NDC Code(s) : 26052-032-01, 26052-032-02
Packager : Burt's Bees

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

BB Broad Spectrum SPF 15 MediumZinc Oxide Titanium Dioxide CREAM
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:26052-032
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE7 g in 100 g
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE4.7 g in 100 g
Inactive Ingredients
Ingredient Name Strength
DOCOSANOL(UNII: 9G1OE216XY)
JOJOBA OIL(UNII: 724GKU717M)
ALCOHOL(UNII: 3K9958V90M)
ISOSTEARIC ACID(UNII: X33R8U0062)
FERRIC OXIDE RED(UNII: 1K09F3G675)
LECITHIN, SOYBEAN(UNII: 1DI56QDM62)
POLYGLYCERYL-3 RICINOLEATE(UNII: MZQ63P0N0W)
TRIHYDROXYSTEARIN(UNII: 06YD7896S3)
ALUMINUM OXIDE(UNII: LMI26O6933)
ARACHIDYL ALCOHOL(UNII: 1QR1QRA9BU)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
DECYL OLEATE(UNII: ZGR06DO97T)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
WATER(UNII: 059QF0KO0R)
GLYCERIN(UNII: PDC6A3C0OX)
XANTHAN GUM(UNII: TTV12P4NEE)
CETYL ALCOHOL(UNII: 936JST6JCN)
YELLOW WAX(UNII: 2ZA36H0S2V)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
TRICAPRIN(UNII: O1PB8EU98M)
SORBITAN MONOSTEARATE(UNII: NVZ4I0H58X)
STEARYL ALCOHOL(UNII: 2KR89I4H1Y)
LAURYL GLUCOSIDE(UNII: 76LN7P7UCU)
OCTYLDODECANOL(UNII: 461N1O614Y)
POLYGLYCERYL-4 CAPRATE(UNII: 3N873UN885)
SUNFLOWER OIL(UNII: 3W1JG795YI)
GLYCERYL STEARATE CITRATE(UNII: WH8T92A065)
SODIUM BENZOATE(UNII: OJ245FE5EU)
PHYTATE SODIUM(UNII: 88496G1ERL)
ISOAMYL COCOATE(UNII: 14OG46E98E)
SORBIC ACID(UNII: X045WJ989B)
POLYHYDROXYSTEARIC ACID (2300 MW)(UNII: YXH47AOU0F)
ISOAMYL LAURATE(UNII: M1SLX00M3M)
MAGNESIUM ALUMINUM SILICATE(UNII: 6M3P64V0NC)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE(UNII: 9229XJ4V12)
STEARIC ACID(UNII: 4ELV7Z65AP)
MORINDA CITRIFOLIA FRUIT(UNII: 7829X3G2X5)
MICA(UNII: V8A1AW0880)
POTASSIUM SORBATE(UNII: 1VPU26JZZ4)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:26052-032-021 in 1 CARTON 11/01/2015
1NDC:26052-032-0148.1 g in 1 TUBE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M020 11/01/2015

LABELER - Burt's Bees(613480946)

PRINCIPAL DISPLAY PANEL

BB CREAM MED

Burt's Bees

BB CREAM

with Noni Extract

MEDIUM

Broad Spectrum SPF 15

Net Wt. 1.7 oz / 48.1 g