![FACE IT 4D PERFECTION ROLLER FOUNDATION 21 (OCTINOXATE, TITANIUM DIOXIDE) CREAM [THEFACESHOP CO., LTD]](https://medic.hrt.org//dailymed/images/a04d9511-66eb-461e-aa0b-fc89f4af6f3b/FACE IT 4D PERFECTION ROLLER FOUND SPF21.jpg)
| NDC | 51523-109-01, 51523-109-02 |
| Set ID | a04d9511-66eb-461e-aa0b-fc89f4af6f3b |
| Category | HUMAN OTC DRUG LABEL |
| Packager | THEFACESHOP CO., LTD |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART352 |
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ACTIVE INGREDIENT
OCTINOXATE (3%)
TITANIUM DIOXIDE (23.51%)TRIETHOXYCAPRYLYLSILANE
WATER
ISONONYL ISONONANOATE
DICAPRYLYL CARBONATE
PHENYL TRIMETHICONE
DIMETHICONE
SILICON DIOXIDE
MINERAL OIL
CALCIUM CARBONATE
HIGH DENSITY POLYETHYLENE
FERRIC OXIDE RED
CARNAUBA WAX
CANDELILLA WAX
MICROCRYSTALLINE WAX
TRIBEHENIN
HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW)
BUTYLENE GLYCOL
CHAMAEMELUM NOBILE FLOWER
GINGER - PURPOSE
- WHEN USING
- STOP USE
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
FACE IT 4D PERFECTION ROLLER FOUNDATION 21
octinoxate, titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51523-109 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 3 g in 100 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 23.51 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) ISONONYL ISONONANOATE (UNII: S4V5BS6GCX) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) DIMETHICONE (UNII: 92RU3N3Y1O) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MINERAL OIL (UNII: T5L8T28FGP) CALCIUM CARBONATE (UNII: H0G9379FGK) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) FERRIC OXIDE RED (UNII: 1K09F3G675) CARNAUBA WAX (UNII: R12CBM0EIZ) CANDELILLA WAX (UNII: WL0328HX19) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) TRIBEHENIN (UNII: 8OC9U7TQZ0) HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG) GINGER (UNII: C5529G5JPQ) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51523-109-02 1 in 1 BOX 1 NDC:51523-109-01 8 g in 1 CONTAINER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 09/01/2011 Labeler - THEFACESHOP CO., LTD (688329416) Registrant - THEFACESHOP CO., LTD (688329416) Establishment Name Address ID/FEI Business Operations THEFACESHOP CO., LTD 688329416 manufacture
