Bullfrog

Manufacturer: Prime Enterprises Inc.
Effective date: 2022-01-17
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 23:47:08

Label at a glance#

ProductBullfrog Broad Spectrum SPF 50 Sunscreen

Active ingredientOCTISALATE, OCTINOXATE, AVOBENZONE, OCTOCRYLENE, HOMOSALATE

Label structure9 sections

Indications and uses

Helps prevent sunburn

Dosage and administration

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: Ask a doctor

Contacts and useful links#

PhoneLabel contact1-800-990-FROG

Websitewww.bullfrogsunscreen.com

www.bullfrogsunscreen.com

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 5%

Octinoxate 7.5%

Purpose

OTC - PURPOSE SECTION

Sunscreens

Uses

INDICATIONS & USAGE SECTION

Helps prevent sunburn

Warnings

WARNINGS SECTION

Skin Alert

Limiting sun exposure, wearing protective clothing and using sunscreen may reduce the risk of skin aging, skin care and other harmful effects of the sun

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

OTC - WHEN USING SECTION

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

OTC - ASK DOCTOR SECTION

Stop use and ask a doctor if rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

SPL UNCLASSIFIED SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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: Ask a doctor

Other Information

OTHER SAFETY INFORMATION

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

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

www.bullfrogsunscreen.com or call toll-free

1-800-990-FROG

Bullfrog SPF 50 Mosquito Coast Sunscreen + Insect Repellent

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principle Display LabelPrinciple Display LabelPrinciple Display LabelPrinciple Display Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
58443-0517-4	2024-01-30	C162847	48780-1	1030e365-1bda-111a-e063-dadaa90a10e2	Bullfrog SPF 50 Moquito Coast Sunscreen + Insect Repellent

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
58443-0517-4	BullfrogBroad Spectrum SPF 50 Sunscreen	138 mL in 1 BOTTLE, SPRAY	SPRAY	138		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58443-0517	BULLFROG BROAD SPECTRUM SPF 50 SUNSCREEN (AVOBENZONE,OCTOCRYLENE,HOMOSALATE, OCTINOXATE, OCTISALATE) SPRAY [PRIME ENTERPRISES INC.]	1	Legacy NDC, 1 package rows	20220118_d5cb6c15-3821-1c92-e053-2995a90a7203.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

Bullfrog Broad Spectrum SPF 50 Sunscreen
Avobenzone,Octocrylene,Homosalate, Octinoxate, Octisalate
OCTISALATE
OCTINOXATE
AVOBENZONE
ALKYL (C12-15) BENZOATE
OCTOCRYLENE
ETHYL BUTYLACETYLAMINOPROPIONATE
ALCOHOL
ALOE VERA LEAF
.ALPHA.-TOCOPHEROL ACETATE
WATER
HOMOSALATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
58443-0517	58443-0517-4

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
OCTISALATE	4X49Y0596W	ACTIB
OCTINOXATE	4Y5P7MUD51	ACTIB
AVOBENZONE	G63QQF2NOX	ACTIB
ALKYL (C12-15) BENZOATE	A9EJ3J61HQ	IACT
OCTOCRYLENE	5A68WGF6WM	ACTIB
ETHYL BUTYLACETYLAMINOPROPIONATE	65GQA237EH	IACT
ALCOHOL	3K9958V90M	IACT
ALOE VERA LEAF	ZY81Z83H0X	IACT
.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	IACT
WATER	059QF0KO0R	IACT
HOMOSALATE	V06SV4M95S	ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
d5cb6c15-3822-1c92-e053-2995a90a7203			d5cb6c15-3821-1c92-e053-2995a90a7203	2022-01-17	Warnings	Exact identifier spl id: d5cb6c15-3822-1c92-e053-2995a90a7203 spl set id: d5cb6c15-3821-1c92-e053-2995a90a7203

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.