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 ingredientsPurpose
Octinoxate 7.5%sunscreen
Zinc Oxide 5%sunscreen

Uses

Warnings

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

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:24623-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.075 g  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide0.05 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
XANTHAN GUM (UNII: TTV12P4NEE)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
DIOCTYL MALEATE (UNII: OD88G8439L)  
WATER (UNII: 059QF0KO0R)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
GLYCOL STEARATE (UNII: 0324G66D0E)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CHONDRUS CRISPUS (UNII: OQS23HUA1X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
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/FEIBusiness Operations
CBI Laboratories623704368MANUFACTURE

Revised: 1/2011
Document Id: 87cf3278-1d2b-4c3c-8fd8-d1ab091b0929
Set id: 74b472f8-da51-42d7-9d54-2719e6c96793
Version: 2
Effective Time: 20110105
 
CBI Laboratories, Inc