EXTRA REPAIR FOUNDATION BROAD SPECTRUM 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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BOBBI BROWN
EXTRA
Repair Foundation
Broad Spectrum SPF 25

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 oocurs

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:

Inactive ingredients

water\aqua\eau • glycerin • bis-diglyceryl polyacyladipate-2 • butyrospermum parkii (shea butter) • peg-4 diheptanoate • cetearyl alcohol • cetyl alcohol • glyceryl stearate • hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer • epilobium angustifolium extract • rosmarinus officinalis (rosemary) • oenothera biennis (evening primrose) oil • pelargonium graveolens (geranium) flower oil • angelica archangelica seed oil • citrus aurantium amara (bitter orange) oil • astrocaryum murumuru seed butter • anthemis nobilis (chamomile) • acetyl hexapeptide-8 • lecithin • dimethicone • phenyl trimethicone • propylene glycol laurate • sorbitan stearate • peg-40 stearate • squalane • ethylhexylglycerin • butylene glycol • dicetylphosphate • ceteth-10 phosphate • polysorbate 60 • peg-12 dimethicone • citrus grandis (grapefruit) peel oil • propylene glycol stearate • sodium hyaluronate • sorbitan laurate • polysorbate 20 • citric acid • tocopheryl acetate • xanthan gum • alumina • pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate • tetrasodium edta • limonene • linalool • citral • geraniol • citronellol • potassium sorbate • phenoxyethanol • chlorphenesin • [+/- titanium dioxide (ci 77891) • iron oxides (ci 77491, ci 77492, ci 77499) • mica]<iln38338>

Other information

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

Dist. Bobbi Brown Professional Cosmetics,
New York

PRINCIPAL DISPLAY PANEL - 30 ml Jar Carton

BOBBI BROWN
EXTRA

Repair Foundation
Broad Spectrum SPF 25

1 FL. OZ./30 ml e

Principal Display Panel - 30 ml Jar Carton
EXTRA REPAIR FOUNDATION  BROAD SPECTRUM SPF 25
octinoxate, homosalate, oxybenzone, avobenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64141-008
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) HOMOSALATE5.0 mL  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE5.0 mL  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2.0 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SHEA BUTTER (UNII: K49155WL9Y)  
GLYCERIN (UNII: PDC6A3C0OX)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
GERANIUM OIL, ALGERIAN TYPE (UNII: 5Q1I94P4WG)  
EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)  
ASTROCARYUM MURUMURU SEED BUTTER (UNII: 12V64UPU6R)  
CARROT (UNII: L56Z1JK48B)  
CHAMAEMELUM NOBILE (UNII: 7NF3GE7IWR)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
SQUALANE (UNII: GW89575KF9)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
PROPYLENE GLYCOL MONOPALMITOSTEARATE (UNII: F76354LMGR)  
SORBITAN MONOLAURATE (UNII: 6W9PS8B71J)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64141-008-011 in 1 CARTON
1NDC:64141-008-0230 mL in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/01/2010
Labeler - Bobbi Brown Professional Cosmetics Inc. (627131279)
Establishment
NameAddressID/FEIBusiness Operations
ELGC K.K.712808195RELABEL(64141-008) , REPACK(64141-008)
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Pennsylvania Distribution Center 2 (PADC 2)828534516MANUFACTURE(64141-008) , RELABEL(64141-008) , REPACK(64141-008)
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Inc.042918826MANUFACTURE(64141-008)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS DISTRIBUTION CENTER208579636REPACK(64141-008) , RELABEL(64141-008)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD253616536MANUFACTURE(64141-008)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD244669714MANUFACTURE(64141-008)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD.205952385MANUFACTURE(64141-008)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER N.V.370151326MANUFACTURE(64141-008)
Establishment
NameAddressID/FEIBusiness Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC809771152MANUFACTURE(64141-008)
Establishment
NameAddressID/FEIBusiness Operations
NORTEC KEYSTONE943871157MANUFACTURE(64141-008) , RELABEL(64141-008) , REPACK(64141-008)
Establishment
NameAddressID/FEIBusiness Operations
NORTHTEC BRISTOL959338336MANUFACTURE(64141-008) , RELABEL(64141-008) , REPACK(64141-008)
Establishment
NameAddressID/FEIBusiness Operations
NORTHTEC KEYSTONE949264774MANUFACTURE(64141-008) , RELABEL(64141-008) , REPACK(64141-008)
Establishment
NameAddressID/FEIBusiness Operations
WHITMAN LABORATORIES, LTD.216866277MANUFACTURE(64141-008)
Establishment
NameAddressID/FEIBusiness Operations
Aveda Corporation071352058MANUFACTURE(64141-008)
Establishment
NameAddressID/FEIBusiness Operations
Pennsylvania Logistics Center078364654REPACK(64141-008) , RELABEL(64141-008)

Revised: 4/2012
Document Id: 611eae2d-9be0-4216-896e-d95b64f4e3ab
Set id: c6dff54d-5a23-4e34-9df5-450647bb16ff
Version: 3
Effective Time: 20120406
 
Bobbi Brown Professional Cosmetics Inc.