BULL FROG- avobenzone, octocrylene, homosalate, octyl methoxycinnamate, octisalate spray 
Prime Enterprises Inc.

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BullFrog SPF 50 Mosquito Coast Sunscreen + Insect Repellent

Active ingredients

Avobenzone 3%

Octocrylene 5%

Homosalate 10%

Octyl Methoxycinnamate 7.5%

Octisalate 5%

Purpose

Sunscreens

Use:

Warnings

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

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

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

Directions

Other information

Inactive ingredients:

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

Questions 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 Label

BULL FROG 
avobenzone, octocrylene, homosalate, octyl methoxycinnamate, octisalate spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0575
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE44.25 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE88.5 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE66.4 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
Inactive Ingredients
Ingredient NameStrength
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ALCOHOL (UNII: 3K9958V90M)  
ETHYL BUTYLACETYLAMINOPROPIONATE (UNII: 65GQA237EH)  
ACRYLATES/OCTYLACRYLAMIDE COPOLYMER (40000 MW) (UNII: 7LL6SY9YFV)  
Product Characteristics
Coloryellow (Very Light Yellow) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58443-0575-4138 mL in 1 TUBE; Type 0: Not a Combination Product12/03/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02012/03/2021
Labeler - Prime Enterprises Inc. (101946028)
Registrant - Prime Enterprises Inc. (101946028)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises Inc.101946028pack(58443-0575) , manufacture(58443-0575) , label(58443-0575) , analysis(58443-0575)

Revised: 5/2024
Document Id: e81d5bbf-61f5-2913-e053-2995a90aa1ce
Set id: e81d5c6e-5873-c9b7-e053-2995a90a6c73
Version: 1
Effective Time: 20240503
 
Prime Enterprises Inc.