BOBBI BROWN EXTRA TINTED MOISTURIZING BALM SPF 25- octinoxate, homosalate, oxybenzone, avobenzone cream 
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:

AVOBENZONE 2.00%

HOMOSALATE 5.00%

OCTINOXATE 7.50%

OXYBENZONE 5.00%

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:
          o limit time in the sun, especially from 10 a.m.–2 p.m.
          o wear long-sleeved shirts, pants, hats and sunglasses
    * children under 6 months of age: ask a doctor

INACTIVE INGREDIENTS

INGREDIENTS: WATER\AQUA\EAU [] GLYCERIN [] PEG-4 DIHEPTANOATE [] BIS-DIGLYCERYL POLYACYLADIPATE-2 [] BUTYROSPERMUM PARKII (SHEA BUTTER) [] CETEARYL ALCOHOL [] CETYL ALCOHOL [] GLYCERYL STEARATE [] HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER [] EPILOBIUM ANGUSTIFOLIUM EXTRACT [] SODIUM HYALURONATE [] TOCOPHERYL ACETATE [] SQUALANE [] ETHYLHEXYLGLYCERIN [] OENOTHERA BIENNIS (EVENING PRIMROSE) OIL [] ROSMARINUS OFFICINALIS (ROSEMARY) [] ANTHEMIS NOBILIS (CHAMOMILE) [] PELARGONIUM GRAVEOLENS (GERANIUM) FLOWER OIL [] ANGELICA ARCHANGELICA SEED OIL [] CITRUS AURANTIUM AMARA (BITTER ORANGE) OIL [] PHENYL TRIMETHICONE [] DIMETHICONE [] LECITHIN [] BUTYLENE GLYCOL [] PEG-12 DIMETHICONE [] DICETYL PHOSPHATE [] CETETH-10 PHOSPHATE [] ASTROCARYUM MURUMURU SEED BUTTER [] SORBITAN STEARATE [] POLYSORBATE 60 [] PEG-40 STEARATE [] CITRUS GRANDIS (GRAPEFRUIT) PEEL OIL [] ALUMINA [] PROPYLENE GLYCOL STEARATE [] POLYSORBATE 20 [] ACETYL HEXAPEPTIDE-8 [] SORBITAN LAURATE [] PROPYLENE GLYCOL LAURATE [] PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE [] XANTHAN GUM [] CITRIC ACID [] TETRASODIUM EDTA [] POTASSIUM SORBATE [] CHLORPHENESIN [] PHENOXYETHANOL [] LIMONENE [] CITRONELLOL [] GERANIOL [] LINALOOL [] CITRAL []  [+/- TITANIUM DIOXIDE (CI 77891) [] IRON OXIDES (CI 77491, CI 77492, CI 77499) [] MICA

OTHER INFORMATION

protect the product in this container from excessive heat and direct sun

BOBBI BROWN

EXTRA

SPF 25 TINTED MOISTURIZING BALM

BROAD SPECTRUM SPF 25



NET WT./ POIDS  NT 1 OZ/ 30 ML



DIST. BOBBI BROWN PROFESSIONAL COSMETICS

NY, NY 10022

FOLDING CARTON


BOBBI BROWN EXTRA  TINTED MOISTURIZING BALM SPF 25
octinoxate, homosalate, oxybenzone, avobenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64141-814
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 mL  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE5 mL  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE5 mL  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2.0 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
PEG-4 DIHEPTANOATE (UNII: 2DQ7O61VHJ)  
SHEA BUTTER (UNII: K49155WL9Y)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
EPILOBIUM ANGUSTIFOLIUM FLOWERING TOP (UNII: 08H094218D)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
SQUALANE (UNII: GW89575KF9)  
EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)  
ROSEMARY (UNII: IJ67X351P9)  
CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)  
PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)  
ANGELICA SEED OIL (UNII: 67IO7RRV7A)  
CITRUS AURANTIUM FRUIT OIL (UNII: 59JDQ5VT0T)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)  
ASTROCARYUM MURUMURU SEED BUTTER (UNII: 12V64UPU6R)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
PEG-40 STEARATE (UNII: ECU18C66Q7)  
CITRUS MAXIMA FRUIT RIND OIL (UNII: 8U3877WD44)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
PROPYLENE GLYCOL STEARATE (UNII: MZM1I680W0)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL)  
SORBITAN MONOLAURATE (UNII: 6W9PS8B71J)  
PROPYLENE GLYCOL MONOLAURATE (UNII: 668Z5835Z3)  
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
XANTHAN GUM (UNII: TTV12P4NEE)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
EDETATE SODIUM (UNII: MP1J8420LU)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
MICA (UNII: V8A1AW0880)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64141-814-011 in 1 CARTON
1NDC:64141-814-0230 mL in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/01/2004
Labeler - Bobbi Brown Professional Cosmetics Inc. (627131279)
Establishment
NameAddressID/FEIBusiness Operations
Len-Ron Manufacturing Division of Aramis Inc.809771152manufacture
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Inc042918826manufacture
Establishment
NameAddressID/FEIBusiness Operations
Northtec Keystone949264774manufacture, relabel, repack
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NameAddressID/FEIBusiness Operations
Northtec Bristol959338336manufacture, relabel, repack
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NameAddressID/FEIBusiness Operations
Northtec Keystone943871157manufacture, relabel, repack
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Pennsylvania Distribution Center 2828534516manufacture, relabel, repack
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Cosmetics Ltd.205952385manufacture
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Cosmetics, Ltd.244669714manufacture
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Cosmetics, Ltd.253616536manufacture
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Cosmetics Distribution Centre208579636repack, relabel
Establishment
NameAddressID/FEIBusiness Operations
ELGC K.K.712808195relabel, repack
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder N.V.370151326manufacture
Establishment
NameAddressID/FEIBusiness Operations
Whitman Laboratories Ltd.216866277manufacture
Establishment
NameAddressID/FEIBusiness Operations
Aveda Corporation071352058manufacture
Establishment
NameAddressID/FEIBusiness Operations
Pennsylvania Logistics Center (PALC)078364654repack, relabel

Revised: 6/2012
Document Id: 21fb384b-d29b-40f3-ab0c-64e00562983e
Set id: e26a2481-ef21-4b19-a682-7fec94dcaf2b
Version: 1
Effective Time: 20120607
 
Bobbi Brown Professional Cosmetics Inc.