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SPF-15 Sunscreen by Continental Manufacturing Chemist, Inc.

Dosage form: lotion
Ingredients: OCTOCRYLENE 100.000g in 1.0L, AVOBENZONE 30.000g in 1.0L
Labeler: Continental Manufacturing Chemist, Inc.
NDC Code: 49794-048

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.

Broad-Spectrum SPF-15 Lotion

Active ingredients

 Octocrylene 10%

Avobenzone 3%

Uses

 Helps Prevent Sunburn

Purpose

 Helps prevent sunburn

Warnings

FOR EXTERNAL USE ONLY

Do not use

 in eyes, if this happens rinse thoroughly with water.

Stop use and ask a doctor if

 if skin irritation develops

Keep out of reach of children

 If swallowed, get medical help or contact a Poison Control Center

Ask a doctor

 before using on children under 6 months

Directions

 Apply liberally 15 minutes before sun exposure

Use a water resistant sunscreen if swimming or sweating

Reaaply at least every 2 hours

Storage

 Store at 20-25C (68-77F)

Inactive ingredients

 Aloe Barbadensis (Aloe Vera) Gel, Benzyl Alcohol, Carbopol, Cetyl Alcohol, Fragrance, (Glyceryl Stearate and PEG 100 Stearate), Methyl Paraben, PEG-40 Stearate, Phenoxyethanol, (Polyacrylamide and C13-14 Isoparrafin and Laureth-7), Propyl Paraben, Purified Water, Shea Butter, Sodium Hydroxide, Sorbitan Monooleate, Stearic Acid, Tetrasodium Ethylenediaminetatraacetate, Vitamin E

Principal Display Panel

 Product

SPF-15 Labels

 Labels

Manufactured By

 Continental Manufacturing Chemist, Inc.

912 S. State Street, Madrid, IA  50156

SPF-15 SUNSCREEN 
octocrylene, avobenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49794-048
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE100.000 g  in 1.0 L
AVOBENZONE (AVOBENZONE) AVOBENZONE30.000 g  in 1.0 L
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
BENZYL ALCOHOL 
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) 
CETYL ALCOHOL 
GLYCERYL MONOSTEARATE 
PEG-100 STEARATE 
METHYLPARABEN 
PEG-40 STEARATE 
PHENOXYETHANOL 
SODIUM ACRYLOYLDIMETHYLTAURATE-ACRYLAMIDE COPOLYMER (1:1; 90000-150000 MPA.S) 
PROPYLPARABEN 
WATER 
SHEA BUTTER 
SODIUM HYDROXIDE 
SORBITAN MONOOLEATE 
STEARIC ACID 
EDETATE SODIUM 
.ALPHA.-TOCOPHEROL 
Packaging
#Item CodePackage Description
1NDC:49794-048-991100 L in 1 CONTAINER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35205/16/2012
Labeler - Continental Manufacturing Chemist, Inc. (005278007)

Revised: 07/2012
 
Continental Manufacturing Chemist, Inc.

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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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