NDC 42508-338 Arbonne Re9 Advanced Extra Moisture Restorative Day Spf 20

Avobenzone, Octinoxate, Octisalate, And Octocrylene

NDC Product Code 42508-338

NDC Code: 42508-338

Proprietary Name: Arbonne Re9 Advanced Extra Moisture Restorative Day Spf 20 What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Avobenzone, Octinoxate, Octisalate, And Octocrylene What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 42508 - Arbonne International, Llc
    • 42508-338 - Arbonne Re9 Advanced

NDC 42508-338-10

Package Description: 3 mL in 1 TUBE

NDC 42508-338-12

Package Description: 1 BOTTLE, PUMP in 1 CARTON > 37 mL in 1 BOTTLE, PUMP

NDC 42508-338-13

Package Description: 8 mL in 1 BOTTLE, PUMP

NDC Product Information

Arbonne Re9 Advanced Extra Moisture Restorative Day Spf 20 with NDC 42508-338 is a a human over the counter drug product labeled by Arbonne International, Llc. The generic name of Arbonne Re9 Advanced Extra Moisture Restorative Day Spf 20 is avobenzone, octinoxate, octisalate, and octocrylene. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Arbonne International, Llc

Dosage Form: Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Arbonne Re9 Advanced Extra Moisture Restorative Day Spf 20 Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • AVOBENZONE 30 mg/mL
  • OCTINOXATE 75 mg/mL
  • OCTISALATE 50 mg/mL
  • OCTOCRYLENE 27.9 mg/mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • 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)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Arbonne International, Llc
Labeler Code: 42508
FDA Application Number: part352 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 08-13-2014 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

End Marketing Date: 09-18-2019 What is the End Marketing Date?
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Arbonne Re9 Advanced Extra Moisture Restorative Day Spf 20 Product Label Images

Arbonne Re9 Advanced Extra Moisture Restorative Day Spf 20 Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Other

Drug Facts

Distributed byArbonne International, LLC9400 Jeronimo RoadIrvine, CA 92618 USA

Active Ingredients

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

Purpose

Sunscreen

Uses

  • Helps prevent sunburnif 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

Otc - Do Not Use

Do not use on damaged or broken skin

Otc - When Using

When using this product keep out of eyes. Rinse with water to remove.

Otc - Stop Use

Stop use and ask a doctor if rash occurs

Otc - Keep Out Of Reach Of Children

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 exposurereapply at least every 2 hoursuse a water-resistant sunscreen if swimming or sweatingSun 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 sunglasseschildren 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, glycerin, octyldodecyl neopentanoate, cocoyl proline, dimethicone, glyceryl stearate, potassium cetyl phosphate, VP/eicosene copolymer, cetearyl alcohol, isopropyl isostearate, 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, 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, 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.

* Please review the disclaimer below.

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