ZO SKIN HEALTH LEVEL II ANTI-AGING PROGRAM WITH GROWTH FACTOR SERUM PLUS- titanium dioxide and zinc oxide
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.

----------

ZO SKIN HEALTH (as PLD) LEVEL II: ANTI-AGING PROGRAM with Growth Factor Serum Plus (42851-153) - DELIST

Drug Facts

Active ingredients	Purpose
Titanium Dioxide 10.2%	Sunscreen
Zinc Oxide 3.7%	Sunscreen

Uses

Helps prevent sunburn.
If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

For external use only.

Do not use on damaged or broken skin.

Stop and ask a doctor if rash occurs.

When using this product keep out of eyes. Rinse with water to remove.

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

Directions

Apply liberally 15 minutes before sun exposure
Use a water resistant sunscreen if swimming or sweating
Reapply at least every 2 hours
Children under 6 months: Ask a doctor
Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
- Limit time in the sun, especially from 10 a.m.- 2 p.m.
- Wear long-sleeved shirts, pants, hats and sunglasses.
Apply to all skin exposed to the sun

Other information

Protect the product in this container from excessive heat and direct sunlight.
You may report a serious adverse reaction to:
1 Technology Dr. B123, Irvine, CA 92618

Inactive ingredients

Cyclopentasiloxane, Cyclotetrasiloxane, Dimethicone/Vinyl Dimethicone Crosspolymer, Methyl Methacrylate/Glycol Dimethacrylate Crosspolymer, Dimethicone Crosspolymer, Melanin, Tribehenin, Calcium Behenate, Sorbitan Isostearate, Dimethiconol, Alumina, Laureth-23, Methicone, PEG-10 Dimethicone, PPG-2 Myristyl Ether Propionate, Propylparaben, Methylparaben, Myristoyl Pentapeptide-8, Iron Oxide (CI 77492).

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

PRINCIPAL DISPLAY PANEL - Kit Carton

ZO ® SKIN HEALTH
BY ZEIN OBAGI, MD

LEVEL II: ANTI-AGING PROGRAM

with Growth Factor Serum Plus

NDC 42851-153-01

beverly hills

ZO SKIN HEALTH LEVEL II ANTI-AGING PROGRAM WITH GROWTH FACTOR SERUM PLUS
titanium dioxide and zinc oxide kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:42851-153

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:42851-153-01	1 in 1 CARTON; Type 0: Not a Combination Product	01/11/2012	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, PUMP	30 mL
Part 4	1 BOTTLE, PUMP	30 mL
Part 5	1 BOTTLE, PUMP	15 mL

Part 1 of 5

OFFECTS EXFOLIATING CLEANSER NORMAL TO DRY SKIN ANTI-AGING FORMULA
cleansing (cold creams, cleansing lotions, liquids, and pads) lotion

Product Information
Route of Administration	TOPICAL

Ingredient Kind	Ingredient Name	Quantity
Other Ingredients
INGR	WATER (UNII: 059QF0KO0R)
INGR	SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)
INGR	COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
INGR	HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)
INGR	SODIUM HYDROXIDE (UNII: 55X04QC32I)
INGR	MANNITOL (UNII: 3OWL53L36A)
INGR	DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)
INGR	CHROMIUM HYDROXIDE GREEN (UNII: RV8FT8XF5R)
INGR	POWDERED CELLULOSE (UNII: SMD1X3XO9M)
INGR	BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
INGR	FILIPENDULA ULMARIA ROOT (UNII: 997724QNDS)
INGR	TEA TREE OIL (UNII: VIF565UC2G)
INGR	SALICYLIC ACID (UNII: O414PZ4LPZ)
INGR	SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
INGR	NIACIN (UNII: 2679MF687A)
INGR	NIACINAMIDE (UNII: 25X51I8RD4)
INGR	AMMONIUM LACTATE (UNII: 67M901L9NQ)
INGR	.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
INGR	HYPROMELLOSES (UNII: 3NXW29V3WO)
INGR	BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)
INGR	EDETATE DISODIUM (UNII: 7FLD91C86K)
INGR	METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
INGR	METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
INGR	MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
INGR	MAGNESIUM NITRATE (UNII: 77CBG3UN78)

#	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		01/11/2012	12/31/2020

Part 2 of 5

OFFECTS EXFOLIATING POLISH ANTI-AGING FORMULA
cleansing (cold creams, cleansing lotions, liquids, and pads) cream

Product Information
Route of Administration	TOPICAL

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	TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
INGR	.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
INGR	VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
INGR	ASCORBYL PALMITATE (UNII: QN83US2B0N)
INGR	MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
INGR	LINOLEIC ACID (UNII: 9KJL21T0QJ)
INGR	OMEGA-3 FATTY ACIDS (UNII: 71M78END5S)
INGR	TEA TREE OIL (UNII: VIF565UC2G)
INGR	PROPYLPARABEN (UNII: Z8IX2SC1OH)
INGR	STEARYL GLYCYRRHETINATE (UNII: 3YYE6VJS0P)
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		01/11/2012	12/31/2020

Part 3 of 5

OSSENTIAL DAILY POWER DEFENSE ANTI-AGING FORMULA
cleansing (cold creams, cleansing lotions, liquids, and pads) lotion

Product Information
Route of Administration	TOPICAL

Ingredient Kind	Ingredient Name	Quantity
Other Ingredients
INGR	WATER (UNII: 059QF0KO0R)
INGR	CETEARYL ISONONANOATE (UNII: P5O01U99NI)
INGR	CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
INGR	CYCLOMETHICONE 6 (UNII: XHK3U310BA)
INGR	PENTYLENE GLYCOL (UNII: 50C1307PZG)
INGR	RETINOL (UNII: G2SH0XKK91)
INGR	EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)
INGR	POLYSORBATE 20 (UNII: 7T1F30V5YH)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	STEARETH-20 (UNII: L0Q8IK9E08)
INGR	CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
INGR	JOJOBA BUTTER (UNII: XIA46H803R)
INGR	VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
INGR	.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
INGR	CURDLAN (UNII: 6930DL209R)
INGR	LACTOSE (UNII: J2B2A4N98G)
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	ARABIDOPSIS THALIANA (UNII: AI3L60HQ81)
INGR	C14-22 ALCOHOLS (UNII: B1K89384RJ)
INGR	CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
INGR	C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA)
INGR	POWDERED CELLULOSE (UNII: SMD1X3XO9M)
INGR	BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
INGR	PALMITOYL OLIGOPEPTIDE (UNII: HO4ZT5S86C)
INGR	PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)
INGR	SODIUM HYDROXIDE (UNII: 55X04QC32I)
INGR	CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
INGR	HYPROMELLOSES (UNII: 3NXW29V3WO)
INGR	HEXYLENE GLYCOL (UNII: KEH0A3F75J)
INGR	EDETATE DISODIUM (UNII: 7FLD91C86K)
INGR	CAPRYLYL GLYCOL (UNII: 00YIU5438U)
INGR	ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
INGR	PHENOXYETHANOL (UNII: HIE492ZZ3T)
INGR	LIMONENE, (+/-)- (UNII: 9MC3I34447)
INGR	ULTRAMARINE BLUE (UNII: I39WR998BI)
INGR	EXT. D&C VIOLET NO. 2 (UNII: G5UX3K0728)

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

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Cosmetic		01/11/2012	12/31/2020

Part 4 of 5

OSSENTIAL GROWTH FACTOR SERUM PLUS ANTI-AGING FORMULA
cleansing (cold creams, cleansing lotions, liquids, and pads) gel

Product Information
Route of Administration	TOPICAL

Ingredient Kind	Ingredient Name	Quantity
Other Ingredients
INGR	WATER (UNII: 059QF0KO0R)
INGR	CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
INGR	DIPROPYLENE GLYCOL (UNII: E107L85C40)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	PEG-12 DIMETHICONE/PPG-20 CROSSPOLYMER (UNII: 965K72OQXO)
INGR	DIMETHICONE (UNII: 92RU3N3Y1O)
INGR	PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
INGR	DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
INGR	DIMETHICONOL (40 CST) (UNII: 343C7U75XW)
INGR	BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
INGR	CURDLAN (UNII: 6930DL209R)
INGR	AMINOPROPYL DIHYDROGEN PHOSPHATE (UNII: D5J0Q2CM4V)
INGR	PHENOXYETHANOL (UNII: HIE492ZZ3T)
INGR	ACETYL L-TYROSINE (UNII: DA8G610ZO5)
INGR	MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)
INGR	OMEGA-3 FATTY ACIDS (UNII: 71M78END5S)
INGR	PANTHENOL TRIACETATE, (+)- (UNII: 1206E8961B)
INGR	ETHYL LINOLEATE (UNII: MJ2YTT4J8M)
INGR	SODIUM PHOSPHATE (UNII: SE337SVY37)
INGR	HYDROLYZED SERICIN (ENZYMATIC; 2500 MW) (UNII: 02EMA6F96C)
INGR	DIPEPTIDE DIAMINOBUTYROYL BENZYLAMIDE DIACETATE (UNII: 38H206R00R)
INGR	OLEYL ALCOHOL (UNII: 172F2WN8DV)
INGR	PROLINE (UNII: 9DLQ4CIU6V)
INGR	RETINOL (UNII: G2SH0XKK91)
INGR	POLYSORBATE 20 (UNII: 7T1F30V5YH)
INGR	ANGELICA SINENSIS ROOT (UNII: B66F4574UG)
INGR	ADENOSINE TRIPHOSPHATE (UNII: 8L70Q75FXE)
INGR	ASIAN GINSENG (UNII: CUQ3A77YXI)
INGR	TOCOPHEROL (UNII: R0ZB2556P8)
INGR	CAPRYLYL GLYCOL (UNII: 00YIU5438U)
INGR	POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
INGR	XANTHAN GUM (UNII: TTV12P4NEE)
INGR	HEXYLENE GLYCOL (UNII: KEH0A3F75J)
INGR	1,2-HEXANEDIOL (UNII: TR046Y3K1G)
INGR	BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
INGR	SODIUM CHLORIDE (UNII: 451W47IQ8X)
INGR	BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)

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

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Cosmetic		01/11/2012	12/31/2020

Part 5 of 5

OCLIPSE SUNSCREEN PLUS PRIMER BROAD-SPECTRUM SPF 30 UVA/UVB PROTECTION
titanium dioxide and zinc oxide lotion

Product Information
Item Code (Source)	NDC:42851-051
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	102 mg in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	37 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
CYCLOMETHICONE 4 (UNII: CZ227117JE)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
CALCIUM BEHENATE (UNII: J5VFA9V6YG)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
DIMETHICONOL (40 CST) (UNII: 343C7U75XW)
ALUMINUM OXIDE (UNII: LMI26O6933)
LAURETH-23 (UNII: N72LMW566G)
METHICONE (20 CST) (UNII: 6777U11MKT)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
PPG-2 MYRISTYL ETHER PROPIONATE (UNII: 88R97D8U8A)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
METHYLPARABEN (UNII: A2I8C7HI9T)
FERRIC OXIDE RED (UNII: 1K09F3G675)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:42851-051-01	15 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	M020	01/11/2012	12/31/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	M020	01/11/2012	12/31/2020

Labeler - ZO Skin Health, Inc. (826468527)

Revised: 3/2023

Document Id: f8367060-5bd4-9bb1-e053-6394a90a6ec7

Set id: 3ffc8c0f-121b-4940-84ff-af111d0aa2ac

Version: 2

Effective Time: 20230331

ZO Skin Health, Inc.