BULLFROG DEET FREE MOSQUITO COAST SUNSCREEN WITH INSECT REPELLENT SPF 30- octinoxate, homosalate, octisalate, 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

Octocrylene: 10%
Octinoxate: 7.5%
Oxybenzone: 6%
Octisalate: 5%

Purpose

Sunscreen

Purpose

Sunscreen

Uses

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging.  This product has been shown only to prevent sunbrun, not skin cancer or early skin aging.

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

BULLFROG DEET FREE MOSQUITO COAST SUNSCREEN WITH INSECT REPELLENT SPF 30 
octinoxate, homosalate, octisalate, octocrylene spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62802-773
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE6 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62802-773-06177 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(62802-773)

Revised: 3/2013
Document Id: eb7591c7-30fc-44fd-9855-65021ddc967c
Set id: 5fb0245e-9c2d-4458-8bb1-f45145756c53
Version: 1
Effective Time: 20130301
 
Sun & Skin Care Research, LLC