ARTISTRY ESSENTIALS HAND TREATMENT- avobenzone, octinoxate cream 
Access Business Group LLC

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.

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Artistry Essentials Hand Treatment

Drug Facts

Active Ingredients

AVOBENZONE 3.0% (W/W P/P)
OCTINOXATE 7.5% (W/W P/P)

Purpose

Sunscreen

Uses

  • Helps prevent sunburn
  • If used as directed with other sun protection measures (see Directions), may decrease the risk of skin cancer and early skin aging caused by the sun

Warnings

For external use only.

Do not use on

broken or damaged skin.

When using this product

eep 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 use as a sunscreen:

  • 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

Other information

  • Protect this product from excessive heat and direct sun

Inactive ingredients

WATER/EAU, GLYCERYL STEARATE, GLYCERIN, CAPRYLIC/CAPRIC TRIGLYCERIDE, MYRISTYL MYRISTATE, C12-15 ALKYL BENZOATE, DIPROPYLENE GLYCOL DIBENZOATE, DIMETHICONE, STEARAMI DOPROPYL DIMETHYLAMINE, BEHENYL ALCOHOL, PHENOXYETHANOL, CETEARYL ALCOHOL, CETYL ALCOHOL, POLYSORBATE 60, PEG-20 SORBITAN ISOSTEARATE, HYDROXYETHYLCELLULOSE, PPG-15 STEARYL ETHER BENZOATE, PHOSPHORIC ACID, METHYLPARABEN, PANTHENOL, TOCOPHERYL ACETATE, FRAGRANCE/PARFUM, TETRAHEXYLDECYL ASCORBATE, HYDROLYZED PEARL, IODOPROPYNYL BUTYLCARBAMATE, LACTIC ACID, SACCHARUM OFFICINARUM (SUGAR CANE) EXTRACT, MORUS BOMBYCIS
ROOT EXTRACT, EDTA, SODIUM SULFITE, SODIUM METABISULFITE, AMINOBUTYRIC ACID, GLUCOSAMINE HCL, GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT, SANGUISORBA OFFICINALIS ROOT EXTRACT, SCUTELLARIA BAICALENSIS ROOT EXTRACT, POLYSORBATE 20, BUTYLENE GLYCOL, HYDROLYZED SOY PROTEIN, ALOE BARBADENSIS LEAF EXTRACT, ETHYLPARABEN, PROPYLPARABEN.

Package Labeling:

Label2Tube

ARTISTRY ESSENTIALS HAND TREATMENT 
avobenzone, octinoxate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10056-005
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
GLYCERIN (UNII: PDC6A3C0OX)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
MYRISTYL MYRISTATE (UNII: 4042ZC00DY)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
DIPROPYLENE GLYCOL DIBENZOATE (UNII: 6OA5ZDY41O)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
STEARAMIDOPROPYL DIMETHYLAMINE (UNII: K7VEI00UFR)  
DOCOSANOL (UNII: 9G1OE216XY)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
PEG-20 SORBITAN ISOSTEARATE (UNII: X958PZJ9ON)  
PPG-15 STEARYL ETHER BENZOATE (UNII: 80D2J6361M)  
PHOSPHORIC ACID (UNII: E4GA8884NN)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PANTHENOL (UNII: WV9CM0O67Z)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
LACTIC ACID (UNII: 33X04XA5AT)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
CALCIUM CARBONATE (UNII: H0G9379FGK)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
SUGARCANE (UNII: 81H2R5AOH3)  
MORUS AUSTRALIS ROOT (UNII: 1VL55O45RF)  
EDETIC ACID (UNII: 9G34HU7RV0)  
SODIUM SULFITE (UNII: VTK01UQK3G)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
.GAMMA.-AMINOBUTYRIC ACID (UNII: 2ACZ6IPC6I)  
GLUCOSAMINE HYDROCHLORIDE (UNII: 750W5330FY)  
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
SANGUISORBA OFFICINALIS ROOT (UNII: 4NYV2HT01X)  
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ETHYLPARABEN (UNII: 14255EXE39)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10056-005-011 in 1 BOX09/01/200902/22/2017
175 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35209/01/200902/22/2017
Labeler - Access Business Group LLC (839830713)

Revised: 11/2019
 
Access Business Group LLC