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Advanced Protection SPF-15

Dosage form: cream
Ingredients: OCTINOXATE 0.075g in 1g, Zinc Oxide 0.05g in 1g
Labeler: CBI Laboratories, Inc
NDC Code: 24623-001

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.

Moisture Defense
SPF 15

Drug Facts

Active ingredientsPurpose
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

ADVANCED PROTECTION   SPF-15
octinoxate and zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24623-001
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE0.075 g  in 1 g
Zinc Oxide (Zinc Oxide) Zinc Oxide0.05 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
XANTHAN GUM 
CYCLOMETHICONE 
CETYL ALCOHOL 
DIOCTYL MALEATE 
WATER 
STEARYL ALCOHOL 
GLYCOL STEARATE 
ALPHA-TOCOPHEROL ACETATE 
GLYCYRRHIZA GLABRA 
CETOSTEARYL ALCOHOL 
CHONDRUS CRISPUS 
Packaging
#Item CodePackage Description
1NDC:24623-001-2056.7 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35208/25/2001
Labeler - CBI Laboratories, Inc (623704368)
Establishment
NameAddressID/FEIOperations
CBI Laboratories623704368MANUFACTURE

Revised: 01/2011
 
CBI Laboratories, Inc

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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