ARBONNE SETTING PRETTY TRANSLUCENT BROAD SPECTRUM SPF 15 SUNSCREEN- titanium dioxide and zinc oxide powder

Arbonne Setting Pretty Translucent Broad Spectrum SPF 15 Sunscreen by

Drug Labeling and Warnings

Arbonne Setting Pretty Translucent Broad Spectrum SPF 15 Sunscreen 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

Titanium dioxide 1.92%
Zinc oxide 15%

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

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?

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

ARBONNE®

SETTING PRETTY

TRANSLUCENT LOOSE POWDER
BROAD SPECTRUM SPF 15
SUNSCREEN

Net wt. 0.30 oz. / 8.5 g

INGREDIENTS AND APPEARANCE

ARBONNE SETTING PRETTY TRANSLUCENT BROAD SPECTRUM SPF 15 SUNSCREEN 
titanium dioxide and zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42508-013
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	19.2 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	150 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)
IMPERATA CYLINDRICA ROOT (UNII: VYT2JA85NH)
LYCOPODIUM CLAVATUM WHOLE (UNII: 005ICF6L27)
OLIVINE (UNII: 95548S7QBV)
MANGANESE CARBONATE (UNII: 9ZV57512ZM)
RIBOSE, D- (UNII: 681HV46001)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE (UNII: 92RU3N3Y1O)
SORBIC ACID (UNII: X045WJ989B)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42508-013-01	1 in 1 CARTON	05/01/2020	08/01/2024
1		8.5 g in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph drug	M020	05/01/2020	08/01/2024

Labeler - Arbonne International, LLC (961643454)