ANEW SKINVINCIBLE DAY- avobenzone, homosalate, octinoxate, octocrylene, oxybenzone lotion

Anew Skinvincible by

Drug Labeling and Warnings

Anew Skinvincible 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

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ANEW SKINVINCIBLE  DAY
avobenzone, homosalate, octinoxate, octocrylene, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71110-0011
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)
DIMETHICONE (UNII: 92RU3N3Y1O)
DILAURYL THIODIPROPIONATE (UNII: V51YH1B080)
STEAROXYTRIMETHYLSILANE (UNII: 9862TW94B2)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CINNAMIDO BENZYLPIPERIDINYL ETHOXYPROPYLBENZAMIDE (UNII: B90L76CSCY)
CETETH-2 (UNII: 7H8VAM7778)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ISOHEXADECANE (UNII: 918X1OUF1E)
LAURETH-12 (UNII: OAH19558U1)
GLYCERIN (UNII: PDC6A3C0OX)
TOCOPHEROL (UNII: R0ZB2556P8)
PHYTOL (UNII: 5BC2RZ81NG)
POLYSORBATE 60 (UNII: CAL22UVI4M)
TROMETHAMINE (UNII: 023C2WHX2V)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71110-0011-1	1.1 g in 1 PACKET; Type 0: Not a Combination Product	03/01/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	03/01/2016

Labeler - Avon Products, Inc. (001468693)

Establishment
Name	Address	ID/FEI	Business Operations
Avon Manufacturing (Guangzhou) Ltd		544863277	manufacture(71110-0011)