LYPSYL VANILLA PLUM INTENSE PROTECTION (LIP BALM) LIPSTICK [LORNAMEAD]

LYPSYL VANILLA PLUM INTENSE PROTECTION (LIP BALM) LIPSTICK [LORNAMEAD]
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NDC 62721-8127-6, 62721-8127-8
Set ID 014c36b5-bbb7-4e65-b42e-33a6af197474
Category HUMAN OTC DRUG LABEL
Packager Lornamead
Generic Name
Product Class
Product Number
Application Number PART352
  • Active Ingredients

    Octyl Methoxycinnamate 5.5%...................................Sunscreen

    Octylcrylene 2.0%....................................................Sunscreen

    Oxybenzone 3.5%....................................................Sunscreen

    Avobenzone 3.0%.....................................................Sunscreen

  • Inactive Ingredients

    Beeswax, Butyrospermum Parkii (Shea Butter), Ceresin, Euterpe Oleracea (Acai) Fruit Extract, Flavor, Hydrogenated Coconut Oil, Mineral Oil, Paraffin, Petrolatum, Retinyl Palmitate (Vitamin A Palmitate), Sodium Ascorbyl Phosphate, Tocopheryl Acetate

  • Directions

    • apply liberally 15 minutes before sun exposure
    • after 40 minutes of swimming or sweating
    • 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 Broad Spectrum SPF vlaue of 15 or higher and other sun protection measures including

    • limit time in the sun, especially from 10a.m. -2 p.m.
    • wear long-sleeved shirts, pants hats and sunglasses
  • Other Information

    Protect this product from excessive heat and direct sun.

  • Use

    Helps prevent sunburn

  • 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

  • Questions or Comments

  • PRINCIPAL DISPLAY PANEL

    MM1.jpg

    Carton Label

    MM2.jpg

    Cylinder Label

  • INGREDIENTS AND APPEARANCE
    LYPSYL VANILLA PLUM  INTENSE PROTECTION
    lip balm lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62721-8127
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE5.5 g  in 100 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2.0 g  in 100 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3.0 g  in 100 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE3.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    CERESIN (UNII: Q1LS2UJO3A)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM)  
    ACAI (UNII: 46AM2VJ0AW)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorPLUM (Vanilla Plum) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62721-8127-82.83 in 1 BLISTER PACK
    1NDC:62721-8127-62.83 g in 1 CANISTER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/01/2014
    Labeler - Lornamead (126440440)
    Registrant - Lornamead (126440440)
    Establishment
    NameAddressID/FEIBusiness Operations
    CSR Cosmetic Solutions243501959manufacture(62721-8127) , pack(62721-8127)

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