OCEAN POTION MOISTURIZING LIP POTION 45 (AVOBENZONE, OCTISALATE, OCTOCRYLENE, OXYBENZONE, OCTINOXATE) LIPSTICK [SUN & SKIN CARE RESEARCH, LLC]

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  • OCEAN POTION MOISTURIZING LIP POTION 45 (AVOBENZONE, OCTISALATE, OCTOCRYLENE, OXYBENZONE, OCTINOXATE) LIPSTICK [SUN & SKIN CARE RESEARCH, LLC]

OCEAN POTION MOISTURIZING LIP POTION 45 (AVOBENZONE, OCTISALATE, OCTOCRYLENE, OXYBENZONE, OCTINOXATE) LIPSTICK [SUN & SKIN CARE RESEARCH, LLC]
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NDC 62802-085-01
Set ID 1928f12e-2064-4ac2-bc24-79c2e8eb6e4e
Category HUMAN OTC DRUG LABEL
Packager Sun & Skin Care Research, LLC
Generic Name
Product Class
Product Number
Application Number PART352
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  • Active Ingredients


    Avobenzone: 2%
    Octinoxate: 7%
    Octisalate: 5%
    Octocrylene: 5%
    Oxybenzone: 5%


  • Purpose

    Sunscreen

  • Uses

    • helps prevent sunburn
    • higher SPF gives more sunburn protection
    • temporarily protects lips from the drying effects of wind and cold weather
  • 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 the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • apply liberally before sun exposure and as needed
    • children under 6 months of age: ask a doctor
    • store at room temperature
  • Other Information

    • For use on skin only
    • Avoid contact with fabric
    • Protect this product from excessive heat and direct sun
  • PRINCIPAL DISPLAY PANEL


    image of carton label

  • INGREDIENTS AND APPEARANCE
    OCEAN POTION MOISTURIZING LIP POTION 45 
    avobenzone, octisalate, octocrylene, oxybenzone, octinoxate lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62802-085
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 5.0 g  in 100 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE5.0 g  in 100 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    CORN OIL (UNII: 8470G57WFM)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    MYRISTYL LACTATE (UNII: 1D822OC34X)  
    CERESIN (UNII: Q1LS2UJO3A)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SACCHARIN (UNII: FST467XS7D)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62802-085-014.4 g in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/01/2012
    Labeler - Sun & Skin Care Research, LLC (849772207)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sun & Skin Care Research, LLC849772207manufacture
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