BULLFROG SPF 50 SUNSCREEN INSECT REPELLENT- avobenzone, homosalate, octisalate, and octinoxate 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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Bullfrog SPF 50 Mosquito Coast Sunscreen + Insect Repellent

Active Ingredients

Avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 5%, and Octixonate 7.5%

Purpose

Sunscreen

Uses

  • Helps prevent sunburn

Warnings

Skin Alert Limiting sun exposure, wearing protective clothing and using sunscreen may reduce the risk of skin aging,skin cancer and other harmful effects of the sun

Do not useon damaged or broken skin.

When using this product: Keep away from face to avoid breathing in • Keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs.

Flammable

  • do not use near heat,flame or while smoking
  • avoid long-term storage above 104ºF (40ºC)
  • do not puncture or incinerate
  • contents under pressure
  • do not store at temperatures above 120ºF (49ºC). Keep out of reach of children if swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • apply liberally 15 minutes before sun exposure
  • reapply:
  • after 80 minutes of swimming and sweating
  • immediately after towel drying
  • at least every 2 hours.
  • children under 6 months: Ask a doctor.

Other information

  • Protect this product from excessive heat and direct sun.

Inactive ingredients

Acrylates/Octylacrylamide Copolymer, SD Alcohol 40 (47% w/w), Aloe Barbadensis Leaf Oil, C12-15 Alkyl Benzoate, Fragrance,Tocopheryl (Vitamin E) Acetate,

Question or comments?

www/bullfrogsunscreen.com or call toll-free 1-800-990-FROG

Bullfrog SPF 50 Sunscreen + Insect Repellent

Principle Display Label

BULLFROG  SPF 50 SUNSCREEN INSECT REPELLENT
avobenzone, homosalate, octisalate, and octinoxate spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13630-0215
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE66.38 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE26.55 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE88.5 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE44.25 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE44.25 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
Product Characteristics
Coloryellow (Very Light Yellow) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13630-0215-4176 mL in 1 CAN; Type 0: Not a Combination Product12/03/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35212/03/2021
Labeler - Prime Packaging Inc. (805987059)
Registrant - Prime Packaging Inc. (805987059)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises Inc101946028manufacture(13630-0215) , analysis(13630-0215)
Establishment
NameAddressID/FEIBusiness Operations
Prime Packaging Inc.805987059pack(13630-0215) , label(13630-0215)

Revised: 1/2022
Document Id: d5e2e691-a133-718b-e053-2a95a90aeb0b
Set id: d5e2e691-a132-718b-e053-2a95a90aeb0b
Version: 1
Effective Time: 20220118
 
Prime Packaging Inc.