ZO SKIN HEALTH GSR (GETTING SKIN READY) SYSTEM- salicylic acid kit

ZO SKIN HEALTH GSR (Getting Skin Ready) SYSTEM by

Drug Labeling and Warnings

ZO SKIN HEALTH GSR (Getting Skin Ready) SYSTEM by is a Otc medication manufactured, distributed, or labeled by ZO Skin Health, Inc., Lifetech Resources. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Salicylic Acid 2.0%

Purpose

Acne Treatment

Uses

Control acne breakouts, oiliness and soothe complexion.

Warnings

For external use only.

Talk to your doctor if you experience excessive burning, dryness, or irritation.

Avoid the eyes, mouth, lips, and mucous membranes.

Do not use on sunburned, windburned, dry, chapped, irritated, or wounded skin.

Keep out of the reach of children.

Directions

• Rinse and dry your face.
• Use pads twice a day, AM and PM.

Sunburn Alert

This product contains an alpha hydroxy acid (AHA) that may increase your skin's sensitivity to the sun and particularly the possibility of sunburn. Use a sunscreen, wear protective clothing, and limit sun exposure while using this product and for a week afterwards.

Other information

You may report a serious adverse reaction to: 5 Technology Dr., Irvine, CA 92618

Inactive ingredients

Water, Alcohol Denat., Propylene Glycol, Urea, Sodium Hydroxide, Fragrance, Glycolic Acid, Butylene Glycol, Denatonium Benzoate, t-Butyl Alcohol, Sodium Chloride, Sodium Carbonate, Spiraea Ulmaria Extract, Pterocarpus Santalinus Wood Extract, Plantago Major Leaf Extract, Phellodendron Amurense Bark Extract, Hordeum Vulgare Seed Extract, Crithmum Maritimum Extract, Camellia Sinensis Leaf Oil, Artemisia Vulgaris Extract, Phenoxyethanol.

SPL UNCLASSIFIED SECTION

DIST BY
ZO Skin Health, Inc. Irvine, CA 92618

PRINCIPAL DISPLAY PANEL - Kit Carton

ZO® SKIN HEALTH
BY ZEIN OBAGI MD

NDC: 42851-172-07

ZO® GSR SYSTEM

For All Skin Types

INGREDIENTS AND APPEARANCE

ZO SKIN HEALTH GSR (GETTING SKIN READY) SYSTEM 
salicylic acid kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42851-172

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42851-172-07	1 in 1 CARTON

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 TUBE	40 mL
Part 2	1 JAR	16.2 g
Part 3	1 BOTTLE, GLASS	75 mL

Part 1 of 3

OFFECTS EXFOLIATING CLEANSER 
cleansing (cold creams, cleansing lotions, liquids, and pads)

Product Information

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	WATER (UNII: 059QF0KO0R)
INGR	SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)
INGR	COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
INGR	PHENOXYETHANOL (UNII: HIE492ZZ3T)
INGR	MANNITOL (UNII: 3OWL53L36A)
INGR	SODIUM CHLORIDE (UNII: 451W47IQ8X)
INGR	SODIUM HYDROXIDE (UNII: 55X04QC32I)
INGR	DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)
INGR	CAPRYLIC ALCOHOL (UNII: NV1779205D)
INGR	POWDERED CELLULOSE (UNII: SMD1X3XO9M)
INGR	ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
INGR	HEXYLENE GLYCOL (UNII: KEH0A3F75J)
INGR	EDETATE DISODIUM (UNII: 7FLD91C86K)
INGR	AMMONIUM LACTATE (UNII: 67M901L9NQ)
INGR	POLYSORBATE 20 (UNII: 7T1F30V5YH)
INGR	POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
INGR	TEA TREE OIL (UNII: VIF565UC2G)
INGR	NIACIN (UNII: 2679MF687A)
INGR	.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
INGR	SODIUM GLYCOLATE (UNII: B75E535IMI)
INGR	SALICYLIC ACID (UNII: O414PZ4LPZ)
INGR	NIACINAMIDE (UNII: 25X51I8RD4)
INGR	BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)
INGR	SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
INGR	HYPROMELLOSES (UNII: 3NXW29V3WO)
INGR	BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
INGR	CHROMIUM HYDROXIDE GREEN (UNII: RV8FT8XF5R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		40 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

Part 2 of 3

OFFECTS EXFOLIATING POLISH 
cleansing (cold creams, cleansing lotions, liquids, and pads)

Product Information

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
INGR	SODIUM BICARBONATE (UNII: 8MDF5V39QO)
INGR	DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
INGR	MAGNESIUM OXIDE (UNII: 3A3U0GI71G)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	OLETH-20 (UNII: YTH167I2AG)
INGR	GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
INGR	TRIHYDROXYSTEARIN (UNII: 06YD7896S3)
INGR	PEG-100 STEARATE (UNII: YD01N1999R)
INGR	.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
INGR	TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
INGR	VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
INGR	TEA TREE OIL (UNII: VIF565UC2G)
INGR	ASCORBYL PALMITATE (UNII: QN83US2B0N)
INGR	STEARYL GLYCYRRHETINATE (UNII: 3YYE6VJS0P)
INGR	PROPYLPARABEN (UNII: Z8IX2SC1OH)
INGR	LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
INGR	LINOLEIC ACID (UNII: 9KJL21T0QJ)
INGR	SOY STEROL (UNII: PL360EPO9J)
INGR	MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
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

Part 3 of 3

OFFECTS TE-PADS ACNE PORE TREATMENT SYSTEM 
salicylic acid solution

Product Information
Item Code (Source)	NDC: 42851-078
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
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
UREA (UNII: 8W8T17847W)
DALTEPARIN SODIUM (UNII: 12M44VTJ7B)
GLYCOLIC ACID (UNII: 0WT12SX38S)
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
FILIPENDULA ULMARIA ROOT (UNII: 997724QNDS)
SANDALWOOD (UNII: 3641YW25N2)
PLANTAGO LANCEOLATA LEAF (UNII: 2YWL9J7EE8)
PHELLODENDRON AMURENSE BARK (UNII: PBG27B754G)
BARLEY (UNII: 5PWM7YLI7R)
CRITHMUM MARITIMUM (UNII: J7IHY79BKY)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
ARTEMISIA VULGARIS ROOT (UNII: 32MP823R8S)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42851-078-07	75 mL in 1 BOTTLE, GLASS; 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	01/01/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	01/01/2011

Labeler - ZO Skin Health, Inc. (826468527)

Establishment
Name	Address	ID/FEI	Business Operations
Lifetech Resources		622559110	MANUFACTURE(42851-172)