FDA.reportPublic FDA data

Bull Frog

Manufacturer
Prime Enterprises Inc.
Effective date
2024-05-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:03:55

Label at a glance#

ProductBull Frog
Active ingredientOCTISALATE, HOMOSALATE, OCTINOXATE, AVOBENZONE, OCTOCRYLENE
Label structure9 sections

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

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%

Octocrylene 5%

Homosalate 10%

Octyl Methoxycinnamate 7.5%

Octisalate 5%

Purpose

OTC - PURPOSE SECTION

Sunscreens

Use:

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn

Warnings

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 product is swallowed, get medical help or contact a Poison Control Center right away.

SPL UNCLASSIFIED 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

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

SPL UNCLASSIFIED SECTION

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

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Acrylates/Octylacrylamide Copolymer, SD Alcohol 40 (47% w/w), Aloe Barabdensis Leaf Oil, C12-15 Alkyl Benzoate, Fragrance, Tocopheryl (Vitamin E) Acetate.

BullFrog SPF 50 Mosquito Coast Sunscreen + Insect Repellent

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principle Display LabelPrinciple Display LabelPrinciple Display LabelPrinciple Display Label

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58443-057558443-0575-4

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
NameUNIIKind
OCTISALATE4X49Y0596WACTIB
HOMOSALATEV06SV4M95SACTIB
OCTINOXATE4Y5P7MUD51ACTIB
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
ALOE VERA LEAFZY81Z83H0XIACT
ALCOHOL3K9958V90MIACT
AVOBENZONEG63QQF2NOXACTIB
OCTOCRYLENE5A68WGF6WMACTIB
ETHYL BUTYLACETYLAMINOPROPIONATE65GQA237EHIACT
ACRYLATES/OCTYLACRYLAMIDE COPOLYMER (40000 MW)7LL6SY9YFVIACT

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
e81d5bbf-61f5-2913-e053-2995a90aa1cee81d5c6e-5873-c9b7-e053-2995a90a6c732024-05-03WarningsExact identifier
spl id: e81d5bbf-61f5-2913-e053-2995a90aa1ce
spl set id: e81d5c6e-5873-c9b7-e053-2995a90a6c73

Reported adverse events (FAERS/openFDA)#

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