BOBBI BROWN SKIN FOUNDATION BROAD SPECTRUM SPF 15- octinoxate and titanium dioxide liquid
Bobbi Brown Professional Cosmetics Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active Ingredients

Octinoxate 7.50%
Titanium Dioxide 1.00%

Purpose

Sunscreen

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 increases 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 • methyl trimethicone • neopentyl glycol diethylhexanoate • isononyl isononanoate • glycerin • pentylene glycol • lauryl peg-9 polydimethylsiloxyethyl dimethicone • hdi/trimethylol hexyllactone crosspolymer • talc • boron nitride • disteardimonium hectorite • stearic acid • palmitic acid • dimethicone • lecithin • aluminum dimyristate • tocopherol • myristic acid • silica • magnesium ascorbyl phosphate • sodium chloride • sodium citrate • sorbic acid • chlorphenesin • phenoxyethanol • [+/- titanium dioxide (ci 77891) • iron oxides (ci 77491, ci 77492, ci 77499)] <iln34969>

Other information

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

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

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton

BOBBI
BROWN

Skin Foundation
Broad Spectrum SPF 15

1 FL. OZ./ 30 ml e

Principal Display Panel - 30 mL Bottle Carton

BOBBI BROWN SKIN FOUNDATION BROAD SPECTRUM SPF 15
octinoxate and titanium dioxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:64141-013
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (OCTINOXATE)	OCTINOXATE	0.078 g in 1 mL
TITANIUM DIOXIDE (TITANIUM DIOXIDE)	TITANIUM DIOXIDE	0.0104 g in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water
methyl trimethicone
neopentyl glycol diethylhexanoate
isononyl isononanoate
glycerin
pentylene glycol
talc
boron nitride
stearic acid
palmitic acid
dimethicone
aluminum dimyristate
tocopherol
myristic acid
silicon dioxide
magnesium ascorbyl phosphate
sodium chloride
sodium citrate
sorbic acid
chlorphenesin
phenoxyethanol
ferric oxide red
ferric oxide yellow
ferrosoferric oxide

Packaging
#	Item Code	Package Description
1	NDC:64141-013-01	1 in 1 CARTON
1		30 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	09/01/2012

Labeler - Bobbi Brown Professional Cosmetics Inc. (627131279)

Establishment
Name	Address	ID/FEI	Business Operations
ELGC K.K.		712808195	RELABEL(64141-013), REPACK(64141-013)

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Pennsylvania Distribution Center 2 (PADC 2)		828534516	MANUFACTURE(64141-013), RELABEL(64141-013), REPACK(64141-013)

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Inc.		042918826	MANUFACTURE(64141-013)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS DISTRIBUTION CENTER		208579636	REPACK(64141-013), RELABEL(64141-013)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		253616536	MANUFACTURE(64141-013)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(64141-013)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		205952385	MANUFACTURE(64141-013)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(64141-013)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(64141-013)

Establishment
Name	Address	ID/FEI	Business Operations
NORTEC KEYSTONE		943871157	MANUFACTURE(64141-013), RELABEL(64141-013), REPACK(64141-013)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC BRISTOL		959338336	MANUFACTURE(64141-013), RELABEL(64141-013), REPACK(64141-013)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC KEYSTONE		949264774	MANUFACTURE(64141-013), RELABEL(64141-013), REPACK(64141-013)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(64141-013)

Establishment
Name	Address	ID/FEI	Business Operations
Aveda Corporation		071352058	MANUFACTURE(64141-013)

Establishment
Name	Address	ID/FEI	Business Operations
Pennsylvania Logistics Center		078364654	RELABEL(64141-013), REPACK(64141-013)

Establishment
Name	Address	ID/FEI	Business Operations
JO COSMETICS		692780372	MANUFACTURE(64141-013)

Revised: 12/2012

Document Id: 2db96819-d54c-41d0-a264-2eab0220afcb

Set id: a3329e11-8f1b-4e66-8b51-4ba0208612fd

Version: 1

Effective Time: 20121211

Bobbi Brown Professional Cosmetics Inc.