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ZO Skin Health Skin Normalizing System with Rozatrol Booster Serum

Dosage form: kit
Ingredients: ; Salicylic Acid 20mg in 1mL
Labeler: ZO Skin Health, Inc.
NDC Code: 42851-186

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.

ZO® Skin Health Skin Normalizing System with Rozatrol® Booster Serum

Drug Facts

Active Ingredient

Salicylic Acid 2.0%

Purpose

Acne Treatment

Uses
  • For the management of acne.
  • Penetrates pores to control acne blemishes.

Warnings

Flammable. Keep away from heat and open flame.

For external use only.

When using this product
  • Skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.

Stop use and ask a doctor if
  • If skin irritation occurs or gets worse.

Keep out of reach of children.

  • If swallowed, get medical help or contact a Poison Control Center right away.

Directions
  • Clean the skin thoroughly before applying this product.
  • Cover the entire affected area with a thin layer one to three times daily.
  • Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor.
  • If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Other Information
  • Read the directions and warnings before use.
  • Store at 15–30°C (59–89°F), away from direct sunlight.

Inactive Ingredients

Alcohol, Artemisia Vulgaris Extract, Butylene Glycol, Camellia Sinensis Leaf Extract, Crithmum Maritimum Extract, Fragrance, Glycolic Acid, Hamamelis Virginiana (Witch Hazel) Extract, Hordeum Vulgare Seed Extract, Mandelic Acid, Menthyl Lactate, Phenoxyethanol, Phellodendron Amureuse Extract, Plantago Lanceolata Leaf Extract, Pterocarpus Soyauxii Wood Extract, Rosa Canina Fruit Extract, Sodium Hydroxide, Spiraea Ulmaria Extract, Urea, Water.

Dist. by ZO Skin Health, Inc.
5 Technology Dr. Irvine, CA 92618 | 910700

PRINCIPAL DISPLAY PANEL - Kit Carton

ZO® SKIN HEALTH
BY ZEIN OBAGI MD

SKIN NORMALIZING SYSTEM
WITH ROZATROL® BOOSTER SERUM

NDC 42851-186-60

DELIVERED BY

hydrafacial©

Established Pharmacological Class
SubstancePharmacological Class
ZO Skin Health HydraFacial Rozatrol Booster SerumLOTIONS, OILS, POWDERS, AND CREAMS
ZO Skin Health Gentle CleanserCLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, AND PADS)
ZO Skin Health Exfoliating PolishLOTIONS, OILS, POWDERS, AND CREAMS
ZO Skin Health Daily Power DefenseLOTIONS, OILS, POWDERS, AND CREAMS
ZO Skin Health Rozatrol Treatment for red, sensitized skinLOTIONS, OILS, POWDERS, AND CREAMS
ZO SKIN HEALTH SKIN NORMALIZING SYSTEM WITH ROZATROL BOOSTER SERUM 
salicylic acid kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42851-186
Packaging
#Item CodePackage Description
1NDC:42851-186-601 KIT in 1 CARTON
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 VIAL, GLASS 9 mL
Part 21 TUBE 60 mL
Part 31 JAR 16.2 g
Part 460 PATCH 48 mL
Part 51 BOTTLE 30 mL
Part 61 TUBE 20 mL
Part 1 of 6
ZO SKIN HEALTH HYDRAFACIAL ROZATROL BOOSTER SERUM 
lotion
Product Information
Route of AdministrationTOPICALDEA Schedule    
Ingredients
Ingredient NameQuantity
Water 
Glycerin 
Butylene Glycol 
Pentylene Glycol 
Lactose 
Propanediol 
Rosa Canina Fruit 
Casein 
Papain 
Tocopherol 
Caprylyl Glycol 
Betasizofiran 
Xanthan Gum 
Lecithin, Soybean 
Carboxypolymethylene 
Sodium Alginate 
Palmitoyl Glycine 
PEG-12 Glyceryl Laurate 
Polyoxyl 35 Castor Oil 
Panthenol Triacetate, (+)- 
1,2-Hexanediol 
Lactic Acid, Unspecified Form 
Caprylhydroxamic Acid 
Sodium Citrate, Unspecified Form 
Farnesol 
Farnesyl Acetate 
Packaging
#Item CodePackage Description
19 mL in 1 VIAL, GLASS
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
COSMETIC05/01/2018
Part 2 of 6
ZO SKIN HEALTH GENTLE CLEANSER 
lotion
Product Information
Route of AdministrationTOPICALDEA Schedule    
Ingredients
Ingredient NameQuantity
Water 
SODIUM LAURETH-3 SULFATE 
Cocamidopropyl Betaine 
Sodium Lauroyl Oat Amino Acids 
Glycerin 
PTEROCARPUS SOYAUXII WOOD 
PHELLODENDRON AMURENSE BARK 
BARLEY 
GREEN TEA LEAF 
PLANTAGO LANCEOLATA LEAF 
CRITHMUM MARITIMUM 
LIMONENE, (+)- 
LINALOOL, (+/-)- 
Sodium Chloride 
Butylene Glycol 
Ethylhexylglycerin 
Phenoxyethanol 
FD&C BLUE NO. 1 
D&C RED NO. 33 
Packaging
#Item CodePackage Description
160 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
COSMETIC05/01/2018
Part 3 of 6
ZO SKIN HEALTH EXFOLIATING POLISH 
cream
Product Information
Route of AdministrationTOPICALDEA Schedule    
Ingredients
Ingredient NameQuantity
POLYETHYLENE GLYCOL 400 
Sodium Bicarbonate 
Magnesium Oxide 
DIETHYLENE GLYCOL MONOETHYL ETHER 
Glycerin 
Butylene Glycol 
Oleth-20 
Trihydroxystearin 
GLYCERYL MONOSTEARATE 
PEG-100 Stearate 
MINERAL OIL 
Water 
.ALPHA.-TOCOPHEROL ACETATE 
TEA TREE OIL 
SOY STEROL 
LIMONENE, (+)- 
LINALOOL, (+/-)- 
Ascorbyl Palmitate 
VITAMIN A PALMITATE 
Stearyl Glycyrrhetinate 
Tetrahexyldecyl Ascorbate 
MEDIUM-CHAIN TRIGLYCERIDES 
Linoleic Acid 
LECITHIN, SOYBEAN 
Phenoxyethanol 
D&C GREEN NO. 6 
Packaging
#Item CodePackage Description
116.2 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
COSMETIC05/01/2018
Part 4 of 6
ZO SKIN HEALTH OIL CONTROL PADS, ACNE TREATMENT 
salicylic acid patch
Product Information
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Salicylic Acid (Salicylic Acid) Salicylic Acid20 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Alcohol 
Butylene Glycol 
GREEN TEA LEAF 
CRITHMUM MARITIMUM 
Glycolic Acid 
HAMAMELIS VIRGINIANA TOP 
BARLEY 
Mandelic Acid 
MENTHYL LACTATE, (-)- 
Phenoxyethanol 
PLANTAGO LANCEOLATA LEAF 
PTEROCARPUS SOYAUXII WOOD 
ROSA CANINA FRUIT 
Sodium Hydroxide 
Urea 
Water 
Packaging
#Item CodePackage Description
160 PATCH in 1 JAR
10.8 mL in 1 PATCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333D05/01/2018
Part 5 of 6
ZO SKIN HEALTH DAILY POWER DEFENSE 
lotion
Product Information
Route of AdministrationTOPICALDEA Schedule    
Ingredients
Ingredient NameQuantity
Water 
Cetearyl Isononanoate 
CYCLOMETHICONE 5 
Glycerin 
CYCLOMETHICONE 6 
Pentylene Glycol 
CETOSTEARYL ALCOHOL 
Steareth-20 
C14-22 Alcohols 
Cetearyl Glucoside 
Safflower Oil 
C12-20 Alkyl Glucoside 
CARBOXYPOLYMETHYLENE 
LACTOSE, UNSPECIFIED FORM 
POWDERED CELLULOSE 
LECITHIN, SOYBEAN 
Retinol 
1,2-Hexanediol 
HYPROMELLOSE, UNSPECIFIED 
ARABIDOPSIS THALIANA 
ORANGE OIL 
MANDARIN OIL 
LEMON OIL 
PEPPERMINT OIL 
MIMOSA TENUIFLORA BARK 
TANGERINE 
Polysorbate 20 
Farnesol 
LIMONENE, (+)- 
EDETATE DISODIUM ANHYDROUS 
Sodium Hydroxide 
Palmitoyl Tripeptide-1 
Palmitoyl Tetrapeptide-7 
VITAMIN A PALMITATE 
.ALPHA.-TOCOPHEROL ACETATE 
Caprylyl Glycol 
Butylene Glycol 
Hexylene Glycol 
Ethylhexylglycerin 
Phenoxyethanol 
ULTRAMARINE BLUE 
EXT. D&C VIOLET NO. 2 
Packaging
#Item CodePackage Description
130 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
COSMETIC05/01/2018
Part 6 of 6
ZO SKIN HEALTH ROZATROL TREATMENT FOR RED, SENSITIZED SKIN 
lotion
Product Information
Route of AdministrationTOPICALDEA Schedule    
Ingredients
Ingredient NameQuantity
Water 
Glycerin 
Cetyl Alcohol 
SUNFLOWER OIL 
ALKYL (C12-15) BENZOATE 
Palmitoyl Glycine 
Neopentyl Glycol Diethylhexanoate 
Dimethicone 
Panthenol 
GLYCERYL MONOSTEARATE 
PEG-100 Stearate 
Potassium Cetyl Phosphate 
LACTOSE, UNSPECIFIED FORM 
CASEIN 
Neopentyl Glycol Diisostearate 
Papain 
Magnesium Aluminum Silicate 
PEG-12 Glyceryl Laurate 
POLYOXYL 35 CASTOR OIL 
PANTHENOL TRIACETATE, (+)- 
Farnesol 
Farnesyl Acetate 
AMINOMETHYLPROPANOL 
Caprylyl Glycol 
EDETATE DISODIUM ANHYDROUS 
1,2-Hexanediol 
CARBOXYPOLYMETHYLENE 
LECITHIN, SOYBEAN 
SODIUM ALGINATE 
Xanthan Gum 
Benzalkonium Chloride 
Chlorphenesin 
Phenoxyethanol 
Packaging
#Item CodePackage Description
120 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
COSMETIC05/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333D05/01/2018
Labeler - ZO Skin Health, Inc. (826468527)
Establishment
NameAddressID/FEIOperations
COSMETIC TECHNOLOGIES830157012MANUFACTURE(42851-186)
Establishment
NameAddressID/FEIOperations
Lifetech Resources, LLC622559110MANUFACTURE(42851-186)
Establishment
NameAddressID/FEIOperations
PakLab790530976MANUFACTURE(42851-186)
Establishment
NameAddressID/FEIOperations
Thibiant International, Inc.083913913MANUFACTURE(42851-186)

 
ZO Skin Health, Inc.

Medically reviewed on Apr 27, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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