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Name:Advanced Protection Spf-15
Manufacturer:Cbi Laboratories, Inc
Category:Over-the-counter (OTC) Marketed Drugs


Moisture Defense SPF 15

ADVANCED PROTECTION  SPF-15 - octinoxate and zinc oxide cream 
CBI Laboratories, Inc

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.

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Moisture Defense
SPF 15

Drug Facts

Active ingredients Purpose
Octinoxate 7.5% sunscreen
Zinc Oxide 5% sunscreen

Uses

  • provides moderate sun protection

Warnings

  • for external use only
  • for adult use only

When using this product

  • keep out of eyes. If contact occurs rinse with water to remove.

  • Stop use if irritation occurs.

  • Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

Directions

  • Apply liberally 20 minutes before sun exposure and reapply as needed.
  • Children under 6 months of age: ask a physician.

Inactive ingredients

Beeswax, Bis-PEG-12 Dimethicone, Butylparaben, C13-14 Isoparaffin, Ceteareth-20, Cetearyl Alcohol, Cetyl Alcohol, Chrondrus Crispus (Carrageenan), Copernicia Cerifera (Carnauba) Wax, Cyclomethicone, Dicaprylyl Maleate, Dimethicone, Ethylparaben, Glycol Stearate, Glycyrrhiza Glabra (Licorice) Extract, Isobutylparaben, Laureth-7, Lecithin, Methylparaben, PEG-100 Stearate, PEG-20, Phenoxyethanol, Plankton Extract, Polyacrylamide, Propylparaben, Sorbitan Tristearate, Steareth-100, Stearyl Alcohol, Synthetic Beeswax, Tocopheryl Acetate, VP/Eicosene Copolymer, Water (Aqua), Xanthan Gum

PRINCIPAL DISPLAY PANEL - 56.7 g Carton

Moisture Defense
SPF 15

Net Wt 2 Oz/56.7 g

Principal Display Panel - 56.7 g Carton

ADVANCED PROTECTION   SPF-15
octinoxate and zinc oxide cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:24623-001
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE (OCTINOXATE) OCTINOXATE 0.075 g  in 1 g
Zinc Oxide (Zinc Oxide) Zinc Oxide 0.05 g  in 1 g
Inactive Ingredients
Ingredient Name Strength
XANTHAN GUM  
CYCLOMETHICONE  
CETYL ALCOHOL  
DIOCTYL MALEATE  
WATER  
STEARYL ALCOHOL  
GLYCOL STEARATE  
ALPHA-TOCOPHEROL ACETATE  
GLYCYRRHIZA GLABRA  
CETOSTEARYL ALCOHOL  
CHONDRUS CRISPUS  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:24623-001-20 56.7 g in 1 TUBE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 08/25/2001

Labeler - CBI Laboratories, Inc (623704368)
Establishment
Name Address ID/FEI Operations
CBI Laboratories 623704368 MANUFACTURE

Revised: 01/2011 CBI Laboratories, Inc



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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