LAB SERIES SKINCARE FOR MEN DAILY MOISTURE DEFENSE BROAD SPECTRUM SPF 15- avobenzone, octinoxate, and octisalate lotion

LAB SERIES SKINCARE FOR MEN DAILY MOISTURE DEFENSE BROAD SPECTRUM SPF 15 by

Drug Labeling and Warnings

LAB SERIES SKINCARE FOR MEN DAILY MOISTURE DEFENSE BROAD SPECTRUM SPF 15 by is a Otc medication manufactured, distributed, or labeled by ARAMIS INC., ESTEE LAUDER COMPANY, THE, ESTEE LAUDER COSMETICS, LTD, ESTEE LAUDER COSMETICS, LTD., ESTEE LAUDER N.V., LEN-RON MANUFACTURING DIVISION OF ARAMIS INC, NORTHTEC INC, PADC 1, WHITMAN LABORATORIES, LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredient	Purpose
Avobenzone 2.00%	Sunscreen
Octinoxate 7.50%	Sunscreen
Octisalate 3.00%	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\AQUA\EAU BUTYLENE GLYCOL SILICA HYDROGENATED POLYISOBUTENE NEOPENTYL GLYCOL DIETHYLHEXANOATE CYCLOPENTASILOXANE PENTYLENE GLYCOL HYDROGENATED LECITHIN ETHYLBISIMINOMETHYLGUAIACOL MANGANESE CHLORIDE SACCHAROMYCES LYSATE EXTRACT ACETYL CARNITINE HCL BETULA ALBA (BIRCH) BARK EXTRACT PHYTOSPHINGOSINE CREATINE OCTYLDODECYL NEOPENTANOATE COFFEA ROBUSTA SEED EXTRACT ASTROCARYUM MURUMURU SEED BUTTER ASCORBYL TOCOPHERYL MALEATE ACETYL GLUCOSAMINE LINOLEIC ACID SODIUM HYALURONATE TOCOPHERYL ACETATE CETEARYL ALCOHOL POLYPHOSPHORYLCHOLINE GLYCOL ACRYLATE ACRYLAMIDE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER PHOSPHOLIPIDS ETHYLHEXYLGLYCERIN ISOHEXADECANE CHOLESTEROL NEOPENTYL GLYCOL DIISOSTEARATE ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER CAPRYLIC/CAPRIC TRIGLYCERIDE GLYCERIN LECITHIN BEHENYL ALCOHOL ROSMARINUS OFFICINALIS (ROSEMARY) LEAF EXTRACT CHAMOMILLA RECUTITA (MATRICARIA) ETHYLHEXYL STEARATE CARBOMER ETHYLHEXYL PALMITATE PROPYLENE GLYCOL DICAPRATE CYCLODEXTRIN NORDIHYDROGUAIARETIC ACID SODIUM DNA LINOLENIC ACID TRIETHANOLAMINE SODIUM HYDROXIDE POLYSORBATE 80 HEXYLENE GLYCOL DISODIUM EDTA POTASSIUM SORBATE SODIUM DEHYDROACETATE CHLORPHENESIN PHENOXYETHANOL SORBIC ACID <ILN37073>

Other information

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

PRINCIPAL DISPLAY PANEL - 100 ml Tube Carton

LAB
SERIES
SKINCARE FOR MEN

DAILY MOISTURE
DEFENSE LOTION
BROAD SPECTRUM
SPF 15

fragrance free

TREAT

3.4 FL. OZ./OZ. LIQ.
100 ml e

INGREDIENTS AND APPEARANCE

LAB SERIES SKINCARE FOR MEN DAILY MOISTURE DEFENSE BROAD SPECTRUM SPF 15 
avobenzone, octinoxate, and octisalate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42472-887
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.0212 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.0795 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.0318 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
NEOPENTYL GLYCOL DIETHYLHEXANOATE (UNII: U68ZV6W62C)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
ETHYLBISIMINOMETHYLGUAIACOL MANGANESE CHLORIDE (UNII: SM5YJ88LTU)
SACCHAROMYCES LYSATE (UNII: R85W246Z1C)
ACETYLCARNITINE HYDROCHLORIDE (UNII: NDW10MX58T)
BETULA PUBESCENS BARK (UNII: 3R504894L9)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
CREATINE (UNII: MU72812GK0)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
ROBUSTA COFFEE BEAN (UNII: V5032728L7)
ASTROCARYUM MURUMURU SEED BUTTER (UNII: 12V64UPU6R)
ASCORBYL TOCOPHERYL MALEATE (UNII: D2G6259XR5)
N-ACETYLGLUCOSAMINE (UNII: V956696549)
LINOLEIC ACID (UNII: 9KJL21T0QJ)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ISOHEXADECANE (UNII: 918X1OUF1E)
CHOLESTEROL (UNII: 97C5T2UQ7J)
NEOPENTYL GLYCOL DIISOSTEARATE (UNII: 4M6OQ34JWW)
GLYCERIN (UNII: PDC6A3C0OX)
DOCOSANOL (UNII: 9G1OE216XY)
ROSEMARY (UNII: IJ67X351P9)
MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ)
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
PROPYLENE GLYCOL DICAPRATE (UNII: U783H9JHWY)
MASOPROCOL (UNII: 7BO8G1BYQU)
LINOLENIC ACID (UNII: 0RBV727H71)
TROLAMINE (UNII: 9O3K93S3TK)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
EDETATE DISODIUM (UNII: 7FLD91C86K)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
CHLORPHENESIN (UNII: I670DAL4SZ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SORBIC ACID (UNII: X045WJ989B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42472-887-01	1 in 1 CARTON	01/01/2005
1		100 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	01/01/2005

Labeler - ARAMIS INC. (042918826)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(42472-887) , REPACK(42472-887)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(42472-887)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(42472-887)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(42472-887)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(42472-887)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(42472-887) , REPACK(42472-887)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(42472-887) , REPACK(42472-887)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(42472-887)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(42472-887)