ARBONNE FUNSUN MINERAL SUNSCREEN BROAD SPECTRUM SPF 30- zinc oxide lotion

Arbonne FunSun Mineral Sunscreen Broad Spectrum SPF 30 by

Drug Labeling and Warnings

Arbonne FunSun Mineral Sunscreen Broad Spectrum SPF 30 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

Zinc Oxide 19%

Purpose

Sunscreen

Uses

• helps prevent sunburn
• higher SPF gives more sunburn protection
• retains SPF after 40 minutes of activity in the water
• 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 or irritation develops and lasts.

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

Directions

• apply liberally and evenly 15 minutes before sun exposure
• reapply:
  • after 40 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
• 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, coco-caprylate, caprylic/capric triglyceride, cetearyl isononanoate, ethylhexyl palmitate, glycerin, isopropyl palmitate, polyglyceryl-4 diisostearate/polyhydroxystearate/sebacate, isopropyl myristate, magnesium sulfate, tocopherol, polyglyceryl-3 polyricinoleate, decylene glycol, camellia sinensis leaf extract, lecithin, aloe barbadensis leaf juice, helianthus annuus (sunflower) seed oil, 1,2-hexanediol, xanthan gum, hydrogenated castor oil, euphorbia cerifera (candelilla) wax, sodium chloride, isostearic acid, silica, polyhydroxystearic acid, sodium benzoate, potassium sorbate, phenoxyethanol, citric acid.

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

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.

PRINCIPAL DISPLAY PANEL – 148 ml Tube Carton

INGREDIENTS AND APPEARANCE

ARBONNE FUNSUN MINERAL SUNSCREEN BROAD SPECTRUM SPF 30 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42508-805
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	190 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
COCO-CAPRYLATE (UNII: 4828G836N6)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CETEARYL ISONONANOATE (UNII: P5O01U99NI)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE (UNII: 687U3PEB2Y)
MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T)
TOCOPHEROL (UNII: R0ZB2556P8)
POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)
DECYLENE GLYCOL (UNII: S57M60MI88)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SUNFLOWER OIL (UNII: 3W1JG795YI)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
XANTHAN GUM (UNII: TTV12P4NEE)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
CANDELILLA WAX (UNII: WL0328HX19)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ISOSTEARIC ACID (UNII: X33R8U0062)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
SODIUM BENZOATE (UNII: OJ245FE5EU)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42508-805-05	1 in 1 CARTON	03/07/2022
1		148 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	03/07/2022

Labeler - Arbonne International, LLC (961643454)

Registrant - Levlad, LLC (076245109)