FACE IT AQUA TINTED BB SPF 20 PA 01- titanium dioxide, octinoxate cream

FACE IT AQUA TINTED BB SPF 20 PA 01 by

Drug Labeling and Warnings

FACE IT AQUA TINTED BB SPF 20 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

TITANIUM DIOXIDE (5.8%)
OCTINOXATE (5%)

WATER, CYCLOMETHICONE 5, BUTYLENE GLYCOL, HEXYL LAURATE, POLYSORBATE 60, SQUALANE, GLYCERIN, BIOSACCHARIDE GUM-1, PHENOXYETHANOL, FERRIC OXIDE YELLOW, METHYLPARABEN, TALC, FERRIC OXIDE RED, ETHYLPARABEN, FERROSOFERRIC OXIDE, TRIETHOXYCAPRYLYLSILANE, BUTYLENE GLYCOL, PONCIRUS TRIFOLIATA FRUIT

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 AQUA TINTED BB SPF 20 PA 01

INGREDIENTS AND APPEARANCE

FACE IT AQUA TINTED BB SPF 20 PA 01 
titanium dioxide, octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51523-105
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	5.80 mL  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	5 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
POLYSORBATE 60 (UNII: CAL22UVI4M)
SQUALANE (UNII: GW89575KF9)
GLYCERIN (UNII: PDC6A3C0OX)
BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
METHYLPARABEN (UNII: A2I8C7HI9T)
TALC (UNII: 7SEV7J4R1U)
FERRIC OXIDE RED (UNII: 1K09F3G675)
ETHYLPARABEN (UNII: 14255EXE39)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PONCIRUS TRIFOLIATA FRUIT (UNII: 44445L49J2)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51523-105-02	1 in 1 BOX
1	NDC: 51523-105-01	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