BOBBI BROWN BB BROAD SPECTRUM SPF 35

Dosage form: cream
Ingredients: OCTINOXATE 7.5mL in 100mL, OCTISALATE 4mL in 100mL, OXYBENZONE 2.5mL in 100mL, TITANIUM DIOXIDE 1.1mL in 100mL
Labeler: Bobbi Brown Professional Cosmetics Inc.
NDC Code: 64141-012

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 BB CREAM
BROAD SPECTRUM SPF 35

Drug Facts

Active IngredientsPurpose
Octinoxate 7.50%Sunscreen
Octisalate 4.00%
Oxybenzone 2.50%
Titanium Dioxide 1.10%

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

Inactive ingredients

water\aqua\eau ■ dimethicone ■ butylene glycol ■ phenyl trimethicone ■ pentylene glycol ■ glyceryl stearate ■ behenyl alcohol ■ trioctyldodecyl citrate ■ polymethylsilsesquioxane ■ octyldodecyl stearoyl stearate ■ peg-40 stearate ■ polyglyceryl-10 pentastearate ■ ammonium acryloyldimethyltaurate/vp copolymer ■ triticum vulgare (wheat) germ extract ■ hordeum vulgare (barley) extract\extrait d'orge ■ cucumis sativus (cucumber) fruit extract ■ laminaria saccharina extract ■ pyrus malus (apple) fruit extract ■ scutellaria baicalensis root extract ■ polyquaternium-51 ■ acetyl hexapeptide-8 ■ trehalose ■ oryzanol ■ octyldodecyl neopentanoate ■ urea ■ polyglyceryl-6 polyricinoleate ■ propylene glycol laurate ■ glycyrrhetinic acid ■ tocopheryl acetate ■ sucrose ■ glycerin ■ sodium stearoyl lactylate ■ caffeine ■ linoleic acid ■ cholesterol ■ lecithin ■ squalane ■ sodium pca ■ isopropyl titanium triisostearate ■ propylene glycol stearate ■ stearic acid ■ polysorbate 20 ■ sorbitan laurate ■ xanthan gum ■ aluminum hydroxide ■ sodium hyaluronate ■ silica ■ disodium edta ■ pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate ■ sodium dehydroacetate ■ chlorphenesin ■ phenoxyethanol ■ [+/- mica ■ titanium dioxide (ci 77891) ■ zinc oxide (ci 77947) ■ iron oxides (ci 77491, ci77492, ci 77499)] <iln37231>

Other information

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

Dist. Bobbi Brown
Professional Cosmetics
New York, N.Y. 10022

PRINCIPAL DISPLAY PANEL - 40 ml Tube Carton

BB Cream
Broad
Spectrum
SPF 35

BOBBI
BROWN

1.35 FL. OZ./40 ml e

BOBBI BROWN BB   BROAD SPECTRUM SPF 35
octinoxate, octisalate, oxybenzone, and titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64141-012
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE7.5 mL  in 100 mL
OCTISALATE (OCTISALATE) OCTISALATE4 mL  in 100 mL
OXYBENZONE (OXYBENZONE) OXYBENZONE2.5 mL  in 100 mL
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE1.1 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
DIMETHICONE 
BUTYLENE GLYCOL 
PHENYL TRIMETHICONE 
PENTYLENE GLYCOL 
GLYCERYL MONOSTEARATE 
DOCOSANOL 
OCTYLDODECYL STEAROYL STEARATE 
PEG-40 STEARATE 
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER 
WHEAT GERM 
CUCUMBER 
SACCHARINA LATISSIMA THALLUS 
APPLE 
SCUTELLARIA BAICALENSIS ROOT 
ACETYL HEXAPEPTIDE-8 
TREHALOSE 
GAMMA ORYZANOL 
OCTYLDODECYL NEOPENTANOATE 
UREA 
ENOXOLONE 
.ALPHA.-TOCOPHEROL ACETATE 
SUCROSE 
GLYCERIN 
SODIUM STEAROYL LACTYLATE 
CAFFEINE 
LINOLEIC ACID 
CHOLESTEROL 
SQUALANE 
SODIUM PYRROLIDONE CARBOXYLATE 
ISOPROPYL TITANIUM TRIISOSTEARATE 
PROPYLENE GLYCOL STEARATE 
STEARIC ACID 
POLYSORBATE 20 
SORBITAN MONOLAURATE 
XANTHAN GUM 
ALUMINUM HYDROXIDE 
HYALURONATE SODIUM 
SILICON DIOXIDE 
EDETATE DISODIUM 
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) 
SODIUM DEHYDROACETATE 
CHLORPHENESIN 
PHENOXYETHANOL 
MICA 
ZINC OXIDE 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
FERROSOFERRIC OXIDE 
Packaging
#Item CodePackage Description
1NDC:64141-012-011 BOTTLE (BOTTLE) in 1 CARTON
140 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35212/01/2010
Labeler - Bobbi Brown Professional Cosmetics Inc. (627131279)
Establishment
NameAddressID/FEIOperations
ELGC K.K.712808195RELABEL(64141-012), REPACK(64141-012)
Establishment
NameAddressID/FEIOperations
Estee Lauder Pennsylvania Distribution Center 2 (PADC 2)828534516MANUFACTURE(64141-012), RELABEL(64141-012), REPACK(64141-012)
Establishment
NameAddressID/FEIOperations
Estee Lauder Inc.042918826MANUFACTURE(64141-012)
Establishment
NameAddressID/FEIOperations
ESTEE LAUDER COSMETICS DISTRIBUTION CENTER208579636RELABEL(64141-012), REPACK(64141-012)
Establishment
NameAddressID/FEIOperations
ESTEE LAUDER COSMETICS, LTD253616536MANUFACTURE(64141-012)
Establishment
NameAddressID/FEIOperations
ESTEE LAUDER COSMETICS, LTD244669714MANUFACTURE(64141-012)
Establishment
NameAddressID/FEIOperations
ESTEE LAUDER COSMETICS, LTD.205952385MANUFACTURE(64141-012)
Establishment
NameAddressID/FEIOperations
ESTEE LAUDER N.V.370151326MANUFACTURE(64141-012)
Establishment
NameAddressID/FEIOperations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC809771152MANUFACTURE(64141-012)
Establishment
NameAddressID/FEIOperations
NORTEC KEYSTONE943871157MANUFACTURE(64141-012), RELABEL(64141-012), REPACK(64141-012)
Establishment
NameAddressID/FEIOperations
NORTHTEC BRISTOL959338336MANUFACTURE(64141-012), RELABEL(64141-012), REPACK(64141-012)
Establishment
NameAddressID/FEIOperations
NORTHTEC KEYSTONE949264774MANUFACTURE(64141-012), RELABEL(64141-012), REPACK(64141-012)
Establishment
NameAddressID/FEIOperations
WHITMAN LABORATORIES, LTD.216866277MANUFACTURE(64141-012)
Establishment
NameAddressID/FEIOperations
Aveda Corporation071352058MANUFACTURE(64141-012)
Establishment
NameAddressID/FEIOperations
Pennsylvania Logistics Center078364654REPACK(64141-012), RELABEL(64141-012)

Revised: 05/2012
 
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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