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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13630-0215
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	66.38 mg in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	26.55 mg in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	88.5 mg in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	44.25 mg in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	44.25 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ALCOHOL (UNII: 3K9958V90M)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)

Product Characteristics
Color	yellow (Very Light Yellow)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:13630-0215-4	176 mL in 1 CAN; Type 0: Not a Combination Product	12/03/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	12/03/2021

Labeler - Prime Packaging Inc. (805987059)

Registrant - Prime Packaging Inc. (805987059)

Name	Address	ID/FEI	Business Operations
Establishment
Prime Enterprises Inc		101946028	manufacture(13630-0215) , analysis(13630-0215)

Name	Address	ID/FEI	Business Operations
Establishment
Prime Packaging Inc.		805987059	pack(13630-0215) , label(13630-0215)

Bullfrog SPF 50 Mosquito Coast Sunscreen + Insect Repellent