TINTED MOISTURIZER OIL FREE SPF 15

Dosage form: liquid
Ingredients: OCTINOXATE 3.5mL in 100mL, TITANIUM DIOXIDE 1.8mL in 100mL
Labeler: Bobbi Brown Professional Cosmetics Inc.
NDC Code: 64141-010

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.

ACTIVE INGREDIENTS: OCTINOXATE 3.50% [] TITANIUM DIOXIDE 1.80%

INACTIVE INGREDIENTS: WATER [] CYCLOPENTASILOXANE [] BUTYLENE GLYCOL [] STEARETH-21 [] GLYCERYL STEARATE [] DIMETHICONE [] ISOSTEARIC ACID [] TROMETHAMINE [] ALOE BARBADENSIS LEAF WATER [] PALMITOYL OLIGOPEPTIDE [] CAFFEINE [] SODIUM HYALURONATE [] ASCORBYL PALMITATE [] CHOLESTEROL [] TOCOPHERYL ACETATE [] GLYCERIN [] SUCROSE [] ANTHEMIS NOBILIS (CHAMOMILE) [] HYDROGENATED LECITHIN [] SORBITOL [] CELLULOSE GUM [] PEG-8 [] CHAMOMILLA RECUTITA (MATRICARIA) [] LECITHIN [] PVP [] STEARIC ACID [] GLYCERYL POLYMETHACRYLATE [] XANTHAN GUM [] STEARETH-2 [] HEXYLENE GLYCOL [] MAGNESIUM ALUMINUM SILICATE [] CAPRYLYL GLYCOL [] SILICA [] ALUMINUM HYDROXIDE [] SODIUM CITRATE [] CETRIMONIUM CHLORIDE [] CARBOMER [] DISODIUM EDTA [] CHLOROXYLENOL [] CHLORPHENESIN [] PHENOXYETHANOL []  [+/- IRON OXIDES (CI 77491, CI 77492, CI 77499) [] TITANIUM DIOXIDE (CI 77891) [] MICA]


WARNING: KEEP OUT OF EYES. STOP USE IF IRRITATION OCCURS.

KEEP OUT OF REACH OF CHILDREN

PRINCIPAL DISPLAY PANEL:

BOBBI BROWN

SPF 15

TINTED MOISTURIZER

OIL FREE


1.7 FL OZ/50 ML

BOBBI BROWN PROF COS DISTR
NY NY


TINTED MOISTURIZER  OIL FREE SPF 15
octinoxate, titanium dioxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64141-010
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE3.5 mL  in 100 mL
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE1.8 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CYCLOMETHICONE 5 
WATER 
BUTYLENE GLYCOL 
GLYCERYL MONOSTEARATE 
DIMETHICONE 
ISOSTEARIC ACID 
PHENOXYETHANOL 
CHOLESTEROL 
.ALPHA.-TOCOPHEROL ACETATE, DL- 
GLYCERIN 
Packaging
#Item CodePackage Description
1NDC:64141-010-011 TUBE (TUBE) in 1 CARTON
1NDC:64141-010-0250 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35212/01/2010
Labeler - Bobbi Brown Professional Cosmetics Inc. (627131279)
Establishment
NameAddressID/FEIOperations
ESTEE LAUDER COSMETICS, LTD205952385manufacture
Establishment
NameAddressID/FEIOperations
ESTEE LAUDER N.V.370151326manufacture
Establishment
NameAddressID/FEIOperations
Len-Ron Manufacturing Division of Aramis Inc.809771152manufacture
Establishment
NameAddressID/FEIOperations
Aramis Inc.042918826manufacture
Establishment
NameAddressID/FEIOperations
Northtec Bristol949264774manufacture, relabel, repack
Establishment
NameAddressID/FEIOperations
Northtec Keystone618107429manufacture, relabel, repack
Establishment
NameAddressID/FEIOperations
Estee Lauder Pennsylvania Distribution Center 2828534516manufacture, relabel, repack
Establishment
NameAddressID/FEIOperations
Estee Lauder Cosmetics, Ltd.255175580manufacture
Establishment
NameAddressID/FEIOperations
Estee Lauder Cosmetics, Ltd253616536manufacture
Establishment
NameAddressID/FEIOperations
Estee Lauder Cosmetics Distribution Center208579636repack, relabel
Establishment
NameAddressID/FEIOperations
Estee Lauder Kabushiki Kaisha712808195relabel, repack
Establishment
NameAddressID/FEIOperations
Whitman Laboratories Ltd.216866277manufacture
Establishment
NameAddressID/FEIOperations
Aveda Corporation071352058manufacture

Revised: 03/2011
 
Bobbi Brown Professional Cosmetics Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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