LAB SERIES DAY RESCUE DEFENSE BROAD SPECTRUM SPF 35- avobenzone, homosalate, octisalate, and oxybenzone lotion

LAB SERIES DAY RESCUE DEFENSE BROAD SPECTRUM SPF 35 by

Drug Labeling and Warnings

LAB SERIES DAY RESCUE DEFENSE BROAD SPECTRUM SPF 35 by is a Otc medication manufactured, distributed, or labeled by Aramis Inc., Estee Lauder Companies Inc., The Estee Lauder Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients	Purpose
Avobenzone 3.0%	Sunscreen
Homosalate 5.0%	Sunscreen
Octisalate 4.5%	Sunscreen
Octocrylene 3.3%	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 ∙ BUTYLOCTYL SALICYLATE ∙ NYLON-12 ∙ OCTYLDODECYL NEOPENTANOATE ∙ BEHENYL ALCOHOL ∙ DIMETHICONE ∙ GLYCERIN ∙ MYRISTYL MYRISTATE ∙ CETYL ESTERS ∙ POLYETHYLENE ∙ BUTYLENE GLYCOL ∙ GLYCERYL STEARATE ∙ PEG-100 STEARATE ∙ PEG-6 ∙ AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER ∙ SIGESBECKIA ORIENTALIS (ST. PAUL'S WORT) EXTRACT ∙ THERMUS THERMOPHILLUS FERMENT ∙ SQUALANE ∙ ANASTATICA HIEROCHUNTICA (ROSE OF JERICHO) EXTRACT ∙ TRITICUM VULGARE (WHEAT) GERM EXTRACT ∙ HORDEUM VULGARE (BARLEY) EXTRACT\EXTRAIT D'ORGE ∙ BETULA ALBA (BIRCH) BARK EXTRACT ∙ LAMINARIA SACCHARINA EXTRACT ∙ SALICORNIA HERBACEA EXTRACT ∙ SACCHAROMYCES LYSATE EXTRACT ∙ ACETYL HEXAPEPTIDE-8 ∙ BIOSACCHARIDE GUM-4 ∙ CAFFEINE ∙ DIPOTASSIUM GLYCYRRHIZATE ∙ CHOLESTEROL ∙ SODIUM PCA ∙ SUCROSE ∙ LINOLEIC ACID ∙ TREHALOSE ∙ ALGAE EXTRACT ∙ TRISILOXANE ∙ SODIUM HYALURONATE ∙ POLYQUATERNIUM-51 ∙ LACTOBACILLUS FERMENT ∙ DI-PPG-2 MYRETH-10 ADIPATE ∙ STEARETH-21 ∙ TOCOPHERYL ACETATE∙ MYRISTYL LAURATE ∙ FRAGRANCE (PARFUM) ∙ CAPRYLYL GLYCOL ∙ MYRISTYL ALCOHOL ∙ UREA ∙ HEXYLENE GLYCOL ∙ SODIUM DEHYDROACETATE ∙ DISODIUM EDTA ∙ BHT ∙ PHENOXYETHANOL <ILN43958>

Other information

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

PRINCIPAL DISPLAY PANEL - 50 ml Tube Carton

LAB
SERIES
SKINCARE FOR MEN

DAY RESCUE
DEFENSE LOTION
BROAD SPECTRUM
SPF 35

TREAT

1.7 FL. OZ.
50 ml e

INGREDIENTS AND APPEARANCE

LAB SERIES DAY RESCUE DEFENSE BROAD SPECTRUM SPF 35 
avobenzone, homosalate, octisalate, and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42472-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.03 g  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	0.05 g  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.045 g  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.033 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
NYLON-12 (UNII: 446U8J075B)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
DOCOSANOL (UNII: 9G1OE216XY)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
MYRISTYL MYRISTATE (UNII: 4042ZC00DY)
CETYL ESTERS WAX (UNII: D072FFP9GU)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
THERMUS THERMOPHILUS LYSATE (UNII: 775R692494)
SQUALANE (UNII: GW89575KF9)
SELAGINELLA LEPIDOPHYLLA (UNII: 02JQ564P1G)
WHEAT (UNII: 4J2I0SN84Y)
BARLEY (UNII: 5PWM7YLI7R)
ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL)
BIOSACCHARIDE GUM-4 (UNII: 9XRL057X90)
CAFFEINE (UNII: 3G6A5W338E)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
CHOLESTEROL (UNII: 97C5T2UQ7J)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
SUCROSE (UNII: C151H8M554)
LINOLEIC ACID (UNII: 9KJL21T0QJ)
TREHALOSE (UNII: B8WCK70T7I)
TRISILOXANE (UNII: 9G1ZW13R0G)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
LACTOBACILLUS REUTERI (UNII: 9913I24QEE)
DI-PPG-2 MYRETH-10 ADIPATE (UNII: 4IN301M0KJ)
STEARETH-21 (UNII: 53J3F32P58)
MYRISTYL LAURATE (UNII: 58U0NZN2BT)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
MYRISTYL ALCOHOL (UNII: V42034O9PU)
UREA (UNII: 8W8T17847W)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42472-010-01	1 in 1 CARTON	12/01/2016
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	12/01/2016

Labeler - ARAMIS INC. (042918826)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(42472-010) , REPACK(42472-010)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(42472-010)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(42472-010)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(42472-010)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(42472-010)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(42472-010) , REPACK(42472-010)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(42472-010) , REPACK(42472-010)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(42472-010)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(42472-010)