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

BB10 INSTANT SKIN PERFECTOR BROAD SPECTRUM by

Drug Labeling and Warnings

BB10 INSTANT SKIN PERFECTOR BROAD SPECTRUM by is a Otc medication manufactured, distributed, or labeled by GOOD SKIN DERMACARE, ELGC K.K., Estee Lauder Pennsylvania Distribution Center 2 (PADC 2), Estee Lauder Inc., ESTEE LAUDER COSMETICS DISTRIBUTION CENTER, 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 7.5%	Sunscreen
Octisalate 4.0%	Sunscreen
Oxybenzone 2.5%	Sunscreen
Titanium Dioxide 1.1%	Sunscreen

Uses

• helps prevent sunburn
• if used as directed with other sun protection measures (see Directions) decreases the risk of skin cancer and early skin aging caused by the sun

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 generously 15 minutes before sun exposure
• reapply 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 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, 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

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68758-010
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 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.0436 g  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.02725 g  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.01199 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68758-010-01	1 in 1 CARTON
1		30 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	10/27/2011

Labeler - GOOD SKIN DERMACARE (143367634)

Establishment
Name	Address	ID/FEI	Business Operations
ELGC K.K.		712808195	RELABEL(68758-010) , REPACK(68758-010)

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Pennsylvania Distribution Center 2 (PADC 2)		828534516	MANUFACTURE(68758-010) , RELABEL(68758-010) , REPACK(68758-010)

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Inc.		042918826	MANUFACTURE(68758-010)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS DISTRIBUTION CENTER		208579636	REPACK(68758-010) , RELABEL(68758-010)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		253616536	MANUFACTURE(68758-010)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(68758-010)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		205952385	MANUFACTURE(68758-010)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(68758-010)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(68758-010)

Establishment
Name	Address	ID/FEI	Business Operations
NORTEC KEYSTONE		943871157	MANUFACTURE(68758-010) , RELABEL(68758-010) , REPACK(68758-010)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC BRISTOL		959338336	MANUFACTURE(68758-010) , RELABEL(68758-010) , REPACK(68758-010)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC KEYSTONE		949264774	MANUFACTURE(68758-010) , RELABEL(68758-010) , REPACK(68758-010)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(68758-010)

Establishment
Name	Address	ID/FEI	Business Operations
Aveda Corporation		071352058	MANUFACTURE(68758-010)

Establishment
Name	Address	ID/FEI	Business Operations
Pennsylvania Logistics Center		078364654	REPACK(68758-010) , RELABEL(68758-010)