CLEAR DIFFERENCE BB COMPLEXION PERFECTING BB 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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CLEAR DIFFERENCE BB COMPLEXION PERFECTING BB CREME BROAD SPECTRUM SPF 35

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 • butylene glycol • dimethicone • 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 • pentylene glycol • 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 • ethylbisiminomethylguaiacol manganese chloride • pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate • disodium edta • phenoxyethanol • chlorphenesin • [+/- mica • titanium dioxide (ci 77891) • zinc oxide (ci 77947) • iron oxides (ci 77492) • iron oxides (ci 77499) • iron oxides (ci 77491) • ferric ferrocyanide (ci 77510) • yellow 5 lake (ci 19140) • chromium oxide greens (ci 77288) • chromium hydroxide green (ci 77289) • carmine (ci 75470) • blue 1 lake (ci 42090) • bismuth oxychloride (ci 77163)] <iln40601>

Other information

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

PRINCIPAL DISPLAY PANEL - 30 ml Tube Carton

ESTĒE LAUDER

Clear
Difference

B•B

Complexion Perfecting
BB Creme
Broad Spectrum
SPF 35

1 FL. OZ. LIQ./30 ml e

Principal Display Panel - 30 ml Tube Carton
CLEAR DIFFERENCE BB COMPLEXION PERFECTING BB BROAD SPECTRUM SPF 35 
octinoxate, octisalate, oxybenzone, and titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11559-039
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.08175 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE0.0436 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.02725 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.01199 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
water (UNII: 059QF0KO0R)  
1,3-butylene glycol (UNII: 3XUS85K0RA)  
dimethicone (UNII: 92RU3N3Y1O)  
phenyl trimethicone (UNII: DR0K5NOJ4R)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
DOCOSANOL (UNII: 9G1OE216XY)  
trioctyldodecyl citrate (UNII: 35X8CT063R)  
octyldodecyl stearoyl stearate (UNII: 3D47Q6D93C)  
peg-40 stearate (UNII: ECU18C66Q7)  
GENTIANA LUTEA ROOT (UNII: S72O3284MS)  
POLYGONUM CUSPIDATUM ROOT (UNII: 7TRV45YZF7)  
THERMUS THERMOPHILUS LYSATE (UNII: 775R692494)  
BARLEY (UNII: 5PWM7YLI7R)  
FUMARIA OFFICINALIS FLOWERING TOP (UNII: VH659J61ZL)  
LEMON (UNII: 24RS0A988O)  
SACCHARINA LATISSIMA (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)  
pentylene glycol (UNII: 50C1307PZG)  
.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)  
isopropyl titanium triisostearate (UNII: 949E3KBJ1I)  
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 MONOLAURATE (UNII: 668Z5835Z3)  
ENOXOLONE (UNII: P540XA09DR)  
trehalose (UNII: B8WCK70T7I)  
fumaric acid (UNII: 88XHZ13131)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
ammonium acryloyldimethyltaurate/vp copolymer (UNII: W59H9296ZG)  
MASOPROCOL (UNII: 7BO8G1BYQU)  
ascorbyl tocopheryl maleate (UNII: D2G6259XR5)  
xanthan gum (UNII: TTV12P4NEE)  
stearic acid (UNII: 4ELV7Z65AP)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
manganese chloride (UNII: QQE170PANO)  
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
phenoxyethanol (UNII: HIE492ZZ3T)  
chlorphenesin (UNII: I670DAL4SZ)  
mica (UNII: V8A1AW0880)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC FERROCYANIDE (UNII: TLE294X33A)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
CHROMIC OXIDE (UNII: X5Z09SU859)  
CHROMIUM HYDROXIDE GREEN (UNII: RV8FT8XF5R)  
CARMINIC ACID (UNII: CID8Z8N95N)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11559-039-011 in 1 CARTON
130 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35212/01/2013
Labeler - ESTEE LAUDER INC (005914387)
Establishment
NameAddressID/FEIBusiness Operations
ELGC K.K.712808195RELABEL(11559-039) , REPACK(11559-039)
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Pennsylvania Distribution Center 2 (PADC 2)828534516MANUFACTURE(11559-039) , RELABEL(11559-039) , REPACK(11559-039)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD244669714MANUFACTURE(11559-039)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD.205952385MANUFACTURE(11559-039)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER N.V.370151326MANUFACTURE(11559-039)
Establishment
NameAddressID/FEIBusiness Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC809771152MANUFACTURE(11559-039)
Establishment
NameAddressID/FEIBusiness Operations
NORTEC KEYSTONE943871157MANUFACTURE(11559-039) , RELABEL(11559-039) , REPACK(11559-039)
Establishment
NameAddressID/FEIBusiness Operations
NORTHTEC BRISTOL959338336MANUFACTURE(11559-039) , RELABEL(11559-039) , REPACK(11559-039)
Establishment
NameAddressID/FEIBusiness Operations
NORTHTEC KEYSTONE949264774MANUFACTURE(11559-039) , RELABEL(11559-039) , REPACK(11559-039)
Establishment
NameAddressID/FEIBusiness Operations
WHITMAN LABORATORIES, LTD.216866277MANUFACTURE(11559-039)
Establishment
NameAddressID/FEIBusiness Operations
Aveda Corporation071352058MANUFACTURE(11559-039)
Establishment
NameAddressID/FEIBusiness Operations
Pennsylvania Logistics Center078364654REPACK(11559-039) , RELABEL(11559-039)

Revised: 1/2014
Document Id: 487e60e5-20ff-454a-a3c4-d605c2cc54ef
Set id: 0b8a87fc-3c6a-443c-92c3-386ca48a0e3c
Version: 1
Effective Time: 20140117
 
ESTEE LAUDER INC