RE9 ADVANCED RESTORATIVE 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 4.9%

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, C12-15 alkyl benzoate, glycerin, isononyl isononanoate, steareth-21, caprylic/capric triglyceride, squalane, dimethicone, sodium acryloyldimethyltaurate/VP crosspolymer, sorbitan oleate, steareth-2, aloe barbadensis leaf juice, citrus aurantium dulcis (orange) callus culture extract, cucumis sativus (cucumber) fruit extract, laminaria digitata extract, lavandula stoechas extract, pyrus malus (apple) fruit extract, nasturtium officinale extract, trifolium pratense (clover) flower extract, hippophae rhamnoides oil, olea europaea (olive) fruit oil, sodium hyaluronate, tetrahexyldecyl ascorbate, palmitoyl tripeptide-38, polyglyceryl-3 laurate, gluconolactone, xanthan gum, calcium gluconate, magnesium ascorbyl phosphate, tocopherol, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, dehydroxanthan gum, triethoxycaprylylsilane, polysorbate 60, sorbitan isostearate, sodium citrate, caprylhydroxamic acid, phytic acid, hydroxypropyl cyclodextrin, aminomethyl propanediol, citric acid, phenoxyethanol, chlorphenesin, potassium sorbate, sodium benzoate.

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 Bottle Carton

ARBONNE®

RE9 ADVANCED®

RESTORATIVE
CREAM

BROAD SPECTRUM
SPF 15 SUNSCREEN

Net wt. 1.7 oz. / 50 g

INGREDIENTS AND APPEARANCE

RE9 ADVANCED   RESTORATIVE BROAD SPECTRUM SPF 15 SUNSCREEN
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42508-456
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 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
GLYCERIN (UNII: PDC6A3C0OX)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
STEARETH-21 (UNII: 53J3F32P58)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
SQUALANE (UNII: GW89575KF9)
DIMETHICONE (UNII: 92RU3N3Y1O)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
STEARETH-2 (UNII: V56DFE46J5)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CUCUMBER (UNII: YY7C30VXJT)
LAMINARIA DIGITATA (UNII: 15E7C67EE8)
LAVANDULA STOECHAS FLOWERING TOP (UNII: 70759G2U6A)
APPLE (UNII: B423VGH5S9)
NASTURTIUM OFFICINALE (UNII: YH89GMV676)
TRIFOLIUM PRATENSE FLOWER (UNII: 4JS0838828)
OLIVE OIL (UNII: 6UYK2W1W1E)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
PALMITOYL LYSYLDIOXYMETHIONYLLYSINE (UNII: T7A529FB8O)
POLYGLYCERYL-3 LAURATE (UNII: Y9ZSR39D0E)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
XANTHAN GUM (UNII: TTV12P4NEE)
CALCIUM GLUCONATE (UNII: SQE6VB453K)
MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)
TOCOPHEROL (UNII: R0ZB2556P8)
DEHYDROXANTHAN GUM (UNII: 63ZP7I1BQO)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
POLYSORBATE 60 (UNII: CAL22UVI4M)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
ANHYDROUS TRISODIUM CITRATE (UNII: RS7A450LGA)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
FYTIC ACID (UNII: 7IGF0S7R8I)
AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CHLORPHENESIN (UNII: I670DAL4SZ)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42508-456-08	1 in 1 CARTON	09/01/2018
1		50 g in 1 BOTTLE, PUMP; 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	09/01/2018

Labeler - Arbonne International, LLC (021541164)