AVON ELEMENTS SKIN REVITALIZE INSTANT RADIANCE- octinoxate, oxybenzone, homosalate, avobenzone lotion

Avon Elements by

Drug Labeling and Warnings

Avon Elements by is a Otc medication manufactured, distributed, or labeled by New Avon LLC, Avon Products, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients
Octinoxate 7.5%.................................
Oxybenzone 3.5%..............................
Homosalate 3.0%...............................
Avobenzone 2.5%...............................

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

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

INDICATIONS & USAGE

Uses

• helps prevent sunburn

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

• apply generously and evenly 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, propanediol, glycerin, DI-C12-15 alkyl fumarate, dilauryl thiodipropionate, PEG-8, steareth-2, silica, ethylhexyl isononanoate, steareth-21, aronia melanocarpa fruit juice, zizyphus jujuba fruit extract, petasites hybridus leaf extract, saccharomyces/platinum ferment, stearyl alcohol, acrylates/C10-30 alkyl acrylate crosspolymer, silica dimethyl silylate, polyester-1, PEG-200, polyurethane-40, carbomer, tromethamine, disodium EDTA, 1,2-hexanediol, caprylyl glycol, parfum/fragrance, iron oxides, mica/CI 77019, titanium dioxide/CI 77891.

QUESTIONS

Questions or comments?
Call toll free 1-800-FOR-AVON

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

AVON ELEMENTS  SKIN REVITALIZE INSTANT RADIANCE
octinoxate, oxybenzone, homosalate, avobenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10096-0302
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	35 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	30 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	25 mg  in 1 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10096-0302-2	1 in 1 CARTON
1	NDC: 10096-0302-1	50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 10096-0302-3	1.1 mL in 1 PACKET; 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	04/01/2013

Labeler - New Avon LLC (080143520)

Establishment
Name	Address	ID/FEI	Business Operations
Avon Products, Inc		005149471	manufacture(10096-0302)