ZO SKIN HEALTH RENEW (TITANIUM DIOXIDE) KIT [ZO SKIN HEALTH, INC.]

ZO SKIN HEALTH RENEW (TITANIUM DIOXIDE) KIT [ZO SKIN HEALTH, INC.]
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NDC 42851-053-01, 42851-163-01
Set ID 3da6948a-d424-40b4-85da-0df8783de580
Category HUMAN OTC DRUG LABEL
Packager ZO Skin Health, Inc.
Generic Name
Product Class
Product Number
Application Number PART352
  • 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

    RE NEW

    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

    PRINCIPAL DISPLAY PANEL - Kit Carton
  • INGREDIENTS AND APPEARANCE
    ZO SKIN HEALTH RENEW 
    titanium dioxide kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42851-163
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42851-163-011 in 1 CARTON12/01/2015
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 TUBE 40 mL
    Part 21 JAR 16.2 g
    Part 31 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 AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWATER (UNII: 059QF0KO0R)  
    INGRSODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)  
    INGRSODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)  
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGRSTEARIC ACID (UNII: 4ELV7Z65AP)  
    INGRGLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    INGRPEG-100 STEARATE (UNII: YD01N1999R)  
    INGRGLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    INGRDISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)  
    INGRCETYL ALCOHOL (UNII: 936JST6JCN)  
    INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
    INGRSODIUM CHLORIDE (UNII: 451W47IQ8X)  
    INGRPANTHENOL (UNII: WV9CM0O67Z)  
    INGRUREA (UNII: 8W8T17847W)  
    INGRSODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    INGRSODIUM HYDROXIDE (UNII: 55X04QC32I)  
    INGRTREHALOSE (UNII: B8WCK70T7I)  
    INGRETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    INGRSODIUM GLYCOLATE (UNII: B75E535IMI)  
    INGRTRIACETIN (UNII: XHX3C3X673)  
    INGRCHLORPHENESIN (UNII: I670DAL4SZ)  
    INGRPOTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    INGRHYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    INGRSORBIC ACID (UNII: X045WJ989B)  
    INGRPOLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)  
    INGRALLANTOIN (UNII: 344S277G0Z)  
    INGRD&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    INGRFD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    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
    Cosmetic12/01/2015
    Part 2 of 3
    ZO SKIN HEALTH OFFECTS EXFOLIATING POLISH 
    cleansing (cold creams, cleansing lotions, liquids, and pads) cream
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRPOLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    INGRSODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    INGRDIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    INGRMAGNESIUM OXIDE (UNII: 3A3U0GI71G)  
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGROLETH-20 (UNII: YTH167I2AG)  
    INGRGLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    INGRTRIHYDROXYSTEARIN (UNII: 06YD7896S3)  
    INGRPEG-100 STEARATE (UNII: YD01N1999R)  
    INGR.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    INGRTETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    INGRVITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    INGRTEA TREE OIL (UNII: VIF565UC2G)  
    INGRASCORBYL PALMITATE (UNII: QN83US2B0N)  
    INGRSTEARYL GLYCYRRHETINATE (UNII: 3YYE6VJS0P)  
    INGRPROPYLPARABEN (UNII: Z8IX2SC1OH)  
    INGRLECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    INGRLINOLEIC ACID (UNII: 9KJL21T0QJ)  
    INGRMEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    INGRD&C GREEN NO. 6 (UNII: 4QP5U84YF7)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    116.2 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic12/01/2015
    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)  
    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 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 finalpart35212/01/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35212/01/2015
    Labeler - ZO Skin Health, Inc. (826468527)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lifetech Resources, LLC.081239587manufacture(42851-163)
    Establishment
    NameAddressID/FEIBusiness Operations
    Thibiant International, Inc.083913913manufacture(42851-163)

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