ZO SKIN HEALTH DAILY SKINCARE PROGRAM- titanium dioxide kit

ZO SKIN HEALTH Daily Skincare Program by

Drug Labeling and Warnings

ZO SKIN HEALTH Daily Skincare Program by is a Otc medication manufactured, distributed, or labeled by ZO Skin Health, Inc., Lifetech Resources, LLC, DIAMOND WIPES INTERNATIONAL, INC., PakLab, Thibiant International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Titanium Dioxide 8.2%

Purpose

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.

When using this product

• keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

• rash or irritation develops and lasts.

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 of age: 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.

Other information

• Protect this product from excessive heat and direct sun.
• You may report a serious adverse reaction to: 5 Technology Dr. Irvine, CA 92618

Inactive ingredients

Aluminum Hydroxide, Aqua/Water/Eau, Ascorbic Acid, Behenyl Behenate, Caprylic/Capric Triglyceride, Caprylyl Glycol, Cetyl PEG/PPG-10/1 Dimethicone, Chlorphenesin, Cyclopentasiloxane, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Disodium Uridine Phosphate, Ethyl Ferulate, Ethylhexylglycerin, Glycerin, Glycine Soja Extract, Helianthus Annuus Seed Oil, Hexyl Laurate, Iron Oxides, Melanin, Myristoyl Pentapeptide-8, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Pentylene Glycol, Phenoxyethanol, Phenyl Trimethicone, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Polyglyceryl-4 Isostearate, Polyglyceryl-5 Trioleate, Polymethyl Methacrylate, Retinyl Palmitate, Rosmarinus Officinalis Leaf Extract, Squalane, Stearic Acid, Tocopherol, Tocopheryl Acetate, Tribehenin, Triethoxycaprylylsilane.

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - Kit Carton

ZO® SKIN HEALTH
BY ZEIN OBAGI MD

DAILY SKINCARE PROGRAM

NDC: 42851-166-15

EXFOLIATING CLEANSER 60 mL / 2 Fl. Oz. EXFOLIATING POLISH Net Wt. 16.2 g / 0.57 Oz.
COMPLEXION RENEWAL PADS 30 Pads DAILY POWER DEFENSE 30 mL / 1 Fl. Oz.
SUNSCREEN + PRIMER SPF 30 15 mL / 0.5 Fl. Oz.

INGREDIENTS AND APPEARANCE

ZO SKIN HEALTH DAILY SKINCARE PROGRAM 
titanium dioxide kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42851-166

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42851-166-15	1 in 1 CARTON	11/01/2017

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 TUBE	60 mL
Part 2	1 JAR	16.2 g
Part 3	1 BOTTLE, GLASS	60
Part 4	1 BOTTLE, PUMP	30 mL
Part 5	1 BOTTLE, PUMP	15 mL

Part 1 of 5

ZO SKIN HEALTH EXFOLIATING CLEANSER 
cleansing (cold creams, cleansing lotions, liquids, and pads) gel

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	Glycerin (UNII: PDC6A3C0OX)
INGR	Cocamidopropyl Betaine (UNII: 5OCF3O11KX)
INGR	Disodium Cocoamphodiacetate (UNII: 18L9G3U51M)
INGR	Cocamidopropyl Hydroxysultaine (UNII: 62V75NI93W)
INGR	Sodium Hydroxide (UNII: 55X04QC32I)
INGR	Powdered Cellulose (UNII: SMD1X3XO9M)
INGR	Mannitol (UNII: 3OWL53L36A)
INGR	Caprylic Alcohol (UNII: NV1779205D)
INGR	Niacin (UNII: 2679MF687A)
INGR	Ammonium Lactate (UNII: 67M901L9NQ)
INGR	Salicylic Acid (UNII: O414PZ4LPZ)
INGR	Edetate Disodium Anhydrous (UNII: 8NLQ36F6MM)
INGR	.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)
INGR	Limonene, (+)- (UNII: GFD7C86Q1W)
INGR	Linalool, (+/-)- (UNII: D81QY6I88E)
INGR	Niacinamide (UNII: 25X51I8RD4)
INGR	Hypromellose, Unspecified (UNII: 3NXW29V3WO)
INGR	Sodium Pyrrolidone Carboxylate (UNII: 469OTG57A2)
INGR	Biosaccharide Gum-1 (UNII: BB4PU4V09H)
INGR	Ethylhexylglycerin (UNII: 147D247K3P)
INGR	Hexylene Glycol (UNII: KEH0A3F75J)
INGR	Butylene Glycol (UNII: 3XUS85K0RA)
INGR	Phenoxyethanol (UNII: HIE492ZZ3T)
INGR	Chromium Hydroxide Green (UNII: RV8FT8XF5R)

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		11/01/2017

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		11/01/2017

Part 3 of 5

ZO SKIN HEALTH COMPLEXION RENEWAL PADS 
cleansing (cold creams, cleansing lotions, liquids, and pads) patch

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	Water (UNII: 059QF0KO0R)
INGR	Propylene Glycol (UNII: 6DC9Q167V3)
INGR	Salicylic Acid (UNII: O414PZ4LPZ)
INGR	Urea (UNII: 8W8T17847W)
INGR	Glycolic Acid (UNII: 0WT12SX38S)
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	Butylene Glycol (UNII: 3XUS85K0RA)
INGR	Limonene, (+)- (UNII: GFD7C86Q1W)
INGR	Linalool, (+/-)- (UNII: D81QY6I88E)
INGR	.Alpha.-Hexylcinnamaldehyde (UNII: 7X6O37OK2I)
INGR	Isomethyl-.Alpha.-Ionone (UNII: 9XP4LC555B)
INGR	Sodium Hydroxide (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		60 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
Cosmetic		11/01/2017

Part 4 of 5

ZO SKIN HEALTH OSSENTIAL DAILY POWER DEFENSE 
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	Cetearyl Isononanoate (UNII: P5O01U99NI)
INGR	Cyclomethicone 5 (UNII: 0THT5PCI0R)
INGR	Cyclomethicone 6 (UNII: XHK3U310BA)
INGR	Glycerin (UNII: PDC6A3C0OX)
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	SAFFLOWER OIL (UNII: 65UEH262IS)
INGR	Carboxypolymethylene (UNII: 0A5MM307FC)
INGR	C12-20 Alkyl Glucoside (UNII: K67N5Z1RUA)
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, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic		11/01/2017

Part 5 of 5

ZO SKIN HEALTH OCLIPSE SUNSCREEN PLUS PRIMER BROAD-SPECTRUM SPF 30 UVA/UVB PROTECTION 
titanium dioxide lotion

Product Information
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	82 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Aluminum Hydroxide (UNII: 5QB0T2IUN0)
Water (UNII: 059QF0KO0R)
Ascorbic Acid (UNII: PQ6CK8PD0R)
Behenyl Behenate (UNII: K8NU647RJ0)
Medium-Chain Triglycerides (UNII: C9H2L21V7U)
Caprylyl Glycol (UNII: 00YIU5438U)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
Chlorphenesin (UNII: I670DAL4SZ)
Cyclomethicone 5 (UNII: 0THT5PCI0R)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
DIMETHICONOL (100000 CST) (UNII: OSA9UP217S)
Uridine Monophosphate Disodium (UNII: KD8E20071T)
Ethyl Ferulate (UNII: 5B8915UELW)
Ethylhexylglycerin (UNII: 147D247K3P)
Glycerin (UNII: PDC6A3C0OX)
Sunflower Oil (UNII: 3W1JG795YI)
Hexyl Laurate (UNII: 4CG9F9W01Q)
Ferric Oxide Red (UNII: 1K09F3G675)
MELANIN SYNTHETIC (TYROSINE, PEROXIDE) (UNII: O0CV1RMR44)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
Pentylene Glycol (UNII: 50C1307PZG)
Phenoxyethanol (UNII: HIE492ZZ3T)
Phenyl Trimethicone (UNII: DR0K5NOJ4R)
POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q)
Polyglyceryl-4 Isostearate (UNII: 820DPX33S7)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
Vitamin A Palmitate (UNII: 1D1K0N0VVC)
Rosemary (UNII: IJ67X351P9)
Squalane (UNII: GW89575KF9)
Stearic Acid (UNII: 4ELV7Z65AP)
Tocopherol (UNII: R0ZB2556P8)
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)
Tribehenin (UNII: 8OC9U7TQZ0)
Triethoxycaprylylsilane (UNII: LDC331P08E)

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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	11/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	11/01/2017

Labeler - ZO Skin Health, Inc. (826468527)

Establishment
Name	Address	ID/FEI	Business Operations
Lifetech Resources, LLC		622559110	MANUFACTURE(42851-166)

Establishment
Name	Address	ID/FEI	Business Operations
DIAMOND WIPES INTERNATIONAL, INC.		161104729	MANUFACTURE(42851-166)

Establishment
Name	Address	ID/FEI	Business Operations
PakLab		790530976	MANUFACTURE(42851-166)

Establishment
Name	Address	ID/FEI	Business Operations
Thibiant International, Inc.		083913913	MANUFACTURE(42851-166)