Label: LYPSYL HONEYBERRY- octinoxate lipstick

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated December 27, 2018

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  • Active ingredients

    Octyl Methoxycinnamate 5.5%
    Octocrylene 2.0%
    Oxybenzone 3.5%

  • Use

    Sunscreen

  • WARNINGS

    Stop use and ask a doctor -

    if rash or irritation develops and lasts

    Keep out of 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

  • Questions or Comments

    Call 1-877-995-5405 or email customerservice@lornameadna.com - www.lypsylhome.com


  • Inactive ingredients

    Beeswax, Persea Gratissima (Avocado), Butter, Butyrospermum Parkii (Shea Butter), Simmondsia,
    Chinensis (Jojoba) Seed Oil, Flavor, Tocopheryl Acetate (Vitamin E Acetate), Retinyl Palmitate (Vitamin A Palmitate)

  • DOSAGE & ADMINISTRATION

    Apply liberally before sun exposure and as needed

  • PRINCIPAL DISPLAY PANEL

    Carton label

    Cylinder label


  • INGREDIENTS AND APPEARANCE
    LYPSYL HONEYBERRY 
    octinoxate lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62721-8106
    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 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) 0.1 g  in 100 g
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1) 0.5 g  in 100 g
    YELLOW WAX (UNII: 2ZA36H0S2V) 24 g  in 100 g
    JOJOBA OIL (UNII: 724GKU717M) 19.4 g  in 100 g
    PERSEA AMERICANA SEED BUTTER (UNII: TSD0N1V8MB) 22.3 g  in 100 g
    SHEA BUTTER (UNII: K49155WL9Y) 21 g  in 100 g
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorBERRY (Dazzle Berry UL036267/00) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62721-8106-81 in 1 BLISTER PACK10/01/2009
    1NDC:62721-8106-62.83 g in 1 CANISTER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35210/01/2009
    Labeler - Lornamead (126440440)
    Registrant - Lornamead (126440440)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lornamead126440440manufacture(62721-8106)
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