SIMPLE PROTECTING LIGHT MOISTURIZER SPF 15- avobenzone, ensulizole, octicsalate lotion

Simple by

Drug Labeling and Warnings

Simple by is a Otc medication manufactured, distributed, or labeled by CONOPCO Inc. d/b/a Unilever, Klocke of America, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients
AVOBENZONE (3.0%)
ENSULIZOLE (1.0%)
OCTISALATE (5.0%)

PURPOSE

Purpose
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 and evenly to face and neck 15 minutes before sun exposure.
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 10a.m. - 2p.m.
· wear long-sleeved shirts, pants, hats, and sunglasses.
· re-apply at least every 2 hours.
· use a water resistant sunscreen if swimming or sweating.
· Children under 6 months of age: Ask a doctor.

INACTIVE INGREDIENT

Inactive ingredients
Water
Glycerin
Stearic Acid
Glycol Stearate
PEG-100 Stearate
Dimethicone
Tocopheryl Acetate
Panthenol
Allantoin
Bisabolol
Glyceryl Stearate
Potassium Stearate
Carbomer
Caprylyl Glycol
Cetyl Alcohol
Xanthan Gum
Stearamide AMP
Phenoxyethanol
Disodium EDTA
Methylisothiazolinone

QUESTIONS

Questions or comments?
Call toll free 1-866-752-4602

PRINCIPAL DISPLAY PANEL

PDP

PRINCIPAL DISPLAY PANEL

Carton

INGREDIENTS AND APPEARANCE

SIMPLE  PROTECTING LIGHT MOISTURIZER SPF 15
avobenzone, ensulizole, octicsalate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64942-1290
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3.0 g  in 100 mL
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42)	ENSULIZOLE	1.0 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5.0 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
STEARIC ACID (UNII: 4ELV7Z65AP)
GLYCOL STEARATE (UNII: 0324G66D0E)
PEG-100 STEARATE (UNII: YD01N1999R)
DIMETHICONE (UNII: 92RU3N3Y1O)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
POTASSIUM STEARATE (UNII: 17V812XK50)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CETYL ALCOHOL (UNII: 936JST6JCN)
XANTHAN GUM (UNII: TTV12P4NEE)
STEARAMIDE AMP (UNII: U3K8640346)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PANTHENOL (UNII: WV9CM0O67Z)
ALLANTOIN (UNII: 344S277G0Z)
LEVOMENOL (UNII: 24WE03BX2T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64942-1290-2	1 in 1 CARTON
1	NDC: 64942-1290-1	124 mL in 1 BOTTLE, PLASTIC
2	NDC: 64942-1290-4	1 in 1 PACKAGE
2	NDC: 64942-1290-3	7.4 mL in 1 PACKET

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	07/01/2013

Labeler - CONOPCO Inc. d/b/a Unilever (001375088)

Establishment
Name	Address	ID/FEI	Business Operations
Klocke of America, Inc.		013950402	pack(64942-1290)