FDA.reportPublic FDA data

BullFrog SPF50 Water Sport C-Spray

Manufacturer
SolSkyn Personal Care LLC
Effective date
2017-08-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:52:07

Label at a glance#

ProductBullFrog SPF50 Water Sport C-Spray
Active ingredientAVOBENZONE, HOMOSALATE, 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

shake well. Hold can 4-6 inches from skin to apply. spray liberally and spread evenly by hand 15 minutes before sun exposure on all exposed areas. Ensure skin is completely covered with product. do not spray directly on face. Spray on hands then apply to face. do not apply in windy conditions. use in a well-ventilated area. re-apply: • after 80 minutes of swimming or sweating • immediately after towel drying • at ...

Storage and handling

for use on skin only protect this product from excessive heat and direct sun

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Product

BullFrog SPF50 Land Sport C-Spray

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 2%, Homosalate 10%, Octisalate 5%, Octocrylene 2%, Oxybenzone 5%

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
  • Flammable: keep away from fire or flame. Contents under pressure. Do not puncture or incinerate. Do not store at temperatures above 120°F.

Do not use

OTC - DO NOT USE SECTION

  • on damaged or broken skin.

When using this product:

OTC - WHEN USING SECTION

  • keep away from face to avoid breathing in
  • 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 swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • shake well. Hold can 4-6 inches from skin to apply.
  • spray liberally and spread evenly by hand 15 minutes before sun exposure on all exposed areas. Ensure skin is completely covered with product.
  • do not spray directly on face. Spray on hands then apply to face.
  • do not apply in windy conditions.
  • use in a well-ventilated area.
  • 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 a 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

  • for use on skin only
  • protect this product from excessive heat and direct sun

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Acacia Farnesiana Extract, Acrylates/Octylacrylamide Copolymer, Camellia Oleifera (Green Tea) Leaf Extract, Chamomile Flower Extract, Dimethyl Capramide, Fragrance, Glycerin, Isopropyl Myristate, Lavender Extract, Polyester-8, Propylene Glycol, Rosemary Leaf Extract, SD Alcohol 40 (72.45% w/w)

Questions or comments?

OTC - QUESTIONS SECTION

www.bullfrogsunscreen.com or call toll-free 1-800-715-3485

MAY STAIN SOME FABRICS, PLASTICS AND WOOD SURFACES.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bull Frog
Sunscreen
Landsport
SPF 50

PRINCIPAL DISPLAY PANEL Bull Frog Sunscreen Landsport SPF 50PRINCIPAL DISPLAY PANEL Bull Frog Sunscreen Landsport SPF 50

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70281-323-112020-09-27C16284748780-1ab0e2407-2ddb-f274-e053-dbdaa90a6471BullFrog Watersport SPF50 CS
70281-323-112020-09-25C16284748780-1ab0e2407-2ddb-f274-e053-dbdaa90a6471BullFrog Watersport SPF50 CS
70281-323-112020-07-22C16284748780-1ab0e2407-2ddb-f274-e053-dbdaa90a6471BullFrog Watersport SPF50 CS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70281-323-11BullFrog SPF50 Water Sport C-Spray170 g in 1 CONTAINERSPRAY1701

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70281-323BULLFROG SPF50 WATER SPORT C-SPRAY (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) SPRAY [SOLSKYN PERSONAL CARE LLC]1Legacy NDC, 1 package rows20170804_60d58f09-0445-40b3-8087-9d03d0d359d0.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70281-32370281-323-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
OXYBENZONE95OOS7VE0YACTIB
VACHELLIA FARNESIANA FLOWER8487B3MG6DIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
GREEN TEA LEAFW2ZU1RY8B0IACT
CHAMAEMELUM NOBILE FLOWERO2T154T6OGIACT
DIMETHYL CAPRAMIDEO29Y6X2JEZIACT
GLYCERINPDC6A3C0OXIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
LAVANDULA ANGUSTIFOLIA FLOWER19AH1RAF4MIACT
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED)T9296U138PIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
ROSEMARYIJ67X351P9IACT
ALCOHOL3K9958V90MIACT

Source Document#

Source XML · Source PDF

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
0ca948d1-a8e6-41c4-88da-469b145f7e5860d58f09-0445-40b3-8087-9d03d0d359d02017-08-07WarningsExact identifier
spl id: 0ca948d1-a8e6-41c4-88da-469b145f7e58
spl set id: 60d58f09-0445-40b3-8087-9d03d0d359d0

Reported adverse events (FAERS/openFDA)#

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