RE9 ADVANCED PREPWORK SOFT FOCUS VEIL BROAD SPECTRUM SPF30 SUNSCREEN- zinc oxide, titanium dioxide lotion

RE9 Advanced Prepwork Soft Focus Veil Broad Spectrum SPF30 Sunscreen by

Drug Labeling and Warnings

RE9 Advanced Prepwork Soft Focus Veil Broad Spectrum SPF30 Sunscreen by is a Otc medication manufactured, distributed, or labeled by Arbonne International, LLC, Autumn Harp, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Titanium Dioxide 2.5%

Zinc Oxide 7.2%

Purpose

Sunscreen

PURPOSE

​ helps prevent sunburn

Uses

​ 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.

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, regulary 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

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.

Other information

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

Inactive ingredients

water, ethylhexyl palmitate, caprylic/capric triglyceride, cyclopentasiloxane, diisopropyl sebacate, isonoyl isononanoate, polyglyceryl-6 polyricinoleate, polymethylsilsesquioxane, glycerin, argania spinosa kernel oil, polyglyceryl-2 isostearate, tocopheryl acetate, silica, caesalpinia spinosa fruit extract, vaccinium vitis-idaea fruit ectract, kappaphycus alvarezii extract, terminalia ferdinandiana fruit extract, chlorella vulgaris extract, aloe barbadensis leaf juice powder, raspberry seed oil/tocopheryl succinate aminopropanediol esters, olive oil decyl esters, hydrolyzed pea protein, sea salt, squalene, saccharide isomerate, bisabolol, isopropyl myristate, hydrogenated castor oil, xanthan gum, gluconolactone, calcium gluconate, hydrated silica, tocopherol, sodium chloride, magnesium stearate, disteardimonium hectorite, stearalkonium hectorite, propylene carbonate, polyhydroxystearic acid, bentonite, alumina, isopropyl titanium triisostearate, lactic acid, citric acid, phenoxyethanol, potassium sorbate, sodium benzoate, mica, iron oxides (CI 77491, CI 77492, CI 77499), titanium dioxide (CI 77891).

Questions or comments?

1.800.272.6663

Monday-Friday

6 a.m.-6 p.m. Pacific time

Principle Display Panel

Arbonne

RE9 Advanced

Soft Focus Veil Broad Spectrum SPF30 Sunscreen

4681R01_01_REAdvanced_Prepwork_SoftFocusVeil_SPF_ctn_FPO Carton.jpg

4681R03_01_RE9Advanced_Prepwork_SoftFocusVeil_SPF_comp_FPO_tube.jpg

INGREDIENTS AND APPEARANCE

RE9 ADVANCED PREPWORK SOFT FOCUS VEIL BROAD SPECTRUM SPF30 SUNSCREEN 
zinc oxide, titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42508-205
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.5 mg  in 100 mg
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	7.2 mg  in 100 mg

Inactive Ingredients
Ingredient Name	Strength
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TOCOPHEROL (UNII: R0ZB2556P8)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
CALCIUM GLUCONATE (UNII: SQE6VB453K)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
MAGNESIUM STEARATE (UNII: 70097M6I30)
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
BENTONITE (UNII: A3N5ZCN45C)
ALUMINUM OXIDE (UNII: LMI26O6933)
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM BENZOATE (UNII: OJ245FE5EU)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
POLYGLYCERYL-2 MONOISOSTEARATE (UNII: 7B8OE71MQC)
ARGAN OIL (UNII: 4V59G5UW9X)
LINGONBERRY (UNII: 0UNK9RZQ7X)
SEA SALT (UNII: 87GE52P74G)
SQUALENE (UNII: 7QWM220FJH)
LEVOMENOL (UNII: 24WE03BX2T)
XANTHAN GUM (UNII: TTV12P4NEE)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DIISOPROPYL SEBACATE (UNII: J8T3X564IH)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
KAPPAPHYCUS ALVAREZII (UNII: T479H08K2O)
KAKADU PLUM (UNII: 0ZQ1D2FDLI)
CHLORELLA VULGARIS (UNII: RYQ4R60M02)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
OLIVE OIL DECYL ESTERS (UNII: 3AQ222F18X)
SACCHARIDE ISOMERATE (UNII: W8K377W98I)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
LACTIC ACID, DL- (UNII: 3B8D35Y7S4)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
WATER (UNII: 059QF0KO0R)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42508-205-19	1 in 1 CARTON	04/19/2018
1		3000 mg 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 not final	part352	04/19/2018

Labeler - Arbonne International, LLC (021541164)

Registrant - Autumn Harp, Inc. (064187883)

Establishment
Name	Address	ID/FEI	Business Operations
Autumn Harp, Inc.		064187883	manufacture(42508-205)