FDA.reportPublic FDA data

BullFrog Land Sport SPF 50 Lip Balm

Manufacturer
SolSkyn Personal Care LLC
Effective date
2017-08-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:52:12

Label at a glance#

ProductBullFrog Land Sport SPF 50 Lip Balm
Active ingredientAVOBENZONE, OCTISALATE, OCTOCRYLENE, OXYBENZONE
Label structure10 sections

Indications and uses

• helps prevent sunburn • if used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun

Dosage and administration

• apply liberally 15 minutes before sun exposure • re-apply:       • after 80 minutes of swimming or sweating       • immediately after towel drying       • at least every 2 hours Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measures includi...

Storage and handling

• protect this product from excessive heat and direct sun • for use on skin only. Avoid contact with fabric

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

BullFrog Land Sport SPF 50 Lip Balm

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 2%, Octisalate 4%, Octocrylene 10%, Oxybenzone 6%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

• helps prevent sunburn

• if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

WARNINGS SECTION

• For external use only

• Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin.

• When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

• Stop use and ask a doctor if rash occurs.

OTC - STOP USE SECTION

• Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

• apply liberally 15 minutes before sun exposure

• re-apply:

      • after 80 minutes of swimming or sweating

      • immediately after towel drying

      • at least every 2 hours

Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measures including:

      • limit time in the sun, especially from 10 a.m.-2 p.m.

      • wear long-sleeved shirts, pants, hats and sunglasses

• children under 6 months: ask a doctor

Other information

STORAGE AND HANDLING SECTION

• protect this product from excessive heat and direct sun

• for use on skin only. Avoid contact with fabric

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Extract, Butylated Hydroxytolulene, Caprylic/Capric Triglyceride, Cetyl Alcohol, Cyclomethicone, Diisobutyl Adipate, Dimethicone, Ethylhexyl Palmitate, Flavor, Glycine Soja (Soybean) Oil, Isostearyl Linoleate, Menthol, Ozokerite, Persea Gratissima (Avocado) Oil, Propylparaben, Saccharin, Simmondsia Chinensis (Jojoba) Seed Oil, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl (Vitamin E) Acetate

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bull Frog
Sunscreen
LAND SPORT
Lip Balm
SPF 50

PRINCIPAL DISPLAY PANEL Bull Frog Sunscreen LAND SPORT Lip Balm SPF 50PRINCIPAL DISPLAY PANEL Bull Frog Sunscreen LAND SPORT Lip Balm SPF 50

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70281-339-032020-09-27C16284748780-1ab0e2407-3437-f274-e053-dbdaa90a6471BullFrog Land Sport Lip SPF50
70281-339-032020-09-25C16284748780-1ab0e2407-3437-f274-e053-dbdaa90a6471BullFrog Land Sport Lip SPF50
70281-339-032020-07-22C16284748780-1ab0e2407-3437-f274-e053-dbdaa90a6471BullFrog Land Sport Lip SPF50

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70281-339-03BullFrog Land Sport SPF 50 Lip Balm4.25 g in 1 CONTAINERSTICK4.251

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70281-339BULLFROG LAND SPORT SPF 50 LIP BALM (AVOBENZONE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) STICK [SOLSKYN PERSONAL CARE LLC]1Legacy NDC, 1 package rows20170816_9aee5f78-5aa8-4e28-ad5f-132c097457ff.zip

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70281-33970281-339-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
AVOBENZONEG63QQF2NOXACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
OXYBENZONE95OOS7VE0YACTIB
ALOE VERA LEAFZY81Z83H0XIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
CETYL ALCOHOL936JST6JCNIACT
CYCLOMETHICONENMQ347994ZIACT
DIISOBUTYL ADIPATE8OPY05ZY7SIACT
DIMETHICONE92RU3N3Y1OIACT
ETHYLHEXYL PALMITATE2865993309IACT
SOYBEAN OIL241ATL177AIACT
ISOSTEARYL LINOLEATE4778M3HR0NIACT
MENTHOLL7T10EIP3AIACT
CERESINQ1LS2UJO3AIACT
AVOCADO OIL6VNO72PFC1IACT
PROPYLPARABENZ8IX2SC1OHIACT
SACCHARINFST467XS7DIACT
JOJOBA OIL724GKU717MIACT
COCOA BUTTER512OYT1CRRIACT
.ALPHA.-TOCOPHEROL SUCCINATE, D-LU4B53JYVEIACT

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
ec345c44-c3af-4a95-bf7d-5d0eee3d86879aee5f78-5aa8-4e28-ad5f-132c097457ff2017-08-16WarningsExact identifier
spl id: ec345c44-c3af-4a95-bf7d-5d0eee3d8687
spl set id: 9aee5f78-5aa8-4e28-ad5f-132c097457ff

Reported adverse events (FAERS/openFDA)#

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