OBAGI 360 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) KIT [OMP, INC.]

OBAGI 360 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) KIT [OMP, INC.]
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NDC 62032-580-88
Set ID 4fa39b43-7a13-47de-88d6-6398a38c9de5
Category HUMAN OTC DRUG LABEL
Packager OMP, Inc.
Generic Name
Product Class
Product Number
Application Number PART352
  • Exfoliating Cleanser AM+PM

    Works to help clear clogged pores that can cause dull, dry, uneven skin. Gentle microbeads aid exfoliation. Gently yet thoroughly cleans your skin to reveal a soft, smooth, radiant complexion.

  • Directions

    Use twice daily, morning and evening. Wet hands and face, then massage cleanser onto skin with a gentle circular motion. Rinse with lukewarm water and gently pat dry.

  • Warnings

    Avoid getting into eyes. For external use only. Keep out of reach of children.

  • Ingredients

    water (aqua), polylactic acid, decyl glucoside, glycerin, sodium cocoyl isethionate, cocamidopropyl betaine, sodium lauroamphoacetate, sodium methyl cocoyl taurate, acrylates/C10-30 alkyl acrylate crosspolymer, fragrance, phenoxyethanol, caprylyl glycol, sodium PCA, panthenol, sodium hydroxide, chlorphenesin, ethylhexylglycerin, hexylene glycol, disodium EDTA, sodium hyaluronate, papain, carbomer, 1,2-hexanediol, algin

  • Retinol 0.5 PM

    Gradually releases retinol, refining the appearance of skin texture and tone for clearer-looking skin.

  • Directions

    Once daily in the evening, apply a pearl-size amount to the face and gently smooth until absorbed.

  • Warnings

    When using this product, you may experience mild redness, peeling, or skin irritation. These are normal, temporary indications the product is working. If irritation occurs, limit use to every other night, or as tolerated. When skin has adjusted, revert to daily use.

    Do not use if you are pregnant, lactating, planning to become pregnant, taking prescription acne medication, have compromised skin such as flaring dermatitis, or are undergoing skin peeling treatments. Daily use of a broad spectrum sunscreen with an SPF of 30 or higher is highly recommended.

    Avoid getting into eyes. If contact occurs, rinse thoroughly with water. For external use only. Keep out of reach of children.

  • Ingredients

    water (aqua), caprylic/capric triglyceride, glyceryl stearate, cyclopentasiloxane, butylene glycol, stearic acid, butyrospermum parkii (shea) butter, polysorbate 60, stearyl alcohol, glycerin, retinol, polysorbate 20, dimethicone, carthamus tinctorius (safflower) seed oil, calendula officinalis flower extract, camellia oleifera leaf extract, camellia sinensis leaf extract, chamomilla recutita (matricaria) flower extract, tocopheryl acetate, ascorbic acid, sodium hyaluronate, cyclohexasiloxane, sorbitol, BHT, bisabolol, allyl methacrylates crosspolymer, dimethicone/vinyl dimethicone crosspolymer, dipotassium glycyrrhizate, disodium EDTA, triethanolamine, carbomer, glyceryl acrylate/acrylic acid copolymer, caprylyl glycol, ethylhexylglycerin, hexylene, glycol, phenoxyethanol

  • HydraFactor Broad Spectrum SPF 30 AM

    Drug Facts

  • Active ingredients

    Avobenzone 1%
    Octinoxate 7.5%

    Octisalate 5%

    Oxybenzone 5%

  • 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 use 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
  • Inactive ingredients

    acrylates/C10-30 alkyl acrylate crosspolymer, butyloctyl salicylate, C12-15 alkyl benzoate, caesalpinia spinosa gum, caprylyl glycol, carbomer, dextrin, disodium EDTA, eperua falcata bark extract, ethylhexylglycerin, glycerin, hexylene glycol, hydrolyzed caesalpinia spinosa gum, phenoxyethanol, pichia/resveratrol ferment extract, polysorbate 20, sodium hyaluronate, sodium hydroxide, sorbitan oleate, tocopheryl acetate, ubiquinone, water

  • Other information

    store at controlled room temperature: 15°C–25°C (59°F–77°F)
    protect this product from excessive heat and direct sun
  • Questions or comments?

    1.800.636.7546
    Monday–Friday 9 a.m.–4 p.m. Pacific Time

  • Principal Display Panel - Kit Carton

    OBAGI 360

    Exfoliating Cleanser

    HydraFactor SPF 30

    Retinol 0.5

    OBAGI®

    MEDICAL

    Obagi 360 - Kit Carton
  • INGREDIENTS AND APPEARANCE
    OBAGI 360 
    avobenzone, octinoxate, octisalate, oxybenzone kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62032-580
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62032-580-881 in 1 CARTON; Type 0: Not a Combination Product09/08/2015
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 TUBE 75 g
    Part 21 TUBE 28 g
    Part 31 TUBE 150 mL
    Part 1 of 3
    OBAGI  HYDRAFACTOR BROAD SPECTRUM SPF 30
    sunscreen lotion
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE10 mg  in 1 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE50 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    CAESALPINIA SPINOSA RESIN (UNII: WL3883U2PO)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    ICODEXTRIN (UNII: 2NX48Z0A9G)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    EPERUA FALCATA BARK (UNII: L43J05M2KO)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    UBIDECARENONE (UNII: EJ27X76M46)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    175 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart352
    Part 2 of 3
    OBAGI  RETINOL 0.5
    night
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWATER (UNII: 059QF0KO0R)  
    INGRMEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    INGRCYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    INGRBUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    INGRSTEARIC ACID (UNII: 4ELV7Z65AP)  
    INGRSHEA BUTTER (UNII: K49155WL9Y)  
    INGRPOLYSORBATE 60 (UNII: CAL22UVI4M)  
    INGRSTEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGRRETINOL (UNII: G2SH0XKK91)  
    INGRPOLYSORBATE 20 (UNII: 7T1F30V5YH)  
    INGRDIMETHICONE (UNII: 92RU3N3Y1O)  
    INGRSAFFLOWER OIL (UNII: 65UEH262IS)  
    INGRCALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    INGRCAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)  
    INGRGREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    INGRCHAMOMILE (UNII: FGL3685T2X)  
    INGR.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    INGRASCORBIC ACID (UNII: PQ6CK8PD0R)  
    INGRHYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    INGRCYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    INGRSORBITOL (UNII: 506T60A25R)  
    INGRBUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    INGRGLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    INGREDETATE DISODIUM (UNII: 7FLD91C86K)  
    INGRCAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    INGRETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    INGRHEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    128 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic
    Part 3 of 3
    OBAGI  EXFOLIATING CLEANSER
    other personal cleanliness products
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWATER (UNII: 059QF0KO0R)  
    INGRDECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGRSODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)  
    INGRCOCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    INGRSODIUM LAUROAMPHOACETATE (UNII: SLK428451L)  
    INGRSODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)  
    INGRCARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
    INGRCAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    INGRSODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    INGRPANTHENOL (UNII: WV9CM0O67Z)  
    INGRSODIUM HYDROXIDE (UNII: 55X04QC32I)  
    INGRCHLORPHENESIN (UNII: I670DAL4SZ)  
    INGRETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    INGRHEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    INGREDETATE DISODIUM (UNII: 7FLD91C86K)  
    INGRHYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    INGRPAPAIN (UNII: A236A06Y32)  
    INGR1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35209/08/2015
    Labeler - OMP, Inc. (790553353)
    Establishment
    NameAddressID/FEIBusiness Operations
    G.S. COSMECEUTICAL USA, INC.017014734MANUFACTURE(62032-580) , LABEL(62032-580) , PACK(62032-580) , ANALYSIS(62032-580)

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