Label: ZO MEDICAL ZO NON-HYDROQUINONE HYPERPIGMENTATION SYSTEM FOR RESTORING EVEN SKIN TONE- titanium dioxide kit

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated April 12, 2016

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Titanium Dioxide 8%

  • 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.

    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.

  • Other information

    • Store product in a cool place away from direct heat and sunlight.
    • You may report a serious adverse reaction to: 5 Technology Dr. #100, Irvine, CA 92618
  • Directions

    • For full protection, apply liberally 15 minutes before sun exposure.
    • Use a water resistant sunscreen if swimming or sweating.
    • Reapply at least every 2 hours.
    • For children under 6 months of age: 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.
  • Inactive ingredients

    Water, Aluminum Hydroxide, Stearic Acid, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Cyclopentasiloxane, Phenyl Trimethicone, Styrene/Acrylates Copolymer, Pentylene Glycol, Dimethicone, Glycerin, Isodecyl Neopentanoate, Diisopropyl Sebacate, Lauryl Lactate, Polyacrylamide, Disodium EDTA, Phytosphingosine, Ceteareth-20, Cetearyl Alcohol, PEG-100 Stearate, Glyceryl Stearate, Sodium Dihydroxycetyl Phosphate, Hydrogenated Palm Glycerides, Melanin, Ethylhexylglycerin, Erythritol, Homarine HCL, Sodium Benzoate, Potassium Sorbate, Phenoxyethanol, Caprylyl Glycol, Chlorphenesin, Nephelium Lappaceum Peel Extract, Glycine Soja (Soybean) Extract, Silica, C13-14 Isoparaffin, Laureth-7.

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - Kit Carton

    ZO® MEDICAL
    BY ZEIN OBAGI MD

    NDC 42851-156-60

    ZO® NON-HYDROQUINONE HYPERPIGMENTATION SYSTEM

    For Restoring Even Skin Tone

    Principal Display Panel - Kit Carton
  • INGREDIENTS AND APPEARANCE
    ZO MEDICAL ZO NON-HYDROQUINONE HYPERPIGMENTATION SYSTEM FOR RESTORING EVEN SKIN TONE  
    titanium dioxide kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42851-156
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42851-156-601 in 1 CARTON06/01/2014
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 TUBE 30 mL
    Part 21 TUBE 30 mL
    Part 31 TUBE 60 g
    Part 41 TUBE 30 mL
    Part 51 BOTTLE, PUMP 30 mL
    Part 1 of 5
    RETAMAX ACTIVE VITAMIN A MICRO EMULSION  
    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)  
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGRCYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    INGRCETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    INGRSTEARETH-20 (UNII: L0Q8IK9E08)  
    INGRPENTYLENE GLYCOL (UNII: 50C1307PZG)  
    INGRCETYL ALCOHOL (UNII: 936JST6JCN)  
    INGRSUNFLOWER OIL (UNII: 3W1JG795YI)  
    INGRRETINOL (UNII: G2SH0XKK91)  
    INGRPROPYLHEPTYL CAPRYLATE (UNII: 991Z19V2OD)  
    INGRPOLYSORBATE 20 (UNII: 7T1F30V5YH)  
    INGRCETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    INGRCAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    INGR1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    INGRAPRICOT KERNEL OIL (UNII: 54JB35T06A)  
    INGRCARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    INGRBROCCOLI (UNII: UOI4FT57BZ)  
    INGRPOLYISOBUTYLENE (1300 MW) (UNII: 241BN7J12Y)  
    INGR.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    INGRASCORBYL PALMITATE (UNII: QN83US2B0N)  
    INGRPOTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    INGRBUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    INGRLECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    INGRHYDROLYZED SERICIN (ENZYMATIC; 2500 MW) (UNII: 02EMA6F96C)  
    INGRSODIUM SULFITE (UNII: VTK01UQK3G)  
    INGRSODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    INGRSODIUM HYDROXIDE (UNII: 55X04QC32I)  
    INGREDETATE DISODIUM (UNII: 7FLD91C86K)  
    INGRCYCLOMETHICONE 4 (UNII: CZ227117JE)  
    INGRSTEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    INGRSORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    INGRMYRISTYL ALCOHOL (UNII: V42034O9PU)  
    INGRBUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    INGRLINALYL ACETATE (UNII: 5K47SSQ51G)  
    INGRCURDLAN (UNII: 6930DL209R)  
    INGRXANTHAN GUM (UNII: TTV12P4NEE)  
    INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
    INGRHEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    INGRBUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
    INGRPELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)  
    INGRETHYL NICOTINATE (UNII: NIJ3H353YH)  
    INGRSodium Benzoate (UNII: OJ245FE5EU)  
    INGRBenzoic Acid (UNII: 8SKN0B0MIM)  
    INGRCARVOMENTHONE (UNII: D5PYY1B83Q)  
    INGRLAVANDULA ANGUSTIFOLIA FLOWERING TOP (UNII: 9YT4B71U8P)  
    INGR.ALPHA.-OCIMENE, (3Z)- (UNII: LTP9229T5N)  
    INGR4-CARVOMENTHENOL (UNII: L65MV77ZG6)  
    INGRTOCOPHEROL (UNII: R0ZB2556P8)  
    INGREXT. D&C VIOLET NO. 2 (UNII: G5UX3K0728)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    130 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic01/11/2012
    Part 2 of 5
    BRIGHTENEX SKIN BRIGHTENER AND CORRECTING, NON-HYDROQUINONE  
    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)  
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGRALMOND OIL (UNII: 66YXD4DKO9)  
    INGRCYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    INGRCETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    INGRSTEARETH-20 (UNII: L0Q8IK9E08)  
    INGRCETYL ALCOHOL (UNII: 936JST6JCN)  
    INGRPENTYLENE GLYCOL (UNII: 50C1307PZG)  
    INGRASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)  
    INGRPOLYSORBATE 20 (UNII: 7T1F30V5YH)  
    INGRRETINOL (UNII: G2SH0XKK91)  
    INGRCARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    INGREDETATE DISODIUM (UNII: 7FLD91C86K)  
    INGRCYCLOMETHICONE 4 (UNII: CZ227117JE)  
    INGRCETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    INGRAPRICOT KERNEL OIL (UNII: 54JB35T06A)  
    INGREGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
    INGRSODIUM HYDROXIDE (UNII: 55X04QC32I)  
    INGRASCORBYL PALMITATE (UNII: QN83US2B0N)  
    INGRGLUTATHIONE (UNII: GAN16C9B8O)  
    INGR.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    INGRPROPYLHEPTYL CAPRYLATE (UNII: 991Z19V2OD)  
    INGRTOCOPHEROL (UNII: R0ZB2556P8)  
    INGRN-ACETYLGLUCOSAMINE (UNII: V956696549)  
    INGRSODIUM CHLORIDE (UNII: 451W47IQ8X)  
    INGR1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    INGRCAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    INGRPOTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    INGRMALTODEXTRIN (UNII: 7CVR7L4A2D)  
    INGRLECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    INGRSOY ISOFLAVONES (UNII: 71B37NR06D)  
    INGRPOLYSORBATE 61 (UNII: X9E1MY2JQG)  
    INGRALCOHOL (UNII: 3K9958V90M)  
    INGRNYLON-12 (UNII: 446U8J075B)  
    INGRSODIUM SULFITE (UNII: VTK01UQK3G)  
    INGRSODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    INGRCORN OIL (UNII: 8470G57WFM)  
    INGR.BETA.-CAROTENE (UNII: 01YAE03M7J)  
    INGRBUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    INGRBUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
    INGRSODIUM BENZOATE (UNII: OJ245FE5EU)  
    INGRGLUCONOLACTONE (UNII: WQ29KQ9POT)  
    INGRPOLYISOBUTYLENE (1300 MW) (UNII: 241BN7J12Y)  
    INGRSORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    INGRLAVENDER OIL (UNII: ZBP1YXW0H8)  
    INGRGERANIUM OIL, ALGERIAN TYPE (UNII: 5Q1I94P4WG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    130 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic01/11/2012
    Part 3 of 5
    ZO MEDICAL OCLIPSE-C BROAD-SPECTRUM SUNSCREEN SPF 50  
    titanium dioxide lotion
    Product Information
    Item Code (Source)NDC:42851-052
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.08 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LAURYL LACTATE (UNII: G5SU0BFK7O)  
    ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)  
    DIISOPROPYL SEBACATE (UNII: J8T3X564IH)  
    POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)  
    SODIUM DIHYDROXYCETYL PHOSPHATE (UNII: YWI33EV595)  
    PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
    HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)  
    MELAMINE (UNII: N3GP2YSD88)  
    ERYTHRITOL (UNII: RA96B954X6)  
    HOMARINE HYDROCHLORIDE (UNII: 8866LNG61N)  
    NEPHELIUM LAPPACEUM FRUIT RIND (UNII: Y0513T90FO)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    LAURETH-7 (UNII: Z95S6G8201)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42851-052-6060 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35206/01/2013
    Part 4 of 5
    RESTORACALM SOOTHING RECOVERY  
    cleansing (cold creams, cleansing lotions, liquids, and pads) lotion
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWATER (UNII: 059QF0KO0R)  
    INGRBUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    INGRBIOSACCHARIDE GUM-4 (UNII: 9XRL057X90)  
    INGRSHEA BUTTER (UNII: K49155WL9Y)  
    INGRETHYLHEXYL PALMITATE (UNII: 2865993309)  
    INGRJOJOBA BUTTER (UNII: XIA46H803R)  
    INGRCURDLAN (UNII: 6930DL209R)  
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGRC10-30 CHOLESTEROL/LANOSTEROL ESTERS (UNII: 137SL7IL0Y)  
    INGRCETYL ALCOHOL (UNII: 936JST6JCN)  
    INGRDICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    INGRISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    INGRETHYLHEXYL ISONONANOATE (UNII: I6KB4GE3K4)  
    INGRARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
    INGRPEG-100 STEARATE (UNII: YD01N1999R)  
    INGRGLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    INGRARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
    INGRDOCOSANOL (UNII: 9G1OE216XY)  
    INGRDIMETHICONE (UNII: 92RU3N3Y1O)  
    INGRCAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    INGRN-ACETYLTYROSINE (UNII: DA8G610ZO5)  
    INGRHYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)  
    INGRLECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    INGRHYDROLYZED SERICIN (ENZYMATIC; 2500 MW) (UNII: 02EMA6F96C)  
    INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
    INGRSUNFLOWER OIL (UNII: 3W1JG795YI)  
    INGRETHYL FERULATE (UNII: 5B8915UELW)  
    INGRPOLYGLYCERYL-10 OLEATE (UNII: 55C81W76DH)  
    INGRROSEMARY (UNII: IJ67X351P9)  
    INGRURIDINE MONOPHOSPHATE DISODIUM (UNII: KD8E20071T)  
    INGRSULFURYL FLUORIDE (UNII: 64B59K7U6Q)  
    INGRCARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    INGR1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    INGRPROLINE (UNII: 9DLQ4CIU6V)  
    INGRRETINOL (UNII: G2SH0XKK91)  
    INGRPOTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    INGRPOLYSORBATE 20 (UNII: 7T1F30V5YH)  
    INGRDEHYDROACETIC ACID (UNII: 2KAG279R6R)  
    INGRANGELICA SINENSIS ROOT (UNII: B66F4574UG)  
    INGRADENOSINE TRIPHOSPHATE (UNII: 8L70Q75FXE)  
    INGRHEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    INGREDETATE DISODIUM (UNII: 7FLD91C86K)  
    INGRPOTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    INGRXANTHAN GUM (UNII: TTV12P4NEE)  
    INGRBUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    INGRBUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    130 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic01/11/2012
    Part 5 of 5
    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, UNSPECIFIED FORM (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 HEXAPEPTIDE-12 (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; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic01/11/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35205/01/2014
    Labeler - ZO Skin Health, Inc. (826468527)
    Establishment
    NameAddressID/FEIBusiness Operations
    THIBIANT INTERNATIONAL, INC.083913913MANUFACTURE(42851-156)
    Establishment
    NameAddressID/FEIBusiness Operations
    SANITOR CORPORATION797472792MANUFACTURE(42851-156)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lifetech Resources622559110MANUFACTURE(42851-156)
    Establishment
    NameAddressID/FEIBusiness Operations
    PAKLAB790530976MANUFACTURE(42851-156)