ARBONNE RE9 ADVANCED EXTRA MOISTURE RESTORATIVE DAY SPF 20- avobenzone, octinoxate, octisalate, and octocrylene lotion

Arbonne RE9 Advanced by

Drug Labeling and Warnings

Arbonne 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 ingredients

Avobenzone 3.0%
Octinoxate 7.5%
Octisalate 5.0%
Octocrylene 2.79%

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 two 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, glycerin, octyldodecyl neopentanoate, dimethicone, potassium cetyl phosphate, VP/eicosene copolymer, cetearyl alcohol, cocoyl proline, isopropyl isostearate, glyceryl distearate, hippophae rhamnoides oil, citrus aurantium dulcis (orange) peel oil, persea gratissima (avocado) oil, borago officinalis seed oil, olea europaea (olive) oil unsaponifiables, fagus sylvatica bud extract, pueraria lobata root extract, lavandula stoechas extract, laminaria digitata extract, cucumis sativus (cucumber) fruit extract, hypericum perforatum extract, nasturtium officinale extract, panax ginseng root extract, trifolium pratense (clover) flower extract, betula alba leaf extract, aloe barbadensis leaf juice, glycine soja (soybean) protein, valine, glycine, butylene glycol, tocopherol, tocopheryl acetate, retinyl palmitate, ascorbyl palmitate, tetrahexyldecyl ascorbate, hydrogenated lecithin, lecithin, glyceryl stearate, carbomer, polysorbate 20, palmitoyl tripeptide-1, palmitoyl tetrapeptide-7, panthenol, stearamine, urea, polyamino sugar condensate, sodium PCA, sorbitan stearate, squalane, phytosterols, C12-15 alkyl benzoate, sodium lauroyl methyl isethionate, disodium cocoamphodiacetate, sodium dextran sulfate, acrylates/C10-30 alkyl acrylate crosspolymer, phytic acid, aminomethyl propanol, caprylyl glycol, caprylic/capric triglyceride, caprylhydroxamic acid, sodium hyaluronate, gluconolactone, sodium dehydroacetate, sodium benzoate, calcium gluconate.

Questions or comments?

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

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

PRINCIPAL DISPLAY PANEL - 50 g Bottle Carton

ARBONNE®

RE9 ADVANCED®

EXTRA MOISTURE
RESTORATIVE
CREAM

BROAD SPECTRUM
SPF 20 SUNSCREEN

Net wt. 1.7 oz./50 g

INGREDIENTS AND APPEARANCE

ARBONNE RE9 ADVANCED   EXTRA MOISTURE RESTORATIVE DAY SPF 20
avobenzone, octinoxate, octisalate, and octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42508-339
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	27.9 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
COCOYL PROLINE (UNII: 0IH06971TF)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERYL 1-STEARATE (UNII: 258491E1RZ)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
EICOSYL POVIDONE (UNII: XQQ9MKE2BJ)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
ISOPROPYL ISOSTEARATE (UNII: C67IXB9Y7T)
HIPPOPHAE RHAMNOIDES SEED OIL (UNII: T53SBG6741)
ORANGE OIL (UNII: AKN3KSD11B)
AVOCADO OIL (UNII: 6VNO72PFC1)
BORAGE SEED OIL (UNII: F8XAG1755S)
FAGUS SYLVATICA FLOWER BUD (UNII: 6D5V13045W)
PUERARIA MONTANA VAR. LOBATA ROOT (UNII: PET93F4I3C)
LAVANDULA STOECHAS FLOWERING TOP (UNII: 70759G2U6A)
LAMINARIA DIGITATA (UNII: 15E7C67EE8)
CUCUMBER (UNII: YY7C30VXJT)
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB)
NASTURTIUM OFFICINALE (UNII: YH89GMV676)
ASIAN GINSENG (UNII: CUQ3A77YXI)
TRIFOLIUM PRATENSE FLOWER (UNII: 4JS0838828)
BETULA PUBESCENS LEAF (UNII: 84SOH0O3OO)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SOY PROTEIN (UNII: R44IWB3RN5)
VALINE (UNII: HG18B9YRS7)
GLYCINE (UNII: TE7660XO1C)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)
DEXPANTHENOL (UNII: 1O6C93RI7Z)
STEARAMINE (UNII: FFV58UNY7O)
UREA (UNII: 8W8T17847W)
SODIUM PIDOLATE (UNII: 1V74VH163T)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
SQUALANE (UNII: GW89575KF9)
SOY STEROL (UNII: PL360EPO9J)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
SODIUM LAUROYL METHYL ISETHIONATE (UNII: II6VCD3S6R)
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)
FYTIC ACID (UNII: 7IGF0S7R8I)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CALCIUM GLUCONATE (UNII: SQE6VB453K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42508-339-08	1 in 1 CARTON	04/17/2017
1		50 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
2	NDC: 42508-339-15	15 g in 1 TUBE; Type 0: Not a Combination Product	04/17/2017	09/18/2019
3	NDC: 42508-339-11	3 g in 1 TUBE; Type 0: Not a Combination Product	04/17/2017	09/18/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	04/17/2017

Labeler - Arbonne International, LLC (021541164)