ZO SKIN HEALTH ORASER ANTI-AGING HAND CARE PROGRAM CORRECT, PROTECT AND PREVENT AGING HANDS (AVOBENZONE, OCTINOXATE, AND OXYBENZONE) KIT [ZO SKIN HEALTH, INC.]

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  • ZO SKIN HEALTH ORASER ANTI-AGING HAND CARE PROGRAM CORRECT, PROTECT AND PREVENT AGING HANDS (AVOBENZONE, OCTINOXATE, AND OXYBENZONE) KIT [ZO SKIN HEALTH, INC.]

ZO SKIN HEALTH ORASER ANTI-AGING HAND CARE PROGRAM CORRECT, PROTECT AND PREVENT AGING HANDS (AVOBENZONE, OCTINOXATE, AND OXYBENZONE) KIT [ZO SKIN HEALTH, INC.]
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NDC 42851-050-04, 42851-151-04
Set ID a514c884-3e7b-4c1a-9a9d-f5fe891cd288
Category HUMAN OTC DRUG LABEL
Packager ZO Skin Health, Inc.
Generic Name
Product Class
Product Number
Application Number PART352
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Avobenzone 3.0%Sunscreen
    Octinoxate 7.5%Sunscreen
    Oxybenzone 2.0%Sunscreen
  • Uses

    • Helps prevent sunburn
    • If used as directed with other sun protection measures (see Directions) decreases the risk of of skin cancer and early aging caused by the sun.
  • Warnings

    For external use only.

    Do not use on damaged skin.

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

    Stop using this product if skin 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
    • 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
  • Other information

    • Protect the product in this container from excessive heat and direct sunlight
    • You may report a serious adverse reaction event from using this product to ZO Skin Health, Inc. 1 Technology Drive, Irvine, CA 92618
  • Inactive ingredients

    Water (Aqua), Caprylic/Capric Triglyceride, Glycerin, C12-15 Alkyl Benzoate, Butyrospermum Parkii (Shea) Butter, Cetearyl Alcohol, Styrene/Acrylates Copolymer, Butyloctyl Salicylate, Pentylene Glycol, Polysorbate 60, Cetyl Alcohol, Stearic Acid, Dimethicone, Phenoxyethanol, Ceteth-10 Phosphate, Dicetyl Phosphate, Tocopheryl Acetate, Tetrahexyldecyl Ascorbate, Ethylhexyl Palmitate, Aminomethyl Propanol, Butylene Glycol, Fragrance (Parfum), Panthenol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Sodium PCA, Sodium Lactate, Capryloyl Glycine, Dipotassium Glycyrrhizate, Laminaria Ochroleuca Extract, Sodium Ascorbate, Tocopherol, Undecylenoyl Glycine, Arginine, Aspartic Acid, Disodium EDTA, PCA, Retinol, Carbomer, Glycine, Silica Dimethyl Silylate, Alanine, Polysorbate 20, Serine, Valine, Isoleucine, Proline, Threonine, Diacetyl Boldine, Histidine, Phenylalanine, Sodium Hyaluronate, Ubiquinone, Palmitoyl Oligopeptide, Palmitoyl Tetrapeptide-7.

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - Kit Carton

    ZO® SKIN HEALTH
    BY ZEIN OBAGI, MD

    ORASER® ANTI-AGING HAND CARE PROGRAM

    Correct, protect and prevent aging hands

    beverly hills

    Principal Display Panel - Kit Carton
  • INGREDIENTS AND APPEARANCE
    ZO SKIN HEALTH ORASER ANTI-AGING HAND CARE PROGRAM CORRECT, PROTECT AND PREVENT AGING HANDS 
    avobenzone, octinoxate, and oxybenzone kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42851-151
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42851-151-041 in 1 CARTON04/01/2013
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 JAR 15 g
    Part 21 TUBE 40 mL
    Part 31 TUBE 40 mL
    Part 1 of 3
    ZO SKIN HEALTH ORASER MICRODERM HAND RENEWAL 
    cleansing (cold creams, cleansing lotions, liquids, and pads) cream
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRSUCROSE (UNII: C151H8M554)  
    INGRSHEA BUTTER (UNII: K49155WL9Y)  
    INGRSAFFLOWER OIL (UNII: 65UEH262IS)  
    INGRMANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)  
    INGRDIPENTAERYTHRITYL HEXA C5-9 ACID ESTERS (UNII: D818OLQ51Z)  
    INGRGLYCERYL DIBEHENATE (UNII: R8WTH25YS2)  
    INGRTRIBEHENIN (UNII: 8OC9U7TQZ0)  
    INGRCETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)  
    INGRSALICYLIC ACID (UNII: O414PZ4LPZ)  
    INGRUBIDECARENONE (UNII: EJ27X76M46)  
    INGR.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    INGRALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    INGRRETINOL (UNII: G2SH0XKK91)  
    INGRPOLYSORBATE 20 (UNII: 7T1F30V5YH)  
    INGRMANNITOL (UNII: 3OWL53L36A)  
    INGRPOWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    INGRHYPROMELLOSES (UNII: 3NXW29V3WO)  
    INGRVITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    INGRTOCOPHEROL (UNII: R0ZB2556P8)  
    INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
    INGRFRAGARIN (UNII: 0416TL8388)  
    INGRULTRAMARINE BLUE (UNII: I39WR998BI)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    115 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic01/01/2012
    Part 2 of 3
    ZO SKIN HEALTH ORASER OVERNIGHT HAND RECOVERY 
    cleansing (cold creams, cleansing lotions, liquids, and pads) cream
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWATER (UNII: 059QF0KO0R)  
    INGRDIPENTAERYTHRITYL HEXA C5-9 ACID ESTERS (UNII: D818OLQ51Z)  
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGRSHEA BUTTER (UNII: K49155WL9Y)  
    INGRBUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    INGRMEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    INGRDIMETHICONE (UNII: 92RU3N3Y1O)  
    INGRNIACINAMIDE (UNII: 25X51I8RD4)  
    INGRTETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    INGRMEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)  
    INGRSTEARIC ACID (UNII: 4ELV7Z65AP)  
    INGRCETYL PHOSPHATE (UNII: VT07D6X67O)  
    INGRGLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    INGRPEG-100 STEARATE (UNII: YD01N1999R)  
    INGRMANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)  
    INGRHEXYLDECANOL (UNII: 151Z7P1317)  
    INGRAVOCADO OIL (UNII: 6VNO72PFC1)  
    INGRAMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
    INGRCARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    INGRFRAGARIN (UNII: 0416TL8388)  
    INGRCHLORPHENESIN (UNII: I670DAL4SZ)  
    INGRCAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    INGRUREA (UNII: 8W8T17847W)  
    INGRGLUCOSAMINE HYDROCHLORIDE (UNII: 750W5330FY)  
    INGRALOE (UNII: V5VD430YW9)  
    INGRSACCHAROMYCES CEREVISIAE (UNII: 978D8U419H)  
    INGRSODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    INGRSODIUM LACTATE (UNII: TU7HW0W0QT)  
    INGRLEVOMENOL (UNII: 24WE03BX2T)  
    INGREDETATE DISODIUM (UNII: 7FLD91C86K)  
    INGRARGININE (UNII: 94ZLA3W45F)  
    INGRCETYLHYDROXYPROLINE PALMITAMIDE (UNII: 74ONU0S62G)  
    INGRASPARTIC ACID (UNII: 30KYC7MIAI)  
    INGRPIDOLIC ACID (UNII: SZB83O1W42)  
    INGRETHYLHEXYL PALMITATE (UNII: 2865993309)  
    INGRALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    INGRGLYCINE (UNII: TE7660XO1C)  
    INGRALANINE (UNII: OF5P57N2ZX)  
    INGRRAPESEED STEROL (UNII: B46B6DD20U)  
    INGRSERINE (UNII: 452VLY9402)  
    INGRVALINE (UNII: HG18B9YRS7)  
    INGRDIACETYL BOLDINE (UNII: 37727Z7M0I)  
    INGRISOLEUCINE (UNII: 04Y7590D77)  
    INGRPROLINE (UNII: 9DLQ4CIU6V)  
    INGRTHREONINE (UNII: 2ZD004190S)  
    INGR.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    INGRHISTIDINE (UNII: 4QD397987E)  
    INGRPHENYLALANINE (UNII: 47E5O17Y3R)  
    INGRUBIDECARENONE (UNII: EJ27X76M46)  
    INGRSILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    INGRHYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    INGRBUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    INGRPOLYSORBATE 20 (UNII: 7T1F30V5YH)  
    INGRRETINOL (UNII: G2SH0XKK91)  
    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
    Cosmetic01/01/2012
    Part 3 of 3
    ORASER DAILY HAND REPAIR BROAD-SPECTRUM SPF 20 SUNSCREEN 
    avobenzone, octinoxate, and oxybenzone lotion
    Product Information
    Item Code (Source)NDC:42851-050
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone30 mg  in 1 mL
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate75 mg  in 1 mL
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Medium-Chain Triglycerides (UNII: C9H2L21V7U)  
    Glycerin (UNII: PDC6A3C0OX)  
    Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)  
    Shea Butter (UNII: K49155WL9Y)  
    Cetostearyl Alcohol (UNII: 2DMT128M1S)  
    Styrene (UNII: 44LJ2U959V)  
    Butyloctyl Salicylate (UNII: 2EH13UN8D3)  
    Pentylene Glycol (UNII: 50C1307PZG)  
    Polysorbate 60 (UNII: CAL22UVI4M)  
    Cetyl Alcohol (UNII: 936JST6JCN)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Ceteth-10 Phosphate (UNII: 4E05O5N49G)  
    Dihexadecyl Phosphate (UNII: 2V6E5WN99N)  
    .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
    Tetrahexyldecyl Ascorbate (UNII: 9LBV3F07AZ)  
    Ethylhexyl Palmitate (UNII: 2865993309)  
    Aminomethylpropanol (UNII: LU49E6626Q)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Panthenol (UNII: WV9CM0O67Z)  
    Carbomer Interpolymer Type A (Allyl Sucrose Crosslinked) (UNII: 59TL3WG5CO)  
    Sodium Pyrrolidone Carboxylate (UNII: 469OTG57A2)  
    Sodium Lactate (UNII: TU7HW0W0QT)  
    Capryloyl Glycine (UNII: 8TY5YO42NJ)  
    Glycyrrhizinate Dipotassium (UNII: CA2Y0FE3FX)  
    Laminaria Ochroleuca (UNII: 4R2124HE76)  
    Sodium Ascorbate (UNII: S033EH8359)  
    Tocopherol (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42851-050-0440 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35201/01/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35203/01/2013
    Labeler - ZO Skin Health, Inc. (826468527)
    Establishment
    NameAddressID/FEIBusiness Operations
    PAKLAB790530976MANUFACTURE(42851-151)
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