Label: SUPER BB 10-IN-1 BEAUTY BALM CREAM SPF 30- titanium dioxide, zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 31645-164-01, 31645-164-02 - Packager: PHYSICIANS FORMULA INC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 December 19, 2012
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INGREDIENTS AND APPEARANCE
SUPER BB 10-IN-1 BEAUTY BALM CREAM SPF 30
titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:31645-164 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 5.76 g in 100 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 2.94 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) DIMETHICONE (UNII: 92RU3N3Y1O) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) SODIUM CHLORIDE (UNII: 451W47IQ8X) GLYCERIN (UNII: PDC6A3C0OX) SALIX ALBA BARK (UNII: 205MXS71H7) SHEA BUTTER (UNII: K49155WL9Y) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) EDETATE DISODIUM (UNII: 7FLD91C86K) LAURETH-12 (UNII: OAH19558U1) MAGNESIUM SILICATE (UNII: 9B9691B2N9) MICA (UNII: V8A1AW0880) PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) POLYSORBATE 60 (UNII: CAL22UVI4M) PROPYLENE CARBONATE (UNII: 8D08K3S51E) SODIUM HYDROXIDE (UNII: 55X04QC32I) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) XANTHAN GUM (UNII: TTV12P4NEE) CAPRYLYL GLYCOL (UNII: 00YIU5438U) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) HEXYLENE GLYCOL (UNII: KEH0A3F75J) PHENOXYETHANOL (UNII: HIE492ZZ3T) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERRIC OXIDE RED (UNII: 1K09F3G675) FERROSOFERRIC OXIDE (UNII: XM0M87F357) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:31645-164-02 1 in 1 BOX 1 NDC:31645-164-01 35 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 01/05/2013 Labeler - PHYSICIANS FORMULA INC (021261805) Establishment Name Address ID/FEI Business Operations PHYSICIANS FORMULA INC 825048945 manufacture(31645-164)
