CLEAR DIFFERENCE BB COMPLEXION PERFECTING BB BROAD SPECTRUM SPF 35- octinoxate, octisalate, oxybenzone, and titanium dioxide cream

CLEAR DIFFERENCE BB COMPLEXION PERFECTING BB BROAD SPECTRUM SPF 35 by

Drug Labeling and Warnings

CLEAR DIFFERENCE BB COMPLEXION PERFECTING BB BROAD SPECTRUM SPF 35 by is a Otc medication manufactured, distributed, or labeled by ESTEE LAUDER INC, ELGC K.K., Estee Lauder Pennsylvania Distribution Center 2 (PADC 2), ESTEE LAUDER COSMETICS, LTD, ESTEE LAUDER COSMETICS, LTD., ESTEE LAUDER N.V., LEN-RON MANUFACTURING DIVISION OF ARAMIS INC, NORTEC KEYSTONE, NORTHTEC BRISTOL, NORTHTEC KEYSTONE, WHITMAN LABORATORIES, LTD., Aveda Corporation, Pennsylvania Logistics Center. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
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:

• 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 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 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

BB

Complexion Perfecting
BB Creme
Broad Spectrum
SPF 35

1 FL. OZ. LIQ./30 ml e

INGREDIENTS AND APPEARANCE

CLEAR DIFFERENCE BB COMPLEXION PERFECTING BB BROAD SPECTRUM SPF 35 
octinoxate, octisalate, oxybenzone, and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11559-039
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.08175 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.0436 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.02725 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.01199 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11559-039-01	1 in 1 CARTON
1		30 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	12/01/2013

Labeler - ESTEE LAUDER INC (005914387)

Establishment
Name	Address	ID/FEI	Business Operations
ELGC K.K.		712808195	RELABEL(11559-039) , REPACK(11559-039)

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Pennsylvania Distribution Center 2 (PADC 2)		828534516	MANUFACTURE(11559-039) , RELABEL(11559-039) , REPACK(11559-039)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(11559-039)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		205952385	MANUFACTURE(11559-039)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(11559-039)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(11559-039)

Establishment
Name	Address	ID/FEI	Business Operations
NORTEC KEYSTONE		943871157	MANUFACTURE(11559-039) , RELABEL(11559-039) , REPACK(11559-039)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC BRISTOL		959338336	MANUFACTURE(11559-039) , RELABEL(11559-039) , REPACK(11559-039)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC KEYSTONE		949264774	MANUFACTURE(11559-039) , RELABEL(11559-039) , REPACK(11559-039)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(11559-039)

Establishment
Name	Address	ID/FEI	Business Operations
Aveda Corporation		071352058	MANUFACTURE(11559-039)

Establishment
Name	Address	ID/FEI	Business Operations
Pennsylvania Logistics Center		078364654	REPACK(11559-039) , RELABEL(11559-039)