CC TOTAL COVER CUSHION SPF 50 APRICOT BEIGE- 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

WATER, CYCLOPENTASILOXANE, PHENYL TRIMETHICONE, TRIETHYLHEXANOIN, CYCLOHEXASILOXANE, BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE, DIPENTAERYTHRITYL HEXA C5-9 ACID ESTERS, CETYL PEG/PPG-10/1 DIMETHICONE, NIACINAMIDE, BUTYLENE GLYCOL, TROMETHAMINE, DIMETHICONE, 1,2-HEXANEDIOL, SORBITAN SESQUIOLEATE, PEG-30 DIPOLYHYDROXYSTEARATE, ZINC STEARATE, STEARIC ACID, SODIUM CHLORIDE, DIMETHICONE/POLYGLYCERIN-3 CROSSPOLYMER, GLYCERIN, DISTEARDIMONIUM HECTORITE, ALUMINUM HYDROXIDE, DISTEARYLDIMONIUM CHLORIDE, HYALURONIC ACID, DIMETHICONOL, TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE, DIMETHICONE CROSSPOLYMER, LAURYL DIMETHICONE/POLYGLYCERIN-3 CROSSPOLYMER, PALMITOYL PROLINE, POLYMETHYLSILSESQUIOXANE, ADENOSINE, TRIETHOXYCAPRYLYLSILANE, SODIUM PALMITOYL SARCOSINATE, MAGNESIUM PALMITOYL GLUTAMATE, PALMITIC ACID, DIPROPYLENE GLYCOL, BORON NITRIDE, SODIUM CITRATE, TOCOPHEROL, SODIUM LAUROYL LACTYLATE, CERAMIDE NP, PHENOXYETHANOL, PHYTOSPHINGOSINE, CHOLESTEROL, CERAMIDE AP, ETHYLHEXYLGLYCERIN, XANTHAN GUM, CARBOMER, CERAMIDE EOP, FRAGRANCE, TITANIUM DIOXIDE(CI 77891), MICA, 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 TOTAL COVER
CUSHION

BROAD SPECTRUM
SPF 50

THEFACESHOP
Net Wt. 0.52 oz | 15g

v201

THEFACESHOP
CC TOTAL COVER CUSHION
V201 APRICOT BEIGE
[Broad Spectrum SPF 50]
Net Wt. 0.52 oz | 15 g.

v201btm

CC TOTAL COVER CUSHION  SPF 50 APRICOT BEIGE
ensulizole, titanium dioxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51523-060
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
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
TOCOPHEROL (UNII: R0ZB2556P8)  
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CERAMIDE AP (UNII: F1X8L2B00J)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
BORON NITRIDE (UNII: 2U4T60A6YD)  
CERAMIDE NP (UNII: 4370DF050B)  
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
XANTHAN GUM (UNII: TTV12P4NEE)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
CERAMIDE 1 (UNII: 5THT33P7X7)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PALMITOYL PROLINE (UNII: I49727TDYF)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
ADENOSINE (UNII: K72T3FS567)  
MAGNESIUM PALMITOYL GLUTAMATE (UNII: DH37YM1F48)  
PALMITIC ACID (UNII: 2V16EO95H1)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
MICA (UNII: V8A1AW0880)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
SODIUM PALMITOYL SARCOSINATE (UNII: 7297LY09YF)  
DIPENTAERYTHRITYL HEXA C5-9 ACID ESTERS (UNII: D818OLQ51Z)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
DIMETHICONOL (100000 CST) (UNII: OSA9UP217S)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)  
ZINC STEARATE (UNII: H92E6QA4FV)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
HYALURONIC ACID (UNII: S270N0TRQY)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
NIACINAMIDE (UNII: 25X51I8RD4)  
TROMETHAMINE (UNII: 023C2WHX2V)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51523-060-012 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(51523-060)
Establishment
NameAddressID/FEIBusiness Operations
ZENISCE Co., Ltd.690188305manufacture(51523-060)

Revised: 1/2021
Document Id: ba885230-2afd-4d69-e053-2995a90af2df
Set id: 680f369e-c408-c5c7-e053-2a91aa0a1a6e
Version: 2
Effective Time: 20210101
 
THEFACESHOP Co., Ltd.