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NDC 72330-0063-03 THEFACESHOP Cushion CC Total Cover SPF 50 Natural Beige .405; .819 g/15g; g/15g Details

THEFACESHOP Cushion CC Total Cover SPF 50 Natural Beige .405; .819 g/15g; g/15g

THEFACESHOP Cushion CC Total Cover SPF 50 Natural Beige is a TOPICAL POWDER in the HUMAN OTC DRUG category. It is labeled and distributed by fmg Co.Ltd. The primary component is ENSULIZOLE; TITANIUM DIOXIDE.

Product Information

NDC	72330-0063
Product ID	72330-063_d30afd94-8bce-01bc-e053-2a95a90afb49
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	THEFACESHOP Cushion CC Total Cover SPF 50 Natural Beige
Proprietary Name Suffix	n/a
Non-Proprietary Name	Ensulizole, Titanium Dioxide
Product Type	HUMAN OTC DRUG
Dosage Form	POWDER
Route	TOPICAL
Active Ingredient Strength	.405; .819
Active Ingredient Units	g/15g; g/15g
Substance Name	ENSULIZOLE; TITANIUM DIOXIDE
Labeler Name	fmg Co.Ltd
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part352
Listing Certified Through	2024-12-31

Package

Package Images

NDC 72330-0063-03 (72330006303)

Pricing Information	N/A
NDC Package Code	72330-063-03
Billing NDC	72330006303
Package	2 CONTAINER in 1 BOX (72330-063-03) / 15 g in 1 CONTAINER
Marketing Start Date	2021-02-04
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL d30afd94-8bcd-01bc-e053-2a95a90afb49 Details

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 TOTAL COVER

CUSHION

BROAD SPECTRUM

SPF 50

THEFACESHOP

Net Wt. 0.52 oz | 15g

V203 NATURAL BEIGE

THEFACESHOP

CC TOTAL COVER CUSHION

HIGH COVERAGE | BRIGHTENING

[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

INGREDIENTS AND APPEARANCE

THEFACESHOP CUSHION CC TOTAL COVER SPF 50 NATURAL BEIGE

ensulizole, titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72330-063
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:72330-063-03	2 in 1 BOX	02/04/2021
1		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	02/04/2021

Labeler - fmg Co.Ltd (690188305)

Registrant - LG HOUSEHOLD & HEALTH CARE LTD (688276187)

Name	Address	ID/FEI	Business Operations
Establishment
fmg Co.Ltd		690188305	manufacture(72330-063)

Revised: 12/2021

Document Id: d30afd94-8bce-01bc-e053-2a95a90afb49

Set id: d30afd94-8bcd-01bc-e053-2a95a90afb49

Version: 1

Effective Time: 20211213