Disney Classic Characters Lip Smacker SPF Lip Balm by Markwins Beauty Products

Disney Classic Characters Lip Smacker SPF Lip Balm by

Drug Labeling and Warnings

Disney Classic Characters Lip Smacker SPF Lip Balm by is a Otc medication manufactured, distributed, or labeled by Markwins Beauty Products. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DISNEY CLASSIC CHARACTERS LIP SMACKER SPF LIP BALM- padimate o, oxybenzone, octinoxate stick 
Markwins Beauty Products

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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DISNEY CLASSIC CHARACTERS LIP SMACKER SPF LIP BALM 
padimate o, oxybenzone, octinoxate stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 12027-202
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PADIMATE O (UNII: Z11006CMUZ) (PADIMATE O - UNII:Z11006CMUZ) PADIMATE O8 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE6 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
YELLOW WAX (UNII: 2ZA36H0S2V)  
PARAFFIN (UNII: I9O0E3H2ZE)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
CETYL ACETATE (UNII: 4Q43814HXS)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
WHEAT GERM OIL (UNII: 14C97E680P)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
CANDELILLA WAX (UNII: WL0328HX19)  
CASTOR OIL (UNII: D5340Y2I9G)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SOYBEAN OIL (UNII: 241ATL177A)  
PROPYLENE GLYCOL 1,2-DISTEARATE (UNII: T65PN3O37H)  
ACETYLATED LANOLIN ALCOHOLS (UNII: SNN716810P)  
POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)  
SESAME OIL (UNII: QX10HYY4QV)  
PROPYL GALLATE (UNII: 8D4SNN7V92)  
CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
NEOTAME (UNII: VJ597D52EX)  
D&C RED NO. 28 (UNII: 767IP0Y5NH)  
D&C RED NO. 6 (UNII: 481744AI4O)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 12027-202-021 in 1 BLISTER PACK03/11/201601/01/2019
1NDC: 12027-202-014 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35203/11/201601/01/2019
Labeler - Markwins Beauty Products (135407760)

Revised: 1/2020
Document Id: 9d6186e4-f7a1-49d7-e053-2a95a90a4915
Set id: 2dba959a-0d61-4317-e054-00144ff8d46c
Version: 2
Effective Time: 20200130
 
Markwins Beauty Products