Medication Guide App

BOBBI BROWN EXTRA TINTED MOISTURIZING BALM SPF 25

Dosage form: cream
Ingredients: OCTINOXATE 7.5mL in 100mL, HOMOSALATE 5mL in 100mL, OXYBENZONE 5mL in 100mL, AVOBENZONE 2.0mL in 100mL
Labeler: Bobbi Brown Professional Cosmetics Inc.
NDC Code: 64141-814

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.

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


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 AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE7.5 mL  in 100 mL
HOMOSALATE (HOMOSALATE) HOMOSALATE5 mL  in 100 mL
OXYBENZONE (OXYBENZONE) OXYBENZONE5 mL  in 100 mL
AVOBENZONE (AVOBENZONE) AVOBENZONE2.0 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
GLYCERIN 
PEG-4 DIHEPTANOATE 
SHEA BUTTER 
CETOSTEARYL ALCOHOL 
CETYL ALCOHOL 
GLYCERYL MONOSTEARATE 
EPILOBIUM ANGUSTIFOLIUM FLOWERING TOP 
HYALURONATE SODIUM 
.ALPHA.-TOCOPHEROL ACETATE 
SQUALANE 
EVENING PRIMROSE OIL 
ROSEMARY 
CHAMAEMELUM NOBILE FLOWER 
PELARGONIUM GRAVEOLENS FLOWER OIL 
ANGELICA SEED OIL 
CITRUS AURANTIUM FRUIT OIL 
PHENYL TRIMETHICONE 
DIMETHICONE 
LECITHIN, SOYBEAN 
BUTYLENE GLYCOL 
DIHEXADECYL PHOSPHATE 
CETETH-10 PHOSPHATE 
ASTROCARYUM MURUMURU SEED BUTTER 
SORBITAN MONOSTEARATE 
POLYSORBATE 60 
PEG-40 STEARATE 
CITRUS MAXIMA FRUIT RIND OIL 
ALUMINUM OXIDE 
PROPYLENE GLYCOL STEARATE 
POLYSORBATE 20 
ACETYL HEXAPEPTIDE-8 
SORBITAN MONOLAURATE 
PROPYLENE GLYCOL MONOLAURATE 
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) 
XANTHAN GUM 
CITRIC ACID MONOHYDRATE 
EDETATE SODIUM 
POTASSIUM SORBATE 
CHLORPHENESIN 
PHENOXYETHANOL 
FERRIC OXIDE RED 
MICA 
Packaging
#Item CodePackage Description
1NDC:64141-814-011 JAR (JAR) 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/FEIOperations
Len-Ron Manufacturing Division of Aramis Inc.809771152manufacture
Establishment
NameAddressID/FEIOperations
Estee Lauder Inc042918826manufacture
Establishment
NameAddressID/FEIOperations
Northtec Keystone949264774manufacture, relabel, repack
Establishment
NameAddressID/FEIOperations
Northtec Bristol959338336manufacture, relabel, repack
Establishment
NameAddressID/FEIOperations
Northtec Keystone943871157manufacture, relabel, repack
Establishment
NameAddressID/FEIOperations
Estee Lauder Pennsylvania Distribution Center 2828534516manufacture, relabel, repack
Establishment
NameAddressID/FEIOperations
Estee Lauder Cosmetics Ltd.205952385manufacture
Establishment
NameAddressID/FEIOperations
Estee Lauder Cosmetics, Ltd.244669714manufacture
Establishment
NameAddressID/FEIOperations
Estee Lauder Cosmetics, Ltd.253616536manufacture
Establishment
NameAddressID/FEIOperations
Estee Lauder Cosmetics Distribution Centre208579636repack, relabel
Establishment
NameAddressID/FEIOperations
ELGC K.K.712808195relabel, repack
Establishment
NameAddressID/FEIOperations
Estee Lauder N.V.370151326manufacture
Establishment
NameAddressID/FEIOperations
Whitman Laboratories Ltd.216866277manufacture
Establishment
NameAddressID/FEIOperations
Aveda Corporation071352058manufacture
Establishment
NameAddressID/FEIOperations
Pennsylvania Logistics Center (PALC)078364654repack, relabel

Revised: 06/2012
 
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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