ZO SKIN HEALTH LEVEL III AGGRESSIVE ANTI-AGING PROGRAM WITH ADVANCED RADICAL NIGHT REPAIR (TITANIUM DIOXIDE AND ZINC OXIDE) KIT [ZO SKIN HEALTH, INC.]

ZO SKIN HEALTH LEVEL III AGGRESSIVE ANTI-AGING PROGRAM WITH ADVANCED RADICAL NIGHT REPAIR (TITANIUM DIOXIDE AND ZINC OXIDE) KIT [ZO SKIN HEALTH, INC.]
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NDC 42851-051-01, 42851-154-01
Set ID 7548e51e-9438-4664-87cc-e9a70397f00f
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 INGREDIENT

    Active ingredientsPurpose
    Titanium Dioxide 10.2%Sunscreen
    Zinc Oxide 3.7%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.

    Stop and ask a doctor if rash occurs.

    When using this product keep out of eyes. Rinse with water to remove.

    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: 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.
    • Apply to all skin exposed to the sun
  • Other information

    • Protect the product in this container from excessive heat and direct sunlight.
    • You may report a serious adverse reaction to:
      1 Technology Dr., B123, Irvine, CA 92618
  • Inactive ingredients

    Cyclopentasiloxane, Cyclotetrasiloxane,Dimethicone/Vinyl Dimethicone Crosspolymer, Methyl Methacrylate/Glycol Dimethacrylate Crosspolymer, Dimethicone Crosspolymer, Melanin,Tribehenin, Calcium Behenate, Sorbitan Isostearate, Dimethiconol, Alumina, Laureth-23, Methicone, PEG-10 Dimethicone, PPG-2 Myristyl Ether Propionate, Propylparaben, Methylparaben, Myristoyl Pentapeptide-8, Iron Oxide (CI 77492).

  • SPL UNCLASSIFIED SECTION

    DIST BY

    ZO Skin Health, Inc. Irvine, CA 92618

  • PRINCIPAL DISPLAY PANEL - Kit Carton

    ZO® SKIN HEALTH
    BY ZEIN OBAGI, MD

    LEVEL III: AGGRESSIVE ANTI-AGING PROGRAM

    with Advanced Radical Night Repair

    NDC 42851-154-01

    beverly hills

    Principal Display Panel - Kit Carton
  • INGREDIENTS AND APPEARANCE
    ZO SKIN HEALTH  LEVEL III AGGRESSIVE ANTI-AGING PROGRAM WITH ADVANCED RADICAL NIGHT REPAIR
    titanium dioxide and zinc oxide kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42851-154
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42851-154-011 in 1 CARTON
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 JAR 16.2 g
    Part 21 TUBE 40 mL
    Part 31 JAR 50 mL
    Part 41 BOTTLE, PUMP 30 mL
    Part 51 TUBE, WITH APPLICATOR 30 mL
    Part 61 BOTTLE, PUMP 15 mL
    Part 1 of 6
    OFFECTS EXFOLIATING POLISH ANTI-AGING FORMULA 
    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)  
    INGRTETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    INGR.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    INGRVITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    INGRASCORBYL PALMITATE (UNII: QN83US2B0N)  
    INGRMEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    INGRLINOLEIC ACID (UNII: 9KJL21T0QJ)  
    INGRSOY STEROL (UNII: PL360EPO9J)  
    INGROMEGA-3 FATTY ACIDS (UNII: 71M78END5S)  
    INGRTEA TREE OIL (UNII: VIF565UC2G)  
    INGRPROPYLPARABEN (UNII: Z8IX2SC1OH)  
    INGRSTEARYL GLYCYRRHETINATE (UNII: 3YYE6VJS0P)  
    INGRD&C GREEN NO. 6 (UNII: 4QP5U84YF7)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    116.2 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    COSMETIC01/11/2012
    Part 2 of 6
    OFFECTS HYDRATING CLEANSER NORMAL TO DRY SKIN ANTI-AGING FORMULA 
    cleansing (cold creams, cleansing lotions, liquids, and pads) lotion
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWATER (UNII: 059QF0KO0R)  
    INGRSODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)  
    INGRSODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)  
    INGRDISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)  
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGRSODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    INGRUREA (UNII: 8W8T17847W)  
    INGRTREHALOSE (UNII: B8WCK70T7I)  
    INGRHYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    INGRGLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    INGRPEG-100 STEARATE (UNII: YD01N1999R)  
    INGRCETYL ALCOHOL (UNII: 936JST6JCN)  
    INGRGLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    INGRSTEARIC ACID (UNII: 4ELV7Z65AP)  
    INGRALLANTOIN (UNII: 344S277G0Z)  
    INGRPANTHENOL (UNII: WV9CM0O67Z)  
    INGRSODIUM HYDROXIDE (UNII: 55X04QC32I)  
    INGRMETHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    INGRMETHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    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
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    COSMETIC01/11/2012
    Part 3 of 6
    OMMERSE RENEWAL ANTI-AGING FORMULA 
    cleansing (cold creams, cleansing lotions, liquids, and pads) cream
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWATER (UNII: 059QF0KO0R)  
    INGRISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    INGRISOCETYL STEARATE (UNII: 3RJ7186O9W)  
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGRCETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    INGRPolysorbate 60 (UNII: CAL22UVI4M)  
    INGREGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
    INGRJOJOBA BUTTER (UNII: XIA46H803R)  
    INGRSILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    INGROAT (UNII: Z6J799EAJK)  
    INGRRETINOL (UNII: G2SH0XKK91)  
    INGRC10-18 TRIGLYCERIDES (UNII: 43AGM4PHPI)  
    INGRBUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
    INGRECTOINE (UNII: 7GXZ3858RY)  
    INGRSTEARETH-21 (UNII: 53J3F32P58)  
    INGRCOCOS NUCIFERA WHOLE (UNII: 245J88W96L)  
    INGRGARDENIA TAITENSIS FLOWER (UNII: T0OCU8201Y)  
    INGRDIMETHICONE (UNII: 92RU3N3Y1O)  
    INGRLAURETH-23 (UNII: N72LMW566G)  
    INGRTOCOPHEROL (UNII: R0ZB2556P8)  
    INGRMAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)  
    INGRCARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    INGRSTEARETH-2 (UNII: V56DFE46J5)  
    INGRCAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    INGRSODIUM HYDROXIDE (UNII: 55X04QC32I)  
    INGREDETATE SODIUM (UNII: MP1J8420LU)  
    INGRETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    INGRSOYBEAN OIL (UNII: 241ATL177A)  
    INGRHEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    INGREPILOBIUM ANGUSTIFOLIUM FLOWERING TOP (UNII: 08H094218D)  
    INGRHYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    INGRHYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    INGRSOY STEROL (UNII: PL360EPO9J)  
    INGRUBIDECARENONE (UNII: EJ27X76M46)  
    INGRSodium Chloride (UNII: 451W47IQ8X)  
    INGRSodium Metabisulfite (UNII: 4VON5FNS3C)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    150 mL in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    COSMETIC01/11/2012
    Part 4 of 6
    OSSENTIAL DAILY POWER DEFENSE ANTI-AGING FORMULA 
    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)  
    INGRRETINOL (UNII: G2SH0XKK91)  
    INGREGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
    INGRPOLYSORBATE 20 (UNII: 7T1F30V5YH)  
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGRSTEARETH-20 (UNII: L0Q8IK9E08)  
    INGRCETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    INGRJOJOBA BUTTER (UNII: XIA46H803R)  
    INGRVITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    INGR.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    INGRCURDLAN (UNII: 6930DL209R)  
    INGRLACTOSE (UNII: J2B2A4N98G)  
    INGRORANGE OIL (UNII: AKN3KSD11B)  
    INGRMANDARIN OIL (UNII: NJO720F72R)  
    INGRLEMON OIL (UNII: I9GRO824LL)  
    INGRPEPPERMINT OIL (UNII: AV092KU4JH)  
    INGRMIMOSA TENUIFLORA BARK (UNII: 515MQE449I)  
    INGRARABIDOPSIS THALIANA (UNII: AI3L60HQ81)  
    INGRC14-22 ALCOHOLS (UNII: B1K89384RJ)  
    INGRCETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    INGRC12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA)  
    INGRPOWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    INGRBUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    INGRPALMITOYL OLIGOPEPTIDE (UNII: HO4ZT5S86C)  
    INGRPALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)  
    INGRSODIUM HYDROXIDE (UNII: 55X04QC32I)  
    INGRCARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    INGRHYPROMELLOSES (UNII: 3NXW29V3WO)  
    INGRHEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    INGREDETATE DISODIUM (UNII: 7FLD91C86K)  
    INGRCAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    INGRETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
    INGRLIMONENE, (+/-)- (UNII: 9MC3I34447)  
    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
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    COSMETIC01/11/2012
    Part 5 of 6
    OSSENTIAL ADVANCED RADICAL NIGHT REPAIR ANTI-AGING FORMULA 
    cleansing (cold creams, cleansing lotions, liquids, and pads) lotion
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRCYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    INGRDIMETHICONE (UNII: 92RU3N3Y1O)  
    INGRALMOND OIL (UNII: 66YXD4DKO9)  
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGRPOLYSORBATE 20 (UNII: 7T1F30V5YH)  
    INGRWATER (UNII: 059QF0KO0R)  
    INGRRETINOL (UNII: G2SH0XKK91)  
    INGRCYCLOMETHICONE 4 (UNII: CZ227117JE)  
    INGRDIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
    INGRPLUKENETIA VOLUBILIS SEED OIL (UNII: 8ED72Z8J1Z)  
    INGROLEYL ALCOHOL (UNII: 172F2WN8DV)  
    INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
    INGR.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    INGRSUNFLOWER OIL (UNII: 3W1JG795YI)  
    INGRBUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    INGRCHLORPHENESIN (UNII: I670DAL4SZ)  
    INGRZANTHOXYLUM BUNGEANUM FRUIT (UNII: 3CIP16A418)  
    INGRSODIUM SULFITE (UNII: VTK01UQK3G)  
    INGRCAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    INGRASCORBYL PALMITATE (UNII: QN83US2B0N)  
    INGRGLUCONOLACTONE (UNII: WQ29KQ9POT)  
    INGRBUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
    INGRROSEMARY (UNII: IJ67X351P9)  
    INGRSODIUM BENZOATE (UNII: OJ245FE5EU)  
    INGREGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
    INGRXANTHAN GUM (UNII: TTV12P4NEE)  
    INGRTOCOPHEROL (UNII: R0ZB2556P8)  
    INGRASCORBIC ACID (UNII: PQ6CK8PD0R)  
    INGRCORN OIL (UNII: 8470G57WFM)  
    INGR.BETA.-CAROTENE (UNII: 01YAE03M7J)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    130 mL in 1 TUBE, WITH APPLICATOR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    COSMETIC01/11/2012
    Part 6 of 6
    OCLIPSE SUNSCREEN PLUS PRIMER BROAD-SPECTRUM SPF 30 UVA/UVB PROTECTION 
    titanium dioxide and zinc oxide lotion
    Product Information
    Item Code (Source)NDC:42851-051
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide102 mg  in 1 mL
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide37 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    CYCLOMETHICONE 4 (UNII: CZ227117JE)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)  
    TRIBEHENIN (UNII: 8OC9U7TQZ0)  
    CALCIUM BEHENATE (UNII: J5VFA9V6YG)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    DIMETHICONOL (40 CST) (UNII: 343C7U75XW)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    LAURETH-23 (UNII: N72LMW566G)  
    METHICONE (20 CST) (UNII: 6777U11MKT)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    PPG-2 MYRISTYL ETHER PROPIONATE (UNII: 88R97D8U8A)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42851-051-0115 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35201/11/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35201/11/2012
    Labeler - ZO Skin Health, Inc. (826468527)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lifetech Resources622559110MANUFACTURE(42851-154)
    Establishment
    NameAddressID/FEIBusiness Operations
    PakLab177711082MANUFACTURE(42851-154)
    Establishment
    NameAddressID/FEIBusiness Operations
    Thibiant International083913913MANUFACTURE(42851-154)
    Establishment
    NameAddressID/FEIBusiness Operations
    Owen Biosciences790003045MANUFACTURE(42851-154)

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