Disney Frozen SPF Lip Smacker Lip Balm by Markwins Beauty Products, Inc

Disney Frozen SPF Lip Smacker Lip Balm by

Drug Labeling and Warnings

Disney Frozen SPF Lip Smacker 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 FROZEN SPF LIP SMACKER 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 FROZEN SPF LIP SMACKER LIP BALM 
padimate o, oxybenzone, octinoxate stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 12027-201
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PADIMATE O (UNII: Z11006CMUZ) (PADIMATE O - UNII:Z11006CMUZ)	PADIMATE O	8 g  in 100 g
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

Inactive Ingredients
Ingredient Name	Strength
PARAFFIN (UNII: I9O0E3H2ZE)
CARNAUBA WAX (UNII: R12CBM0EIZ)
HYDROGENATED SOYBEAN OIL (UNII: A2M91M918C)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
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)
NEOTAME (UNII: VJ597D52EX)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
YELLOW WAX (UNII: 2ZA36H0S2V)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
CASTOR OIL (UNII: D5340Y2I9G)
CANDELILLA WAX (UNII: WL0328HX19)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 12027-201-02	1 in 1 BLISTER PACK	02/18/2016	01/01/2019
1	NDC: 12027-201-01	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	02/18/2016	01/01/2019

Labeler - Markwins Beauty Products, Inc (135407760)

Revised: 1/2020

Document Id: 9d613381-a20f-639c-e053-2a95a90a3fcb

34390-5

Set id: 2c11bb07-0615-20b1-e054-00144ff8d46c

Version: 2

Effective Time: 20200130

 

Markwins Beauty Products, Inc