ANEW REVERSALIST COMPLETE RENEWAL DAY- homosalate, octinoxate, oxybenzone, avobenzone cream

Anew Reversalist by

Drug Labeling and Warnings

Anew Reversalist 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 ingredient
Homosalate 7.0%...............
Octinoxate 7.0%.................
Oxybenzone 4.0%...........
Avobenzone 2.85%..........

Purpose
.................................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

STORAGE AND HANDLING

Other information

protect the product in this container from excessive heat and direct sun

INACTIVE INGREDIENT

Inactive Ingredients:
water/eau, glycerin, dimethicone, butylene glycol, isodecyl isononanoate, tromethamine, dilauryl thiodipropionate, phytol, ethylhexylglycerin, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, cetearyl alcohol, nylon-12, polymethylsilsesquioxane, isohexadecane, phenoxyethanol, polymethyl methacrylate, thiodipropionic acid, parfum/fragrance, carbomer, xanthan gum, ceteareth-20, sodium PCA, acrylates/C10-30 alkyl acrylate crosspolymer, disodium EDTA, hydrogenated lecithin, kaempferia galanga root extract, silica, polysorbate 60, trimethylsiloxysilicate, dimethicone crosspolymer, thiazolylalanine, amorphophallus campanulatus rhizome/root extract, punica granatum fruit juice, sesbania grandiflora flower extract, portulaca oleracea extract, tocopherol, palmitoyl lysyl aminovaleroyl lysine.

QUESTIONS

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ANEW REVERSALIST  COMPLETE RENEWAL DAY
homosalate, octinoxate, oxybenzone, avobenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10096-0312
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	70 mg  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	70 mg  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	40 mg  in 1 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	28.5 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: 10096-0312-2	1 in 1 CARTON	12/12/2013
1	NDC: 10096-0312-1	50 g in 1 JAR; Type 0: Not a Combination Product
2	NDC: 10096-0312-4	1 in 1 CARTON	12/12/2013
2	NDC: 10096-0312-3	15 g in 1 JAR; Type 0: Not a Combination Product
3	NDC: 10096-0312-5	1.1 g in 1 PACKET; Type 0: Not a Combination Product	12/12/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	12/12/2013

Labeler - New Avon LLC (080143520)