BULL FROG INSTA-COOL MIST 50- avobenzone, homosalate, octisalate, oxybenzone, octocrylene spray 
Sun & Skin Care Research, LLC

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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Drug Facts

Active Ingredients

Homosalate: 10%
Octisalate: 5%
Oxybenzone: 5%
Octocrylene: 2%
Avobenzone: 2%

Purpose

Sunscreen

Uses

Warnings

For external use only.  Do not use on damaged or broken skin. Stop use and ask a doctor if rash occurs. When using this product keep away from face to avoid breathing in.  Rinse with water to remove. Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.  Flammable  Do not use near heat, flame or while smoking.  Avoid long term storage above 104°F (40°C).  Avoid spraying in eyes.  Contents under pressure.  Do not puncture or incinerate.  Do not store in temperatures above 120°F.

Directions

Other Information

image of carton label

BULL FROG INSTA-COOL MIST 50 
avobenzone, homosalate, octisalate, oxybenzone, octocrylene spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62802-668
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
ALCOHOL (UNII: 3K9958V90M)  
DIMETHYL CAPRAMIDE (UNII: O29Y6X2JEZ)  
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)  
CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)  
ROSMARINUS OFFICINALIS FLOWER (UNII: NR1A27F29O)  
MENTHOL (UNII: L7T10EIP3A)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62802-668-06177 g in 1 CAN
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/01/2014
Labeler - Sun & Skin Care Research, LLC (849772207)
Establishment
NameAddressID/FEIBusiness Operations
Sun & Skin Care Research, LLC849772207manufacture(62802-668)

Revised: 3/2014
Document Id: 6c05d663-b2ed-4301-9661-9dc509c274d9
Set id: 021f4901-d1bd-4928-b82b-c5b8ffdf558a
Version: 1
Effective Time: 20140324
 
Sun & Skin Care Research, LLC