BULLFROG SPF 50 SUNSCREEN INSECT REPELLENT- avobenzone, homosalate, octisalate, and octinoxate spray

Bullfrog by

Drug Labeling and Warnings

Bullfrog by is a Otc medication manufactured, distributed, or labeled by Prime Packaging Inc., Prime Enterprises Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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

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

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

Labeler - Prime Packaging Inc. (805987059)

Registrant - Prime Packaging Inc. (805987059)

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

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