FDA.reportPublic FDA data

BF Water Sport SPF50 Lotion

Manufacturer
SolSkyn Personal Care LLC
Effective date
2018-02-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:54:34

Label at a glance#

ProductBullFrog SPF50 Water Sport
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

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 ...

Storage and handling

protect this product from excessive heat and direct sun

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

BullFrog SPF50 Water Sport Lotion

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.

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin.

When using this product keep out of eyes.

OTC - WHEN USING SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Acrylates Copolymer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Carbomer, Diisopropyl Adipate, Dimethyl Capramide, Disodium EDTA, Ethylhexylglycerin, Fragrance, Hydroxypropyl Methylcellulose, Macrocystis Pyrifera Extract, Phenoxyethanol, Polyester-8, Polyisobutene, Propylene Glycol, Silica, Sorbitan Oleate, Tocopheryl (Vitamin E) Acetate, Triethanolamine, Water

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
WATER SPORT
with Water Armor TECH
Lotion
50
BROAD SPECTRUM SPF 50
5 FL OZ (147 mL)

PRINCIPAL DISPLAY PANEL BULL FROG SUNSCREEN WATER SPORT with Water Armor TECH Lotion 50 BROAD SPECTRUM SPF 50 5 FL OZ (147 mL)PRINCIPAL DISPLAY PANEL BULL FROG SUNSCREEN WATER SPORT with Water Armor TECH Lotion 50 BROAD SPECTRUM SPF 50 5 FL OZ (147 mL)

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70281-324-132020-09-27C16284748780-1ab0e2407-2ff9-f274-e053-dbdaa90a6471BF Water Sport SPF50 Lotion
70281-324-132020-09-25C16284748780-1ab0e2407-2ff9-f274-e053-dbdaa90a6471BF Water Sport SPF50 Lotion
70281-324-132020-07-22C16284748780-1ab0e2407-2ff9-f274-e053-dbdaa90a6471BF Water Sport SPF50 Lotion

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70281-324-13BullFrog SPF50 Water Sport147 mg in 1 BOTTLELOTION1471

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70281-324BULLFROG SPF50 WATER SPORT (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [SOLSKYN PERSONAL CARE LLC]1Legacy NDC, 1 package rows20180215_fa7c4631-e207-4cbf-9119-fc643f29612e.zip

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70281-32470281-324-13

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
OXYBENZONE95OOS7VE0YACTIB
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW)JZ1374NL9EIACT
CARBOMER INTERPOLYMER TYPE A (55000 CPS)59TL3WG5COIACT
CARBOMER COPOLYMER TYPE A71DD5V995LIACT
POLYISOBUTYLENE (1300 MW)241BN7J12YIACT
DIISOPROPYL ADIPATEP7E6YFV72XIACT
DIMETHYL CAPRAMIDEO29Y6X2JEZIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
HYPROMELLOSES3NXW29V3WOIACT
MACROCYSTIS PYRIFERAK31S3OG5C4IACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED)T9296U138PIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SORBITAN MONOOLEATE06XEA2VD56IACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT

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
a963c88f-c8f5-4a7b-874f-8fcbb9d836bbfa7c4631-e207-4cbf-9119-fc643f29612e2018-02-16WarningsExact identifier
spl id: a963c88f-c8f5-4a7b-874f-8fcbb9d836bb
spl set id: fa7c4631-e207-4cbf-9119-fc643f29612e

Reported adverse events (FAERS/openFDA)#

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