ANEW MEN DAILY MOISTURIZER- avobenzone, homosalate, octinoxate, octocrylene, oxybenzone lotion

Anew Men by

Drug Labeling and Warnings

Anew Men 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
Avobenzone 2.8%...........................
Homosalate 9.5%...........................
Octinoxate 7.5%............................
Octocrylene 2.56%.......................
Oxybenzone 4.75%........................

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

​For sunscreen use:
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 INGREDIENT

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

QUESTIONS

Questions?
1-800-FOR-AVON or 1-800-265-AVON in Canada

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ANEW MEN  DAILY MOISTURIZER
avobenzone, homosalate, octinoxate, octocrylene, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10096-0326
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	28 mg  in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	95 mg  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	25.6 mg  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	47.5 mg  in 1 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10096-0326-2	1 in 1 CARTON
1	NDC: 10096-0326-1	30 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
2	NDC: 10096-0326-4	1 in 1 CARTON
2	NDC: 10096-0326-3	7 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 10096-0326-5	1.1 g 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	04/20/2015

Labeler - New Avon LLC (080143520)

Establishment
Name	Address	ID/FEI	Business Operations
Avon Products, Inc		005149471	manufacture(10096-0326)