DEFENSE ZONE SPORT C/S BROAD SPECTRUM SPF 30- avobenzone, homosalate, octisalate, oxybenzone spray 
Prime Packaging 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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Defense Zone Sport C/S Broad Spectrum SPF 30

Active Ingredients

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Oxybenzone 4%

Purpose

Sunscreen

Uses

Warnings

For external use only

Do not use on damaged or broken skin

When using this product keep away from face to avoid breathing it

  • 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 product is swallowed, get medical help or contact a Poison Control Center right away.

Caution: Flammable: Do not use near heat, flame or while smoking. Contents under pressure. Do not puncture or incinerate. Store at temperatures below 120ºF (48ºC).

Directions

Inactive Ingredients

Fragrance (Parfum), SD Alcohol 40-B (Alcohol Denat.), VA/Butyl Maleate/Isobornyl Acrylate Copolymer

Other Information

Question or comments?

Call toll free 1-855-LIV-GOLD (548-4653)

Defense Zone Sport Broad Spectrum SPF 30 C/S

Principal Display Image

DEFENSE ZONE  SPORT C/S BROAD SPECTRUM SPF 30
avobenzone, homosalate, octisalate, oxybenzone spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13630-0108
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE24.1 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE80.2 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE40.1 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE32.1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BUTYL ACRYLATE/C16-C20 ALKYL METHACRYLATE/METHACRYLIC ACID/METHYL METHACRYLATE COPOLYMER (UNII: 7K68DGG29P)  
ALCOHOL (UNII: 3K9958V90M)  
Product Characteristics
ColoryellowScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13630-0108-4177 mL in 1 CAN; Type 0: Not a Combination Product05/11/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35205/11/2016
Labeler - Prime Packaging Inc. (805987059)
Registrant - Prime Packaging Inc. (805987059)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises Inc101946028manufacture(13630-0108) , analysis(13630-0108)
Establishment
NameAddressID/FEIBusiness Operations
Prime Packaging Inc.805987059pack(13630-0108) , label(13630-0108)

Revised: 1/2020
Document Id: 9c5c37f9-87b0-a9ff-e053-2a95a90a2a8f
Set id: 3398af9c-c5ae-086b-e054-00144ff8d46c
Version: 2
Effective Time: 20200117
 
Prime Packaging Inc.