Artistry Essentials Hand Treatment

Artistry Essentials Hand Treatment by

Drug Labeling and Warnings

Artistry Essentials Hand Treatment by is a Otc medication manufactured, distributed, or labeled by Access Business Group LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

ARTISTRY ESSENTIALS HAND TREATMENT 
avobenzone, octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10056-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10056-005-01	1 in 1 BOX	09/01/2009	02/22/2017
1		75 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	09/01/2009	02/22/2017

Labeler - Access Business Group LLC (839830713)

Revised: 11/2019

Document Id: 97684b73-4be5-cfcf-e053-2995a90a790b

34390-5

Set id: ce55ba28-e77a-4660-b239-1319eaab876a

Version: 4

Effective Time: 20191115

 

Access Business Group LLC