DAYWEAR BB  ANTI OXIDANT BEAUTY BENEFIT BROAD SPECTRUM SPF 35- octinoxate, octisalate, oxybenzone, and titanium dioxide cream 
ESTEE LAUDER 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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ESTĒE LAUDER
DayWear B☁B Anti-Oxidant Beauty Broad Spectrum Benefit Creme

Drug Facts

Active ingredientsPurpose
Octinoxate 7.50%Sunscreen
Octisalate 4.00%Sunscreen
Oxybenzone 2.50%Sunscreen
Titanium dioxide 1.10%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 • dimethicone • butylene glycol • pentylene glycol • phenyl trimethicone • glyceryl stearate • behenyl alcohol • trioctyldodecyl citrate • polymethylsilsesquioxane • octyldodecyl stearoyl stearate • peg-40 stearate • polyglyceryl-10 pentastearate • gentiana lutea (gentian) root extract • polygonum cuspidatum root extract • thermus thermophillus ferment • hordeum vulgare (barley) extract\extrait d' orge • fumaria officinalis flower/leaf/stem extract • citrus medica limonum (lemon) fruit extract • hydrolyzed rice bran extract • laminaria saccharina extract • hydrolyzed rice extract • rosmarinus officinalis (rosemary) leaf extract • artemia extract • vitis vinifera (grape) seed extract • triticum vulgare (wheat) germ extract • cholesterol • caffeine • propylene glycol stearate • octyldodecyl neopentanoate • polyglyceryl-6 polyricinoleate • tocopheryl acetate • sucrose • glycerin • sodium stearoyl lactylate • linoleic acid • lecithin • squalane • sodium pca • urea • isopropyl titanium triisostearate • ergothioneine • sodium dehydroacetate • tetrahexyldecyl ascorbate • polysorbate 20 • sorbitan laurate • sodium hyaluronate • citric acid • propylene glycol laurate • glycyrrhetinic acid • trehalose • polyquaternium-51 • hydrogenated lecithin • fumaric acid • alumina • palmitoyl hydroxypropyltrimonium amylopectin/glycerin crosspolymer • ammonium acryloyldimethyltaurate/vp copolymer • cyclodextrin • nordihydroguaiaretic acid • ascorbyl tocopheryl maleate • xanthan gum • stearic acid • silica • fragrance (parfum) • ethylbisiminomethylguaiacol manganese chloride • pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate • disodium edta • phenoxyethanol • chlorphenesin • [+/- titanium dioxide (ci 77891) • zinc oxide (ci 77947) • iron oxides (ci 77491, ci 77492, ci 77499) • yellow 5 lake (ci 19140) • chromium oxide greens (ci 77288) • mica • ferric ferrocyanide (ci 77510) • chromium hydroxide green (ci 77289) • carmine (ci 75470) • bismuth oxychloride (ci 77163) • blue 1 lake (ci 42090)] [iln38365]

Other information

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

© ESTĒE LAUDER, DIST.
NEW YORK, N.Y. 10022

PRINCIPAL DISPLAY PANEL - 30 ml Carton

ESTĒE LAUDER

DayWear

B•B

Anti-Oxidant
Beauty Benefit Creme
Broad Spectrum
SPF 35

All Skintypes

1 FL. OZ. LIQ./30 ml e

Principal Display Panel - 30 ml Carton
DAYWEAR BB   ANTI OXIDANT BEAUTY BENEFIT BROAD SPECTRUM SPF 35
octinoxate, octisalate, oxybenzone, and titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11559-015
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 mL  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4 mL  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE2.5 mL  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.1 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
DOCOSANOL (UNII: 9G1OE216XY)  
OCTYLDODECYL STEAROYL STEARATE (UNII: 3D47Q6D93C)  
PEG-40 STEARATE (UNII: ECU18C66Q7)  
GENTIANA LUTEA ROOT (UNII: S72O3284MS)  
POLYGONUM CUSPIDATUM ROOT (UNII: 7TRV45YZF7)  
HORDEUM VULGARE ROOT (UNII: 790S39483Z)  
FUMARIA OFFICINALIS FLOWERING TOP (UNII: VH659J61ZL)  
LEMON (UNII: 24RS0A988O)  
SACCHARINA LATISSIMA THALLUS (UNII: 68CMP2MB55)  
ROSEMARY (UNII: IJ67X351P9)  
VITIS VINIFERA SEED (UNII: C34U15ICXA)  
WHEAT GERM (UNII: YR3G369F5A)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
CAFFEINE (UNII: 3G6A5W338E)  
PROPYLENE GLYCOL STEARATE (UNII: MZM1I680W0)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
SUCROSE (UNII: C151H8M554)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)  
LINOLEIC ACID (UNII: 9KJL21T0QJ)  
SQUALANE (UNII: GW89575KF9)  
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
UREA (UNII: 8W8T17847W)  
ERGOTHIONEINE (UNII: BDZ3DQM98W)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
SORBITAN MONOLAURATE (UNII: 6W9PS8B71J)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
PROPYLENE GLYCOL LAURATES (UNII: 40KT317HGP)  
ENOXOLONE (UNII: P540XA09DR)  
TREHALOSE (UNII: B8WCK70T7I)  
FUMARIC ACID (UNII: 88XHZ13131)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
MASOPROCOL (UNII: 7BO8G1BYQU)  
XANTHAN GUM (UNII: TTV12P4NEE)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
CHROMIC OXIDE (UNII: X5Z09SU859)  
MICA (UNII: V8A1AW0880)  
FERRIC FERROCYANIDE (UNII: TLE294X33A)  
COCHINEAL (UNII: TZ8Z31B35M)  
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11559-015-011 in 1 CARTON
130 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35209/01/2011
Labeler - ESTEE LAUDER INC (005914387)
Establishment
NameAddressID/FEIBusiness Operations
ELGC K.K.712808195RELABEL(11559-015) , REPACK(11559-015)
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Pennsylvania Distribution Center 2 (PADC 2)828534516MANUFACTURE(11559-015) , RELABEL(11559-015) , REPACK(11559-015)
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Inc.042918826MANUFACTURE(11559-015)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS DISTRIBUTION CENTER208579636REPACK(11559-015) , RELABEL(11559-015)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD253616536MANUFACTURE(11559-015)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD244669714MANUFACTURE(11559-015)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD.205952385MANUFACTURE(11559-015)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER N.V.370151326MANUFACTURE(11559-015)
Establishment
NameAddressID/FEIBusiness Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC809771152MANUFACTURE(11559-015)
Establishment
NameAddressID/FEIBusiness Operations
NORTEC KEYSTONE943871157MANUFACTURE(11559-015) , RELABEL(11559-015) , REPACK(11559-015)
Establishment
NameAddressID/FEIBusiness Operations
NORTHTEC BRISTOL959338336MANUFACTURE(11559-015) , RELABEL(11559-015) , REPACK(11559-015)
Establishment
NameAddressID/FEIBusiness Operations
NORTHTEC KEYSTONE949264774MANUFACTURE(11559-015) , RELABEL(11559-015) , REPACK(11559-015)
Establishment
NameAddressID/FEIBusiness Operations
WHITMAN LABORATORIES, LTD.216866277MANUFACTURE(11559-015)
Establishment
NameAddressID/FEIBusiness Operations
Aveda Corporation071352058MANUFACTURE(11559-015)
Establishment
NameAddressID/FEIBusiness Operations
Pennsylvania Logistics Center078364654REPACK(11559-015) , RELABEL(11559-015)

Revised: 4/2012
Document Id: 07be7bfd-5feb-4481-9559-4e6d4b556212
Set id: ee84ca59-079a-4f0a-a6f1-f85a52e8abf5
Version: 2
Effective Time: 20120406
 
ESTEE LAUDER INC