KISS THERAPY SPF 30 CUCUMBER MELON 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 CUCUMBER MELON LIP BALM 
avobenzone, homosalate, octocrylene stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12027-212
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
MANDARIN OIL (UNII: NJO720F72R)  
COCONUT OIL (UNII: Q9L0O73W7L)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
ACAI OIL (UNII: Z0W6766A2W)  
KONJAC MANNAN (UNII: 36W3E5TAMG)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
RASPBERRY SEED OIL (UNII: 9S8867952A)  
JOJOBA OIL (UNII: 724GKU717M)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
SYNTHETIC WAX (2900 MW) (UNII: U5UP035C8A)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
TRIHYDROXYSTEARIN (UNII: 06YD7896S3)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:12027-212-021 in 1 BLISTER PACK01/02/2018
1NDC:12027-212-013.5 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: 65453d6d-3350-1363-e053-2991aa0aa223
Set id: 61d35e86-27fd-4d99-e053-2991aa0a0db7
Version: 3
Effective Time: 20180215
 
Marwins Beauty Products, Inc.