THEFACESHOP COLOR CONTROL CUSHION APRICOT BEIGE OIL-FREE SPF 50- ensulizole, titanium dioxide powder 
THEFACESHOP Co., Ltd.

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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ACTIVE INGREDIENTS

Ensulizole 2.7%

Titanium Dioxide 5.46%

PURPOSE

SUNSCREEN

USES

WARNINGS

For external use only

Do not use ​on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove

Stop use and ask doctor if rash occurs

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

- Limit time in the sun, especially from 10 a.m. to 2 p.m.

- Wear long-sleeved shirts, pants, hats, and sunglasses

INACTIVE INGREDIENTS

CYCLOPENTASILOXANE, WATER, TRIETHYLHEXANOIN, PEG-10 DIMETHICONE, POLYMETHYL METHACRYLATE, NIACINAMIDE, DIPROPYLENE GLYCOL, TROMETHAMINE, 1,2-HEXANEDIOL, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, ZINC STEARATE, DISTEARDIMONIUM HECTORITE, SODIUM CHLORIDE, STEARIC ACID, SORBITAN SESQUIISOSTEARATE, SORBITAN SESQUIOLEATE, ALUMINUM HYDROXIDE, DISTEARYLDIMONIUM CHLORIDE, TOCOPHERYL ACETATE, PALMITOYL PROLINE, CITRUS UNSHIU PEEL EXTRACT, BUTYLENE GLYCOL, ADENOSINE, TRIETHOXYCAPRYLYLSILANE, MAGNESIUM PALMITOYL GLUTAMATE, SODIUM PALMITOYL SARCOSINATE, TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE, PHENOXYETHANOL, PALMITIC ACID, BIOSACCHARIDE GUM-1, CALCIUM CARBONATE, SILICA, ALBIZIA JULIBRISSIN BARK EXTRACT, FRAGRANCE, TITANIUM DIOXIDE(CI 77891), MICA(CI 77019), IRON OXIDES(CI 77491, CI 77492, CI 77499)

OTHER INFORMATION

Protect this product from excessive heat and direct sun

QUESTIONS OR COMMENTS?

Call toll free 1-888-498-9004

PRINCIPAL DISPLAY PANEL

CC OIL-FREE
CUSHION

BROAD SPECTRUM
SPF 50

THEFACESHOP
Net Wt. 0.52 oz | 15g

OILFREE V201

THEFACESHOP COLOR CONTROL CUSHION APRICOT BEIGE  OIL-FREE SPF 50
ensulizole, titanium dioxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51523-050
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.819 g  in 15 g
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE0.405 g  in 15 g
Inactive Ingredients
Ingredient NameStrength
BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MICA (UNII: V8A1AW0880)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
SODIUM PALMITOYL SARCOSINATE (UNII: 7297LY09YF)  
PALMITIC ACID (UNII: 2V16EO95H1)  
CALCIUM CARBONATE (UNII: H0G9379FGK)  
ALBIZIA JULIBRISSIN BARK (UNII: 0J9G6W44DV)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
METHYL METHACRYLATE (UNII: 196OC77688)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)  
ZINC STEARATE (UNII: H92E6QA4FV)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)  
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
NIACINAMIDE (UNII: 25X51I8RD4)  
TROMETHAMINE (UNII: 023C2WHX2V)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PALMITOYL PROLINE (UNII: I49727TDYF)  
TANGERINE PEEL (UNII: JU3D414057)  
ADENOSINE (UNII: K72T3FS567)  
MAGNESIUM PALMITOYL GLUTAMATE (UNII: DH37YM1F48)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51523-050-012 in 1 BOX01/01/2018
115 g in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/01/2018
Labeler - THEFACESHOP Co., Ltd. (688329416)
Establishment
NameAddressID/FEIBusiness Operations
THEFACESHOP Co., Ltd.688329416label(51523-050)
Establishment
NameAddressID/FEIBusiness Operations
ZENISCE Co., Ltd.690188305manufacture(51523-050)

Revised: 1/2021
Document Id: ba885230-2afb-4d69-e053-2995a90af2df
Set id: 67be9830-c8b3-46cf-e053-2a91aa0a6b71
Version: 2
Effective Time: 20210101
 
THEFACESHOP Co., Ltd.