FDA.reportPublic FDA data

Arbonne Setting Pretty Translucent Broad Spectrum SPF 15 Sunscreen

Manufacturer
Arbonne International, LLC
Effective date
2023-12-18
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:17:41

Label at a glance#

ProductArbonne Setting Pretty Translucent Broad Spectrum SPF 15 Sunscreen
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure11 sections

Indications and 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

Dosage and administration

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 ...

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanium dioxide 1.92%
Zinc oxide 15%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

silica, methyl methacrylate crosspolymer, sodium potassium aluminum silicate, oryza sativa (rice) lipids, imperata cylindrica root extract, lycopodium clavatum extract, olivine extract, rhodochrosite extract, ribose, water, glycerin, dimethicone, sorbic acid, sodium metabisulfite, phenoxyethanol, sodium dehydroacetate, potassium sorbate, mica, titanium dioxide (CI 77891), iron oxides (CI 77491, CI 77492, CI 77499).

Questions or comments?

OTC - QUESTIONS SECTION

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 - 8.5 g Jar Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ARBONNE®

SETTING PRETTY

TRANSLUCENT LOOSE POWDER
BROAD SPECTRUM SPF 15
SUNSCREEN

Net wt. 0.30 oz. / 8.5 g

PRINCIPAL DISPLAY PANEL - 8.5 g Jar Carton
PRINCIPAL DISPLAY PANEL - 8.5 g Jar Carton

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42508-01342508-013-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
TITANIUM DIOXIDE15FIX9V2JPACTIB
ZINC OXIDESOI2LOH54ZACTIB
SILICON DIOXIDEETJ7Z6XBU4IACT
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMEREG97988M5QIACT
IMPERATA CYLINDRICA ROOTVYT2JA85NHIACT
LYCOPODIUM CLAVATUM WHOLE005ICF6L27IACT
OLIVINE95548S7QBVIACT
MANGANESE CARBONATE9ZV57512ZMIACT
RIBOSE, D-681HV46001IACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
DIMETHICONE92RU3N3Y1OIACT
SORBIC ACIDX045WJ989BIACT
SODIUM METABISULFITE4VON5FNS3CIACT
PHENOXYETHANOLHIE492ZZ3TIACT
SODIUM DEHYDROACETATE8W46YN971GIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
MICAV8A1AW0880IACT
FERRIC OXIDE RED1K09F3G675IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
FERROSOFERRIC OXIDEXM0M87F357IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
f198eeed-1023-4bd5-ad25-671a6fe4df4c211c8995-558b-4d5f-a0d7-fd0b17ca67342023-12-18WarningsExact identifier
spl id: f198eeed-1023-4bd5-ad25-671a6fe4df4c
spl set id: 211c8995-558b-4d5f-a0d7-fd0b17ca6734

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.