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

United States - English - NLM (National Library of Medicine)

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Active ingredient:
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S), OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51), OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y), AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)
Available from:
New Avon LLC
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
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
Authorization status:
OTC monograph not final
Authorization number:
10096-0311-1, 10096-0311-2, 10096-0311-3, 10096-0311-4, 10096-0311-5

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

avobenzone lotion

New Avon LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Anew Reversalist Complete Renewal Day Lotion Broad Spectrum SPF 25

Active ingredient

Homosalate 8.0%..............

Octinoxate 5.0%...............

Oxybenzone 4.0%...........

Avobenzone 2.85%..........

Purpose

.................................Sunsc re e n

.................................Sunsc re e n

.................................Sunsc re e n

.................................Sunsc re e n

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

Other information

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

Inactive Ingredients:

water/eau, butylene glycol, glycerin, dimethicone, PEG-8, trisiloxane, ethylhexyl isononanoate,

HDI/trimethylol hexyllactone crosspolymer, cetyl alcohol, caprylyl glycol, behenyl alcohol, dilauryl

thiodipropionate, thiodipropionic acid, carbomer, glyceryl stearate, parfum/fragrance, sodium

hydroxide, phenoxyethanol, trimethylsiloxysilicate, hydrogenated lecithin, acrylates/C10-30 alkyl

acrylate crosspolymer, disodium EDTA, polyglyceryl-3 diisostearate, choleth-24, hexylene glycol,

ceteth-24, silica, amorphophallus campanulatus rhizome/root extract, punica granatum fruit juice,

sesbania grandiflora flower extract, portulaca oleracea extract, palmitoyl lysyl aminovaleroyl lysine.

Questions?

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

New Avon LLC

ANEW REVERSALIST COMPLETE RENEWAL DAY

homosalate, octinoxate, oxybenzone, avobenzone lotion

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:10 0 9 6 -0 311

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

HO MO SALATE (UNII: V0 6 SV4M9 5S) (HOMOSALATE - UNII:V0 6 SV4M9 5S)

HOMOSALATE

8 0 mg in 1 mL

O CTINO XATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)

OCTINOXATE

50 mg in 1 mL

O XYBENZO NE (UNII: 9 5OOS7VE0 Y) (OXYBENZONE - UNII:9 5OOS7VE0 Y)

OXYBENZONE

40 mg in 1 mL

AVO BENZO NE (UNII: G6 3QQF2NOX) (AVOBENZONE - UNII:G6 3QQF2NOX)

AVOBENZONE

28 .5 mg in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:10 0 9 6 -0 311-

1 in 1 CARTON

12/12/20 13

1

NDC:10 0 9 6 -0 311-

50 mL in 1 BOTTLE, PUMP; Type 0 : No t a Co mbinatio n

Pro duc t

2

NDC:10 0 9 6 -0 311-

1 in 1 CARTON

12/12/20 13

2

NDC:10 0 9 6 -0 311-

15 mL in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

3

NDC:10 0 9 6 -0 311-

1.1 mL in 1 PACKET; Type 0 : No t a Co mbinatio n Pro duct

12/12/20 13

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt352

12/12/20 13

Labeler -

New Avon LLC (080143520)

Revised: 1/2019

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