KISS THERAPY SPF 30 BLUEBERRY LIME LIP BALM- avobenzone, homosalate, octocrylene stick 
Marwins Beauty Products, Inc.

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.

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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)

Revised: 2/2018
Document Id: 6544ed86-c39d-d944-e053-2a91aa0af69f
Set id: 61d08802-588f-1c96-e053-2a91aa0a316f
Version: 2
Effective Time: 20180215
 
Marwins Beauty Products, Inc.