ARBONNE SOFT FOCUS VEIL BROAD SPECTRUM SPF 30 SUNSCREEN- titanium dioxide and zinc oxide lotion

Arbonne Soft Focus Veil Broad Spectrum SPF 30 Sunscreen by

Drug Labeling and Warnings

Arbonne Soft Focus Veil Broad Spectrum SPF 30 Sunscreen by is a Otc medication manufactured, distributed, or labeled by Arbonne International, LLC, Levlad, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Titanium dioxide 2.6%
Zinc oxide 7.2%

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 useon damaged or broken skin

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

Stop use and ask a doctor ifrash 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 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, polyglyceryl-2 dipolyhydroxystearate, diisopropyl sebacate, caprylic/capric triglyceride, isononyl isononanoate, polyglyceryl-4 diisostearate/polyhydroxystearate/sebacate, ethylhexyl palmitate, undecane, glycerin, carpobrotus edulis extract, propanediol, argania spinosa kernel oil, silica, tocopheryl acetate, dimethicone, sodium chloride, tridecane, jojoba esters, isostearic acid, copernicia cerifera (carnauba) wax, euphorbia cerifera (candelilla) wax, butyrospermum parkii (shea) butter, hydrogenated castor oil, polyglyceryl-3 polyricinoleate, isopropyl myristate, lecithin, caesalpinia spinosa fruit extract, kappaphycus alvarezii extract, bisabolol, helianthus annuus (sunflower) seed oil, polyhydroxystearic acid, stearalkonium hectorite, isopropyl titanium triisostearate, xanthan gum, tocopherol, citric acid, propylene carbonate, caprylyl glycol, caprylhydroxamic acid, ethylhexylglycerin, sodium benzoate, potassium sorbate, iron oxides (CI 77491, CI 77492, CI 77499).

Questions or comments?

1-800-272-6663

Monday–Friday 6 a.m.–6 p.m. PST

SPL UNCLASSIFIED SECTION

Distributed by Arbonne International, LLC,Greenwood, IN 46143 USA

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton

arbonne ®

100% VEGAN

DERMRESULTS

SOFT FOCUS VEIL
BROAD SPECTRUM
SPF 30 SUNSCREEN

Face Lotion for All Skin Types

1.7 fl. oz. / 50 mL

INGREDIENTS AND APPEARANCE

ARBONNE SOFT FOCUS VEIL BROAD SPECTRUM SPF 30 SUNSCREEN 
titanium dioxide and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42508-881
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	26 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	72 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
DIISOPROPYL SEBACATE (UNII: J8T3X564IH)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE (UNII: 687U3PEB2Y)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
UNDECANE (UNII: JV0QT00NUE)
GLYCERIN (UNII: PDC6A3C0OX)
PROPANEDIOL (UNII: 5965N8W85T)
ARGAN OIL (UNII: 4V59G5UW9X)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
DIMETHICONE (UNII: 92RU3N3Y1O)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TRIDECANE (UNII: A3LZF0L939)
HYDROGENATED JOJOBA OIL (UNII: 7F674YQ5SO)
ISOSTEARIC ACID (UNII: X33R8U0062)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CANDELILLA WAX (UNII: WL0328HX19)
SHEA BUTTER (UNII: K49155WL9Y)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)
LEVOMENOL (UNII: 24WE03BX2T)
SUNFLOWER OIL (UNII: 3W1JG795YI)
POLYHYDROXYSTEARIC ACID STEARATE (UNII: 8KQ7I65XZE)
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)
XANTHAN GUM (UNII: TTV12P4NEE)
TOCOPHEROL (UNII: R0ZB2556P8)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SODIUM BENZOATE (UNII: OJ245FE5EU)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
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: 42508-881-06	1 in 1 CARTON	04/01/2023
1		50 mL in 1 TUBE; 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	04/01/2023

Labeler - Arbonne International, LLC (961643454)

Registrant - Levlad, LLC (076245109)