ZO SKIN HEALTH ZO FAVORITES (MOTHERS DAY GWP)- titanium dioxide 
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 ZO ® Favorites (Mother's Day GWP)
NDC 42851-162

Drug Facts

Active ingredients

Titanium Dioxide 8.2%

Purpose

Sunscreen

Uses

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

Other information

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.

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.

PRINCIPAL DISPLAY PANEL - Kit Carton
ZO SKIN HEALTH ZO FAVORITES (MOTHERS DAY GWP) 
titanium dioxide kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42851-162
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42851-162-011 in 1 CARTON04/01/2015
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 TUBE 40 mL
Part 21 BOTTLE, PUMP 30 mL
Part 31 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 AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRTEA TREE OIL (UNII: VIF565UC2G)  
INGRWATER (UNII: 059QF0KO0R)  
INGRSODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
INGRCOCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
INGRHIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
INGRGLYCERIN (UNII: PDC6A3C0OX)  
INGRCOCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)  
INGRDISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)  
INGRMANNITOL (UNII: 3OWL53L36A)  
INGRPOWDERED CELLULOSE (UNII: SMD1X3XO9M)  
INGRSODIUM HYDROXIDE (UNII: 55X04QC32I)  
INGRBUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
INGRFILIPENDULA ULMARIA ROOT (UNII: 997724QNDS)  
INGRSALICYLIC ACID (UNII: O414PZ4LPZ)  
INGRSODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
INGRNIACIN (UNII: 2679MF687A)  
INGRNIACINAMIDE (UNII: 25X51I8RD4)  
INGRAMMONIUM LACTATE (UNII: 67M901L9NQ)  
INGR.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
INGRHYPROMELLOSES (UNII: 3NXW29V3WO)  
INGRBIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)  
INGREDETATE DISODIUM (UNII: 7FLD91C86K)  
INGRSODIUM CHLORIDE (UNII: 451W47IQ8X)  
INGRSODIUM CARBONATE (UNII: 45P3261C7T)  
INGRMETHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
INGRMETHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
INGRMAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
INGRMAGNESIUM NITRATE (UNII: 77CBG3UN78)  
INGRLIMONENE, (+)- (UNII: GFD7C86Q1W)  
INGRCHROMIUM HYDROXIDE GREEN (UNII: RV8FT8XF5R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
140 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic04/01/2015
Part 2 of 3
ZO SKIN HEALTH OSSENTIAL DAILY POWER DEFENSE 
cleansing (cold creams, cleansing lotions, liquids, and pads) lotion
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRWATER (UNII: 059QF0KO0R)  
INGRCETEARYL ISONONANOATE (UNII: P5O01U99NI)  
INGRCYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
INGRCYCLOMETHICONE 6 (UNII: XHK3U310BA)  
INGRPENTYLENE GLYCOL (UNII: 50C1307PZG)  
INGRCETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
INGRGLYCERIN (UNII: PDC6A3C0OX)  
INGRSTEARETH-20 (UNII: L0Q8IK9E08)  
INGRCARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
INGRC14-22 ALCOHOLS (UNII: B1K89384RJ)  
INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
INGRCETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
INGRPOLYSORBATE 20 (UNII: 7T1F30V5YH)  
INGRBUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
INGRPALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)  
INGRSODIUM HYDROXIDE (UNII: 55X04QC32I)  
INGRCAPRYLYL GLYCOL (UNII: 00YIU5438U)  
INGRC12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA)  
INGRETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
INGRLACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
INGREDETATE DISODIUM (UNII: 7FLD91C86K)  
INGRPOWDERED CELLULOSE (UNII: SMD1X3XO9M)  
INGRHEXYLENE GLYCOL (UNII: KEH0A3F75J)  
INGRPOTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
INGR1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
INGRMETHYLPARABEN (UNII: A2I8C7HI9T)  
INGRLECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
INGRHYPROMELLOSES (UNII: 3NXW29V3WO)  
INGRSORBITOL (UNII: 506T60A25R)  
INGREDETIC ACID (UNII: 9G34HU7RV0)  
INGRBENZOIC ACID (UNII: 8SKN0B0MIM)  
INGRSODIUM BENZOATE (UNII: OJ245FE5EU)  
INGRARABIDOPSIS THALIANA (UNII: AI3L60HQ81)  
INGRRETINOL (UNII: G2SH0XKK91)  
INGRVITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
INGR.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
INGRLEMON OIL (UNII: I9GRO824LL)  
INGRMANDARIN OIL (UNII: NJO720F72R)  
INGRPEPPERMINT OIL (UNII: AV092KU4JH)  
INGRMIMOSA TENUIFLORA BARK (UNII: 515MQE449I)  
INGRTOCOPHEROL (UNII: R0ZB2556P8)  
INGRLIMONENE, (+)- (UNII: GFD7C86Q1W)  
INGRULTRAMARINE BLUE (UNII: I39WR998BI)  
INGREXT. D&C VIOLET NO. 2 (UNII: G5UX3K0728)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
130 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic04/01/2015
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 AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE82 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42851-053-0115 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35204/01/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35204/01/2015
Labeler - ZO Skin Health, Inc. (826468527)
Establishment
NameAddressID/FEIBusiness Operations
Lifetech Resources, LLC.081239587manufacture(42851-162)
Establishment
NameAddressID/FEIBusiness Operations
Thibiant International, Inc.083913913manufacture(42851-162)
Establishment
NameAddressID/FEIBusiness Operations
PakLab790530976manufacture(42851-162)

Revised: 6/2020
Document Id: a83c599c-97e9-e4dc-e053-2995a90a757b
Set id: f0511ded-4e60-4924-812b-c4f32c1065ab
Version: 2
Effective Time: 20200616
 
ZO Skin Health, Inc.