Label: BROAD SPECTRUM SPF 15 CITRUS LIP BALM stick

  • 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 23, 2020

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

View All Sections
  • Active Ingredients

    Avobenzone 2.0%

    Octinoxate 6.5%

    Octisalate 5.0%

    Octocrylene 1.5%

  • Purpose

    Sunscreen

  • Warnings

    For external use only

  • Do not use

    on damaged or broken skin.

  • Stop Use and ask a doctor if

    Rash Occurs

  • When Using this Product

    Keep out of eyes. Rinse well with water to remove.

  • Keep out of reach of children

    Keep out of reach of children.

    If swallowed, get medical help or 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 of age: Ask a doctor

  • Inactive ingredients:

    Petrolatum, Mineral Oil, Paraffin Wax, Flavor, Ozokerite Wax, Coconut Oil, Tocopherol, Soybean Oil.

  • Package Label

    C10648 CITRUS SPF 15 VALUE BALM

  • INGREDIENTS AND APPEARANCE
    BROAD SPECTRUM SPF 15 CITRUS LIP BALM 
    broad spectrum spf 15 citrus lip balm stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65692-0548
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE0.21 g  in 4.25 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE0.09 g  in 4.25 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE0.06 g  in 4.25 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.28 g  in 4.25 g
    Inactive Ingredients
    Ingredient NameStrength
    COCONUT OIL (UNII: Q9L0O73W7L)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
    CERESIN (UNII: Q1LS2UJO3A)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCITRUSImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65692-0548-14.25 g in 1 TUBE; Type 0: Not a Combination Product02/17/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35202/17/2020
    Labeler - Raining Rose, Inc (083819404)
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!