilla cera (euphorbia cerifera (candelilla) wax), butyrospermum parkii (butyrospermum parkii (shea butter)), cera alba (beeswax), silica dimethyl silylate, glycerin, octyldodecanol, parfum (fragrance), glyceryl isostearate, isostearyl alcohol, sodium saccharin, propylparaben, cera microcristallina (microcrystalline wax), beta-sitosterol, petrolatum, bht, phospholipids, cholesterol, cetearyl alcohol, cetearyl glucoside, copernicia cerifera cera (copernicia cerifera (carnauba ) wax), polyglyceryl-2 dipolyhydroxystearate, glycosphingolipids, CI 77742 (manganese violet), CI 77491 (iron oxides), CI 77499 (iron oxides), CI 77492 (iron oxides), CI 77891 (titanium dioxide ), CI 45410 (red 27 lake), CI 15850 (red 7 lake), CI 45380 (red 21 lake), CI 19140 (yellow 5 lake), CI 77019 (mica), CI 73360 (red 30 lake), talc, CI 42090 (blue 1 lake), CI 75470 (carmine)

PRINCIPAL DISPLAY PANEL - 4 g Carton - ROJO PROVOCACION

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ēsika

Ultra-Softening
Lipstick SPF 15

4 g e (.14 oz.)

Principal Display Panel - 4 g Carton - ROJO PROVOCACION

4 g e (.14 oz.)

Principal Display Panel - 4 g Carton - MARRON TENTACION

PRINCIPAL DISPLAY PANEL - 4 g Carton - ROSADO MAGICO

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ēsika

Ultra-Softening
Lipstick SPF 15

4 g e (.14 oz.)

Principal Display Panel - 4 g Carton - ROSADO MAGICO

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
13537-049-02	2025-03-31	C162847	48780-1	960f7f55-bf57-8e05-e053-dbdaa90a074a	Esika Ultra-Softening Lipstick FPS 15
13537-050-02	2025-03-31	C162847	48780-1	960f7f55-bf57-8e05-e053-dbdaa90a074a	Esika Ultra-Softening Lipstick FPS 15
13537-051-02	2025-03-31	C162847	48780-1	960f7f55-bf57-8e05-e053-dbdaa90a074a	Esika Ultra-Softening Lipstick FPS 15
13537-052-02	2025-03-31	C162847	48780-1	960f7f55-bf57-8e05-e053-dbdaa90a074a	Esika Ultra-Softening Lipstick FPS 15
13537-053-02	2025-03-31	C162847	48780-1	960f7f55-bf57-8e05-e053-dbdaa90a074a	Esika Ultra-Softening Lipstick FPS 15
13537-054-02	2025-03-31	C162847	48780-1	960f7f55-bf57-8e05-e053-dbdaa90a074a	Esika Ultra-Softening Lipstick FPS 15
13537-055-02	2025-03-31	C162847	48780-1	960f7f55-bf57-8e05-e053-dbdaa90a074a	Esika Ultra-Softening Lipstick FPS 15
13537-056-02	2025-03-31	C162847	48780-1	960f7f55-bf57-8e05-e053-dbdaa90a074a	Esika Ultra-Softening Lipstick FPS 15
13537-057-02	2025-03-31	C162847	48780-1	960f7f55-bf57-8e05-e053-dbdaa90a074a	Esika Ultra-Softening Lipstick FPS 15
13537-058-02	2025-03-31	C162847	48780-1	960f7f55-bf57-8e05-e053-dbdaa90a074a	Esika Ultra-Softening Lipstick FPS 15
13537-059-02	2025-03-31	C162847	48780-1	960f7f55-bf57-8e05-e053-dbdaa90a074a	Esika Ultra-Softening Lipstick FPS 15
13537-060-02	2025-03-31	C162847	48780-1	960f7f55-bf57-8e05-e053-dbdaa90a074a	Esika Ultra-Softening Lipstick FPS 15
13537-049-02	2019-10-29	C162847	48780-1	960f7f55-bf57-8e05-e053-dbdaa90a074a	Esika Ultra-Softening Lipstick FPS 15
13537-050-02	2019-10-29	C162847	48780-1	960f7f55-bf57-8e05-e053-dbdaa90a074a	Esika Ultra-Softening Lipstick FPS 15
13537-051-02	2019-10-29	C162847	48780-1	960f7f55-bf57-8e05-e053-dbdaa90a074a	Esika Ultra-Softening Lipstick FPS 15
13537-052-02	2019-10-29	C162847	48780-1	960f7f55-bf57-8e05-e053-dbdaa90a074a	Esika Ultra-Softening Lipstick FPS 15
13537-053-02	2019-10-29	C162847	48780-1	960f7f55-bf57-8e05-e053-dbdaa90a074a	Esika Ultra-Softening Lipstick FPS 15
13537-054-02	2019-10-29	C162847	48780-1	960f7f55-bf57-8e05-e053-dbdaa90a074a	Esika Ultra-Softening Lipstick FPS 15
13537-055-02	2019-10-29	C162847	48780-1	960f7f55-bf57-8e05-e053-dbdaa90a074a	Esika Ultra-Softening Lipstick FPS 15
13537-056-02	2019-10-29	C162847	48780-1	960f7f55-bf57-8e05-e053-dbdaa90a074a	Esika Ultra-Softening Lipstick FPS 15
13537-057-02	2019-10-29	C162847	48780-1	960f7f55-bf57-8e05-e053-dbdaa90a074a	Esika Ultra-Softening Lipstick FPS 15
13537-058-02	2019-10-29	C162847	48780-1	960f7f55-bf57-8e05-e053-dbdaa90a074a	Esika Ultra-Softening Lipstick FPS 15
13537-059-02	2019-10-29	C162847	48780-1	960f7f55-bf57-8e05-e053-dbdaa90a074a	Esika Ultra-Softening Lipstick FPS 15
13537-060-02	2019-10-29	C162847	48780-1	960f7f55-bf57-8e05-e053-dbdaa90a074a	Esika Ultra-Softening Lipstick FPS 15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Octinoxate	ACTIVE INGREDIENT	4Y5P7MUD51	1
Oxybenzone	ACTIVE INGREDIENT	95OOS7VE0Y	1
Octinoxate	ACTIVE MOIETY	4Y5P7MUD51	1
Oxybenzone	ACTIVE MOIETY	95OOS7VE0Y	1
.beta.-sitosterol	INACTIVE INGREDIENT	S347WMO6M4	1
aluminum oxide	INACTIVE INGREDIENT	LMI26O6933	1
butylated hydroxytoluene	INACTIVE INGREDIENT	1P9D0Z171K	1
candelilla wax	INACTIVE INGREDIENT	WL0328HX19	1
carnauba wax	INACTIVE INGREDIENT	R12CBM0EIZ	1
castor oil	INACTIVE INGREDIENT	D5340Y2I9G	1
cetearyl glucoside	INACTIVE INGREDIENT	09FUA47KNA	1
cetostearyl alcohol	INACTIVE INGREDIENT	2DMT128M1S	1
cholesterol	INACTIVE INGREDIENT	97C5T2UQ7J	1
cochineal	INACTIVE INGREDIENT	TZ8Z31B35M	1
D&C red no. 21	INACTIVE INGREDIENT	08744Z6JNY	1
D&C red no. 27	INACTIVE INGREDIENT	2LRS185U6K	1
D&C red no. 30	INACTIVE INGREDIENT	2S42T2808B	1
D&C red no. 7	INACTIVE INGREDIENT	ECW0LZ41X8	1
ethylhexyl palmitate	INACTIVE INGREDIENT	2865993309	1
FD&C blue no. 1	INACTIVE INGREDIENT	H3R47K3TBD	1
FD&C yellow no. 5	INACTIVE INGREDIENT	I753WB2F1M	1
ferric oxide red	INACTIVE INGREDIENT	1K09F3G675	1
ferric oxide yellow	INACTIVE INGREDIENT	EX438O2MRT	1
ferrosoferric oxide	INACTIVE INGREDIENT	XM0M87F357	1
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	1
glyceryl isostearate	INACTIVE INGREDIENT	HYE7O27HAO	1
high density polyethylene	INACTIVE INGREDIENT	UG00KM4WR7	1
isostearyl alcohol	INACTIVE INGREDIENT	Q613OCQ44Y	1
medium-chain triglycerides	INACTIVE INGREDIENT	C9H2L21V7U	1
mica	INACTIVE INGREDIENT	V8A1AW0880	1
microcrystalline wax	INACTIVE INGREDIENT	XOF597Q3KY	1
octyldodecanol	INACTIVE INGREDIENT	461N1O614Y	1
petrolatum	INACTIVE INGREDIENT	4T6H12BN9U	1
propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	1
saccharin sodium	INACTIVE INGREDIENT	SB8ZUX40TY	1
shea butter	INACTIVE INGREDIENT	K49155WL9Y	1
talc	INACTIVE INGREDIENT	7SEV7J4R1U	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	1
yellow wax	INACTIVE INGREDIENT	2ZA36H0S2V	1

Products#

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

DailyMed product names page 1 of 1 · 39 matching rows.

ESIKA Ultra Softening SPF 15
Octinoxate and Oxybenzone
Octinoxate
Oxybenzone
castor oil
ethylhexyl palmitate
medium-chain triglycerides
high density polyethylene
candelilla wax
shea butter
yellow wax
glycerin
octyldodecanol
glyceryl isostearate
isostearyl alcohol
saccharin sodium
propylparaben
microcrystalline wax
.beta.-sitosterol
petrolatum
butylated hydroxytoluene
cholesterol
cetostearyl alcohol
cetearyl glucoside
carnauba wax
ferric oxide red
ferrosoferric oxide
ferric oxide yellow
titanium dioxide
D&C red no. 27
D&C red no. 7
D&C red no. 21
FD&C yellow no. 5
D&C red no. 30
FD&C blue no. 1
mica
talc
cochineal
aluminum oxide

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
13537-049	13537-049-01, 13537-049-02
13537-050	13537-050-01, 13537-050-02
13537-051	13537-051-01, 13537-051-02
13537-052	13537-052-01, 13537-052-02
13537-053	13537-053-01, 13537-053-02
13537-054	13537-054-01, 13537-054-02
13537-055	13537-055-01, 13537-055-02
13537-056	13537-056-01, 13537-056-02
13537-057	13537-057-01, 13537-057-02
13537-058	13537-058-01, 13537-058-02
13537-059	13537-059-01, 13537-059-02
13537-060	13537-060-01, 13537-060-02

Ingredients#

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

DailyMed ingredient rows page 1 of 12 · 443 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Octinoxate	4Y5P7MUD51	ACTIB
Oxybenzone	95OOS7VE0Y	ACTIB
castor oil	D5340Y2I9G	IACT
ethylhexyl palmitate	2865993309	IACT
medium-chain triglycerides	C9H2L21V7U	IACT
high density polyethylene	UG00KM4WR7	IACT
candelilla wax	WL0328HX19	IACT
shea butter	K49155WL9Y	IACT
yellow wax	2ZA36H0S2V	IACT
glycerin	PDC6A3C0OX	IACT
octyldodecanol	461N1O614Y	IACT
glyceryl isostearate	HYE7O27HAO	IACT
isostearyl alcohol	Q613OCQ44Y	IACT
saccharin sodium	SB8ZUX40TY	IACT
propylparaben	Z8IX2SC1OH	IACT
microcrystalline wax	XOF597Q3KY	IACT
.beta.-sitosterol	S347WMO6M4	IACT
petrolatum	4T6H12BN9U	IACT
butylated hydroxytoluene	1P9D0Z171K	IACT
cholesterol	97C5T2UQ7J	IACT
cetostearyl alcohol	2DMT128M1S	IACT
cetearyl glucoside	09FUA47KNA	IACT
carnauba wax	R12CBM0EIZ	IACT
ferric oxide red	1K09F3G675	IACT
ferrosoferric oxide	XM0M87F357	IACT
ferric oxide yellow	EX438O2MRT	IACT
titanium dioxide	15FIX9V2JP	IACT
D&C red no. 27	2LRS185U6K	IACT
D&C red no. 7	ECW0LZ41X8	IACT
D&C red no. 21	08744Z6JNY	IACT
FD&C yellow no. 5	I753WB2F1M	IACT
D&C red no. 30	2S42T2808B	IACT
FD&C blue no. 1	H3R47K3TBD	IACT
mica	V8A1AW0880	IACT
talc	7SEV7J4R1U	IACT
cochineal	TZ8Z31B35M	IACT
Octinoxate	4Y5P7MUD51	ACTIB
Oxybenzone	95OOS7VE0Y	ACTIB
castor oil	D5340Y2I9G	IACT
ethylhexyl palmitate	2865993309	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 10 · 546 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	FILM, SOLUBLE / BUCCAL		1 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
ferric oxide yellow	FERRIC OXIDE YELLOW	EX438O2MRT	TABLET, FILM COATED / ORAL		6 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION, EXTENDED RELEASE / ORAL		4 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
high density polyethylene	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	PASTE / DENTAL		60 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	CAPSULE, LIQUID FILLED / ORAL		185 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
saccharin sodium	SACCHARIN SODIUM	SB8ZUX40TY	TABLET, ORALLY DISINTEGRATING / ORAL		10 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	FILM / BUCCAL	0.22 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
high density polyethylene	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	TABLET, COATED / ORAL	25 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	POWDER, FOR SUSPENSION / ORAL		297 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
FD&C yellow no. 5	FD&C YELLOW NO. 5	I753WB2F1M	SYRUP / ORAL	0.1 mg		Exact identifier — unii candidate 22 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
glycerin	GLYCERIN	PDC6A3C0OX	DOUCHE / VAGINAL	1 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE / ORAL		72 mg	Exact identifier — unii candidate 40 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
high density polyethylene	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	OINTMENT / OPHTHALMIC	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	SUSPENSION, EXTENDED RELEASE / ORAL		2000 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
talc	TALC	7SEV7J4R1U	DROPS / ORAL	NA		Exact identifier — unii candidate 35 equally ranked IID candidates
FD&C blue no. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET, EXTENDED RELEASE / ORAL		4 mg	Exact identifier — unii candidate 37 equally ranked IID candidates
petrolatum	PETROLATUM	4T6H12BN9U	TABLET, EXTENDED RELEASE / ORAL	0.18 mg		Exact identifier — unii candidate 18 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
glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION / OPHTHALMIC	6 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	TABLET, EXTENDED RELEASE / ORAL	0.12 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	0.4 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
ferric oxide yellow	FERRIC OXIDE YELLOW	EX438O2MRT	TABLET, COATED / ORAL		1 mg	Exact identifier — unii candidate 20 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
saccharin sodium	SACCHARIN SODIUM	SB8ZUX40TY	PASTE, DENTIFRICE / DENTAL	0.2 %w/w		Exact identifier — unii candidate 34 equally ranked IID candidates
saccharin sodium	SACCHARIN SODIUM	SB8ZUX40TY	WAFER / ORAL	8 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
carnauba wax	CARNAUBA WAX	R12CBM0EIZ	TABLET, FILM COATED / ORAL		1 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
butylated hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SOLUTION, CONCENTRATE / ORAL	0.1 mg/1ml		Exact identifier — unii candidate 32 equally ranked IID candidates
butylated hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SUPPOSITORY / RECTAL		1 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
butylated hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SPRAY / TOPICAL		3 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
cetostearyl alcohol	CETOSTEARYL ALCOHOL	2DMT128M1S	OINTMENT / TOPICAL	1.2 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		11 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	GRANULE, FOR SUSPENSION / ORAL		143 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
medium-chain triglycerides	MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	POWDER / SUBLINGUAL		2 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
octyldodecanol	OCTYLDODECANOL	461N1O614Y	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 9 equally ranked IID candidates
petrolatum	PETROLATUM	4T6H12BN9U	SUPPOSITORY / VAGINAL	27 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
saccharin sodium	SACCHARIN SODIUM	SB8ZUX40TY	SOLUTION / ORAL		665 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / ORAL	100 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	FILM, SOLUBLE / ORAL		2 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
butylated hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	FILM, SOLUBLE / ORAL	0.06 mg		Exact identifier — unii candidate 32 equally ranked IID candidates
petrolatum	PETROLATUM	4T6H12BN9U	TABLET / ORAL	3.5 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
D&C red no. 7	D&C RED NO. 7	ECW0LZ41X8	TABLET / SUBLINGUAL	0.01 mg		Exact identifier — unii candidate 7 equally ranked IID candidates
D&C red no. 7	D&C RED NO. 7	ECW0LZ41X8	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL	0.4 mg		Exact identifier — unii candidate 7 equally ranked IID candidates
carnauba wax	CARNAUBA WAX	R12CBM0EIZ	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 11 equally ranked IID candidates
shea butter	SHEA BUTTER	K49155WL9Y	LOTION / TOPICAL		2340 mg	Exact identifier — unii candidate
yellow wax	YELLOW WAX	2ZA36H0S2V	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 9 equally ranked IID candidates
petrolatum	PETROLATUM	4T6H12BN9U	SPONGE / TOPICAL	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
FD&C blue no. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE, EXTENDED RELEASE / ORAL		1 mg	Exact identifier — unii candidate 37 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	TABLET, FILM COATED / ORAL	1.55 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	INJECTION / INTRADERMAL	1.6 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / INTRAMUSCULAR	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
carnauba wax	CARNAUBA WAX	R12CBM0EIZ	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 11 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	TABLET, COATED / ORAL	1 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
talc	TALC	7SEV7J4R1U	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 35 equally ranked IID candidates
ferrosoferric oxide	FERROSOFERRIC OXIDE	XM0M87F357	CAPSULE, EXTENDED RELEASE / ORAL	1.49 mg		Exact identifier — unii candidate 10 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	POWDER / RESPIRATORY (INHALATION)	2 mg		Exact identifier — unii candidate 40 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SYSTEM / TOPICAL		21 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
petrolatum	PETROLATUM	4T6H12BN9U	OINTMENT / OPHTHALMIC	88.4 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	DROPS / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 68 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
ae986dde-2ea0-43d8-b660-a695436ec75c			504660ed-a805-4443-954e-c567d13b9ca3	2011-09-20	Warnings	Exact identifier spl id: ae986dde-2ea0-43d8-b660-a695436ec75c spl set id: 504660ed-a805-4443-954e-c567d13b9ca3

Reported adverse events (FAERS/openFDA)#

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