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EXTRA REPAIR FOUNDATION BROAD SPECTRUM SPF 25

Dosage form: cream
Ingredients: OCTINOXATE 7.5mL in 100mL, HOMOSALATE 5.0mL in 100mL, OXYBENZONE 5.0mL in 100mL, AVOBENZONE 2.0mL in 100mL
Labeler: Bobbi Brown Professional Cosmetics Inc.
NDC Code: 64141-008

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.

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:

  • 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, regulary 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-sleezed shirts, pants, hats and sunglasses
  • children under 6 months of age: ask a doctor

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

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 AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE7.5 mL  in 100 mL
HOMOSALATE (HOMOSALATE) HOMOSALATE5.0 mL  in 100 mL
OXYBENZONE (OXYBENZONE) OXYBENZONE5.0 mL  in 100 mL
AVOBENZONE (AVOBENZONE) AVOBENZONE2.0 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
SHEA BUTTER 
GLYCERIN 
CETOSTEARYL ALCOHOL 
CETYL ALCOHOL 
GLYCERYL MONOSTEARATE 
GERANIUM OIL, ALGERIAN TYPE 
EVENING PRIMROSE OIL 
ASTROCARYUM MURUMURU SEED BUTTER 
CARROT 
CHAMAEMELUM NOBILE 
LECITHIN, SOYBEAN 
DIMETHICONE 
SORBITAN MONOSTEARATE 
SQUALANE 
BUTYLENE GLYCOL 
POLYSORBATE 60 
PROPYLENE GLYCOL MONOPALMITOSTEARATE 
SORBITAN MONOLAURATE 
POLYSORBATE 20 
CITRIC ACID MONOHYDRATE 
POTASSIUM SORBATE 
PHENOXYETHANOL 
Packaging
#Item CodePackage Description
1NDC:64141-008-011 JAR (JAR) 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/FEIOperations
ELGC K.K.712808195RELABEL(64141-008), REPACK(64141-008)
Establishment
NameAddressID/FEIOperations
Estee Lauder Pennsylvania Distribution Center 2 (PADC 2)828534516MANUFACTURE(64141-008), RELABEL(64141-008), REPACK(64141-008)
Establishment
NameAddressID/FEIOperations
Estee Lauder Inc.042918826MANUFACTURE(64141-008)
Establishment
NameAddressID/FEIOperations
ESTEE LAUDER COSMETICS DISTRIBUTION CENTER208579636REPACK(64141-008), RELABEL(64141-008)
Establishment
NameAddressID/FEIOperations
ESTEE LAUDER COSMETICS, LTD253616536MANUFACTURE(64141-008)
Establishment
NameAddressID/FEIOperations
ESTEE LAUDER COSMETICS, LTD244669714MANUFACTURE(64141-008)
Establishment
NameAddressID/FEIOperations
ESTEE LAUDER COSMETICS, LTD.205952385MANUFACTURE(64141-008)
Establishment
NameAddressID/FEIOperations
ESTEE LAUDER N.V.370151326MANUFACTURE(64141-008)
Establishment
NameAddressID/FEIOperations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC809771152MANUFACTURE(64141-008)
Establishment
NameAddressID/FEIOperations
NORTEC KEYSTONE943871157MANUFACTURE(64141-008), RELABEL(64141-008), REPACK(64141-008)
Establishment
NameAddressID/FEIOperations
NORTHTEC BRISTOL959338336MANUFACTURE(64141-008), RELABEL(64141-008), REPACK(64141-008)
Establishment
NameAddressID/FEIOperations
NORTHTEC KEYSTONE949264774MANUFACTURE(64141-008), RELABEL(64141-008), REPACK(64141-008)
Establishment
NameAddressID/FEIOperations
WHITMAN LABORATORIES, LTD.216866277MANUFACTURE(64141-008)
Establishment
NameAddressID/FEIOperations
Aveda Corporation071352058MANUFACTURE(64141-008)
Establishment
NameAddressID/FEIOperations
Pennsylvania Logistics Center078364654REPACK(64141-008), RELABEL(64141-008)

Revised: 04/2012
 
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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