BOBBI BROWN EXTRA  REPAIR FOUNDATION BROAD SPECTRUM SPF 25- octinoxate, homosalate, oxybenzone, and 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 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:

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 ▪ dicetyl phosphate ▪ 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.

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
BOBBI BROWN EXTRA   REPAIR FOUNDATION BROAD SPECTRUM SPF 25
octinoxate, homosalate, oxybenzone, and avobenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64141-015
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.0821 g  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE0.0548 g  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.0548 g  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE0.0219 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
SHEA BUTTER (UNII: K49155WL9Y)  
PEG-4 DIHEPTANOATE (UNII: 2DQ7O61VHJ)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
ROSEMARY (UNII: IJ67X351P9)  
EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)  
PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)  
ANGELICA SEED OIL (UNII: 67IO7RRV7A)  
CITRUS AURANTIUM FRUIT (UNII: DQD16J2B5O)  
ASTROCARYUM MURUMURU SEED BUTTER (UNII: 12V64UPU6R)  
CHAMOMILE (UNII: FGL3685T2X)  
ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
PROPYLENE GLYCOL MONOLAURATE (UNII: 668Z5835Z3)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
PEG-40 STEARATE (UNII: ECU18C66Q7)  
SQUALANE (UNII: GW89575KF9)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
CITRUS MAXIMA FRUIT RIND OIL (UNII: 8U3877WD44)  
PROPYLENE GLYCOL MONOSTEARATE (UNII: MZM1I680W0)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
SORBITAN MONOLAURATE (UNII: 6W9PS8B71J)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
XANTHAN GUM (UNII: TTV12P4NEE)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
EDETATE SODIUM (UNII: MP1J8420LU)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
CITRAL (UNII: T7EU0O9VPP)  
GERANIOL (UNII: L837108USY)  
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
MICA (UNII: V8A1AW0880)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64141-015-011 in 1 CARTON11/01/2010
130 mL in 1 JAR; Type 0: Not a Combination Product
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)
Registrant - Estee Lauder Companies Inc. (790802086)
Establishment
NameAddressID/FEIBusiness Operations
Whitman Laboratories Ltd.216866277MANUFACTURE(64141-015) , REPACK(64141-015) , RELABEL(64141-015)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COMPANY, THE828534516REPACK(64141-015) , RELABEL(64141-015)
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Cosmetics Ltd.202952982MANUFACTURE(64141-015) , REPACK(64141-015) , RELABEL(64141-015)
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Cosmetics Ltd.204132062REPACK(64141-015) , RELABEL(64141-015)
Establishment
NameAddressID/FEIBusiness Operations
NORTHTEC INC943871157REPACK(64141-015) , RELABEL(64141-015)
Establishment
NameAddressID/FEIBusiness Operations
NORTHTEC PALC102631997REPACK(64141-015) , RELABEL(64141-015)
Establishment
NameAddressID/FEIBusiness Operations
Len-Ron Manufacturing Division of Aramis Inc.809771152MANUFACTURE(64141-015) , REPACK(64141-015) , RELABEL(64141-015)
Establishment
NameAddressID/FEIBusiness Operations
PADC 1949264774REPACK(64141-015) , RELABEL(64141-015)
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder N.V.370151326MANUFACTURE(64141-015) , REPACK(64141-015) , RELABEL(64141-015)

Revised: 8/2021
Document Id: 43731d5b-09a7-4c13-9ac2-ea7534bc748a
Set id: 6a1fa3dc-3016-419a-bbfa-118434b22e49
Version: 3
Effective Time: 20210812
 
Bobbi Brown Professional Cosmetics Inc.