Lip Smacker Sport SPF Lip Balm by Markwins Beauty Products, Inc.

Lip Smacker Sport SPF Lip Balm by

Drug Labeling and Warnings

Lip Smacker Sport 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]

LIP SMACKER SPORT SPF 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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LIP SMACKER SPORT SPF LIP BALM 
padimate o, octinoxate, oxybenzone stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 12027-200
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
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
YELLOW WAX (UNII: 2ZA36H0S2V)
CANDELILLA WAX (UNII: WL0328HX19)
HYDROGENATED SOYBEAN OIL (UNII: A2M91M918C)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
STEARIC ACID (UNII: 4ELV7Z65AP)
CETYL ACETATE (UNII: 4Q43814HXS)
ACETYLATED LANOLIN ALCOHOLS (UNII: SNN716810P)
PROPYLENE GLYCOL 1,2-DISTEARATE (UNII: T65PN3O37H)
CARNAUBA WAX (UNII: R12CBM0EIZ)
PARAFFIN (UNII: I9O0E3H2ZE)
WHEAT GERM OIL (UNII: 14C97E680P)
CITRIC ACID ACETATE (UNII: DSO12WL7AU)
NEOTAME (UNII: VJ597D52EX)
SESAME OIL (UNII: QX10HYY4QV)
CASTOR OIL (UNII: D5340Y2I9G)
POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)
PROPYL GALLATE (UNII: 8D4SNN7V92)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 6 (UNII: 481744AI4O)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 12027-200-02	1 in 1 BLISTER PACK	03/18/2016	01/01/2019
1	NDC: 12027-200-01	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	03/18/2016	01/01/2019

Labeler - Markwins Beauty Products, Inc. (135407760)

Revised: 1/2020

Document Id: 9d616f95-03d8-8311-e053-2995a90a5db8

34390-5

Set id: 2c28b23e-9f0e-2519-e054-00144ff8d46c

Version: 3

Effective Time: 20200130

 

Markwins Beauty Products, Inc.