FDA.reportPublic FDA data

Bullfrog

Manufacturer
Prime Packaging Inc. | Prime Enterprises Inc
Effective date
2022-01-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:13:59

Label at a glance#

ProductBullfrog SPF 50 Sunscreen Insect Repellent
Active ingredientOCTINOXATE, AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Label structure10 sections

Indications and uses

Helps prevent sunburn

Dosage and administration

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.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 5%, and Octixonate 7.5%

Purpose

OTC - PURPOSE SECTION

Sunscreen

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 cancer and other harmful effects of the sun

OTC - DO NOT USE SECTION

Do not useon damaged or broken skin.

OTC - WHEN USING SECTION

When using this product: Keep away from face to avoid breathing in • Keep out of eyes. Rinse with water to remove.

OTC - ASK DOCTOR SECTION

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

DOSAGE & ADMINISTRATION SECTION

  • 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

SPL UNCLASSIFIED SECTION

  • Protect this product from excessive heat and direct sun.

Inactive ingredients

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

www/bullfrogsunscreen.com or call toll-free 1-800-990-FROG

Bullfrog SPF 50 Sunscreen + Insect Repellent

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principle Display LabelPrinciple Display Label

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
13630-021513630-0215-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTINOXATE4Y5P7MUD51ACTIB
ALCOHOL3K9958V90MIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
ALOE VERA LEAFZY81Z83H0XIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
d5e2e691-a133-718b-e053-2a95a90aeb0bd5e2e691-a132-718b-e053-2a95a90aeb0b2022-01-18WarningsExact identifier
spl id: d5e2e691-a133-718b-e053-2a95a90aeb0b
spl set id: d5e2e691-a132-718b-e053-2a95a90aeb0b

Reported adverse events (FAERS/openFDA)#

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