BAIN DE SOLEIL ORANGE GELEE SPF 4 (OCTINOXATE) GEL [BAYER HEALTHCARE LLC]

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BAIN DE SOLEIL ORANGE GELEE SPF 4 (OCTINOXATE) GEL [BAYER HEALTHCARE LLC]
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NDC 11523-7189-1
Set ID 7222f6f9-689e-4e00-91f5-4db159348dfd
Category HUMAN OTC DRUG LABEL
Packager Bayer HealthCare LLC
Generic Name
Product Class
Product Number
Application Number PART352
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Octinoxate 2.5%

  • Purpose

    Sunscreen

  • Use

    helps prevent sunburn

  • Warnings

    Skin Cancer/Skin Aging Alert

    Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

    For external use only

    Do not use on damaged or broken skin

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

    Stop use and ask a doctor if rash occurs

    Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • to open, use pointed end on cap to puncture seal
    • 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
  • Other information

    • store between 20˚ to 25˚C (68˚ to 77˚F)
    • protect this product from excessive heat and direct sun
    • may stain or damage some fabrics or surfaces
  • Inactive ingredients

    Mineral Oil, Petrolatum, Paraffin, Ozokerite, Isopropyl Myristate, Hydrogenated Vegetable Oil, Fragrance, Propylparaben, Tocopherol (Vitamin E), D&C Yellow No. 10 Aluminum Lake, D&C Red No. 17

  • Questions?

    866-288-3330

  • SPL UNCLASSIFIED SECTION

    Distributed by

    Bayer HealthCare LLC

    Whippany, NJ 07981

  • PRINCIPAL DISPLAY PANEL - 88 g Tube Carton

    SPF

    4

    BAIN de

    SOLEIL ®

    SUNSCREEN

    ORANGE GELÉE ®

    Classic Formula

    Luxurious Emollients

    NET WT 3.12 OZ (88g)

    Carton label

  • INGREDIENTS AND APPEARANCE
    BAIN DE SOLEIL  ORANGE GELEE SPF 4
    octinoxate gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-7189
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE25 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    D&C RED NO. 17 (UNII: ND733RX3JN)  
    Product Characteristics
    ColororangeScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11523-7189-11 in 1 CARTON05/21/1999
    188 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35205/21/1999
    Labeler - Bayer HealthCare LLC (112117283)
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