Label: ARTISTRY IDEAL RADIANCE ILLUMINATING CC SPF50 BROAD SPECTRUM SUNSCREEN - LIGHT- ensulizole,octinoxate, oxybenzone, titanium dioxide, zinc oxide cream
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- NDC Code(s): 10056-030-30
- Packager: Access Business Group LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated October 26, 2021
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- Drug Facts
- Active Ingredients
- Uses
- Warnings
- Other Information
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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).
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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 - Package Labeling:
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INGREDIENTS AND APPEARANCE
ARTISTRY IDEAL RADIANCE ILLUMINATING CC SPF50 BROAD SPECTRUM SUNSCREEN - LIGHT
ensulizole,octinoxate, oxybenzone, titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10056-030 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 55 mg in 1 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 5 mg in 1 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 8.8 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 98 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) METHYL TRIMETHICONE (UNII: S73ZQI0GXM) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) GLYCERIN (UNII: PDC6A3C0OX) LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA) TALC (UNII: 7SEV7J4R1U) TRIMETHYLOLPROPANE TRICAPRYLATE/TRICAPRATE (UNII: N1TRQ06KVJ) TROLAMINE (UNII: 9O3K93S3TK) HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM CITRATE (UNII: 1Q73Q2JULR) PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) ALUMINUM OXIDE (UNII: LMI26O6933) TRISILOXANE (UNII: 9G1ZW13R0G) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) STEARIC ACID (UNII: 4ELV7Z65AP) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) METHYLPARABEN (UNII: A2I8C7HI9T) EDETATE DISODIUM (UNII: 7FLD91C86K) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) PROPYLPARABEN (UNII: Z8IX2SC1OH) BELLIS PERENNIS FLOWER (UNII: 26I94X9A1K) MALTODEXTRIN (UNII: 7CVR7L4A2D) ETHYLPARABEN (UNII: 14255EXE39) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) JASMINUM OFFICINALE FLOWER (UNII: 0Q8K841432) GERANIUM ROBERTIANUM (UNII: R5I1HK0UBL) EVENING PRIMROSE OIL (UNII: 3Q9L08K71N) GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) .BETA.-SITOSTEROL (UNII: S347WMO6M4) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10056-030-30 1 in 1 CARTON 12/11/2015 1 30 mL in 1 BOTTLE, PLASTIC; 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 12/11/2015 Labeler - Access Business Group LLC (839830713) Establishment Name Address ID/FEI Business Operations Access Business Group LLC 839830713 manufacture(10056-030)
