ZO SKIN HEALTH ZO FAVORITES (MOTHERS DAY GWP)- titanium dioxide kit

ZO Skin Health ZO Favorites (Mothers Day GWP) by

Drug Labeling and Warnings

ZO Skin Health ZO Favorites (Mothers Day GWP) by is a Otc medication manufactured, distributed, or labeled by ZO Skin Health, Inc., Lifetech Resources, LLC., PakLab, 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

• 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, Dimethiconol, Aluminum Hydroxide, Stearic Acid, Dimethicone/Vinyl Dimethicone Crosspolymer, Tribehenin, Helianthus Annuus Seed Oil, Polymethyl Methacrylate, Water, Cetyl PEG/PPG-10/1 Dimethicone, Hexyl Laurate, Polyglyceryl-4 Isostearate, Glycerin, Glycine Soja Seed Extract, Caprylic/Capric Triglyceride, Behenyl Behenate, Squalane, Tocopheryl Acetate, Melanin, Ethyl Ferulate, Polyglyceryl-5 Trioleate, Triethoxycaprylylsilane, Ascorbic Acid, Methylisothiazolinone, Retinyl Palmitate, Pentylene Glycol, Rosmarinus Officinalis Leaf Extract, Ethylhexylglycerin, Disodium Uridine Phosphate, Tocopherol, Myristoyl Pentapeptide-8, 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

NDC: 42851-162-01

ZO★ FAVORITES

OFFECTS® EXFOLIATING CLEANSER
40 mL / 1.5 Fl. Oz.
OSSENTIAL® DAILY POWER DEFENSE
30 mL / 1 Fl. Oz.
OCLIPSE® SUNSCREEN + PRIMER SPF 30
15 mL / 0.5 Fl. Oz.

INGREDIENTS AND APPEARANCE

ZO SKIN HEALTH ZO FAVORITES (MOTHERS DAY GWP) 
titanium dioxide kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42851-162

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42851-162-01	1 in 1 CARTON	04/01/2015

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 TUBE	40 mL
Part 2	1 BOTTLE, PUMP	30 mL
Part 3	1 BOTTLE, PUMP	15 mL

Part 1 of 3

ZO SKIN HEALTH OFFECTS EXFOLIATING 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 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	Disodium Cocoamphodiacetate (UNII: 18L9G3U51M)
INGR	Mannitol (UNII: 3OWL53L36A)
INGR	Powdered Cellulose (UNII: SMD1X3XO9M)
INGR	Sodium Hydroxide (UNII: 55X04QC32I)
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	Sodium Chloride (UNII: 451W47IQ8X)
INGR	Sodium Carbonate (UNII: 45P3261C7T)
INGR	Methylchloroisothiazolinone (UNII: DEL7T5QRPN)
INGR	Methylisothiazolinone (UNII: 229D0E1QFA)
INGR	Magnesium Chloride (UNII: 02F3473H9O)
INGR	Magnesium Nitrate (UNII: 77CBG3UN78)
INGR	Limonene, (+)- (UNII: GFD7C86Q1W)
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		04/01/2015

Part 2 of 3

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	Pentylene Glycol (UNII: 50C1307PZG)
INGR	Cetostearyl Alcohol (UNII: 2DMT128M1S)
INGR	Glycerin (UNII: PDC6A3C0OX)
INGR	Steareth-20 (UNII: L0Q8IK9E08)
INGR	Carboxypolymethylene (UNII: 0A5MM307FC)
INGR	C14-22 Alcohols (UNII: B1K89384RJ)
INGR	Phenoxyethanol (UNII: HIE492ZZ3T)
INGR	Cetearyl Glucoside (UNII: 09FUA47KNA)
INGR	Polysorbate 20 (UNII: 7T1F30V5YH)
INGR	Butylene Glycol (UNII: 3XUS85K0RA)
INGR	Palmitoyl Tetrapeptide-7 (UNII: Q41S464P1R)
INGR	Sodium Hydroxide (UNII: 55X04QC32I)
INGR	Caprylyl Glycol (UNII: 00YIU5438U)
INGR	C12-20 Alkyl Glucoside (UNII: K67N5Z1RUA)
INGR	Ethylhexylglycerin (UNII: 147D247K3P)
INGR	Lactose, Unspecified Form (UNII: J2B2A4N98G)
INGR	Edetate Disodium (UNII: 7FLD91C86K)
INGR	Powdered Cellulose (UNII: SMD1X3XO9M)
INGR	Hexylene Glycol (UNII: KEH0A3F75J)
INGR	Potassium Sorbate (UNII: 1VPU26JZZ4)
INGR	1,2-Hexanediol (UNII: TR046Y3K1G)
INGR	Methylparaben (UNII: A2I8C7HI9T)
INGR	Lecithin, Soybean (UNII: 1DI56QDM62)
INGR	Hypromelloses (UNII: 3NXW29V3WO)
INGR	Sorbitol (UNII: 506T60A25R)
INGR	Edetic Acid (UNII: 9G34HU7RV0)
INGR	Benzoic Acid (UNII: 8SKN0B0MIM)
INGR	Sodium Benzoate (UNII: OJ245FE5EU)
INGR	Arabidopsis Thaliana (UNII: AI3L60HQ81)
INGR	Retinol (UNII: G2SH0XKK91)
INGR	Vitamin A Palmitate (UNII: 1D1K0N0VVC)
INGR	.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)
INGR	Lemon Oil (UNII: I9GRO824LL)
INGR	Mandarin Oil (UNII: NJO720F72R)
INGR	Peppermint Oil (UNII: AV092KU4JH)
INGR	Mimosa Tenuiflora Bark (UNII: 515MQE449I)
INGR	Tocopherol (UNII: R0ZB2556P8)
INGR	Limonene, (+)- (UNII: GFD7C86Q1W)
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		04/01/2015

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)
Aluminum Hydroxide (UNII: 5QB0T2IUN0)
Stearic Acid (UNII: 4ELV7Z65AP)
Dimethicone/Vinyl Dimethicone Crosspolymer (soft particle) (UNII: 9E4CO0W6C5)
Tribehenin (UNII: 8OC9U7TQZ0)
Sunflower Oil (UNII: 3W1JG795YI)
Poly(Methyl Methacrylate; 450000 MW) (UNII: Z47NNT4J11)
Water (UNII: 059QF0KO0R)
Hexyl Laurate (UNII: 4CG9F9W01Q)
Polyglyceryl-4 Isostearate (UNII: 820DPX33S7)
Glycerin (UNII: PDC6A3C0OX)
Medium-Chain Triglycerides (UNII: C9H2L21V7U)
Behenyl Behenate (UNII: K8NU647RJ0)
Squalane (UNII: GW89575KF9)
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)
Melanin Synthetic (Tyrosine, Peroxide) (UNII: O0CV1RMR44)
Ethyl Ferulate (UNII: 5B8915UELW)
Triethoxycaprylylsilane (UNII: LDC331P08E)
Ascorbic Acid (UNII: PQ6CK8PD0R)
Methylisothiazolinone (UNII: 229D0E1QFA)
Vitamin A Palmitate (UNII: 1D1K0N0VVC)
Pentylene Glycol (UNII: 50C1307PZG)
Rosemary (UNII: IJ67X351P9)
Ethylhexylglycerin (UNII: 147D247K3P)
Uridine Monophosphate Disodium (UNII: KD8E20071T)
Tocopherol (UNII: R0ZB2556P8)
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	04/01/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	04/01/2015

Labeler - ZO Skin Health, Inc. (826468527)

Establishment
Name	Address	ID/FEI	Business Operations
Lifetech Resources, LLC.		622559110	MANUFACTURE(42851-162)

Establishment
Name	Address	ID/FEI	Business Operations
PakLab		790530976	MANUFACTURE(42851-162)

Establishment
Name	Address	ID/FEI	Business Operations
Thibiant International, Inc.		083913913	MANUFACTURE(42851-162)