BB10 INSTANT SKIN PERFECTOR BROAD SPECTRUM  SPF 35- octinoxate, octisalate, oxybenzone, and titanium dioxide liquid 
GOOD SKIN DERMACARE

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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BB10 INSTANT SKIN PERFECTOR BROAD SPECTRUM SPF 35

Drug Facts

Active IngredientsPurpose
Octinoxate 7.5%Sunscreen
Octisalate 4.0%Sunscreen
Oxybenzone 2.5%Sunscreen
Titanium Dioxide 1.1%Sunscreen

Uses

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, Phenyl Trimethicone, Pentylene Glycol, Glyceryl Stearate, Behenyl Alcohol, Trioctyldodecyl Citrate, Polymethylsilsesquioxane, Octyldodecyl Stearoyl Stearate, PEG-40 Stearate, Polyglyceryl-10 Pentastearate, Tocopheryl Acetate, Sodium Hyaluronate, Lecithin, Squalane, Cucumis Sativus (Cucumber) Fruit Extract, Pyrus Malus (Apple) Fruit Extract, Scutellaria Baicalensis Root Extract, Hordeum Vulgare (Barley) Extract\Extrait d'Orge, Laminaria Saccharina Extract, Triticum Vulgare (Wheat) Germ Extract, Caffeine, Glycerin, Cholesterol, Sodium PCA, Polyglyceryl-6 Polyricinoleate, Octyldodecyl Neopentanoate, Acetyl Hexapeptide-8, Oryzanol, Trehalose, Sucrose, Alumina, Silica, Urea, Xanthan Gum, Ammonium Acryloyldimethyltaurate/VP Copolymer, Polyquaternium-51, Sodium Stearoyl Lactylate, Polysorbate 20, Sorbitan Laurate, Propylene Glycol Laurate, Stearic Acid, Glycyrrhetinic Acid, Linoleic Acid, Isopropyl Titanium Triisostearate, Propylene Glycol Stearate, Disodium EDTA, Phenoxyethanol, Chlorphenesin, Sodium Dehydroacetate, [+/- Mica, Titanium Dioxide (CI 77891), Iron Oxides (Ci 77491), Iron Oxides (CI 77492), Iron Oxides (CI 77499), Zinc Oxide (CI 77947)] [ILN39504]

Other information

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

GOOD SKIN LABS, DIST.
NEW YORK, NY 10153

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton

GoodSkin Labs

BB10
Instant
Skin Perfector
Broad Spectrum
SPF 35

Instantly: smoother,
more radiant, visibly
flawless skin.

After 4 weeks: clinically
proven reduction in
the appearance of lines
and wrinkles.

1 FL.OZ./30 mL e

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton
BB10 INSTANT SKIN PERFECTOR BROAD SPECTRUM   SPF 35
octinoxate, octisalate, oxybenzone, and titanium dioxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68758-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.08175 g  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE0.0436 g  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.02725 g  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.01199 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Dimethicone (UNII: 92RU3N3Y1O)  
Butylene Glycol (UNII: 3XUS85K0RA)  
Phenyl Trimethicone (UNII: DR0K5NOJ4R)  
Pentylene Glycol (UNII: 50C1307PZG)  
Glyceryl Monostearate (UNII: 230OU9XXE4)  
Docosanol (UNII: 9G1OE216XY)  
Trioctyldodecyl Citrate (UNII: 35X8CT063R)  
Octyldodecyl Stearoyl Stearate (UNII: 3D47Q6D93C)  
PEG-40 Stearate (UNII: ECU18C66Q7)  
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
Hyaluronate Sodium (UNII: YSE9PPT4TH)  
Squalane (UNII: GW89575KF9)  
Cucumber (UNII: YY7C30VXJT)  
Apple (UNII: B423VGH5S9)  
Scutellaria Baicalensis Root (UNII: 7J95K7ID2S)  
Barley (UNII: 5PWM7YLI7R)  
Saccharina Latissima (UNII: 68CMP2MB55)  
Wheat Germ (UNII: YR3G369F5A)  
Caffeine (UNII: 3G6A5W338E)  
Glycerin (UNII: PDC6A3C0OX)  
Cholesterol (UNII: 97C5T2UQ7J)  
Sodium Pyrrolidone Carboxylate (UNII: 469OTG57A2)  
Octyldodecyl Neopentanoate (UNII: X8725R883T)  
Acetyl Hexapeptide-8 (UNII: L4EL31FWIL)  
Gamma Oryzanol (UNII: SST9XCL51M)  
Trehalose (UNII: B8WCK70T7I)  
Sucrose (UNII: C151H8M554)  
Aluminum Oxide (UNII: LMI26O6933)  
Silicon Dioxide (UNII: ETJ7Z6XBU4)  
Urea (UNII: 8W8T17847W)  
Xanthan Gum (UNII: TTV12P4NEE)  
Ammonium Acryloyldimethyltaurate/VP Copolymer (UNII: W59H9296ZG)  
Sodium Stearoyl Lactylate (UNII: IN99IT31LN)  
Polysorbate 20 (UNII: 7T1F30V5YH)  
Sorbitan Monolaurate (UNII: 6W9PS8B71J)  
Propylene Glycol Monolaurate (UNII: 668Z5835Z3)  
Stearic Acid (UNII: 4ELV7Z65AP)  
Enoxolone (UNII: P540XA09DR)  
Linoleic Acid (UNII: 9KJL21T0QJ)  
Isopropyl Titanium Triisostearate (UNII: 949E3KBJ1I)  
Propylene Glycol Stearate (UNII: MZM1I680W0)  
Edetate Disodium (UNII: 7FLD91C86K)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Chlorphenesin (UNII: I670DAL4SZ)  
Sodium Dehydroacetate (UNII: 8W46YN971G)  
Mica (UNII: V8A1AW0880)  
Ferric Oxide Red (UNII: 1K09F3G675)  
Ferric Oxide Yellow (UNII: EX438O2MRT)  
Ferrosoferric Oxide (UNII: XM0M87F357)  
Zinc Oxide (UNII: SOI2LOH54Z)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68758-010-011 in 1 CARTON
130 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35210/27/2011
Labeler - GOOD SKIN DERMACARE (143367634)
Establishment
NameAddressID/FEIBusiness Operations
ELGC K.K.712808195RELABEL(68758-010) , REPACK(68758-010)
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Pennsylvania Distribution Center 2 (PADC 2)828534516MANUFACTURE(68758-010) , RELABEL(68758-010) , REPACK(68758-010)
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Inc.042918826MANUFACTURE(68758-010)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS DISTRIBUTION CENTER208579636REPACK(68758-010) , RELABEL(68758-010)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD253616536MANUFACTURE(68758-010)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD244669714MANUFACTURE(68758-010)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD.205952385MANUFACTURE(68758-010)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER N.V.370151326MANUFACTURE(68758-010)
Establishment
NameAddressID/FEIBusiness Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC809771152MANUFACTURE(68758-010)
Establishment
NameAddressID/FEIBusiness Operations
NORTEC KEYSTONE943871157MANUFACTURE(68758-010) , RELABEL(68758-010) , REPACK(68758-010)
Establishment
NameAddressID/FEIBusiness Operations
NORTHTEC BRISTOL959338336MANUFACTURE(68758-010) , RELABEL(68758-010) , REPACK(68758-010)
Establishment
NameAddressID/FEIBusiness Operations
NORTHTEC KEYSTONE949264774MANUFACTURE(68758-010) , RELABEL(68758-010) , REPACK(68758-010)
Establishment
NameAddressID/FEIBusiness Operations
WHITMAN LABORATORIES, LTD.216866277MANUFACTURE(68758-010)
Establishment
NameAddressID/FEIBusiness Operations
Aveda Corporation071352058MANUFACTURE(68758-010)
Establishment
NameAddressID/FEIBusiness Operations
Pennsylvania Logistics Center078364654REPACK(68758-010) , RELABEL(68758-010)

Revised: 10/2012
Document Id: 25b253bd-6daa-47f1-bdcb-66812d2671a7
Set id: 535af36f-960d-4169-84c6-14af6731bfb1
Version: 1
Effective Time: 20121004
 
GOOD SKIN DERMACARE