MEGACUSHION FOUNDATION SPF 15- octinoxate, octisalate, titanium dioxide, zinc oxide liquid
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.

----------

Megacushion Foundation

PDP

MEGACUSHION FOUNDATION SPF 15
octinoxate, octisalate, titanium dioxide, zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:12027-107
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	1.96 g in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	6.73 g in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7 g in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2.5 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
WATER (UNII: 059QF0KO0R)
MICA (UNII: V8A1AW0880)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
BROWN IRON OXIDE (UNII: 1N032N7MFO)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
LAUROYL LYSINE (UNII: 113171Q70B)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
DIMETHICONE 100 (UNII: RO266O364U)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
EDETATE DISODIUM (UNII: 7FLD91C86K)
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:12027-107-02	1 in 1 CARTON	01/11/2018	12/31/2020
1	NDC:12027-107-01	15 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	01/05/2018	12/31/2020

Labeler - Markwins Beauty Products, Inc. (135407760)

Revised: 4/2020

Document Id: a382e522-56da-fae5-e053-2995a90a84d0

Set id: 6289bfa9-1730-e564-e053-2a91aa0aa0b7

Version: 3

Effective Time: 20200417

Markwins Beauty Products, Inc.