Nioxin Scalp Treatment System 4 SPF 15 Sunscreen - Fine Hair - Chemically Treated

Dosage form: liquid
Ingredients: Ensulizole 41.2mg in 1mL, Sulisobenzone 16.48mg in 1mL
Labeler: Procter & Gamble Manufacturing Company
NDC Code: 37000-736

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

NIOXIN®
FOR FINE HAIR

NIOXIN Scalp Activating Treatment™ System 4

Activates the scalp and hair by breaking down the sebum containing environmental residues and DHT; and delivers vitamins and nutrients to the scalp and hair. SPF 15 protects the scalp skin from harmful UVA/UVB rays.

WARNING

FOR EXTERNAL USE ONLY.

WHEN USING THIS PRODUCT KEEP OUT OF EYES. RINSE WITH WATER TO REMOVE.

STOP USE AND ASK DOCTOR IF RASH OR IRRITATION DEVELOPS AND LASTS. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER.

KEEP OUT OF THE REACH OF CHILDREN.

ACTIVE INGREDIENTS

PHENYLBENZIMIDAZOLE SULFONIC ACID (ENSULIZOLE) 4% SULISOBENZONE 1.6%

INACTIVE INGREDIENTS

AQUA/EAU/WATER, COCAMIDOPROPYL BETAINE, PEG-12 DIMETHICONE, ISOPROPYL C12-15-PARETH-9 CARBOXYLATE, GLYCOPROTEINS, PEG-23M, CAMELLIA OLEIFERA, CENTELLA ASIATICA, CUCUBITA PEPO, DIOSCOREA VILLOSA, FOENICULUM VULGARE, MENTHA PIPERITA, PRUNUS AFRICANA, ROSMARINUS OFFICINALIS, VISNAGA VERA, VITIS VINIFERA, LACTOBACILLUS/ERIODICTYON CALIFORNICUM FERMENT EXTRACT, LACTOBACILLUS/OLIVE LEAF FERMENT EXTRACT, LACTOBACILLUS/WASABIA JAPONICA ROOT FERMENT EXTRACT, GLYCYRRHETINIC ACID, PHOSPHOLIPIDS, POLYSORBATE-20, POLYSORBATE-60, POLYSORBATE-80, QUATERNIUM-51, HYDROLYZED ALGIN, HYDROLYZED KERATIN, PANTHENOL, CYSTINE BIS-PG-PROPYL SILANETRIOL, ACETAMIDE MEA, PHENOXYETHANOL, ETHOXYDIGLYCOL, HEXYLENE GLYCOL, HEXAPEPTIDE-11, SACCHAROMYCES LYSATE EXTRACT, SACCHAROMYCES FERMENT LYSATE FILTRATE, BETAINE, DIMETHYL ISOSORBIDE, PPG-26-BUTETH-26, PEG-40 HYDROGENATED CASTOR OIL, TRIS-OLEOYLTROMETHAMINE ETHANE SULFATE, COENZYME A, PANTOTHENIC ACID, PYRIDOXINE, CYANOCOBALAMIN, BIOTIN, FOLIC ACID, NIACIN, THIAMINE HCl, UBIQUINONE, CARNITINE, BIOFLAVONOIDS, CAFFEINE, ALGAE EXTRACT, PEG-18/18 DIMETHICONE, TEA-SALICYLATE, SACCHAROMYCES/COPPER FERMENT, SACCHAROMYCES/IRON FERMENT, SACCHAROMYCES/MAGNESIUM FERMENT, SACCHAROMYCES/SILICON FERMENT, SACCHAROMYCES/ZINC FERMENT, SODIUM HYDROXIDE, SUPEROXIDE DISMUTASE, DIMETHICONE PROPYL PG-BETAINE, METHYL NICOTINATE, MELANIN, TETRASODIUM EDTA, CAPRYLYL GLYCOL, CHLORPHENESIN.

PRINCIPAL DISPLAY PANEL - Kit Carton

NIOXIN®
FOR FINE HAIR

4

CHEMICALLY ENHANCED HAIR | NOTICEABLY THINNING

9 OUT OF 10 PEOPLE
NOTICED AN
INCREASE IN HAIR DENSITY
*

BONUS VALUE:
Twice as much
CLEANSER FREE

SPF
15

SUNBLOCK

8.5 fl oz (250ml)   3.4 fl oz (100ml)   4.2 fl oz (125ml)

NIOXIN SCALP TREATMENT SYSTEM 4   SPF 15 SUNSCREEN - FINE HAIR - CHEMICALLY TREATED
ensulizole and sulisobenzone liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37000-736
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Ensulizole (Ensulizole) Ensulizole41.2 mg  in 1 mL
Sulisobenzone (Sulisobenzone) Sulisobenzone16.48 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
COCAMIDOPROPYL BETAINE 
PEG-12 DIMETHICONE (300 CST) 
POLYETHYLENE GLYCOL 1000000 
CENTELLA ASIATICA 
DIOSCOREA VILLOSA TUBER 
FENNEL SEED 
MENTHA PIPERITA 
ROSMARINUS OFFICINALIS FLOWERING TOP 
AMMI VISNAGA FRUIT 
WINE GRAPE 
ERIODICTYON CALIFORNICUM LEAF 
OLEA EUROPAEA LEAF 
WASABI ROOT 
ENOXOLONE 
POLYSORBATE 20 
POLYSORBATE 60 
POLYSORBATE 80 
PANTHENOL 
ACETIC MONOETHANOLAMIDE 
PHENOXYETHANOL 
DIETHYLENE GLYCOL MONOETHYL ETHER 
HEXYLENE GLYCOL 
SACCHAROMYCES LYSATE 
BETAINE 
NIACIN 
THIAMINE HYDROCHLORIDE 
CARNITINE 
DIMETHYL ISOSORBIDE 
POLYOXYL 40 HYDROGENATED CASTOR OIL 
COENZYME A 
PANTOTHENIC ACID 
PYRIDOXINE 
CYANOCOBALAMIN 
BIOTIN 
FOLIC ACID 
CAFFEINE 
ALOE 
POLYETHYLENE GLYCOL 900 
SODIUM HYDROXIDE 
METHYL NICOTINATE 
EDETATE SODIUM 
CAPRYLYL GLYCOL 
CHLORPHENESIN 
Packaging
#Item CodePackage Description
1NDC:37000-736-101 BOTTLE, PLASTIC in 1 CARTON
1100 mL in 1 BOTTLE, PLASTIC
2NDC:37000-736-201 BOTTLE, PLASTIC in 1 CARTON
2200 mL in 1 BOTTLE, PLASTIC
3NDC:37000-736-401 BOTTLE, PLASTIC in 1 CARTON
340 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35205/01/201106/29/2014
Labeler - Procter & Gamble Manufacturing Company (004238200)

Revised: 12/2012
 
Procter & Gamble Manufacturing Company

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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