Waterful Sun

Manufacturer
ARI&J Inc | Cosmecca Korea Co., Ltd.
Effective date
2017-06-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:51:48

Label at a glance#

ProductWaterful Sun
Active ingredientOCTINOXATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Ethylhexyl Methoxycinnamate, Octocrylene, Ethylhexyl Salicylate, Butyl Methoxydibenzoylmethane

INACTIVE INGREDIENT SECTION

Water, Butylene Glycol, etc

OTC - PURPOSE SECTION

  • Suncreen
  • protects skin from UV rays
  • 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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

keep out or reach of the children

INDICATIONS & USAGE SECTION

apply generously 15 minutes before sun sxposure

reapply:

  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every two hours

Sun Protection Measures. Spending thime 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 value of 15 or higher and other sun protection measures including:

  • limit time in the sun, expecially from 10 a.m. - 2 p.m.
  • wear long-sleeved shirts, pants, hats, and sunglasses

children under 6 months of age: Ask a doctor

WARNINGS SECTION

  • For external use only.
  • Do not use on damaged or broken skin.
  • When using this product keep out of eyes. Rinse with water to remove.
  • Stop use and ask a doctor if rash occurs.
  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
  • do not place this product in this container in the excessive heat and direct sun.

DOSAGE & ADMINISTRATION SECTION

for external use only


PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71496-0003-12020-01-31C16284748780-19d75b9d0-8c50-f424-e053-dadaa90a57ce5326ae14-eb97-1351-e054-00144ff8d46c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71496-0003-1Waterful Sun50 mL in 1 TUBEGEL501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71496-0003WATERFUL SUN (ETHYLHEXYL METHOXYCINNAMATE, OCTOCRYLENE, ETHYLHEXYL SALICYLATE, BUTYL METHOXYDIBENZOYLMETHANE) GEL [ARI&J INC]1Legacy NDC, 1 package rows20170630_5326ae14-eb97-1351-e054-00144ff8d46c.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71496-000371496-0003-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

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
5326ae14-eb98-1351-e054-00144ff8d46c5326ae14-eb97-1351-e054-00144ff8d46c2017-06-30WarningsExact identifier
spl id: 5326ae14-eb98-1351-e054-00144ff8d46c
spl set id: 5326ae14-eb97-1351-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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