FACE IT HD PERFECT BB SPF30 PA 01- octinoxate, titanium dioxide, zinc oxide, betaine, talc cream

FACE IT HD PERFECT BB SPF30 PA 01 by

Drug Labeling and Warnings

FACE IT HD PERFECT BB SPF30 PA 01 by is a Otc medication manufactured, distributed, or labeled by THEFACESHOP CO., LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

OCTINOXATE (6%)
TITANIUM DIOXIDE (6.36%)
ZINC OXIDE (2.88%)
BETAINE (2%)
TALC (0.684%)

WATER, CYCLOMETHICONE, DIPROPYLENE GLYCOL, DIMETHICONE, GLYCERIN, MICA, TITANIUM DIOXIDE, ALUMINUM HYDROXIDE, STEARIC ACID, DIMETHICONE, MAGNESIUM SULFATE, TRIETHOXYCAPRYLYLSILANE, POLYGLYCERYL-4 ISOSTEARATE, HEXYL LAURATE, PHENOXYETHANOL, TRIETHOXYCAPRYLYLSILANE, METHYLPARABEN, DISTEARYLDIMONIUM CHLORIDE, STEARIC ACID, CAREX HUMILIS ROOT, ETHYLPARABEN, PROPYLPARABEN, MICA, TRIETHYLHEXANOIN, MARITIME PINE

PURPOSE

Provides high protection against sunburn and tanning.

WHEN USING

Avoid contact with eyes.

STOP USE

Discontinue use if sign of irritation or rash appear.

DOSAGE & ADMINISTRATION

Dispense an adequate amount and apply evenly. (At the final stage of basic skincare, dispense an adequate amount and apply evenly to desired parts)

PRINCIPAL DISPLAY PANEL

FACE IT HD PERFECT BB SPF30 PA++ 01

INGREDIENTS AND APPEARANCE

FACE IT HD PERFECT BB SPF30 PA 01 
octinoxate, titanium dioxide, zinc oxide, betaine, talc cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51523-103
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	6 mL  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	6.36 mL  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	2.88 mL  in 100 mL
BETAINE (UNII: 3SCV180C9W) (BETAINE - UNII:3SCV180C9W)	BETAINE	2 mL  in 100 mL
TALC (UNII: 7SEV7J4R1U) (TALC - UNII:7SEV7J4R1U)	TALC	0.684 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE (UNII: NMQ347994Z)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
MICA (UNII: V8A1AW0880)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
DIMETHICONE (UNII: 92RU3N3Y1O)
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
METHYLPARABEN (UNII: A2I8C7HI9T)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
STEARIC ACID (UNII: 4ELV7Z65AP)
CAREX HUMILIS ROOT (UNII: QFR9QY5U3V)
ETHYLPARABEN (UNII: 14255EXE39)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
MICA (UNII: V8A1AW0880)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
MARITIME PINE (UNII: 50JZ5Z98QY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51523-103-02	1 in 1 BOX
1	NDC: 51523-103-01	40 mL in 1 CONTAINER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	08/23/2011

Labeler - THEFACESHOP CO., LTD (688329416)

Registrant - THEFACESHOP CO., LTD (688329416)

Establishment
Name	Address	ID/FEI	Business Operations
THEFACESHOP CO., LTD		688329416	manufacture