Label: KISS THERAPY SPF 30 BLUEBERRY LIME LIP BALM- avobenzone, homosalate, octocrylene 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 February 15, 2018

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  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel

  • INGREDIENTS AND APPEARANCE
    KISS THERAPY SPF 30 BLUEBERRY LIME LIP BALM 
    avobenzone, homosalate, octocrylene stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12027-209
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10 g  in 100 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10 g  in 100 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    KONJAC MANNAN (UNII: 36W3E5TAMG)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    RASPBERRY SEED OIL (UNII: 9S8867952A)  
    JOJOBA OIL (UNII: 724GKU717M)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    TRIHYDROXYSTEARIN (UNII: 06YD7896S3)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    MANDARIN OIL (UNII: NJO720F72R)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    ACAI OIL (UNII: Z0W6766A2W)  
    SYNTHETIC WAX (2900 MW) (UNII: U5UP035C8A)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:12027-209-021 in 1 BLISTER PACK01/02/2018
    1NDC:12027-209-013.5 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35201/02/2018
    Labeler - Marwins Beauty Products, Inc. (135407760)