Disney Cars Lip Smacker SPF Lip Balm by Markwins Beauty Products, Inc.

Disney Cars Lip Smacker SPF Lip Balm by

Drug Labeling and Warnings

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

Drug Details [pdf]

DISNEY CARS LIP SMACKER SPF LIP BALM- padimate o, oxybenzone, octinoxate stick 
Markwins 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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DISNEY CARS LIP SMACKER SPF LIP BALM 
padimate o, oxybenzone, octinoxate stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 12027-203
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	6 g  in 100 g
PADIMATE O (UNII: Z11006CMUZ) (PADIMATE O - UNII:Z11006CMUZ)	PADIMATE O	8 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
CASTOR OIL (UNII: D5340Y2I9G)
YELLOW WAX (UNII: 2ZA36H0S2V)
CANDELILLA WAX (UNII: WL0328HX19)
PARAFFIN (UNII: I9O0E3H2ZE)
CARNAUBA WAX (UNII: R12CBM0EIZ)
SOYBEAN OIL (UNII: 241ATL177A)
STEARIC ACID (UNII: 4ELV7Z65AP)
CETYL ACETATE (UNII: 4Q43814HXS)
ACETYLATED LANOLIN ALCOHOLS (UNII: SNN716810P)
POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)
SESAME OIL (UNII: QX10HYY4QV)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
WHEAT GERM OIL (UNII: 14C97E680P)
PROPYLENE GLYCOL 1,2-DISTEARATE (UNII: T65PN3O37H)
PROPYL GALLATE (UNII: 8D4SNN7V92)
CITRIC ACID ACETATE (UNII: DSO12WL7AU)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
NEOTAME (UNII: VJ597D52EX)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 6 (UNII: 481744AI4O)
D&C RED NO. 7 (UNII: ECW0LZ41X8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 12027-203-02	1 in 1 BLISTER PACK	03/11/2016	01/01/2019
1	NDC: 12027-203-01	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	03/11/2016	01/01/2019

Labeler - Markwins Beauty Products, Inc. (135407760)

Revised: 1/2020

Document Id: 9d6186e4-f79e-49d7-e053-2a95a90a4915

34390-5

Set id: 2dccf452-a894-0bd5-e054-00144ff8d46c

Version: 2

Effective Time: 20200130

 

Markwins Beauty Products, Inc.