Simple Protecting Light Moisturizer SPF 15

Dosage form: lotion
Ingredients: AVOBENZONE 3.0mL in 100mL, ENSULIZOLE 1.0mL in 100mL, OCTISALATE 5.0mL in 100mL
Labeler: CONOPCO Inc. d/b/a Unilever
NDC Code: 64942-1255

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.

Simple Protecting Light Moisturizer SPF 15

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

Purpose
Sunscreen

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 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 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

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Carton
SIMPLE  PROTECTING LIGHT MOISTURIZER SPF 15
avobenzone, ensulizole, octicsalate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64942-1255
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (AVOBENZONE) AVOBENZONE3.0 mL  in 100 mL
ENSULIZOLE (ENSULIZOLE) ENSULIZOLE1.0 mL  in 100 mL
OCTISALATE (OCTISALATE) OCTISALATE5.0 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
GLYCERIN 
STEARIC ACID 
GLYCOL STEARATE 
PEG-100 STEARATE 
DIMETHICONE 
METHYLISOTHIAZOLINONE 
POTASSIUM STEARATE 
GLYCERYL MONOSTEARATE 
CAPRYLYL GLYCOL 
CETYL ALCOHOL 
XANTHAN GUM 
STEARAMIDE AMP 
.ALPHA.-TOCOPHEROL ACETATE, D- 
PHENOXYETHANOL 
EDETATE DISODIUM 
PANTHENOL 
ALLANTOIN 
LEVOMENOL 
Packaging
#Item CodePackage Description
1NDC:64942-1255-21 BOTTLE, PLASTIC (BOTTLE) in 1 CARTON
1NDC:64942-1255-1124 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35208/01/2012
Labeler - CONOPCO Inc. d/b/a Unilever (001375088)

Revised: 07/2012
 
CONOPCO Inc. d/b/a Unilever

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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