Seborrheic

Manufacturer: Zenith Medicosm SL
Effective date: 2012-01-21
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: full-release
Hydrated at: 2026-05-31 22:30:40

Label at a glance#

ProductSeborrheic Purifying

Active ingredientOCTINOXATE

Label structure5 sections

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 7.5%

Description

DESCRIPTION SECTION

A gel-like cream containing biosulfur, hamamelis (witch hazel) and vitamin B that balances the skin's oil levels and combats the bacteria that cause pore blocking, micro cysts and papules. It regulates the hydro lipid mantle and reduces oiliness. Especially indicated for young and oily and/or acned skins.

200ml. 6.8Fl.Oz.

Warning

WARNINGS SECTION

TOPICAL USE

PROFESSIONAL ONLY

Instructions for use:

INDICATIONS & USAGE SECTION

Use after SEBORMARINE EXTRACT and rub in gently until completely absorbed.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
42248-117-01	2019-11-13	C162847	48780-1	97449f38-bbb2-f6ea-e053-dbdaa90aa703	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
42248-117-01	SeborrheicPurifying	200 mL in 1 TUBE	CREAM	200		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42248-117	SEBORRHEIC PURIFYING (OCTINOXATE) CREAM [ZENITH MEDICOSM SL]	4	Legacy NDC, 1 package rows	20120123_a0850664-f5ca-4ae5-b4d4-19239ed23b5d.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	4
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	4
ALLANTOIN	INACTIVE INGREDIENT	344S277G0Z	4
ALOE	INACTIVE INGREDIENT	V5VD430YW9	4
CARBOMER 934	INACTIVE INGREDIENT	Z135WT9208	4
COLLAGEN, SOLUBLE, FISH SKIN	INACTIVE INGREDIENT	8JC99XGU4W	4
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	4
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	4
HAMAMELIS VIRGINIANA LEAF	INACTIVE INGREDIENT	T07U1161SV	4
LAMINARIA DIGITATA	INACTIVE INGREDIENT	15E7C67EE8	4
LANOLIN	INACTIVE INGREDIENT	7EV65EAW6H	4
LEVOMENOL	INACTIVE INGREDIENT	24WE03BX2T	4
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	4
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	4
PEG-8 STEARATE	INACTIVE INGREDIENT	2P9L47VI5E	4
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	4
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	4
SULFUR	INACTIVE INGREDIENT	70FD1KFU70	4
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	4
THYME	INACTIVE INGREDIENT	CW657OBU4N	4
TRICLOSAN	INACTIVE INGREDIENT	4NM5039Y5X	4
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	4
YEAST	INACTIVE INGREDIENT	3NY3SM6B8U	4

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

Seborrheic Purifying
OCTINOXATE
LANOLIN
PROPYLPARABEN
TALC
THYME
ALOE
HAMAMELIS VIRGINIANA LEAF
WATER
MINERAL OIL
TRICLOSAN
PEG-8 STEARATE
TROLAMINE
LEVOMENOL
SULFUR
YEAST
LAMINARIA DIGITATA
CARBOMER 934
ALLANTOIN
PROPYLENE GLYCOL
METHYLPARABEN
COLLAGEN, SOLUBLE, FISH SKIN
FD&C BLUE NO. 1
FD&C YELLOW NO. 5

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
42248-117	42248-117-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
LANOLIN	7EV65EAW6H	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
TALC	7SEV7J4R1U	IACT
THYME	CW657OBU4N	IACT
ALOE	V5VD430YW9	IACT
HAMAMELIS VIRGINIANA LEAF	T07U1161SV	IACT
WATER	059QF0KO0R	IACT
MINERAL OIL	T5L8T28FGP	IACT
TRICLOSAN	4NM5039Y5X	IACT
PEG-8 STEARATE	2P9L47VI5E	IACT
TROLAMINE	9O3K93S3TK	IACT
LEVOMENOL	24WE03BX2T	IACT
SULFUR	70FD1KFU70	IACT
YEAST	3NY3SM6B8U	IACT
LAMINARIA DIGITATA	15E7C67EE8	IACT
CARBOMER 934	Z135WT9208	IACT
ALLANTOIN	344S277G0Z	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
COLLAGEN, SOLUBLE, FISH SKIN	8JC99XGU4W	IACT
OCTINOXATE	4Y5P7MUD51	ACTIB
FD&C BLUE NO. 1	H3R47K3TBD	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 · 402 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SPRAY / TOPICAL		1379 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE / ORAL	26.3 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	PASTE / DENTAL	0.5 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION / ORAL		64 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	FILM / TRANSDERMAL	11.42 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	PASTE / DENTAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	AEROSOL, FOAM / VAGINAL	6.4 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
CARBOMER 934	CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)	Z135WT9208	LOTION / TOPICAL	0.5 %w/w		Exact identifier — unii candidate 14 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
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	EMULSION / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SPRAY / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	LOTION / TOPICAL		3392 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	DROPS / ORAL	NA		Exact identifier — unii candidate 35 equally ranked IID candidates
CARBOMER 934	CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)	Z135WT9208	GEL / TOPICAL		30 mg	Exact identifier — unii candidate 14 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	SPONGE / TOPICAL	11 %w/w		Exact identifier — unii candidate 22 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE, DELAYED RELEASE / ORAL		2 mg	Exact identifier — unii candidate 37 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / INTRA-ARTICULAR	0.03 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	CREAM / TOPICAL	1 %w/w		Exact identifier — unii candidate 22 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	CREAM / VAGINAL		22 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET / SUBLINGUAL	0.03 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	OINTMENT / TOPICAL		9938 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / INTRAMUSCULAR	0.13 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SUSPENSION / OPHTHALMIC	0.1 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	OINTMENT / TOPICAL		29 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	POWDER, FOR SOLUTION / ORAL	0.04 mg/5ml		Exact identifier — unii candidate 37 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CLOTH / TOPICAL	0.03 mg/mg		Exact identifier — unii candidate 81 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	DROPS / NASAL	NA		Exact identifier — unii candidate 22 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
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, SOLUTION / INTRAVENOUS		5 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	OIL / TOPICAL	43.29 %v/v		Exact identifier — unii candidate 30 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	FILM / BUCCAL	1.48 mg		Exact identifier — unii candidate 81 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
CARBOMER 934	CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)	Z135WT9208	SUSPENSION/ DROPS / OPHTHALMIC	0.4 %w/v		Exact identifier — unii candidate 14 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CREAM / TOPICAL		76000 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SUSPENSION / TOPICAL	82 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	GEL / TOPICAL		4 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE, DELAYED RELEASE PELLETS / ORAL	0.01 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
PEG-8 STEARATE	PEG-8 MONOSTEARATE	2P9L47VI5E	SUSPENSION / ORAL		60 mg	Exact identifier — unii candidate 4 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, EXTENDED RELEASE / ORAL		300 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	AEROSOL, METERED / RECTAL	ADJ PH		Exact identifier — unii candidate 22 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	JELLY / NASAL	140 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE / ORAL		1072 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET / ORAL		64 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION/ DROPS / OPHTHALMIC	0.75 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	LOTION / TOPICAL		351 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	FILM, SOLUBLE / BUCCAL		3 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE, EXTENDED RELEASE / ORAL		8 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	TABLET, COATED / ORAL	0.8 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	CONCENTRATE / ORAL	2.5 mg/5ml		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
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	CREAM, AUGMENTED / TOPICAL		2 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	FILM, EXTENDED RELEASE / TRANSDERMAL	34 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION / SUBCUTANEOUS	1.4 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	SOLUTION / TOPICAL	0.06 %w/w		Exact identifier — unii candidate 22 equally ranked IID candidates
LANOLIN	LANOLIN	7EV65EAW6H	CREAM / TOPICAL		10 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	SOLUTION / TOPICAL	0.01 %w/w		Exact identifier — unii candidate 37 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	CAPSULE, EXTENDED RELEASE / ORAL		120 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	CAPSULE, COATED / ORAL		87 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION/ DROPS / OPHTHALMIC	0.01 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	GEL / VAGINAL		2 mg	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
dcacb642-3435-4ed8-b0c6-c26d68b7588c			a0850664-f5ca-4ae5-b4d4-19239ed23b5d	2012-01-21	Warnings	Exact identifier spl id: dcacb642-3435-4ed8-b0c6-c26d68b7588c spl set id: a0850664-f5ca-4ae5-b4d4-19239ed23b5d

Reported adverse events (FAERS/openFDA)#

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