THEFACESHOP CC Oil-Free Cushion SPF 50 Apricot Beige V201

THEFACESHOP Cushion by

Drug Labeling and Warnings

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

Drug Details [pdf]

THEFACESHOP CUSHION CC OIL-FREE 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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THEFACESHOP CC Oil-Free Cushion SPF 50 Apricot Beige V201

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 ​on damaged or broken skin

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

Stop use and ask doctor rash or irritation develops and lasts.

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

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. Store at 15 - 30 °C

QUESTIONS?

Call 1-888-498-9004

PRINCIPAL DISPLAY PANEL

CC OIL-FREE
CUSHION

BROAD SPECTRUM
SPF 50

THEFACESHOP
Net Wt. 0.52 oz | 15g

V201 APRICOT BEIGE

THEFACESHOP

CC OIL-FREE CUSHION

MOIST COVER | FRESH FIT

[Broad Spectrum SPF 50]

Imported by LG H&H USA, INC.

165 BROADWAY, ONE LIBERTY PLAZA, 25TH FLOOR

NEW YORK, NY 10006, USA

Questions: 1-888-498-9004 / MADE IN KOREA

THEFACESHOP CUSHION  CC OIL-FREE SPF 50 APRICOT BEIGE
ensulizole, titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51523-052
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
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51523-052-01	2 in 1 BOX	02/04/2021	05/31/2021
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	02/04/2021	05/31/2021

Labeler - THEFACESHOP Co., Ltd. (688329416)

Establishment
Name	Address	ID/FEI	Business Operations
fmg Co.Ltd		690188305	manufacture(51523-052)

Revised: 12/2021

Document Id: d32034b2-bc44-979a-e053-2995a90a5324

34390-5

Set id: ba8893a6-9e94-0593-e053-2a95a90a8890

Version: 2

Effective Time: 20211201