RE9 ADVANCED FOR MEN ANTI-AGING SKINCARE LINE- zinc oxide kit

RE9 Advanced for Men Anti-Aging Skincare Line by

Drug Labeling and Warnings

RE9 Advanced for Men Anti-Aging Skincare Line by is a Otc medication manufactured, distributed, or labeled by Arbonne International, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Zinc Oxide 4.95%

Purpose

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 swallowed, get medical help or contact a Poison Control Center right away.

Directions

For sunscreen use:

• apply liberally and evenly 15 minutes before sun exposure
• reapply at least every 2 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

Other information

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

Inactive ingredients

water, C12-15 alkyl benzoate, glycerin, isononyl isononanoate, saccharide isomerate, steareth-21, squalane, ammonium acryloyldimethyltaurate/VP copolymer, caprylic/capric triglyceride, dimethicone, steareth-2, aloe barbadensis leaf juice, hydrolyzed ceratonia siliqua seed extract, laminaria digitata extract, chamomilla recutita (matricaria) flower extract, sophora japonica flower extract, tripleurospermum maritimum extract, malachite extract, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, dehydroxanthan gum, tetrahexyldecyl ascorbate, dipotassium glycyrrhizate, menthol, adenosine, sodium hyaluronate, polyglyceryl-3 laurate, sorbitan oleate, sorbitan isostearate, myristic acid, palmitic acid, stearic acid, triethoxycaprylylsilane, polysorbate 60, propanediol, trisodium ethylenediamine disuccinate, sodium citrate, citric acid, caprylhydroxamic acid, caprylyl glycol, phenoxyethanol, chlorphenesin, sodium benzoate, potassium sorbate, sorbic acid.

Questions or comments?

1.800.272.6663
Monday–Friday 6 a.m.–6 p.m. Pacific time

SPL UNCLASSIFIED SECTION

Distributed by
Arbonne International, LLC
9400 Jeronimo Road
Irvine, CA 92618 USA

PRINCIPAL DISPLAY PANEL - Kit Carton

ARBONNE®
pure safe beneficial™

RE9 ADVANCED®
FOR MEN

Anti-Aging Skincare Line

3 x 0.1 fl. oz./3 ml

INGREDIENTS AND APPEARANCE

RE9 ADVANCED FOR MEN ANTI-AGING SKINCARE LINE 
zinc oxide kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42508-024

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42508-024-00	1 in 1 CARTON	04/14/2016

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 TUBE	3 mL
Part 2	1 TUBE	3 mL
Part 3	1 TUBE	3 g

Part 1 of 3

RE9 ADVANCED FOR MEN   ANTI-AGING MOISTURIZER BROAD SPECTRUM SPF 15 SUNSCREEN
zinc oxide lotion

Product Information
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	49.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)
Glycerin (UNII: PDC6A3C0OX)
Isononyl Isononanoate (UNII: S4V5BS6GCX)
Saccharide Isomerate (UNII: W8K377W98I)
Steareth-21 (UNII: 53J3F32P58)
Squalane (UNII: GW89575KF9)
Ammonium Acryloyldimethyltaurate/VP Copolymer (UNII: W59H9296ZG)
Medium-Chain Triglycerides (UNII: C9H2L21V7U)
Dimethicone (UNII: 92RU3N3Y1O)
Steareth-2 (UNII: V56DFE46J5)
Aloe Vera Leaf (UNII: ZY81Z83H0X)
Phenoxyethanol (UNII: HIE492ZZ3T)
Caprylyl Glycol (UNII: 00YIU5438U)
Tetrahexyldecyl Ascorbate (UNII: 9LBV3F07AZ)
Sorbitan Monooleate (UNII: 06XEA2VD56)
Propanediol (UNII: 5965N8W85T)
Chlorphenesin (UNII: I670DAL4SZ)
Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer (100000 MPA.S at 1.5%) (UNII: 86FQE96TZ4)
Palmitic Acid (UNII: 2V16EO95H1)
Dehydroxanthan Gum (UNII: 63ZP7I1BQO)
Stearic Acid (UNII: 4ELV7Z65AP)
Trisodium Ethylenediamine Disuccinate (UNII: YA22H34H9Q)
Caprylhydroxamic Acid (UNII: UPY805K99W)
Glycyrrhizinate Dipotassium (UNII: CA2Y0FE3FX)
Menthol, Unspecified Form (UNII: L7T10EIP3A)
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Sodium Citrate, Unspecified Form (UNII: 1Q73Q2JULR)
Adenosine (UNII: K72T3FS567)
Triethoxycaprylylsilane (UNII: LDC331P08E)
Polysorbate 60 (UNII: CAL22UVI4M)
Hyaluronate Sodium (UNII: YSE9PPT4TH)
Sorbitan Isostearate (UNII: 01S2G2C1E4)
Sodium Benzoate (UNII: OJ245FE5EU)
Laminaria Digitata (UNII: 15E7C67EE8)
Myristic Acid (UNII: 0I3V7S25AW)
Chamomile (UNII: FGL3685T2X)
Styphnolobium Japonicum Flower (UNII: 644C3CSB6E)
Potassium Sorbate (UNII: 1VPU26JZZ4)
Polyglyceryl-3 Laurate (UNII: Y9ZSR39D0E)
Sorbic Acid (UNII: X045WJ989B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		3 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	04/14/2016

Part 2 of 3

RE9 ADVANCED FOR MEN   MICRO-EXFOLIATING CLEANSER
cleansing (cold creams, cleansing lotions, liquids, and pads)

Product Information

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	Water (UNII: 059QF0KO0R)
INGR	Sodium Cocoyl Isethionate (UNII: 518XTE8493)
INGR	Cetyl Alcohol (UNII: 936JST6JCN)
INGR	Glycerin (UNII: PDC6A3C0OX)
INGR	Glyceryl Monostearate (UNII: 230OU9XXE4)
INGR	Sodium C14-16 Olefin Sulfonate (UNII: O9W3D3YF5U)
INGR	Palmitic Acid (UNII: 2V16EO95H1)
INGR	Stearic Acid (UNII: 4ELV7Z65AP)
INGR	Cellulose, Microcrystalline (UNII: OP1R32D61U)
INGR	Cocamidopropyl Betaine (UNII: 5OCF3O11KX)
INGR	Lauryl Laurate (UNII: GPW77G0937)
INGR	Decyl Glucoside (UNII: Z17H97EA6Y)
INGR	Titanium Dioxide (UNII: 15FIX9V2JP)
INGR	Coconut Acid (UNII: 40U37V505D)
INGR	Myristic Acid (UNII: 0I3V7S25AW)
INGR	Sodium Isethionate (UNII: 3R36J71C17)
INGR	Caprylyl Glycol (UNII: 00YIU5438U)
INGR	Diheptyl Succinate (UNII: 057N7SS26Y)
INGR	Dimethicone (UNII: 92RU3N3Y1O)
INGR	HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)
INGR	Laminaria Digitata (UNII: 15E7C67EE8)
INGR	Tetrahexyldecyl Ascorbate (UNII: 9LBV3F07AZ)
INGR	.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)
INGR	Panthenol Triacetate, (+)- (UNII: 1206E8961B)
INGR	Sodium Chloride (UNII: 451W47IQ8X)
INGR	Sodium Sulfate (UNII: 0YPR65R21J)
INGR	Caprylhydroxamic Acid (UNII: UPY805K99W)
INGR	Trisodium Ethylenediamine Disuccinate (UNII: YA22H34H9Q)
INGR	Sodium Hydroxide (UNII: 55X04QC32I)
INGR	Sodium Carbonate (UNII: 45P3261C7T)
INGR	Phenoxyethanol (UNII: HIE492ZZ3T)
INGR	Sorbic Acid (UNII: X045WJ989B)
INGR	Ultramarine Blue (UNII: I39WR998BI)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		3 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
COSMETIC		04/14/2016

Part 3 of 3

RE9 ADVANCED FOR MEN   EYE REPAIR CREAM
eye lotion

Product Information

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	Water (UNII: 059QF0KO0R)
INGR	Medium-Chain Triglycerides (UNII: C9H2L21V7U)
INGR	Cetearyl Olivate (UNII: 58B69Q84JO)
INGR	Glycerin (UNII: PDC6A3C0OX)
INGR	Coco-Caprylate (UNII: 4828G836N6)
INGR	Helianthus Annuus Seed Wax (UNII: 42DG15CHXV)
INGR	Sorbitan Olivate (UNII: MDL271E3GR)
INGR	Caprylyl Glycol (UNII: 00YIU5438U)
INGR	Glyceryl Stearate SE (UNII: FCZ5MH785I)
INGR	Cetostearyl Alcohol (UNII: 2DMT128M1S)
INGR	CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
INGR	Sorbitan Monopalmitate (UNII: 77K6Z421KU)
INGR	Sorbitan Monooleate (UNII: 06XEA2VD56)
INGR	Laminaria Digitata (UNII: 15E7C67EE8)
INGR	Styphnolobium Japonicum Flower (UNII: 644C3CSB6E)
INGR	Acacia Decurrens Flower Wax (UNII: AU6XZE9IY9)
INGR	Tetrahexyldecyl Ascorbate (UNII: 9LBV3F07AZ)
INGR	Cetyl Palmitate (UNII: 5ZA2S6B08X)
INGR	Propyl Gallate (UNII: 8D4SNN7V92)
INGR	Polyglycerin-3 (UNII: 4A0NCJ6RD6)
INGR	Adenosine (UNII: K72T3FS567)
INGR	Tocopherol (UNII: R0ZB2556P8)
INGR	Propanediol (UNII: 5965N8W85T)
INGR	1,2-Hexanediol (UNII: TR046Y3K1G)
INGR	Sodium Chloride (UNII: 451W47IQ8X)
INGR	Caprylhydroxamic Acid (UNII: UPY805K99W)
INGR	Trisodium Ethylenediamine Disuccinate (UNII: YA22H34H9Q)
INGR	Sodium Carbonate (UNII: 45P3261C7T)
INGR	Citric Acid Monohydrate (UNII: 2968PHW8QP)
INGR	Sodium Hydroxide (UNII: 55X04QC32I)
INGR	Phenoxyethanol (UNII: HIE492ZZ3T)
INGR	Benzyl Alcohol (UNII: LKG8494WBH)
INGR	Dehydroacetic Acid (UNII: 2KAG279R6R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		3 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
COSMETIC		04/14/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	04/14/2016

Labeler - Arbonne International, LLC (021541164)