BOBBI BROWN BB BROAD SPECTRUM SPF 35- octinoxate, octisalate, oxybenzone, and titanium dioxide cream

BOBBI BROWN BB by

Drug Labeling and Warnings

BOBBI BROWN BB by is a Otc medication manufactured, distributed, or labeled by Bobbi Brown Professional Cosmetics Inc., Estee Lauder Companies Inc., Whitman Laboratories Ltd., ESTEE LAUDER COMPANY, THE, Estee Lauder Cosmetics Ltd., Estee Lauder N.V., Len-Ron Manufacturing Division of Aramis Inc., NORTHTEC INC, PADC 1, NORTHTEC PALC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients	Purpose
Octinoxate 7.50%	Sunscreen
Octisalate 4.00%
Oxybenzone 2.50%
Titanium Dioxide 1.10%

Use

Helps prevent sunburn

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

For sunscreen use:

• apply liberally 15 minutes before sun exposure
• reapply at least every two hours
• use a water resistant sunscreen if swimming or sweating
• Sun Protection Measures. Spending time in the sun increase your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
  • limit time in the sun, especially from 10 a.m.–2 p.m.
  • wear long-sleeved shirts, pants, hats and sunglasses
• children under 6 months of age: ask a doctor

Inactive ingredients

water\aqua\eau ■ dimethicone ■ butylene glycol ■ phenyl trimethicone ■ pentylene glycol ■ glyceryl stearate ■ behenyl alcohol ■ trioctyldodecyl citrate ■ polymethylsilsesquioxane ■ octyldodecyl stearoyl stearate ■ peg-40 stearate ■ polyglyceryl-10 pentastearate ■ ammonium acryloyldimethyltaurate/vp copolymer ■ triticum vulgare (wheat) germ extract ■ hordeum vulgare (barley) extract\extrait d'orge ■ cucumis sativus (cucumber) fruit extract ■ laminaria saccharina extract ■ pyrus malus (apple) fruit extract ■ scutellaria baicalensis root extract ■ polyquaternium-51 ■ acetyl hexapeptide-8 ■ trehalose ■ oryzanol ■ octyldodecyl neopentanoate ■ urea ■ polyglyceryl-6 polyricinoleate ■ propylene glycol laurate ■ glycyrrhetinic acid ■ tocopheryl acetate ■ sucrose ■ glycerin ■ sodium stearoyl lactylate ■ caffeine ■ linoleic acid ■ cholesterol ■ lecithin ■ squalane ■ sodium pca ■ isopropyl titanium triisostearate ■ propylene glycol stearate ■ stearic acid ■ polysorbate 20 ■ sorbitan laurate ■ xanthan gum ■ aluminum hydroxide ■ sodium hyaluronate ■ silica ■ disodium edta ■ pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate ■ sodium dehydroacetate ■ chlorphenesin ■ phenoxyethanol ■ [+/- mica ■ titanium dioxide (ci 77891) ■ zinc oxide (ci 77947) ■ iron oxides (ci 77491, ci77492, ci 77499)] <iln37231>

Other information

Protect the product in this container from excessive heat and direct sun.

SPL UNCLASSIFIED SECTION

Dist. Bobbi Brown
Professional Cosmetics
New York, N.Y. 10022

PRINCIPAL DISPLAY PANEL - 40 ml Tube Carton

BB Cream
Broad
Spectrum
SPF 35

BOBBI
BROWN

1.35 FL. OZ./40 ml e

INGREDIENTS AND APPEARANCE

BOBBI BROWN BB   BROAD SPECTRUM SPF 35
octinoxate, octisalate, oxybenzone, and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64141-012
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 mL  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4 mL  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	2.5 mL  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.1 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
DOCOSANOL (UNII: 9G1OE216XY)
OCTYLDODECYL STEAROYL STEARATE (UNII: 3D47Q6D93C)
PEG-40 STEARATE (UNII: ECU18C66Q7)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
WHEAT GERM (UNII: YR3G369F5A)
CUCUMBER (UNII: YY7C30VXJT)
SACCHARINA LATISSIMA THALLUS (UNII: 68CMP2MB55)
APPLE (UNII: B423VGH5S9)
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)
ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL)
TREHALOSE (UNII: B8WCK70T7I)
GAMMA ORYZANOL (UNII: SST9XCL51M)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
UREA (UNII: 8W8T17847W)
ENOXOLONE (UNII: P540XA09DR)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SUCROSE (UNII: C151H8M554)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)
CAFFEINE (UNII: 3G6A5W338E)
LINOLEIC ACID (UNII: 9KJL21T0QJ)
CHOLESTEROL (UNII: 97C5T2UQ7J)
SQUALANE (UNII: GW89575KF9)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)
PROPYLENE GLYCOL STEARATE (UNII: MZM1I680W0)
STEARIC ACID (UNII: 4ELV7Z65AP)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SORBITAN MONOLAURATE (UNII: 6W9PS8B71J)
XANTHAN GUM (UNII: TTV12P4NEE)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
CHLORPHENESIN (UNII: I670DAL4SZ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
MICA (UNII: V8A1AW0880)
ZINC OXIDE (UNII: SOI2LOH54Z)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64141-012-01	1 in 1 CARTON
1		40 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	12/01/2010

Labeler - Bobbi Brown Professional Cosmetics Inc. (627131279)

Establishment
Name	Address	ID/FEI	Business Operations
ELGC K.K.		712808195	RELABEL(64141-012) , REPACK(64141-012)

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Pennsylvania Distribution Center 2 (PADC 2)		828534516	MANUFACTURE(64141-012) , RELABEL(64141-012) , REPACK(64141-012)

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Inc.		042918826	MANUFACTURE(64141-012)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS DISTRIBUTION CENTER		208579636	RELABEL(64141-012) , REPACK(64141-012)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		253616536	MANUFACTURE(64141-012)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(64141-012)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		205952385	MANUFACTURE(64141-012)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(64141-012)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(64141-012)

Establishment
Name	Address	ID/FEI	Business Operations
NORTEC KEYSTONE		943871157	MANUFACTURE(64141-012) , RELABEL(64141-012) , REPACK(64141-012)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC BRISTOL		959338336	MANUFACTURE(64141-012) , RELABEL(64141-012) , REPACK(64141-012)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC KEYSTONE		949264774	MANUFACTURE(64141-012) , RELABEL(64141-012) , REPACK(64141-012)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(64141-012)

Establishment
Name	Address	ID/FEI	Business Operations
Aveda Corporation		071352058	MANUFACTURE(64141-012)

Establishment
Name	Address	ID/FEI	Business Operations
Pennsylvania Logistics Center		078364654	REPACK(64141-012) , RELABEL(64141-012)