Label: BIRDS GARDEN LIP BALM- octinoxate, octocrylene, octisalate, and oxybenzone stick

  • 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 March 21, 2011

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

View All Sections
  • INGREDIENTS

    MEDICINAL INGREDIENTS (W/W)

    Octinoxate 7.5%, Octocrylene 7.0%, Octyl Salicylate 5.0%, Oxybenzone 5.0%.

    NON-MEDICINAL INGREDIENTS

    Petrolatum, Isopropyl Myristate, Paraffin, Candelilla Cera, Synthetic Beeswax, Polyethylene, Cetyl Alcohol, Lanolin, Isopropyl Lanolate, Oleyl Alcohol, Octyldodecanol, Phenyl Trimethicone, Flavor, Tocopheryl Acetate, Aloe Barbadensis Leaf Extract, Glycine Soja (Soybean) Oil, Titanium Dioxide, Methylparaben, Propylparaben, Silica, Saccharin, DEA-Oleth-3 Phosphate.

  • CONTAINS

    Soy

  • STORAGE AND HANDLING

    Store between 15°C and 30°C

  • PRECAUTIONS

    Avoid eye contact. For external use only.

    Keep out of reach of children.

  • PRINCIPAL DISPLAY PANEL - 4 g Carton

    LIP BALM

    ALOE & VITAMIN E
    UVA / UVB PROTECTION

    SPF 30

    Principal Display Panel - 4 g Carton
  • INGREDIENTS AND APPEARANCE
    BIRDS GARDEN LIP BALM   WESTERN TANAGER - SPF 30
    octinoxate, octocrylene, octisalate, and oxybenzone stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55143-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE7 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    LOW DENSITY POLYETHYLENE (UNII: J245LN42AI)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    LANOLIN (UNII: 7EV65EAW6H)  
    OLEYL ALCOHOL (UNII: 172F2WN8DV)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SACCHARIN (UNII: FST467XS7D)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55143-010-504 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/01/2011
    Labeler - Norwood Packaging Ltd. (243693926)
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!