Label: TRUAGE LIP BALM POMEGRANATE MINT SPF15- avobenzone, ocitnoxate, octocrylene, oxybenzone 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 8, 2020

If you are a consumer or patient please visit this version.

View All Sections
  • Active Ingredients

    Avobenzone  3%

    Octinoxate  7.5%

    Octocrylene 2.5%

    Oxybenzone 4%

  • INDICATIONS & USAGE

    Helps protect against sunburn and chapped lips

  • Other Ingredients

    Camphor, Carnosine, Cornus Officinalis Fruit Extract, Diethylhexyl Carbonate, Euphorbia Cerifera (Candelilla) Wax, Flavor, Glycerin, Hydrogenated Castor Oil, Macadamia Ternifolia Seed Oil, Menthol, Morinda Citrifolia Fruit Juice, Morinda Citrifolia L. (Noni) Seed Oil, Olea Europaea (Olive) Leaf Extract, Ozokerite, Phenoxyethanol, Ricinus Communis (Castor) Seed Oil, Sorbitan Oleate, Stevia Rebaudiana Leaf/Stem Extract, Tocopheryl Acetate, Vaccinium Corymbosum (Blueberry) Fruit Extract, Vaccinium Macrocarpon (Cranberry) Fruit Extract, Water

  • WARNINGS

    Do not used on damaged or broken skin.   Do not use if cap is not sealed.

    Stop use and ask a doctor if rash occurs.

    Keep out of reach of children.

  • PRINCIPAL DISPLAY PANEL

    Pomegranate

  • INGREDIENTS AND APPEARANCE
    TRUAGE LIP BALM POMEGRANATE MINT  SPF15
    avobenzone, ocitnoxate, octocrylene, oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14743-337
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Avobenzone (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) Avobenzone3 g  in 100 g
    Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate7.5 g  in 100 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2.5 g  in 100 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
    CARNOSINE (UNII: 8HO6PVN24W)  
    CORNUS OFFICINALIS FRUIT (UNII: 23NL8NQ187)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEG-10 HYDROGENATED CASTOR OIL (UNII: MH590ECD4O)  
    MACADAMIA OIL (UNII: 515610SU8C)  
    MENTHOL (UNII: L7T10EIP3A)  
    MORINDA CITRIFOLIA SEED OIL (UNII: 84J6H9QZUA)  
    NONI FRUIT JUICE (UNII: 6ULF85Z07J)  
    OLEA EUROPAEA FLOWER (UNII: 498M34P1VZ)  
    CERESIN (UNII: Q1LS2UJO3A)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    RICINUS COMMUNIS SEED (UNII: 7EK4SFN1TX)  
    PEG-6 SORBITAN OLEATE (UNII: 58O7V09UCI)  
    STEVIA REBAUDIANA WHOLE (UNII: 6U422Y08O2)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    VACCINIUM CORYMBOSUM WHOLE (UNII: G1DGA0BS6T)  
    VACCINIUM MACROCARPON WHOLE (UNII: D11KO7O2DX)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14743-337-014.6 g in 1 CYLINDER; Type 0: Not a Combination Product12/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35212/01/2016
    Labeler - Tahitian Noni International (609927905)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!