ZO SKIN HEALTH SKIN NORMALIZING SYSTEM THERAPEUTIC TREATMENT FOR RED, SENSITIZED SKIN- salicylic acid kit

ZO Skin Health Skin Normalizing System Therapeutic Treatment for red, sensitized skin by

Drug Labeling and Warnings

ZO Skin Health Skin Normalizing System Therapeutic Treatment for red, sensitized skin by is a Otc medication manufactured, distributed, or labeled by ZO Skin Health, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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.

SPL UNCLASSIFIED SECTION

Dist. by ZO Skin Health, Inc. Irvine, CA 92618

PRINCIPAL DISPLAY PANEL - Kit Carton

ZO® SKIN HEALTH
BY ZEIN OBAGI MD

SKIN NORMALIZING SYSTEM
Therapeutic treatment for red, sensitized skin

NDC: 42851-111-60

GENTLE CLEANSER 60 mL / 2 Fl. Oz. EXFOLIATING POLISH Net Wt. 16.2 g / 0.57 Oz.
OIL CONTROL PADS 60 Pads DAILY POWER DEFENSE 30 mL / 1 Fl. Oz.
ROZATROL® 20 mL / 0.67 Fl. Oz.

INGREDIENTS AND APPEARANCE

ZO SKIN HEALTH SKIN NORMALIZING SYSTEM THERAPEUTIC TREATMENT FOR RED, SENSITIZED SKIN 
salicylic acid kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42851-111

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42851-111-60	1 in 1 CARTON	05/01/2018

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 TUBE	60 mL
Part 2	1 JAR	16.2 g
Part 3	60 PATCH	48 mL
Part 4	1 BOTTLE	30 mL
Part 5	1 TUBE	20 mL

Part 1 of 5

ZO SKIN HEALTH GENTLE CLEANSER 
cleansing (cold creams, cleansing lotions, liquids, and pads) lotion

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	Water (UNII: 059QF0KO0R)
INGR	SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)
INGR	Cocamidopropyl Betaine (UNII: 5OCF3O11KX)
INGR	Sodium Lauroyl Oat Amino Acids (UNII: FSW2K9B9N5)
INGR	Glycerin (UNII: PDC6A3C0OX)
INGR	PTEROCARPUS SOYAUXII WOOD (UNII: 0V6QB4C61P)
INGR	PHELLODENDRON AMURENSE BARK (UNII: PBG27B754G)
INGR	BARLEY (UNII: 5PWM7YLI7R)
INGR	GREEN TEA LEAF (UNII: W2ZU1RY8B0)
INGR	PLANTAGO LANCEOLATA LEAF (UNII: 2YWL9J7EE8)
INGR	CRITHMUM MARITIMUM (UNII: J7IHY79BKY)
INGR	LIMONENE, (+)- (UNII: GFD7C86Q1W)
INGR	LINALOOL, (+/-)- (UNII: D81QY6I88E)
INGR	Sodium Chloride (UNII: 451W47IQ8X)
INGR	Butylene Glycol (UNII: 3XUS85K0RA)
INGR	Ethylhexylglycerin (UNII: 147D247K3P)
INGR	Phenoxyethanol (UNII: HIE492ZZ3T)
INGR	FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
INGR	D&C RED NO. 33 (UNII: 9DBA0SBB0L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		60 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
COSMETIC		05/01/2018

Part 2 of 5

ZO SKIN HEALTH EXFOLIATING POLISH 
lotions, oils, powders, and creams cream

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
INGR	Sodium Bicarbonate (UNII: 8MDF5V39QO)
INGR	Magnesium Oxide (UNII: 3A3U0GI71G)
INGR	DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
INGR	Glycerin (UNII: PDC6A3C0OX)
INGR	Butylene Glycol (UNII: 3XUS85K0RA)
INGR	Oleth-20 (UNII: YTH167I2AG)
INGR	Trihydroxystearin (UNII: 06YD7896S3)
INGR	GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
INGR	PEG-100 Stearate (UNII: YD01N1999R)
INGR	MINERAL OIL (UNII: T5L8T28FGP)
INGR	Water (UNII: 059QF0KO0R)
INGR	.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
INGR	TEA TREE OIL (UNII: VIF565UC2G)
INGR	SOY STEROL (UNII: PL360EPO9J)
INGR	LIMONENE, (+)- (UNII: GFD7C86Q1W)
INGR	LINALOOL, (+/-)- (UNII: D81QY6I88E)
INGR	Ascorbyl Palmitate (UNII: QN83US2B0N)
INGR	VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
INGR	Stearyl Glycyrrhetinate (UNII: 3YYE6VJS0P)
INGR	Tetrahexyldecyl Ascorbate (UNII: 9LBV3F07AZ)
INGR	MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
INGR	Linoleic Acid (UNII: 9KJL21T0QJ)
INGR	LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
INGR	Phenoxyethanol (UNII: HIE492ZZ3T)
INGR	D&C GREEN NO. 6 (UNII: 4QP5U84YF7)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		16.2 g in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
COSMETIC		05/01/2018

Part 3 of 5

ZO SKIN HEALTH OIL CONTROL PADS, ACNE TREATMENT 
salicylic acid patch

Product Information
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ)	Salicylic Acid	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Alcohol (UNII: 3K9958V90M)
Butylene Glycol (UNII: 3XUS85K0RA)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CRITHMUM MARITIMUM (UNII: J7IHY79BKY)
Glycolic Acid (UNII: 0WT12SX38S)
HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY)
BARLEY (UNII: 5PWM7YLI7R)
Mandelic Acid (UNII: NH496X0UJX)
MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)
Phenoxyethanol (UNII: HIE492ZZ3T)
PLANTAGO LANCEOLATA LEAF (UNII: 2YWL9J7EE8)
PTEROCARPUS SOYAUXII WOOD (UNII: 0V6QB4C61P)
ROSA CANINA FRUIT (UNII: 3TNW8D08V3)
Sodium Hydroxide (UNII: 55X04QC32I)
Urea (UNII: 8W8T17847W)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		60 in 1 JAR
1		0.8 mL in 1 PATCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part333D	05/01/2018

Part 4 of 5

ZO SKIN HEALTH DAILY POWER DEFENSE 
lotions, oils, powders, and creams lotion

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	Water (UNII: 059QF0KO0R)
INGR	Cetearyl Isononanoate (UNII: P5O01U99NI)
INGR	CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
INGR	Glycerin (UNII: PDC6A3C0OX)
INGR	CYCLOMETHICONE 6 (UNII: XHK3U310BA)
INGR	Pentylene Glycol (UNII: 50C1307PZG)
INGR	CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
INGR	Steareth-20 (UNII: L0Q8IK9E08)
INGR	C14-22 Alcohols (UNII: B1K89384RJ)
INGR	Cetearyl Glucoside (UNII: 09FUA47KNA)
INGR	C12-20 Alkyl Glucoside (UNII: K67N5Z1RUA)
INGR	CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
INGR	LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)
INGR	POWDERED CELLULOSE (UNII: SMD1X3XO9M)
INGR	LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
INGR	Retinol (UNII: G2SH0XKK91)
INGR	1,2-Hexanediol (UNII: TR046Y3K1G)
INGR	HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
INGR	ARABIDOPSIS THALIANA (UNII: AI3L60HQ81)
INGR	ORANGE OIL (UNII: AKN3KSD11B)
INGR	MANDARIN OIL (UNII: NJO720F72R)
INGR	LEMON OIL (UNII: I9GRO824LL)
INGR	PEPPERMINT OIL (UNII: AV092KU4JH)
INGR	MIMOSA TENUIFLORA BARK (UNII: 515MQE449I)
INGR	TANGERINE (UNII: KH3E3096OO)
INGR	Polysorbate 20 (UNII: 7T1F30V5YH)
INGR	Farnesol (UNII: EB41QIU6JL)
INGR	LIMONENE, (+)- (UNII: GFD7C86Q1W)
INGR	EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
INGR	Sodium Hydroxide (UNII: 55X04QC32I)
INGR	Palmitoyl Tripeptide-1 (UNII: RV743D216M)
INGR	Palmitoyl Tetrapeptide-7 (UNII: Q41S464P1R)
INGR	VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
INGR	.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
INGR	Caprylyl Glycol (UNII: 00YIU5438U)
INGR	Butylene Glycol (UNII: 3XUS85K0RA)
INGR	Hexylene Glycol (UNII: KEH0A3F75J)
INGR	Ethylhexylglycerin (UNII: 147D247K3P)
INGR	Phenoxyethanol (UNII: HIE492ZZ3T)
INGR	ULTRAMARINE BLUE (UNII: I39WR998BI)
INGR	EXT. D&C VIOLET NO. 2 (UNII: G5UX3K0728)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
COSMETIC		05/01/2018

Part 5 of 5

ZO SKIN HEALTH ROZATROL TREATMENT FOR RED, SENSITIZED SKIN 
lotions, oils, powders, and creams lotion

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	Water (UNII: 059QF0KO0R)
INGR	Glycerin (UNII: PDC6A3C0OX)
INGR	Cetyl Alcohol (UNII: 936JST6JCN)
INGR	SUNFLOWER OIL (UNII: 3W1JG795YI)
INGR	ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
INGR	Palmitoyl Glycine (UNII: M6V3RIU5KI)
INGR	Neopentyl Glycol Diethylhexanoate (UNII: U68ZV6W62C)
INGR	Dimethicone (UNII: 92RU3N3Y1O)
INGR	Panthenol (UNII: WV9CM0O67Z)
INGR	GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
INGR	PEG-100 Stearate (UNII: YD01N1999R)
INGR	Potassium Cetyl Phosphate (UNII: 03KCY6P7UT)
INGR	LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)
INGR	CASEIN (UNII: 48268V50D5)
INGR	Neopentyl Glycol Diisostearate (UNII: 4M6OQ34JWW)
INGR	Papain (UNII: A236A06Y32)
INGR	Magnesium Aluminum Silicate (UNII: 6M3P64V0NC)
INGR	PEG-12 Glyceryl Laurate (UNII: J07WW42G15)
INGR	POLYOXYL 35 CASTOR OIL (UNII: 6D4M1DAL6O)
INGR	PANTHENOL TRIACETATE, (+)- (UNII: 1206E8961B)
INGR	Farnesol (UNII: EB41QIU6JL)
INGR	Farnesyl Acetate (UNII: 2ARF3ZNJ1R)
INGR	AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
INGR	Caprylyl Glycol (UNII: 00YIU5438U)
INGR	EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
INGR	CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
INGR	LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
INGR	SODIUM ALGINATE (UNII: C269C4G2ZQ)
INGR	Xanthan Gum (UNII: TTV12P4NEE)
INGR	Benzalkonium Chloride (UNII: F5UM2KM3W7)
INGR	Chlorphenesin (UNII: I670DAL4SZ)
INGR	Phenoxyethanol (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		20 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
COSMETIC		05/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part333D	05/01/2018

Labeler - ZO Skin Health, Inc. (826468527)

Establishment
Name	Address	ID/FEI	Business Operations
Lifetech Resources, LLC		622559110	MANUFACTURE(42851-111)

Establishment
Name	Address	ID/FEI	Business Operations
PakLab		790530976	MANUFACTURE(42851-111)

Establishment
Name	Address	ID/FEI	Business Operations
Thibiant International, Inc.		083913913	MANUFACTURE(42851-111)