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

BB Broad Spectrum SPF 15 Light to Medium by

Drug Labeling and Warnings

BB Broad Spectrum SPF 15 Light to 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

Uses

• helps prevent sunburn
• if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early 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 or 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 resistent sunscreen if swimming or sweating

Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early 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 ethe sun, especially from 10 a.m.- 2 p.m.
• wear long-sleeve shirts, pants, hats and sunglasses
• reapply at least every 2 hours
• use a water resistent 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 citrifilia 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, xanthan gum, citric acid, isostearic acid, lecithin, polyglyceryl-3polyricinoleate, polyhydroxysteric acid, sodium phytate, trihydroxystearin, alumina, arachidyl alcohol, sorbic acid, alcohol denat., potassium sorbate, sodium benzoate, fragrance*, phenoxyehtanol

*natural fragrance

Other Information:

• Protect this product from heat and direct sun.

Questions?

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

PRINCIPAL DISPLAY PANEL

Burt's Bees

BB Cream

with Noni Extract

LIGHT/MED

Broad Spectrum SPF 15

Net Wt 1.7 oz / 48.1g

INGREDIENTS AND APPEARANCE

BB BROAD SPECTRUM SPF 15 LIGHT TO MEDIUM 
zinc oxide titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 26052-031
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
ISOAMYL COCOATE (UNII: 14OG46E98E)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)
SODIUM BENZOATE (UNII: OJ245FE5EU)
TRICAPRIN (UNII: O1PB8EU98M)
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
OCTYLDODECANOL (UNII: 461N1O614Y)
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)
DOCOSANOL (UNII: 9G1OE216XY)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
DECYL OLEATE (UNII: ZGR06DO97T)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
POLYGLYCERYL-4 CAPRATE (UNII: 3N873UN885)
JOJOBA OIL (UNII: 724GKU717M)
ALUMINUM OXIDE (UNII: LMI26O6933)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
SORBIC ACID (UNII: X045WJ989B)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
XANTHAN GUM (UNII: TTV12P4NEE)
CETYL ALCOHOL (UNII: 936JST6JCN)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
SUNFLOWER OIL (UNII: 3W1JG795YI)
TRIHYDROXYSTEARIN (UNII: 06YD7896S3)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
ISOSTEARIC ACID (UNII: X33R8U0062)
ALCOHOL (UNII: 3K9958V90M)
PHYTATE SODIUM (UNII: 88496G1ERL)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
YELLOW WAX (UNII: 2ZA36H0S2V)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
FERRIC OXIDE RED (UNII: 1K09F3G675)
ISOAMYL LAURATE (UNII: M1SLX00M3M)
STEARIC ACID (UNII: 4ELV7Z65AP)
MORINDA CITRIFOLIA FRUIT (UNII: 7829X3G2X5)
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 26052-031-01	1 in 1 CARTON	11/01/2015
1	NDC: 26052-031-02	48.1 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 26052-031-03	0.85 g in 1 PACKET; Type 0: Not a Combination Product	11/01/2015	12/01/2016

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)