BB BROAD SPECTRUM SPF 15 MEDIUM- zinc oxide titanium dioxide cream

BB Broad Spectrum SPF 15 Medium by

Drug Labeling and Warnings

BB Broad Spectrum SPF 15 Medium by is a Otc medication manufactured, distributed, or labeled by Burt's Bees. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Titanium Dioxide 4.7%

Zinc Oxide 7.0%

PURPOSE

Sunscreen

Sunscreen

INDICATIONS & USAGE

Uses

• helps prevent sunburn
• if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

For external use only.

Do not use on damaged or broken skin.

When using this product keep out of eyes.

Rinse with water to remove.

Stop use and ask a doctor if rash occurs.

Keep out of reach of children.

If product is swallowed, get medical help pr contact a poison control center right away.

Directions

• Use in the morning after cleansing
• Apply liberally 15 minutes before sun exposure
• Children under 6 months: Ask a doctor
• Use a water resistant sunscreen if swimming or sweating

Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:

• limit time in the sun, especially from 10 a.m. to 2 p.m.
• wear long sleeve shirts, pants, hats and sunglasses
• reapply at least every two hours
• use a water resistant sunscreen if swimming or sweating

INACTIVE INGREDIENT

Inactive Ingredients: water, glycerin, decyl oleate, isoamyl cocoate, isoamyl laurate, octyldodecanol, polyglyceryl-4 caprate, caprylic/capric triglyceride, cetyl alcohol, helianthus annuus (sunflower) seed oil, polyglyceryl-2 dipolyhydroxystearate, glyceryl stearate citrate, stearic acid, morinda citrifolia fruit extract, beeswax, jojoba esters, mica, iron oxides, silica, sorbitan stearate, stearyl alcohol, behenyl alcohol, sodium carboxymethyl C10-16 alkyl glucoside, lauryl glucoside, magnesium aluminum silicate, xanthum gum, citric acid, isostearic acid, lecithin, polyglyceryl-3 polyrincinoleate, polyhydroxystearic acid, sodium phytate, trihydroxystearin, alumina, arachidyl alcohol, sorbic acid, alcohol denat., potassium sorbate, sodium benzoate, fragrance, phenoxyethanol

Other Information

• Protect this product from excessive heat and direct sun.

Questions?

(800) 849-7112 or www.burtsbees.com

PRINCIPAL DISPLAY PANEL

Burt's Bees

BB CREAM

with Noni Extract

MEDIUM

Broad Spectrum SPF 15

Net Wt. 1.7 oz / 48.1 g

INGREDIENTS AND APPEARANCE

BB BROAD SPECTRUM SPF 15 MEDIUM 
zinc oxide titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 26052-032
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	7 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	4.7 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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)
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)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 26052-032-02	1 in 1 CARTON	11/01/2015
1	NDC: 26052-032-01	48.1 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 not final	part352	11/01/2015

Labeler - Burt's Bees (613480946)