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Anew Clinical

Avon Products, Inc.




FULL PRESCRIBING INFORMATION

Active ingredient

Active ingredients
Avobenzone 2.8%...........................
Homosalate 9.5%...........................
Octinoxate 7.5%............................
Octocrylene 2.56%.......................
Oxybenzone 4.75%........................

Purpose

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

Uses

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
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.

Directions
• apply liberally 15 minutes before sun exposure
• children under 6 months 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

Inactive ingredients
water/eau, propanediol, butyloctyl salicylate, dimethicone, dilauryl thiodipropionate, polymethylsilsesquioxane, silica, glycerin, cinnamido benzylpiperidinyl ethoxypropylbenzamide, retinol/saccharomyces polypeptide, phyllanthus emblica fruit extract, cocos nucifera (coconut) seed butter, hydrolyzed wheat starch, hydrolyzed wheat protein, oryzanol, phytol, camellia sinensis leaf extract, phaeodactylum tricornutum extract, tocopherol, ceteareth-20, PEG-8, polysilicone-11, stearoxytrimethylsilane, cetearyl alcohol, ceteth-2, hydrogenated lecithin, stearyl alcohol, caprylyl glycol, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, caprylic/capric triglyceride, isohexadecane, carbomer, polysorbate 60, laureth-12, tromethamine, disodium EDTA, phenoxyethanol, parfum/fragrance.

Questions?
1-800-FOR-AVON

Anew Clinical Anew Clinical

Anew Clinical

Avobenzone, Homosalate, Octinoxate, Octocrylene, Oxybenzone LOTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:10096-0304
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
AVOBENZONE AVOBENZONE 28 mg
HOMOSALATE Homosalate 95 mg
OCTINOXATE OCTINOXATE 75 mg
OCTOCRYLENE Octocrylene 25.6 mg
OXYBENZONE OXYBENZONE 47.5 mg

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:10096-0304-1 30 in 1 BOTTLE, PUMP
2 NDC:10096-0304-3 7 in 1 TUBE
3 NDC:10096-0304-5 1.1 in 1 PACKET

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2013-05-22


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