ARTISTRY BEAUTY BALM PERFECTING PRIMER SPF 35 BROAD SPECTRUM SUNSCREEN- ensulizole, octinoxate, zinc oxide cream

Artistry Beauty Balm Perfecting Primer SPF 35 Broad Spectrum Sunscreen by

Drug Labeling and Warnings

Artistry Beauty Balm Perfecting Primer SPF 35 Broad Spectrum Sunscreen by is a Otc medication manufactured, distributed, or labeled by Amway Corp, Access Business Group LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Ensulizole 2.0% (W/W P/P)
Octinoxate 5.0% (W/W P/P)
Zinc Oxide 5.49% (W/W P/P)......

Purpose

Sunscreen

Uses

■ Helps prevent sunburn

Warnings

For external use only

Do not use

on broken or damaged skin

When using this product

keep out of eyes. Rinse with water to remove.

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

Other Information

Protect this product from excessive heat and direct sun

Inactive ingredients

WATER/EAU, DIMETHICONE, CYCLOPENTASILOXANE, BUTYLENE GLYCOL, GLYCERIN, TALC, METHYL TRIMETHICONE, TRIMETHYLOLPROPANE TRICAPRYLATE/ TRICAPRATE, LAURYL PEG-9, POLYDIMETHYLSILOXYETHYL DIMETHICONE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, DIMETHICONE/PEG-10/15 CROSSPOLYMER, TRIETHANOLAMINE, POLYGLYCERYL-6 POLYRICINOLEATE, POLYSILICONE-11, LECITHIN, PHENOXYETHANOL, SODIUM CHLORIDE, SODIUM CITRATE, POLYMETHYL
METHACRYLATE, ALUMINA, POLYSORBATE-20, PEG/ PPG-18/18 DIMETHICONE, TRISILOXANE, HYDROGEN DIMETHICONE, METHYLPARABEN, DISODIUM EDTA, SILICA, PROPYLPARABEN, TRIETHOXYCAPRYLYLSILANE, ETHYLPARABEN, LAURETH-12, METHYLDIHYDROJASMONATE,
IODOPROPYNYL BUTYLCARBAMATE, PEARL POWDER,ETHYLENE BRASSYLATE, ETHYL 2,2-DIMETHYLHYDROCINNAMAL, YEAST EXTRACT, CERAMIDE 3, BETA-SITOSTEROL, SODIUM HYALURONATE, GLUCOSAMINE HCL, UREA, ALGAE EXTRACT, TOCOPHEROL. MAY CONTAIN/PEUT CONTEINIR: IRON OXIDES (CI 77491, 77492, 77499), MICA (CI 77019), TITANIUM DIOXIDE (CI 77891).

Directions

For suncreen use

• Apply liberally 15 minutes before sun exposure
• Use a water resistant sunscreen if swimming or sweating or
  washing
• Reapply at least every 2 hours
• 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 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-sleeve shirts, pants, hats, and sunglasses
• Children under 6 months: ask a doctor

Package Labeling

INGREDIENTS AND APPEARANCE

ARTISTRY BEAUTY BALM PERFECTING PRIMER SPF 35 BROAD SPECTRUM SUNSCREEN 
ensulizole, octinoxate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50390-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42)	ENSULIZOLE	20 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	50 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	54.9 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
TALC (UNII: 7SEV7J4R1U)
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)
TRIMETHYLOLPROPANE TRICAPRYLATE/TRICAPRATE (UNII: N1TRQ06KVJ)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
DIMETHICONE/DIENE DIMETHICONE CROSSPOLYMER (UNII: RSA9I561OK)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
TROLAMINE (UNII: 9O3K93S3TK)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
ALUMINUM OXIDE (UNII: LMI26O6933)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
TRISILOXANE (UNII: 9G1ZW13R0G)
METHYLPARABEN (UNII: A2I8C7HI9T)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
LAURETH-12 (UNII: OAH19558U1)
METHYL DIHYDROJASMONATE (SYNTHETIC) (UNII: 3GW44CIE3Y)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
PEARL (HYRIOPSIS CUMINGII) (UNII: A75L5FZ40U)
ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)
ETHYL 2,2-DIMETHYLHYDROCINNAMAL (UNII: 5V2FN5AA3W)
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)
CERAMIDE 3 (UNII: 4370DF050B)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
GLUCOSAMINE HYDROCHLORIDE (UNII: 750W5330FY)
UREA (UNII: 8W8T17847W)
TOCOPHEROL (UNII: R0ZB2556P8)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MICA (UNII: V8A1AW0880)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50390-004-30	30 mL in 1 TUBE; Type 0: Not a Combination Product	05/05/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	05/05/2015

Labeler - Amway Corp (083416854)

Establishment
Name	Address	ID/FEI	Business Operations
Access Business Group LLC		839830713	manufacture(50390-004)