Label: FACE IT OIL CUT DUAL BB EMULSION SPF20- titanium dioxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 51523-111-01, 51523-111-02 - 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 1, 2011
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- Official Label (Printer Friendly)
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ACTIVE INGREDIENT
TITANIUM DIOXIDE (10%)
WATER
TRIETHOXYCAPRYLYLSILANE
CYCLOMETHICONE
BUTYLENE GLYCOL
CYCLOMETHICONE 5
ALUMINUM HYDROXIDE
STEARIC ACID
DIPROPYLENE GLYCOL
DIMETHICONE
TALC
SODIUM CHLORIDE
METHYLPARABEN
PROPYLPARABEN
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
TRIBASIC CALCIUM PHOSPHATE
BETULA PLATYPHYLLA VAR. JAPONICA BARK
RUMEX CRISPUS ROOT
CITRAL
HYDROXYCITRONELLAL
LINALOOL, (+/-)-
MUNG BEAN
- PURPOSE
- WHEN USING
- STOP USE
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
FACE IT OIL CUT DUAL BB EMULSION SPF20
titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51523-111 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 10 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) CYCLOMETHICONE (UNII: NMQ347994Z) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) STEARIC ACID (UNII: 4ELV7Z65AP) DIPROPYLENE GLYCOL (UNII: E107L85C40) DIMETHICONE (UNII: 92RU3N3Y1O) TALC (UNII: 7SEV7J4R1U) SODIUM CHLORIDE (UNII: 451W47IQ8X) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) BETULA PLATYPHYLLA VAR. JAPONICA BARK (UNII: ZF70YKN0YO) RUMEX CRISPUS ROOT (UNII: 9N1RM2S62C) CITRAL (UNII: T7EU0O9VPP) HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR) LINALOOL, (+/-)- (UNII: D81QY6I88E) MUNG BEAN (UNII: 1LIB31N73G) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51523-111-02 1 in 1 BOX 1 NDC:51523-111-01 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 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