ZO SKIN HEALTH RENEW- titanium dioxide kit

ZO SKIN HEALTH RENEW by

Drug Labeling and Warnings

ZO SKIN HEALTH RENEW by is a Otc medication manufactured, distributed, or labeled by ZO Skin Health, Inc., Lifetech Resources, LLC., Thibiant International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

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 occurs

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
• children under 6 months of age: ask a doctor
• reapply at least every two hours
• 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

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

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - Kit Carton

ZO® SKIN HEALTH
BY ZEIN OBAGI MD

RENEW

OFFECTS® HYDRATING CLEANSER
40 mL / 1.5 Fl. Oz.

OFFECTS® EXFOLIATING POLISH
Net Wt. 16.2 g / 0.57 Oz.

OCLIPSE® SUNSCREEN + PRIMER
BROAD-SPECTRUM SPF 30
15 mL / 0.5 Fl. Oz.

NDC: 42851-163-01

INGREDIENTS AND APPEARANCE

ZO SKIN HEALTH RENEW 
titanium dioxide kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42851-163

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42851-163-01	1 in 1 CARTON	12/01/2015

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, PUMP	15 mL

Part 1 of 3

ZO SKIN HEALTH OFFECTS HYDRATING 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 Cocoyl Isethionate (UNII: 518XTE8493)
INGR	Sodium Methyl Cocoyl Taurate (UNII: JVL98CG53G)
INGR	Glycerin (UNII: PDC6A3C0OX)
INGR	Stearic Acid (UNII: 4ELV7Z65AP)
INGR	Glyceryl Monostearate (UNII: 230OU9XXE4)
INGR	PEG-100 Stearate (UNII: YD01N1999R)
INGR	Glycol Distearate (UNII: 13W7MDN21W)
INGR	Disodium Cocoamphodiacetate (UNII: 18L9G3U51M)
INGR	Cetyl Alcohol (UNII: 936JST6JCN)
INGR	Phenoxyethanol (UNII: HIE492ZZ3T)
INGR	Sodium Chloride (UNII: 451W47IQ8X)
INGR	Panthenol (UNII: WV9CM0O67Z)
INGR	Urea (UNII: 8W8T17847W)
INGR	Sodium Pyrrolidone Carboxylate (UNII: 469OTG57A2)
INGR	Sodium Hydroxide (UNII: 55X04QC32I)
INGR	Trehalose (UNII: B8WCK70T7I)
INGR	Ethylhexylglycerin (UNII: 147D247K3P)
INGR	Sodium Glycolate (UNII: B75E535IMI)
INGR	Triacetin (UNII: XHX3C3X673)
INGR	Chlorphenesin (UNII: I670DAL4SZ)
INGR	Potassium Sorbate (UNII: 1VPU26JZZ4)
INGR	Hyaluronate Sodium (UNII: YSE9PPT4TH)
INGR	Sorbic Acid (UNII: X045WJ989B)
INGR	Polyquaternium-51 (2-Methacryloyloxyethyl Phosphorylcholine/N-Butyl Methacrylate; 3:7) (UNII: EL9825H96J)
INGR	Allantoin (UNII: 344S277G0Z)
INGR	D&C Red No. 33 (UNII: 9DBA0SBB0L)
INGR	Fd&C Yellow No. 6 (UNII: H77VEI93A8)

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		12/01/2015

Part 2 of 3

ZO SKIN HEALTH OFFECTS EXFOLIATING POLISH 
cleansing (cold creams, cleansing lotions, liquids, and pads) 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	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	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		12/01/2015

Part 3 of 3

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

Product Information
Item Code (Source)	NDC: 42851-053
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
Cyclomethicone 5 (UNII: 0THT5PCI0R)
Dimethicone Crosspolymer (450000 mpa.s at 12% in Cyclopentasiloxane) (UNII: UF7620L1W6)
Phenyl Trimethicone (UNII: DR0K5NOJ4R)
Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone (4000 mpa.s) (UNII: RLA2U05Z4Q)
Stearic Acid (UNII: 4ELV7Z65AP)
Aluminum Hydroxide (UNII: 5QB0T2IUN0)
Dimethicone/Vinyl Dimethicone Crosspolymer (Soft Particle) (UNII: 9E4CO0W6C5)
Tribehenin (UNII: 8OC9U7TQZ0)
Water (UNII: 059QF0KO0R)
Sunflower Oil (UNII: 3W1JG795YI)
Poly(Methyl Methacrylate; 450000 mw) (UNII: Z47NNT4J11)
Polyglyceryl-4 Isostearate (UNII: 820DPX33S7)
Hexyl Laurate (UNII: 4CG9F9W01Q)
Cetyl PEG/PPG-10/1 Dimethicone (HLB 2) (UNII: V2W71V8T0X)
Glycerin (UNII: PDC6A3C0OX)
Dimethiconol (100000 CST) (UNII: OSA9UP217S)
Cyclomethicone 4 (UNII: CZ227117JE)
Squalane (UNII: GW89575KF9)
Medium-Chain Triglycerides (UNII: C9H2L21V7U)
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)
Melanin Synthetic (Tyrosine, Peroxide) (UNII: O0CV1RMR44)
Behenyl Behenate (UNII: K8NU647RJ0)
Triethoxycaprylylsilane (UNII: LDC331P08E)
Ethyl Ferulate (UNII: 5B8915UELW)
Soybean (UNII: L7HT8F1ZOD)
Calcium Chloride (UNII: M4I0D6VV5M)
Vitamin A Palmitate (UNII: 1D1K0N0VVC)
Pentylene Glycol (UNII: 50C1307PZG)
Methylisothiazolinone (UNII: 229D0E1QFA)
Ascorbic Acid (UNII: PQ6CK8PD0R)
Rosemary (UNII: IJ67X351P9)
Phenoxyethanol (UNII: HIE492ZZ3T)
Potassium Sorbate (UNII: 1VPU26JZZ4)
Ethylhexylglycerin (UNII: 147D247K3P)
Tocopherol (UNII: R0ZB2556P8)
Uridine Monophosphate Disodium (UNII: KD8E20071T)
Pentaerythritol Tetrakis(3-(3,5-Di-Tert-Butyl-4-Hydroxyphenyl)Propionate) (UNII: 255PIF62MS)
Ferric Oxide Red (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42851-053-01	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	12/01/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	12/01/2015

Labeler - ZO Skin Health, Inc. (826468527)

Establishment
Name	Address	ID/FEI	Business Operations
Lifetech Resources, LLC.		622559110	MANUFACTURE(42851-163)

Establishment
Name	Address	ID/FEI	Business Operations
Thibiant International, Inc.		083913913	MANUFACTURE(42851-163)