ANEW VITALE DAY- homosalate, octinoxate, oxybenzone, avobenzone lotion

Anew Vitale by

Drug Labeling and Warnings

Anew Vitale by is a Otc medication manufactured, distributed, or labeled by Avon Products, Inc., Avon Manufacturing (Guangzhou) Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients

Homosalate 8%............................

Octinoxate 5%..............................

Oxybenzone 4%.........................

Avobenzone 2.85%...........................

Purpose
............... Sunscreen
............... Sunscreen
.............. Sunscreen

.............. Sunscreen

INDICATIONS & USAGE

Uses

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

WARNINGS

Warnings

For external use only

Do not use on damaged or broken 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 swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

​For sunscreen use:

• apply liberally 15 minutes before sun exposure
• children under 6 month of age:ask a doctor
• reapply at least every 2 hours
• use a water resistant sunscreen if swimming or sweating
• 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 value 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-sleeved shirts, pants, hats, and sunglasses

STORAGE AND HANDLING

Other Information

• protect the product in this container from excessive heat and direct sun

INACTIVE INGREDIENT

Inactive ingredients:

water/eau, butylene glycol, dimethicone, PEG-8, trisiloxane, glycerin, ethylhexyl isononanoate, HDI/trimethylol hexyllactone crosspolymer, cetyl alcohol, caprylyl glycol, behenyl alcohol, dilauryl thiodipropionate, thiodipropionic acid, carbomer, glyceryl stearate, parfum/fragrance, sodium hydroxide, phenoxyethanol, trimethylsiloxysilicate, hydrogenated lecithin, acrylates/C10-30 alkyl acrylate crosspolymer, disodium EDTA, polyglyceryl-3 diisostearate, choleth-24, hexylene glycol, ceteth-24, panthenol, silica, mesyloxybenzyl methoxyethyl chlorobenzamide, pichia ferment lysate filtrate, saccharomyces ferment lysate filtrate, palmitoyl tetrapeptide-10.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ANEW VITALE  DAY
homosalate, octinoxate, oxybenzone, avobenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71110-0017
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	80 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	50 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	40 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	28.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
PANTHENOL (UNII: WV9CM0O67Z)
MESYLOXYBENZYL METHOXYETHYL CHLOROBENZAMIDE (UNII: 3HB4C300XB)
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
TRISILOXANE (UNII: 9G1ZW13R0G)
CETYL ALCOHOL (UNII: 936JST6JCN)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DILAURYL THIODIPROPIONATE (UNII: V51YH1B080)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
THIODIPROPIONIC ACID (UNII: 3BBK323ED8)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
GLYCERIN (UNII: PDC6A3C0OX)
ETHYLHEXYL ISONONANOATE (UNII: I6KB4GE3K4)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CHOLETH-24 (UNII: 5UE7I54O43)
CETETH-24 (UNII: 0EV3Z43Y2I)
DIMETHICONE (UNII: 92RU3N3Y1O)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71110-0017-1	1.1 mL in 1 PACKET; Type 0: Not a Combination Product	12/19/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	12/19/2014

Labeler - Avon Products, Inc. (001468693)

Establishment
Name	Address	ID/FEI	Business Operations
Avon Manufacturing (Guangzhou) Ltd		544863277	manufacture(71110-0017)