SUPER BB 10-IN-1 BEAUTY BALM CREAM SPF 30- titanium dioxide, zinc oxide cream

SUPER BB 10-IN-1 BEAUTY BALM CREAM by

Drug Labeling and Warnings

SUPER BB 10-IN-1 BEAUTY BALM CREAM by is a Otc medication manufactured, distributed, or labeled by PHYSICIANS FORMULA INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

WARNINGS AND PRECAUTIONS

Warning: For external use only. When using this product, keep out of eyes. rinse with water to remove.

ACTIVE INGREDIENT

Active Ingredients: Titanium Dioxide 5.76% Zinc Oxide 2.94%

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SUPER BB 10-IN-1 BEAUTY BALM CREAM  SPF 30
titanium dioxide, zinc oxide cream

Product 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)