Label: FACE IT RADIANCE FOUNDATION SPF20 NB21- octinoxate, titanium dioxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 51523-118-01, 51523-118-02 - Packager: THEFACESHOP CO., LTD
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated September 13, 2011
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ACTIVE INGREDIENT
OCTINOXATE (4.5%)
TITANIUM DIOXIDE (11.476%)
CYCLOMETHICONE
SILICON DIOXIDE
MICA
MICA
TRIETHOXYCAPRYLYLSILANE
WATER
DIPROPYLENE GLYCOL
GLYCERIN
DIMETHICONE
SODIUM CHLORIDE
DICAPRYLYL CARBONATE
OCTYLDODECYL NEOPENTANOATE
CYCLOMETHICONE 5
PHENYL TRIMETHICONE
PROPYLENE CARBONATE
GRAPEFRUIT
MEADOWFOAM SEED OIL
SACCHARIDE ISOMERATE
HYALURONATE SODIUM
DIAMOND TURBOT
BENZIMIDAZOLE
METHYLPARABEN
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
ISOMETHYL-.ALPHA.-IONONE
BENZYL SALICYLATE
BUTYLPHENYL METHYLPROPIONAL
.BETA.-CITRONELLOL, (R)-
GERANIOL
LINALOOL, (+/-)-
- PURPOSE
- WHEN USING
- STOP USE
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
FACE IT RADIANCE FOUNDATION SPF20 NB21
octinoxate, titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51523-118 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 11.476 mL in 100 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 4.5 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) TALC (UNII: 7SEV7J4R1U) MICA (UNII: V8A1AW0880) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CYCLOMETHICONE (UNII: NMQ347994Z) DIPROPYLENE GLYCOL (UNII: E107L85C40) GLYCERIN (UNII: PDC6A3C0OX) DIMETHICONE (UNII: 92RU3N3Y1O) SODIUM CHLORIDE (UNII: 451W47IQ8X) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) PROPYLENE CARBONATE (UNII: 8D08K3S51E) GRAPEFRUIT (UNII: O82C39RR8C) MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y) SACCHARIDE ISOMERATE (UNII: W8K377W98I) HYALURONATE SODIUM (UNII: YSE9PPT4TH) DIAMOND TURBOT (UNII: JYS56A4S2S) BENZIMIDAZOLE (UNII: E24GX49LD8) METHYLPARABEN (UNII: A2I8C7HI9T) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B) BENZYL SALICYLATE (UNII: WAO5MNK9TU) BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69) .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) GERANIOL (UNII: L837108USY) LINALOOL, (+/-)- (UNII: D81QY6I88E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51523-118-02 1 in 1 BOX 1 NDC:51523-118-01 35 mL in 1 CONTAINER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 09/13/2011 Labeler - THEFACESHOP CO., LTD (688329416) Registrant - THEFACESHOP CO., LTD (688329416) Establishment Name Address ID/FEI Business Operations THEFACESHOP CO., LTD 688329416 manufacture
