ANEW CLINICAL SKINVINCIBLE MULTI-SHIELD- avobenzone, homosalate, octinoxate, octocrylene, oxybenzone lotion

Anew Clinical by

Drug Labeling and Warnings

Anew Clinical by is a Otc medication manufactured, distributed, or labeled by New Avon LLC. 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
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
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, 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

Questions?
1-800-FOR-AVON

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ANEW CLINICAL  SKINVINCIBLE MULTI-SHIELD
avobenzone, homosalate, octinoxate, octocrylene, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10096-0304
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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10096-0304-2	1 in 1 CARTON	05/22/2013
1	NDC: 10096-0304-1	30 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
2	NDC: 10096-0304-4	1 in 1 CARTON	05/22/2013
2	NDC: 10096-0304-3	7 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 10096-0304-5	1.1 g in 1 PACKET; Type 0: Not a Combination Product	05/22/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	05/22/2013

Labeler - New Avon LLC (080143520)