SUNSCREEN AND INSECT REPELLENT BULL FROG- spf 50 solution

Sunscreen and insect repellent by

Drug Labeling and Warnings

Sunscreen and insect repellent by is a Otc medication manufactured, distributed, or labeled by Bullfrog Brands, LLC, Prime Enterprises. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Avobenzone 3.0%, Octocrylene 5%, Homosalate 10.0%, Octyl methoxycinnamate 7.5%, Octisalate 5%

Purpose

Sunscreen

Uses

• helps prevent sunburn

Warnings

For external use only

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:

do not use near heat, flame or while smoking

avoid long term storage above 104°F (40°C)

do not puncture or incinerate

contents under pressure

do not store at temperatures above 120°F (49°C).

DO NOT USE

Do not use  on damaged or broken skin.

WHEN USING

When using this product  keep out of eyes. Rinse with water to remove.

ASK DOCTOR

Stop use and ask a doctor if  rash occurs.

KEEP OUT OF REACH OF CHILDREN

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 or sweating

immediately after towel drying

at least every 2 hours

• children under 6 months of age: ask a doctor

Other information

Protect the product in this container from excessive heat and direct sun.

Inactive ingredients

Acrylates/Octylacrylamide Copolymer, SD Alcohol 40 (47% w/w), AloeBarbadensis 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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SUNSCREEN AND INSECT REPELLENT  BULL FROG
spf 50 solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77714-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	50 mg  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 g

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77714-005-15	138 g in 1 CAN; Type 0: Not a Combination Product	01/19/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/19/2022

Labeler - Bullfrog Brands, LLC (117426500)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises		101946028	manufacture(77714-005)