CC TOTAL COVER CUSHION SPF 50 NATURAL BEIGE- ensulizole, titanium dioxide powder

CC Total Cover Cushion by

Drug Labeling and Warnings

CC Total Cover Cushion by is a Otc medication manufactured, distributed, or labeled by THEFACESHOP Co., Ltd., ZENISCE Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

Ensulizole 2.7%

Titanium Dioxide 5.46%

PURPOSE

SUNSCREEN

USES

• Helps prevent sunbrun
• If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

WARNINGS

For external use only

DO NOT USE

Do not use ​on damaged or broken skin

WHEN USING

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

STOP USE

Stop use and ask doctor if rash occurs

KEEP OUT OF REACH OF CHILDREN

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

DIRECTIONS

• Apply liberally 15 minutes before sun exposure and as needed.
• Reapply as needed or after towel drying, swimming, or sweating.
• Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

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

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

• Children under 6 months: Ask a doctor

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

THEFACESHOP CC TOTAL COVER CUSHION V203 NATURAL BEIGE [Broad Spectrum SPF 50] Net Wt. 0.52 oz | 15 g.

INGREDIENTS AND APPEARANCE

CC TOTAL COVER CUSHION  SPF 50 NATURAL BEIGE
ensulizole, titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51523-061
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.819 g  in 15 g
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42)	ENSULIZOLE	0.405 g  in 15 g

Inactive Ingredients
Ingredient Name	Strength
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)
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51523-061-03	2 in 1 BOX	01/01/2018
1		15 g in 1 CONTAINER; Type 0: Not a Combination Product

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

Labeler - THEFACESHOP Co., Ltd. (688329416)

Establishment
Name	Address	ID/FEI	Business Operations
THEFACESHOP Co., Ltd.		688329416	label(51523-061)

Establishment
Name	Address	ID/FEI	Business Operations
ZENISCE Co., Ltd.		690188305	manufacture(51523-061)