Disney Little Mermaid SPF Lip Smacker Lip Balm by Markwins Beauty Products, Inc

Disney Little Mermaid SPF Lip Smacker Lip Balm by

Drug Labeling and Warnings

Disney Little Mermaid 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 LITTLE MERMAID SPF LIP SMACKER LIP BALM- padimate o, octinoxate, oxybenzone 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 LITTLE MERMAID SPF LIP SMACKER LIP BALM 
padimate o, octinoxate, oxybenzone stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 12027-204
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
CASTOR OIL (UNII: D5340Y2I9G)
CANDELILLA WAX (UNII: WL0328HX19)
ACETYLATED LANOLIN ALCOHOLS (UNII: SNN716810P)
POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)
PROPYL GALLATE (UNII: 8D4SNN7V92)
CITRIC ACID ACETATE (UNII: DSO12WL7AU)
NEOTAME (UNII: VJ597D52EX)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 6 (UNII: 481744AI4O)
CARMINIC ACID (UNII: CID8Z8N95N)
HYDROGENATED SOYBEAN OIL (UNII: A2M91M918C)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
STEARIC ACID (UNII: 4ELV7Z65AP)
CETYL ACETATE (UNII: 4Q43814HXS)
WHEAT GERM OIL (UNII: 14C97E680P)
CARNAUBA WAX (UNII: R12CBM0EIZ)
YELLOW WAX (UNII: 2ZA36H0S2V)
PARAFFIN (UNII: I9O0E3H2ZE)
SESAME OIL (UNII: QX10HYY4QV)
PROPYLENE GLYCOL 1,2-DISTEARATE (UNII: T65PN3O37H)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 12027-204-02	1 in 1 BLISTER PACK	02/22/2016	01/01/2019
1	NDC: 12027-204-01	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	02/22/2016	01/01/2019

Labeler - Markwins Beauty Products, Inc (135407760)

Revised: 1/2020

Document Id: 9d618429-84f2-42b3-e053-2a95a90ad689

34390-5

Set id: 2c24d6ab-cc92-6bbd-e054-00144ff8d46c

Version: 2

Effective Time: 20200130

 

Markwins Beauty Products, Inc