Label: PETROLEUM-FREE LIP BALM- octinoxate and oxybenzone lipstick

  • NDC Code(s): 53329-092-83
  • Packager: Medline Industries, LP
  • 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 August 8, 2023

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  • Active ingredients

    Octinoxate 2.0%

    Oxybenzone 4.5%

  • Purpose

    Sunscreen

    Sunscreen

  • Use

    • helps protect against sunburn and chapped lips
  • 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 or irritation develops and lasts

    Keep out of reach of children.

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

  • Directions

    • 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

    • protect this product from excessive heat and direct sun
    • to report a suspected adverse reaction, contact Curad.
  • Inactive ingredients

    beeswax, BHT, cocos nucifera (coconut) oil, flavor, helianthus annuus (sunflower) seed oil, lanolin, melaleuca alternifolia (tea tree) leaf oil, ricinus communis (castor) seed oil, tocopheryl acetate, zea mays (corn) oil.

  • Manufacturing Information

    Manufactured for:

    Medline Industries, LP

    Three Lakes Drive, Northfield, IL 60093 USA

    Made in USA of foreign and domestic materials

    www.curad.com

    1-800-633-5463

    REF: CUR0415

    V1 RD22OLB

  • Package Label

    Label V1 RD22OLB

  • INGREDIENTS AND APPEARANCE
    PETROLEUM-FREE LIP BALM 
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-092
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2 g  in 100 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE4.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    LANOLIN (UNII: 7EV65EAW6H)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    CORN OIL (UNII: 8470G57WFM)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53329-092-831 in 1 BOX04/01/2010
    14.2 g in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM02004/01/2010
    Labeler - Medline Industries, LP (025460908)
    Registrant - Medline Industries, LP (025460908)
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