RE9 ADVANCED LIFTING AND CONTOURING BROAD SPECTRUM SPF 15 SUNSCREEN- zinc oxide cream

RE9 Advanced by

Drug Labeling and Warnings

RE9 Advanced 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 4.45%

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 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, simmondsia chinensis (jojoba) seed oil, polyglyceryl-3 methylglucose distearate, cetyl alcohol, caprylic/capric triglyceride, cetyl dimethicone, cetyl palmitate, dimethicone, behenyl alcohol, cetearyl alcohol, glyceryl stearate, squalane, butyrospermum parkii (shea) butter, isononyl isononanoate, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, hydroxyethylcellulose, xanthan gum, caprylyl glycol, sodium lauroyl glutamate, stearic acid, polysorbate 60, sorbitan isostearate, olea europaea (olive) fruit oil, hippophae rhamnoides oil, aloe barbadensis leaf juice, osmanthus fragrans flower extract, paeonia albiflora root extract, chondrus crispus extract, laminaria digitata extract, ganoderma lucidum (mushroom) stem extract, serenoa serrulata fruit extract, anthemis nobilis flower extract, cucumis sativus (cucumber) fruit extract, trifolium pratense (clover) flower extract, undaria pinnatifida extract, tetrahexyldecyl ascorbate, panthenol, tocopheryl acetate, pantolactone, acetyl tetrapeptide-2, vinyl dimethicone/methicone silsesquioxane crosspolymer, micrococcus lysate, biosaccharide gum-1, disodium acetyl glucosamine phosphate, ethylhexylglycerin, citric acid, caprylhydroxamic acid, phytic acid, sodium citrate, aminomethyl propanediol, propanediol, triethoxycaprylylsilane, chlorphenesin, phenoxyethanol, glyoxal, sodium nitrate.

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 - 50 g Jar Carton

ARBONNE®

RE9 ADVANCED®

LIFTING AND CONTOURING CREAM
BROAD SPECTRUM SPF 15 SUNSCREEN

Net wt. 1.7 oz./50 g

INGREDIENTS AND APPEARANCE

RE9 ADVANCED   LIFTING AND CONTOURING BROAD SPECTRUM SPF 15 SUNSCREEN
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42508-079
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	4.45 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
Aloe Vera Leaf (UNII: ZY81Z83H0X)
Aminomethyl Propanediol (UNII: CZ7BU4QZJZ)
Chamaemelum Nobile Flower (UNII: O2T154T6OG)
Docosanol (UNII: 9G1OE216XY)
Biosaccharide Gum-1 (UNII: BB4PU4V09H)
Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)
Caprylhydroxamic Acid (UNII: UPY805K99W)
Medium-Chain Triglycerides (UNII: C9H2L21V7U)
Caprylyl Glycol (UNII: 00YIU5438U)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
Cetyl Alcohol (UNII: 936JST6JCN)
Cetyl Dimethicone 25 (UNII: U4AS1BW4ZB)
Cetyl Palmitate (UNII: 5ZA2S6B08X)
Chlorphenesin (UNII: I670DAL4SZ)
Chondrus Crispus (UNII: OQS23HUA1X)
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Cucumber (UNII: YY7C30VXJT)
Dimethicone (UNII: 92RU3N3Y1O)
Ethylhexylglycerin (UNII: 147D247K3P)
Ganoderma Lucidum Stem (UNII: U8PA41532G)
Glycerin (UNII: PDC6A3C0OX)
Glyceryl Monostearate (UNII: 230OU9XXE4)
Glyoxal (UNII: 50NP6JJ975)
Hippophae Rhamnoides Seed Oil (UNII: T53SBG6741)
Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer (100000 Mpa.S At 1.5%) (UNII: 86FQE96TZ4)
Cetyl Hydroxyethylcellulose (350000 MW) (UNII: T7SWE4S2TT)
Isononyl Isononanoate (UNII: S4V5BS6GCX)
Laminaria Digitata (UNII: 15E7C67EE8)
Olive Oil (UNII: 6UYK2W1W1E)
Osmanthus Fragrans Flower (UNII: 4VA0BH57HU)
Paeonia Lactiflora Root (UNII: 3Z3866YW6P)
Dexpanthenol (UNII: 1O6C93RI7Z)
Pantolactone, (R)- (UNII: J288D7O0JS)
Phenoxyethanol (UNII: HIE492ZZ3T)
Fytic Acid (UNII: 7IGF0S7R8I)
Polysorbate 60 (UNII: CAL22UVI4M)
Propanediol (UNII: 5965N8W85T)
Saw Palmetto (UNII: J7WWH9M8QS)
Jojoba Oil (UNII: 724GKU717M)
Sodium Citrate, Unspecified Form (UNII: 1Q73Q2JULR)
Sodium Lauroyl Glutamate (UNII: NCX1UU2D33)
Sodium Nitrate (UNII: 8M4L3H2ZVZ)
Sorbitan Isostearate (UNII: 01S2G2C1E4)
Squalane (UNII: GW89575KF9)
Stearic Acid (UNII: 4ELV7Z65AP)
Tetrahexyldecyl Ascorbate (UNII: 9LBV3F07AZ)
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)
Triethoxycaprylylsilane (UNII: LDC331P08E)
Trifolium Pratense Flower (UNII: 4JS0838828)
Undaria Pinnatifida (UNII: ICV1OK7M1S)
Water (UNII: 059QF0KO0R)
Xanthan Gum (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42508-079-08	1 in 1 CARTON	09/01/2015
1		50 g in 1 JAR; Type 0: Not a Combination Product
2	NDC: 42508-079-11	3 g in 1 TUBE; Type 0: Not a Combination Product	09/01/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	09/01/2015

Labeler - Arbonne International, LLC (021541164)