LAB SERIES SKINCARE FOR MEN BB TINTED MOISTURIZER BROAD SPECTRUM SPF 35- octinoxate, octisalate, oxybenzone, titanium dioxide, and zinc oxide liquid

LAB SERIES SKINCARE FOR MEN by

Drug Labeling and Warnings

LAB SERIES SKINCARE FOR MEN by is a Otc medication manufactured, distributed, or labeled by Aramis Inc., Estee Lauder Companies Inc., Estee Lauder N.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients	Purpose
Octinoxate 7.40%	Sunscreen
Octisalate 4.00%	Sunscreen
Oxybenzone 2.50%	Sunscreen
Titanium Dioxide 2.20%	Sunscreen
Zinc Oxide 2.00%	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

• 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 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 TRIOCTYLDODECYL CITRATE METHYL TRIMETHICONE DIMETHICONE OCTYLDODECYL STEAROYL STEARATE BUTYLENE GLYCOL PHENYL TRIMETHICONE PENTYLENE GLYCOL GLYCERYL STEARATE BEHENYL ALCOHOL POLYMETHYLSILSESQUIOXANE PEG-40 STEARATE POLYGLYCERYL-10 PENTASTEARATE ACETYL GLUCOSAMINE TOCOPHERYL ACETATE SODIUM HYALURONATE LECITHIN SQUALANE SIGESBECKIA ORIENTALIS (ST. PAUL'S WORT) EXTRACT HORDEUM VULGARE (BARLEY) EXTRACT TRITICUM VULGARE (WHEAT) GERM EXTRACT LAMINARIA SACCHARINA EXTRACT CUCUMIS SATIVUS (CUCUMBER) FRUIT EXTRACT PYRUS MALUS (APPLE) FRUIT EXTRACT SCUTELLARIA BAICALENSIS ROOT EXTRACT CAFFEINE CHOLESTEROL GLYCERIN SODIUM PCA POLYGLYCERYL-6 POLYRICINOLEATE ORYZANOL TREHALOSE OCTYLDODECYL NEOPENTANOATE ACETYL HEXAPEPTIDE-8 PROPYLENE GLYCOL STEARATE PROPYLENE GLYCOL LAURATE ISOPROPYL MYRISTATE ALUMINA SODIUM STEAROYL LACTYLATE XANTHAN GUM SUCROSE UREA POLYMETHYL METHACRYLATE DISODIUM EDTA AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER SILICA ISOPROPYL TITANIUM TRIISOSTEARATE SORBITAN LAURATE POLYSORBATE 20 POLYQUATERNIUM-51 STEARIC ACID LINOLEIC ACID GLYCYRRHETINIC ACID PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE PHENOXYETHANOL CHLORPHENESIN SODIUM DEHYDROACETATE [+/- IRON OXIDES (CI 77491, CI 77492, CI 77499) TITANIUM DIOXIDE (CI 77891)] <ILN37913>

Other information

• Protect the product in this container from excessive heat and direct sun

PRINCIPAL DISPLAY PANEL - 50 ml Carton

LAB
SERIES
SKINCARE FOR MEN

BB TINTED
MOISTURIZER
BROAD
SPECTRUM
SPF 35

oil free

TREAT

1.7 FL. OZ./OZ. LIQ.
50 ml e

INGREDIENTS AND APPEARANCE

LAB SERIES SKINCARE FOR MEN   BB TINTED MOISTURIZER BROAD SPECTRUM SPF 35
octinoxate, octisalate, oxybenzone, titanium dioxide, and zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42472-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.4 mL  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4 mL  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	2.5 mL  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.2 mL  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	2 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
TRIOCTYLDODECYL CITRATE (UNII: 35X8CT063R)
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)
DIMETHICONE (UNII: 92RU3N3Y1O)
OCTYLDODECYL STEAROYL STEARATE (UNII: 3D47Q6D93C)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
DOCOSANOL (UNII: 9G1OE216XY)
PEG-40 STEARATE (UNII: ECU18C66Q7)
N-ACETYLGLUCOSAMINE (UNII: V956696549)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SQUALANE (UNII: GW89575KF9)
WHEAT GERM (UNII: YR3G369F5A)
SACCHARINA LATISSIMA THALLUS (UNII: 68CMP2MB55)
CUCUMBER (UNII: YY7C30VXJT)
APPLE (UNII: B423VGH5S9)
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)
CAFFEINE (UNII: 3G6A5W338E)
CHOLESTEROL (UNII: 97C5T2UQ7J)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
GAMMA ORYZANOL (UNII: SST9XCL51M)
TREHALOSE (UNII: B8WCK70T7I)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL)
PROPYLENE GLYCOL STEARATE (UNII: MZM1I680W0)
PROPYLENE GLYCOL MONOLAURATE (UNII: 668Z5835Z3)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
ALUMINUM OXIDE (UNII: LMI26O6933)
SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)
XANTHAN GUM (UNII: TTV12P4NEE)
SUCROSE (UNII: C151H8M554)
UREA (UNII: 8W8T17847W)
EDETATE DISODIUM (UNII: 7FLD91C86K)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)
SORBITAN MONOLAURATE (UNII: 6W9PS8B71J)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
STEARIC ACID (UNII: 4ELV7Z65AP)
LINOLEIC ACID (UNII: 9KJL21T0QJ)
ENOXOLONE (UNII: P540XA09DR)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CHLORPHENESIN (UNII: I670DAL4SZ)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42472-002-01	1 in 1 CARTON
1		50 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	04/24/2011

Labeler - Aramis Inc. (042918826)

Establishment
Name	Address	ID/FEI	Business Operations
ELGC K.K.		712808195	RELABEL(42472-002) , REPACK(42472-002)

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Pennsylvania Distribution Center 2 (PADC 2)		828534516	MANUFACTURE(42472-002) , RELABEL(42472-002) , REPACK(42472-002)

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Inc.		042918826	MANUFACTURE(42472-002)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS DISTRIBUTION CENTER		208579636	REPACK(42472-002) , RELABEL(42472-002)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		253616536	MANUFACTURE(42472-002)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(42472-002)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		205952385	MANUFACTURE(42472-002)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(42472-002)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(42472-002)

Establishment
Name	Address	ID/FEI	Business Operations
NORTEC KEYSTONE		943871157	MANUFACTURE(42472-002) , RELABEL(42472-002) , REPACK(42472-002)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC BRISTOL		959338336	MANUFACTURE(42472-002) , RELABEL(42472-002) , REPACK(42472-002)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC KEYSTONE		949264774	MANUFACTURE(42472-002) , RELABEL(42472-002) , REPACK(42472-002)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(42472-002)

Establishment
Name	Address	ID/FEI	Business Operations
Aveda Corporation		071352058	MANUFACTURE(42472-002)

Establishment
Name	Address	ID/FEI	Business Operations
Pennsylvania Logistics Center		078364654	REPACK(42472-002) , RELABEL(42472-002)