BULLFROG BROAD SPECTRUM SPF 50 SUNSCREEN- avobenzone,octocrylene,homosalate, octinoxate, octisalate spray 
Prime Enterprises 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 Moquito Coast Sunscreen + Insect Repellent

Active Ingredients

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 5%

Octinoxate 7.5%

Purpose

Sunscreens

Uses

Helps prevent sunburn

Warnings

Skin Alert

For external use only

Do not use on damaged or broken skin

When using this product 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 swallowed, get medical help or contact a Poison Control Center right away.

Flammable Keep away from heat and open flame. Do not puncture or incinerate.

Directions

Other Information

Acrylates/Octylacrylamide Copolymer, Aloe Barbadensis Leaf Juice, Butyl Methoxydibenzoylmethane, C12-15 Alkyl Benzoate, Ethyl Butylacetylaminopropionate, Ethylhexyl Salicylate, Homosalate, Octinoxate (Ethylhexyl Methoxycinnamate), Octocrylene, SD Alcohol 40 (Alcohol Denat.), Tocopheryl Acetate, Water

Question or comments?

www.bullfrogsunscreen.com or call toll-free

1-800-990-FROG

Bullfrog SPF 50 Mosquito Coast Sunscreen + Insect Repellent

Principle Display LabelPrinciple Display LabelPrinciple Display LabelPrinciple Display Label

BULLFROG  BROAD SPECTRUM SPF 50 SUNSCREEN
avobenzone,octocrylene,homosalate, octinoxate, octisalate spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0517
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE44.25 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE66.38 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE26.55 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE44.25 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE88.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
ETHYL BUTYLACETYLAMINOPROPIONATE (UNII: 65GQA237EH)  
ALCOHOL (UNII: 3K9958V90M)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Coloryellow (Light Yellow) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58443-0517-4138 mL in 1 BOTTLE, SPRAY; 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 Enterprises Inc. (101946028)
Registrant - Prime Enterprises Inc. (101946028)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises Inc.101946028pack(58443-0517) , manufacture(58443-0517) , label(58443-0517) , analysis(58443-0517)

Revised: 1/2022
Document Id: d5cb6c15-3822-1c92-e053-2995a90a7203
Set id: d5cb6c15-3821-1c92-e053-2995a90a7203
Version: 1
Effective Time: 20220117
 
Prime Enterprises Inc.