ARAMIS LAB SERIES POWER PROTECTOR BROAD SPECTRUM SPF 50- avobenzone, homosalate, octisalate, and oxybenzone lotion

ARAMIS LAB SERIES POWER PROTECTOR BROAD SPECTRUM SPF 50 by

Drug Labeling and Warnings

ARAMIS LAB SERIES POWER PROTECTOR BROAD SPECTRUM SPF 50 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 3.00%	Sunscreen
Homosalate 5.00%	Sunscreen
Octisalate 5.00%	Sunscreen
Oxybenzone 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 ∙ BUTYLOCTYL SALICYLATE ∙ METHYL TRIMETHICONE ∙ NEOPENTYL GLYCOL DIHEPTANOATE ∙ POLYESTER-8 ∙ ALEURITES MOLUCCANA (KUKUI) SEED OIL ∙ LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE ∙ PEG-100 STEARATE ∙ BUTYLENE GLYCOL ∙ GLYCERYL STEARATE ∙ DIPENTAERYTHRITYL TRI-POLYHYDROXYSTEARATE ∙ MORUS NIGRA (MULBERRY) ROOT EXTRACT ∙ LAMINARIA OCHROLEUCA EXTRACT ∙ VITIS VINIFERA (GRAPE) FRUIT EXTRACT ∙ POTASSIUM CETYL PHOSPHATE ∙ SCUTELLARIA BAICALENSIS ROOT EXTRACT ∙ WHEY PROTEIN\LACTIS PROTEIN\PROTEINE DU PETIT-LAIT ∙ CAFFEINE ∙ CETYL ALCOHOL ∙ VP/EICOSENE COPOLYMER ∙ C30-38 OLEFIN/ISOPROPYL MALEATE/MA COPOLYMER ∙ ETHYLHEXYLGYLCERIN ∙ CAPRYLYL GLYCOL ∙ AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER ∙ YEAST EXTRACT\FAEX\EXTRAIT DE LEVURE ∙ CAPRYLIC/CAPRIC TRIGLYCERIDE ∙ ACETYL GLUCOSAMINE ∙ DEHYDROXANTHAN GUM ∙ STEARIC ACID ∙ FRAGRANCE (PARFUM) ∙ DISODIUM EDTA ∙ SODIUM DEHYDROACETATE ∙ PHENOXYETHANOL ∙ MICA <ILN36042>

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

POWER
PROTECTOR
BROAD SPECTRUM
SPF 50

T R E A T

3.4 FL. OZ.
100 ml e

INGREDIENTS AND APPEARANCE

ARAMIS LAB SERIES POWER PROTECTOR BROAD SPECTRUM SPF 50 
avobenzone, homosalate, octisalate, and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42472-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.0309 g  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	0.0515 g  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.015 g  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.0309 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
KUKUI NUT OIL (UNII: TP11QR7B8R)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
PEG-100 STEARATE (UNII: YD01N1999R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
DIPENTAERYTHRITYL TRI-POLYHYDROXYSTEARATE (UNII: D21K655H52)
WHITE MULBERRY (UNII: MN25R0HH5A)
GRAPE (UNII: 6X543N684K)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)
WHEY (UNII: 8617Z5FMF6)
CAFFEINE (UNII: 3G6A5W338E)
CETYL ALCOHOL (UNII: 936JST6JCN)
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
N-ACETYLGLUCOSAMINE (UNII: V956696549)
DEHYDROXANTHAN GUM (UNII: 63ZP7I1BQO)
STEARIC ACID (UNII: 4ELV7Z65AP)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42472-005-01	1 in 1 CARTON	12/01/2009
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	12/01/2009

Labeler - ARAMIS INC. (042918826)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(42472-005) , REPACK(42472-005)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(42472-005)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(42472-005)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(42472-005)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(42472-005)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(42472-005) , REPACK(42472-005)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(42472-005) , REPACK(42472-005)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(42472-005)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(42472-005)