ZO SKIN HEALTH GSR (GETTING SKIN READY)- salicylic acid
ZO Skin Health, Inc.

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.

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ZO SKIN HEALTH (as PLD) - GSR (Getting Skin Ready) SYSTEM (42851-172) - DELIST

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.

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

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

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:42851-172-07	1 in 1 CARTON; Type 0: Not a Combination Product	01/01/2011	12/31/2020

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
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

Ingredient Kind	Ingredient Name	Quantity
Other Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		40 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Cosmetic		01/01/2011	12/31/2020

Part 2 of 3

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

Product Information

Ingredient Kind	Ingredient Name	Quantity
Other Ingredients
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)

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

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Cosmetic		01/01/2011	12/31/2020

Part 3 of 3

OFFECTS TE-PADS ACNE PORE TREATMENT
salicylic acid solution

Product Information
Item Code (Source)	NDC:42851-078
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:42851-078-07	75 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	M006	01/01/2011	12/31/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	M006	01/01/2011	12/31/2020

Labeler - ZO Skin Health, Inc. (826468527)

Revised: 4/2023

Document Id: f871337c-6177-d56a-e053-6294a90a152b

Set id: a82129fc-0b0d-4ade-96cd-94917caac930

Version: 3

Effective Time: 20230403

ZO Skin Health, Inc.