ESSENTIALS BY ARTISTRY MULTI-PROTECT SPF 30 BROAD SPECTRUM SUNSCREEN- ensulizole, octinoxate, zinc oxide lotion

essentials by ARTISTRY MULTI-PROTECT SPF 30 Broad Spectrum Sunscreen by

Drug Labeling and Warnings

essentials by ARTISTRY MULTI-PROTECT SPF 30 Broad Spectrum Sunscreen by is a Otc medication manufactured, distributed, or labeled by Access Business Group LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts 

Active ingredients

Ensulizole 3% (W/W P/P)
Octinoxate 7.49% (W/W P/P)
Zinc oxide 9.19% (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.

Stop use and ask a doctor

if rash occurs

Keep out of reach of children.

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

Directions

For sunscreen use

• Shake well, then apply liberally 15 minutes before sun exposure
• Use a water resistant susncreen if swimming or sweating or washing
• Reapply at least every 2 hours
• Childrens under 6 months: ask a doctor

Other information

• Protect this product from excessive heat and direct sun

Inactive ingredients

Cyclopentasiloxane, Water / Aqua /Eau, Pentylene Glycol, Propanediol, Cocos Nucifera (Coconut) Water, Peg-10 Dimethicone, Triethanolamine, Cetyl PEG/PPG-10/1 Dimethicone, Disteardimonium Hectorite, Aloe Barbadensis Leaf Juice, Hydroxyacetophenone, Silica, Sodium Citrate, Alcohol, Sodium Chloride, Triethoxycaprylylsilane, Glycerin, Alcohol Denat., Fragrance/ Parfum, PEG-60 Almond Glycerides, Allantoin, Hamamelis Virginiana (Witch Hazel) Bark/Twig Extract, Butylene Glycol, Disodium EDTA, TocopherylAcetate, Xanthan Gum, Dimethicone, Leuconostoc/Radish Root Ferment Filtrate, Malpighia Punicifolia (Acerola) Fruit Extract, Lecithin, PEG/PPG-18/18 Dimethicone, Maltodextrin, Trisiloxane, Zinc PCA, Hydrogen Dimethicone, BHT, Citrullus Lanatus (Watermelon) Fruit Extract, Phenoxyethanol, Potassium Sorbate, Sodium Benzoate, Theobroma Cacao (Cocoa) Seed Extract, Citrulline, Ceramide NP, Beta-Sitosterol, Chlorphenesin, Propylene Glycol, PentaerythritylTetra-Di-T-Butyl Hydroxyhydrocinnamate, Tocopherol.

Questions?

Canada: 1-800-265-5470
USA/DR: 1-800-253-6500

Package Labeling:

INGREDIENTS AND APPEARANCE

ESSENTIALS BY ARTISTRY MULTI-PROTECT SPF 30 BROAD SPECTRUM SUNSCREEN 
ensulizole, octinoxate, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10056-140
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42)	ENSULIZOLE	30 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	74.9 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	91.9 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
WATER (UNII: 059QF0KO0R)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
PROPANEDIOL (UNII: 5965N8W85T)
COCONUT WATER (UNII: 267F5Y81NT)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
TROLAMINE (UNII: 9O3K93S3TK)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
ALCOHOL (UNII: 3K9958V90M)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-60 ALMOND GLYCERIDES (UNII: 4Y0E651N0F)
ALLANTOIN (UNII: 344S277G0Z)
HAMAMELIS VIRGINIANA BARK (UNII: IH3063S9MY)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
XANTHAN GUM (UNII: TTV12P4NEE)
DIMETHICONE (UNII: 92RU3N3Y1O)
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)
MALPIGHIA GLABRA FRUIT (UNII: B94O42LA9M)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
TRISILOXANE (UNII: 9G1ZW13R0G)
ZINC PIDOLATE (UNII: C32PQ86DH4)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
WATERMELON (UNII: 231473QB6R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
COCOA (UNII: D9108TZ9KG)
CITRULLINE (UNII: 29VT07BGDA)
CERAMIDE NP (UNII: 4370DF050B)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
CHLORPHENESIN (UNII: I670DAL4SZ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10056-140-50	1 in 1 CARTON	05/15/2018
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 not final	part352	05/15/2018

Labeler - Access Business Group LLC (839830713)