Label: USANA LIP MOISTURIZER- avobenzone, octinoxate, octisalate lipstick

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 April 23, 2012

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  • Active ingredient

    Avobenzone 3.0%

    Octinoxate 7.5%

    Octisalate 5.0%

  • Purpose

    Sunscreen

  • Keep Out of Reach of Children

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Uses

    Helps prevent sunburn. Help prevent and temporarily protect dry, chapped, or windburned lips if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

  • Warnings

    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 or irritation develops.

  • Directions

    Apply liberally before sun exposure and as needed.

    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 a broad spectrum SPF or higher and other sun protection measures including: limiting time in the sun (especially from 10 a.m. - 2 p.m.) and wearing long-sleeve shirts, pants, hats, and sunglasses.

    Children under 6 months of age: Ask a doctor before use.

  • Inactive ingredients

    Cocos Nucifera (Coconut) Oil, Beeswax, Ricinus Communis (Castor) Seed Oil, Flavor, Tocopherol, Butyrospermum Parki (Shea) Butter, Theobroma Cacao (Cocoa) Seed Butter

  • Package/Label Principal Display Panel

    Usana SPF 30 Lip Moisturizer
  • INGREDIENTS AND APPEARANCE
    USANA LIP MOISTURIZER 
    avobenzone, octinoxate, octisalate lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63645-128
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3.0 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5.0 g
    Inactive Ingredients
    Ingredient NameStrength
    COCONUT OIL (UNII: Q9L0O73W7L) 30 g
    CASTOR OIL (UNII: D5340Y2I9G) 23 g
    WHITE WAX (UNII: 7G1J5DA97F) 27.5 g
    COCOA BUTTER (UNII: 512OYT1CRR) 0.001 g
    SHEA BUTTER (UNII: K49155WL9Y) 0.001 g
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) 1.998 g
    PEAR JUICE (UNII: F214DLA9BE) 2.0 g
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorFRUITImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63645-128-021 in 1 APPLICATOR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35207/06/2012
    Labeler - Oralabs (801824756)
    Registrant - Usana (804413250)
    Establishment
    NameAddressID/FEIBusiness Operations
    OraLabs801824756LABEL(63645-128) , MANUFACTURE(63645-128)
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