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Simple

Conopco Inc. d/b/a Unilever

Simple Light Moisturizer SPF 15


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient

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

Octocrylene (1.3%)

Purpose

Purpose
Sunscreen

Uses

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 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 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 or comments?
1-866-752-4602

PDP 4.2 fl. oz.

Simple

4.2 fl. oz. carton

Simple

Simple

AVOBENZONE, ENSULIZOLE, OCTICSALATE, OCTOCRYLENE LOTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:64942-1355
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
AVOBENZONE AVOBENZONE 2.0 g
Ensulizole Ensulizole 1.5 g
OCTISALATE OCTISALATE 5.0 g
OCTOCRYLENE Octocrylene 1.3 g

Inactive Ingredients

Ingredient Name Strength
water
GLYCERIN
STEARIC ACID
GLYCOL STEARATE
PEG-100 STEARATE
DIMETHICONE
potassium stearate
GLYCERYL MONOSTEARATE
CAPRYLYL GLYCOL
CETYL ALCOHOL
XANTHAN GUM
STEARAMIDE AMP
.ALPHA.-TOCOPHEROL ACETATE, D-
PHENOXYETHANOL
EDETATE DISODIUM
PANTHENOL
ALLANTOIN
LEVOMENOL
BUTYLATED HYDROXYTOLUENE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:64942-1355-1 124 in 1 BOTTLE, PLASTIC
2 NDC:64942-1355-2 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2014-04-01


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