Artistry Ideal Radiance Illuminating Cc Spf 50 Broad Spectrum Med/deep

Artistry Ideal Radiance Illuminating Cc Spf 50 Broad Spectrum Med/deep
SPL v4
SPL
SPL Set ID 20c432e2-4c63-485b-9dd5-2bc73b6f4285
Route
TOPICAL
Published
Effective Date 2017-09-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ensulizole (20 mg) Octinoxate (55 mg) Oxybenzone (5 mg) Titanium Dioxide (84 mg) Zinc Cation (98 mg)
Inactive Ingredients
Water Dimethicone Cyclomethicone 5 Methyl Trimethicone Butylene Glycol Glycerin Lauryl Peg-9 Polydimethylsiloxyethyl Dimethicone Talc Trimethylolpropane Tricaprylate/tricaprate Trolamine Hexamethylene Diisocyanate/trimethylol Hexyllactone Crosspolymer Phenoxyethanol Sodium Chloride Sodium Citrate Peg/ppg-18/18 Dimethicone Aluminum Oxide Trisiloxane Aluminum Hydroxide Stearic Acid Triethoxycaprylylsilane Methylparaben Edetate Disodium Anhydrous Silicon Dioxide Propylparaben Bellis Perennis Flower Maltodextrin Ethylparaben Iodopropynyl Butylcarbamate Jasminum Officinale Flower Geranium Robertianum Evening Primrose Oil Glycyrrhiza Glabra .alpha.-tocopherol Acetate Ceramide Np .beta.-sitosterol Tetrahexyldecyl Ascorbate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-09-23

Description

Ensulizole 2.0% (W/W P/P) Octinoxate 5.5% (W/W P/P) Oxybenzone 0.5% (WW P/P) Titanium Dioxide 0.84% (W/W P/P) Zinc Oxide 9.8% (W/W P/P)

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Ensulizole 2.0% (W/W P/P) Octinoxate 5.5% (W/W P/P) Oxybenzone 0.5% (WW P/P) Titanium Dioxide 0.84% (W/W P/P) Zinc Oxide 9.8% (W/W P/P)

Uses
  • Helps prevent sunburn
Warnings

For external use only

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
  • 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: Sun Protection Measures.
  • 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
Do Not Use

on broken or damaged skin

Other Information
  • Protect this product from excessive heat and direct sun
Package Labeling:

Active Ingredients

Ensulizole 2.0% (W/W P/P) Octinoxate 5.5% (W/W P/P) Oxybenzone 0.5% (WW P/P) Titanium Dioxide 0.84% (W/W P/P) Zinc Oxide 9.8% (W/W P/P)







Inactive Ingredients

WATER/EAU/AQUA, DIMETHICONE, CYCLOPENTASILOXANE, METHYL TRIMETHICONE, BUTYLENE GLYCOL, GLYCERIN, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, TALC, DIMETHICONE/ VINYL DIMETHICONE CROSSPOLYMER, TRIMETHYLOLPROPANE TRICAPRYLATE/TRICAPRATE, TRIETHANOLAMINE, HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, POLYGLYCERYL-6 POLYRICINOLEATE, DIMETHICONE/PEG-10/15 CROSSPOLYMER, PHENOXYETHANOL, SODIUM CHLORIDE, SODIUM CITRATE, PEG/PPG-18/18 DIMETHICONE, ALUMINA, POLYGLYCERYL-3, POLYDIMETHYLSILOXYETHYL DIMETHICONE, TRISILOXANE, HYDROGEN DIMETHICONE, ALUMINUM HYDROXIDE, STEARIC ACID, TRIETHOXYCAPRYLYLSILANE, METHYLPARABEN, DISODIUM EDTA, FRAGRANCE/PARFUM, SILICA, PROPYLPARABEN, BELLIS PERENNIS (DAISY) FLOWER EXTRACT, MALTODEXTRIN, ETHYLPARABEN,, IODOPROPYNYL BUTYLCARBAMATE, JASMINUM OFFICINALE (JASMINE) FLOWER EXTRACT, LECITHIN, SOPHORA JAPONICA FLOWER POWDER, GERANIUM ROBERTIANUM EXTRACT, OENOTHERA BIENNIS (EVENING PRIMROSE) SEED EXTRACT, LACTOBACILLUS/ACEROLA CHERRY FERMENT, GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT, HYDROLYZED CONCHIOLIN PROTEIN, TOCOPHERYL ACETATE, CERAMIDE-3, BETA-SITOSTEROL, TETRAHEXYLDECYL ASCORBATE, MAY CONTAIN/ PEUT CONTEINIR: IRON OXIDES (CI 77491, CI 77492, CI 77499), MICA (CI 77019), TITANIUM DIOXIDE (CI 77891).



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.


Structured Label Content

Uses
  • Helps prevent sunburn
Purpose

Sunscreen

Warnings

For external use only

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
  • 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: Sun Protection Measures.
  • 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
Do Not Use (Do not use)

on broken or damaged skin

Other Information
  • Protect this product from excessive heat and direct sun
Package Labeling:

Active Ingredients

Ensulizole 2.0% (W/W P/P) Octinoxate 5.5% (W/W P/P) Oxybenzone 0.5% (WW P/P) Titanium Dioxide 0.84% (W/W P/P) Zinc Oxide 9.8% (W/W P/P)







Inactive Ingredients (Inactive ingredients)

WATER/EAU/AQUA, DIMETHICONE, CYCLOPENTASILOXANE, METHYL TRIMETHICONE, BUTYLENE GLYCOL, GLYCERIN, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, TALC, DIMETHICONE/ VINYL DIMETHICONE CROSSPOLYMER, TRIMETHYLOLPROPANE TRICAPRYLATE/TRICAPRATE, TRIETHANOLAMINE, HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, POLYGLYCERYL-6 POLYRICINOLEATE, DIMETHICONE/PEG-10/15 CROSSPOLYMER, PHENOXYETHANOL, SODIUM CHLORIDE, SODIUM CITRATE, PEG/PPG-18/18 DIMETHICONE, ALUMINA, POLYGLYCERYL-3, POLYDIMETHYLSILOXYETHYL DIMETHICONE, TRISILOXANE, HYDROGEN DIMETHICONE, ALUMINUM HYDROXIDE, STEARIC ACID, TRIETHOXYCAPRYLYLSILANE, METHYLPARABEN, DISODIUM EDTA, FRAGRANCE/PARFUM, SILICA, PROPYLPARABEN, BELLIS PERENNIS (DAISY) FLOWER EXTRACT, MALTODEXTRIN, ETHYLPARABEN,, IODOPROPYNYL BUTYLCARBAMATE, JASMINUM OFFICINALE (JASMINE) FLOWER EXTRACT, LECITHIN, SOPHORA JAPONICA FLOWER POWDER, GERANIUM ROBERTIANUM EXTRACT, OENOTHERA BIENNIS (EVENING PRIMROSE) SEED EXTRACT, LACTOBACILLUS/ACEROLA CHERRY FERMENT, GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT, HYDROLYZED CONCHIOLIN PROTEIN, TOCOPHERYL ACETATE, CERAMIDE-3, BETA-SITOSTEROL, TETRAHEXYLDECYL ASCORBATE, MAY CONTAIN/ PEUT CONTEINIR: IRON OXIDES (CI 77491, CI 77492, CI 77499), MICA (CI 77019), TITANIUM DIOXIDE (CI 77891).



When Using This Product (When using this product)

keep out of eyes. Rinse with water to remove.

Keep Out of Reach of Children. (Keep out of reach of children.)

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


Advanced Ingredient Data


Raw Label Data

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