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

Simple by

Drug Labeling and Warnings

Simple by is a Otc medication manufactured, distributed, or labeled by CONOPCO Inc. d/b/a Unilever, Unilever Manufacturing (US), Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients
Avobenzone (2.0%)
Ensulizole (1.5%)
Octisalate (5.0%)

Octocrylene (1.3%)

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 to face and neck 15 minutes before sun exposure.

· Children under 6 months: Ask a doctor.

·​ Reapply at least every two hours.

· Use 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 10a.m. - 2p.m.

· Wear long-sleeved shirts, pants, hats, and sunglasses.

INACTIVE INGREDIENT

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

QUESTIONS

Questions or comments?
1-866-752-4602

PDP 4.2 fl. oz.

4.2 fl. oz. carton

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64942-1355
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2 g  in 100 mL
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42)	ENSULIZOLE	1.5 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1.3 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)
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)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64942-1355-2	1 in 1 CARTON	01/22/2016
1	NDC: 64942-1355-1	124 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/22/2016

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