MANICURE BY OPI - FINISHING BUTTER (OCTINOXATE, OXYBENZONE) CREAM [OPI PRODUCTS, INC]

MANICURE BY OPI - FINISHING BUTTER (OCTINOXATE, OXYBENZONE) CREAM [OPI PRODUCTS, INC]
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NDC 61852-978-04, 61852-978-85
Set ID a9287997-6c24-4452-8191-bd46dd2d8c76
Category HUMAN OTC DRUG LABEL
Packager OPI Products, Inc
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    Drug Facts
    Active ingredients . . . . . . . . . . . . . . . . .        Purpose
    Octinoxate 7.5% . . . . . . . . . . . . . . . . . . . . . . . Sunscreen
    Oxybenzone 3.5%. . . . . . . . . . . . . . . . . . . . . . Sunscreen

  • PURPOSE

    Use
    • Helps prevent sunburn
    • Provides moderate protection against sunburn

  • WARNINGS

    Warnings
    For external use only
    When using this product keep out of eyes. Rinse
    with water to remove.
    Stop use and ask a doctor if irritation develops and
    lasts.

  • DOSAGE & ADMINISTRATION

    Directions
    • Apply evenly before sun exposure and as needed.
    • Children under 6 months of age: ask a doctor

  • INACTIVE INGREDIENT

    Inactive Ingredients Water/Aqua/Eau,
    Cyclopentasiloxane, Caprylyl Methicone, Sucrose
    Stearate, Dimethicone Crosspolymer, Glyceryl Stearate,
    PEG-100 Stearate, Hydroxyethyl Acrylate/Sodium
    Acryloyldimethyl Taurate Copolymer, Squalane,
    Polysorbate 60, Isopropylparaben, Isobutylparaben,
    Butylparaben, Phenoxyethanol, Dehydroacetic Acid,
    Salicylic Acid, Benzoic Acid, Benzethonium Chloride,
    Benzyl Alcohol, Polysilicone-11, Ethylhexyl
    Hydroxystearate, Xanthan Gum, Fragrance, Orange 4.

  • QUESTIONS

    Questions or comments?
    Call toll free Mon-Fri 1-800-341-9999

  • SPL UNCLASSIFIED SECTION

    A luxurious, professional massage and finishing
    butter. Envelops skin in a protective layer of silky
    emollients to combat dryness. Protects against sun’s
    harmful rays and helps prevent age spots from
    returning when used with Manicure by OPI
    Rejuvenating Serum. Apply before sun exposure and
    as needed.

    PRECAUTION: Tenir hors de portée des enfants. En cas
    d’irritation, en cesser l’utilisation.
    PRECAUCION: Mantener lejos del alcance de los niños. Si
    hubiera irritación descontinuar su uso.

    ©2010 OPI Products Inc., N. Hollywood, CA 91605 • 818.759.2400
    www.opi.com • Ver. 10-0066 • OPI Item No. MC 134 • Made in USA
    OPI Products Europe, 5708 JW, Helmond, Netherlands

  • PRINCIPAL DISPLAY PANEL

    MANICURE by OPI

    finishing
    butter
    skin massage and moisturizing
    butter. beurre de massage
    hydratant pour la peau. crema
    para hacer masajes e hidratar
    la piel. hautmassage und
    feuchtigkeitskreme.
    spf 15


  • PRINCIPAL DISPLAY PANEL

    A luxurious, professional massage and finishing butter. Envelops skin in a
    protective layer of silky emollients to combat dryness. Protects against sun’s
    harmful rays and helps prevent age spots from returning when used with
    Manicure by OPI Rejuvenating Serum.

    Un soin de massage professionnel de luxe, enrichi au beurre. Il enveloppe la
    peau d’une couche protectrice composée d’émollients soyeux qui combattent
    la sécheresse. Il protège contre les rayons néfastes du soleil, et le retour des
    taches de vieillesse quand utilisé conjointement avec Manicure by OPI
    Rejuvenating Serum.

    Un lujoso masaje profesional y crema de terminación.Envuelve la piel con una
    capa protectora de sedosos emolientes que combaten la sequedad. Protege
    contra los dañinos rayos solares y ayuda a prevenir el retorno de las manchas
    de la edad cuando se utiliza con Manicure por OPI Rejuvenating Serum.
    Eine luxerioese, professionelle Massagen- und Feuchtigkeitskreme.

    Seidene Weichmacher huellen die Haut gegen Trockenheit ein. Schuetzt die
    Haut gegen schaedliche Sonnenstrahlen und vermindert "age spots" durch

    Anwendung mit Manicure by OPI Rejuvenating Serum.

    Active Ingredients: Octinoxate 7.5%, Oxybenzone 3.5%
    Ingrédients Actifs: Octinoxate 7.5%, Oxybenzone 3.5%
    Ingredientes Activos: Octinoxato 7.5%, Oxibenzona 3.5%
    Aktive Inhaltsstoffe: Octinoxate 7.5%, Oxybenzone 3.5%

    CAUTION: Keep out of reach of children. If irritation occurs, discontinue use.

    Contains Oxybenzone. PRECAUTION: Tenir hors de portée des
    enfants. En cas d’irritation, en cesser l’utilisation. Contient de
    l’oxybenzone. PRECAUCION: Mantener lejos del alcance de los niños.
    Si hubiera irritación descontinuar su uso. Contiene Oxibenzona.

    VORSICHT: Von Kindern fernhalten. Gebrauch einstellen, falls
    Irritationen auftreten sollten. Enthaelt Oxybenzone.


    ©2006 OPI Products Inc., N. Hollywood, CA 91605 • 818.759.2400
    www.opi.com • Ver. 06-1012 • OPI Item No. MC 134
    Made in USA • OPI Products Europe, 5708 JW, Helmond, Netherlands

  • PRINCIPAL DISPLAY PANEL

    butterbottlelabel

  • PRINCIPAL DISPLAY PANEL

    butterboxlabel

  • INGREDIENTS AND APPEARANCE
    MANICURE BY OPI - FINISHING BUTTER 
    octinoxate, oxybenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61852-978
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 mL  in 100 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE3.5 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    POLYOXYL 100 STEARATE (UNII: YD01N1999R)  
    SQUALENE (UNII: 7QWM220FJH)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
    SALICYLIC ACID (UNII: O414PZ4LPZ)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    BENZETHONIUM CHLORIDE (UNII: PH41D05744)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61852-978-041 in 1 BOX
    1120 mL in 1 BOTTLE
    2NDC:61852-978-851 in 1 BOX
    2250 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35207/22/2010
    Labeler - OPI Products, Inc (103062204)
    Establishment
    NameAddressID/FEIBusiness Operations
    OPI Products, Inc103062204manufacture

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