RE9 ADVANCED PREPWORK- titanium dioxide and zinc oxide kit

RE9 Advanced Prepwork by

Drug Labeling and Warnings

RE9 Advanced Prepwork 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 ingredients

Titanium Dioxide 2.5%
Zinc Oxide 7.2%

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
• children under 6 months of age: ask a doctor
• 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

Other information

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

Inactive ingredients

water, ethylhexyl palmitate, caprylic/capric triglyceride, cyclopentasiloxane, diisopropyl sebacate, isononyl isononanoate, polyglyceryl-6 polyricinoleate, polymethylsilsesquioxane, glycerin, argania spinosa kernel oil, polyglyceryl-2 isostearate, tocopheryl acetate, silica, caesalpinia spinosa fruit extract, vaccinium vitis-idaea fruit extract, kappaphycus alvarezii extract, terminalia ferdinandiana fruit extract, chlorella vulgaris extract, aloe barbadensis leaf juice powder, raspberry seed oil/tocopheryl succinate aminopropanediol esters, olive oil decyl esters, hydrolyzed pea protein, sea salt, squalene, saccharide isomerate, bisabolol, isopropyl myristate, hydrogenated castor oil, xanthan gum, gluconolactone, calcium gluconate, hydrated silica, tocopherol, sodium chloride, magnesium stearate, disteardimonium hectorite, stearalkonium hectorite, propylene carbonate, polyhydroxystearic acid, bentonite, alumina, isopropyl titanium triisostearate, lactic acid, citric acid, phenoxyethanol, potassium sorbate, sodium benzoate, mica, iron oxides (CI 77491, CI 77492, CI 77499), titanium dioxide (CI 77891).

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®
PREPWORK

3 x 0.1 fl. oz. / 3 mL

INGREDIENTS AND APPEARANCE

RE9 ADVANCED PREPWORK 
titanium dioxide and zinc oxide kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42508-096

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42508-096-10	1 in 1 CARTON	04/19/2018

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 mL

Part 1 of 3

RE9 ADVANCED PREPWORK   CLEANSING POLISH
cleansing (cold creams, cleansing lotions, liquids, and pads)

Product Information

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	Water (UNII: 059QF0KO0R)
INGR	Glycerin (UNII: PDC6A3C0OX)
INGR	COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)
INGR	Lauryl Glucoside (UNII: 76LN7P7UCU)
INGR	Methacrylic Acid - Ethyl Acrylate Copolymer (4500 MPA.S) (UNII: T967IEU43C)
INGR	Sodium Lauryl Sulfoacetate (UNII: D0Y70F2B9J)
INGR	Prunus Armeniaca Seed (UNII: 75356789IW)
INGR	Glyceryl 1-Undecylenate (UNII: B68LJT9544)
INGR	Xanthan Gum (UNII: TTV12P4NEE)
INGR	Sunflower Oil (UNII: 3W1JG795YI)
INGR	Lingonberry (UNII: 0UNK9RZQ7X)
INGR	Apple (UNII: B423VGH5S9)
INGR	Passiflora Incarnata Fruit (UNII: SF206I8G4P)
INGR	Hylocereus Undatus Fruit (UNII: WUG58TD53X)
INGR	Kakadu Plum (UNII: 0ZQ1D2FDLI)
INGR	Niacinamide (UNII: 25X51I8RD4)
INGR	Ethylhexylglycerin (UNII: 147D247K3P)
INGR	Hexylene Glycol (UNII: KEH0A3F75J)
INGR	Sodium Carbonate (UNII: 45P3261C7T)
INGR	Sodium Sulfate (UNII: 0YPR65R21J)
INGR	Gluconolactone (UNII: WQ29KQ9POT)
INGR	Calcium Gluconate (UNII: SQE6VB453K)
INGR	Caprylhydroxamic Acid (UNII: UPY805K99W)
INGR	Sodium Chloride (UNII: 451W47IQ8X)
INGR	Citric Acid Monohydrate (UNII: 2968PHW8QP)
INGR	Sodium Hydroxide (UNII: 55X04QC32I)
INGR	Caprylyl Glycol (UNII: 00YIU5438U)
INGR	Phenoxyethanol (UNII: HIE492ZZ3T)
INGR	Potassium Sorbate (UNII: 1VPU26JZZ4)
INGR	Sodium Benzoate (UNII: OJ245FE5EU)

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		04/19/2018

Part 2 of 3

RE9 ADVANCED PREPWORK   HYDRATING DEW CREAM
moisturizing

Product Information

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	Water (UNII: 059QF0KO0R)
INGR	Isononyl Isononanoate (UNII: S4V5BS6GCX)
INGR	Medium-Chain Triglycerides (UNII: C9H2L21V7U)
INGR	Glycerin (UNII: PDC6A3C0OX)
INGR	Apple (UNII: B423VGH5S9)
INGR	Steareth-21 (UNII: 53J3F32P58)
INGR	Steareth-2 (UNII: V56DFE46J5)
INGR	Dimethicone (UNII: 92RU3N3Y1O)
INGR	Cetyl Alcohol (UNII: 936JST6JCN)
INGR	Stearyl Alcohol (UNII: 2KR89I4H1Y)
INGR	Ammonium Acryloyldimethyltaurate/Beheneth-25 Methacrylate Crosspolymer (52000 MPA.S) (UNII: LZ291VH90H)
INGR	Xanthan Gum (UNII: TTV12P4NEE)
INGR	Lingonberry (UNII: 0UNK9RZQ7X)
INGR	Lentil (UNII: 6O38V6B52O)
INGR	Clary Sage (UNII: U3HSK5JC0Q)
INGR	Kakadu Plum (UNII: 0ZQ1D2FDLI)
INGR	Fig (UNII: TGD87RII2U)
INGR	Niacinamide (UNII: 25X51I8RD4)
INGR	Poly(Methyl Methacrylate; 450000 MW) (UNII: Z47NNT4J11)
INGR	Propanediol (UNII: 5965N8W85T)
INGR	Ammonium Acryloyldimethyltaurate/VP Copolymer (UNII: W59H9296ZG)
INGR	Hyaluronate Sodium (UNII: YSE9PPT4TH)
INGR	Gluconolactone (UNII: WQ29KQ9POT)
INGR	Calcium Gluconate (UNII: SQE6VB453K)
INGR	Sodium Carbonate (UNII: 45P3261C7T)
INGR	Citric Acid Monohydrate (UNII: 2968PHW8QP)
INGR	Lactic Acid, Dl- (UNII: 3B8D35Y7S4)
INGR	Sodium Hydroxide (UNII: 55X04QC32I)
INGR	Sodium Chloride (UNII: 451W47IQ8X)
INGR	Ethylhexylglycerin (UNII: 147D247K3P)
INGR	Phenoxyethanol (UNII: HIE492ZZ3T)
INGR	Sodium Benzoate (UNII: OJ245FE5EU)
INGR	Potassium Sorbate (UNII: 1VPU26JZZ4)
INGR	Tert-Butyl Alcohol (UNII: MD83SFE959)

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		04/19/2018

Part 3 of 3

RE9 ADVANCED PREPWORK   SOFT FOCUS VEIL BROAD SPECTRUM SPF 30 SUNSCREEN
titanium dioxide and zinc oxide lotion

Product Information
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	2.5 mg  in 100 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	7.2 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Ethylhexyl Palmitate (UNII: 2865993309)
Medium-Chain Triglycerides (UNII: C9H2L21V7U)
Cyclomethicone 5 (UNII: 0THT5PCI0R)
Diisopropyl Sebacate (UNII: J8T3X564IH)
Isononyl Isononanoate (UNII: S4V5BS6GCX)
Polymethylsilsesquioxane (4.5 Microns) (UNII: 59Z907ZB69)
Glycerin (UNII: PDC6A3C0OX)
Argan Oil (UNII: 4V59G5UW9X)
Polyglyceryl-2 Monoisostearate (UNII: 7B8OE71MQC)
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Lingonberry (UNII: 0UNK9RZQ7X)
Kappaphycus Alvarezii (UNII: T479H08K2O)
Kakadu Plum (UNII: 0ZQ1D2FDLI)
Chlorella Vulgaris (UNII: RYQ4R60M02)
Aloe Vera Leaf (UNII: ZY81Z83H0X)
Olive Oil Decyl Esters (UNII: 3AQ222F18X)
Sea Salt (UNII: 87GE52P74G)
Squalene (UNII: 7QWM220FJH)
Saccharide Isomerate (UNII: W8K377W98I)
Levomenol (UNII: 24WE03BX2T)
Isopropyl Myristate (UNII: 0RE8K4LNJS)
Hydrogenated Castor Oil (UNII: ZF94AP8MEY)
Xanthan Gum (UNII: TTV12P4NEE)
Gluconolactone (UNII: WQ29KQ9POT)
Calcium Gluconate (UNII: SQE6VB453K)
Hydrated Silica (UNII: Y6O7T4G8P9)
Tocopherol (UNII: R0ZB2556P8)
Sodium Chloride (UNII: 451W47IQ8X)
Magnesium Stearate (UNII: 70097M6I30)
Disteardimonium Hectorite (UNII: X687XDK09L)
Stearalkonium Hectorite (UNII: OLX698AH5P)
Propylene Carbonate (UNII: 8D08K3S51E)
Polyhydroxystearic Acid (2300 MW) (UNII: YXH47AOU0F)
Bentonite (UNII: A3N5ZCN45C)
Aluminum Oxide (UNII: LMI26O6933)
Isopropyl Titanium Triisostearate (UNII: 949E3KBJ1I)
Lactic Acid, Dl- (UNII: 3B8D35Y7S4)
Anhydrous Citric Acid (UNII: XF417D3PSL)
Phenoxyethanol (UNII: HIE492ZZ3T)
Potassium Sorbate (UNII: 1VPU26JZZ4)
Sodium Benzoate (UNII: OJ245FE5EU)
Mica (UNII: V8A1AW0880)
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		1 in 1 CARTON
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	04/19/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	04/19/2018

Labeler - Arbonne International, LLC (021541164)