FDA.reportPublic FDA data

Sunstation Sport Sunscreen SPF 30

Manufacturer
Impact Melanoma Inc | Pure Source, LLC
Effective date
2025-04-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:59:44

Label at a glance#

ProductSunstation Sport Sunscreen SPF 30
Active ingredientOCTISALATE, OCTOCRYLENE, ZINC OXIDE
Label structure7 sections

Indications and uses

Helps prevent sunburn. Higher SPF gives more sunburn protection Retains SPF after 80 minutes of swimming or sweating 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 & as needed. For children under 6 months of age: ask a doctor. REAPPLY:: 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 ot...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Octisalate 5%
Octocrylene 8%
Zinc Oxide 8%

Purpose

OTC - PURPOSE SECTION

Sunscreen

USES:

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn.
  • Higher SPF gives more sunburn protection
  • Retains SPF after 80 minutes of swimming or sweating
  • 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

OTC - STOP USE SECTION

  • Rash or irritation develops and lasts.

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.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes before sun exposure & as needed.
  • For children under 6 months of age: ask a doctor.
  • REAPPLY::
  • 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. -2p.m.
  • Wear long-sleeved shirts, pants, hats, and sunglasses.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Juice, Butyloctyl Salicylate, Calendula Officinalis Extract, Capryloyl Glycerin/Sebacic Acid Copolymer, Carbomer,
Ceteareth-20, Cetearyl Alcohol, Chamomilla Recutita (Matricaria) Flower Extract, Dimethicone, Ethylhexylglycerin, Glycerin, Glyceryl Stearate
SE, 1,2-Hexanediol, Isocetyl Stearate, Malva Sylvestris (Mallow) Flower Extract, Panax Ginseng Root Extract, Phenoxyethanol,
Polyhydroxystearic Acid, Polysorbate 20, Sorbitan Stearate, Sorbitol, Stearic Acid, Symphytum Officinale Extract, Tocopheryl Acetate,
Triethanolamine, Water (Aqua)

OTHER INFORMATION:

SPL UNCLASSIFIED SECTION

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

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BottleBottle

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85528-592-00Sunstation Sport Sunscreen SPF 301000 mL in 1 BOTTLECREAM10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85528-592SUNSTATION SPORT SUNSCREEN SPF 30 (OCTISALATE, OCTOCRYLENE, ZINC OXIDE) CREAM [IMPACT MELANOMA INC]1Current NDC, 1 package rows20250426_ba78aa73-a25b-4a8e-99b2-9262bb9a7d27.zip

Products#

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

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85528-59285528-592-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
CETEARETH-20YRC528SWUYIACT
CETEARYL ALCOHOL2DMT128M1SIACT
CHAMOMILEFGL3685T2XIACT
DIMETHICONE92RU3N3Y1OIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
ISOCETYL STEARATE3RJ7186O9WIACT
MALVA SYLVESTRIS FLOWER12X9JI52BSIACT
ASIAN GINSENGCUQ3A77YXIIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYSORBATE 207T1F30V5YHIACT
SORBITAN MONOSTEARATENVZ4I0H58XIACT
SORBITOL506T60A25RIACT
STEARIC ACID4ELV7Z65APIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
ZINC OXIDESOI2LOH54ZACTIM

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
Sunstation Sport Sunscreen SPF 30OCTISALATE, OCTOCRYLENE, ZINC OXIDEImpact Melanoma Incba78aa73-a25b-4a8e-99b2-9262bb9a7d272025-04-24WarningsExact identifier
ndc (package): 85528-592-00
ndc (product): 85528-592
ndc11 (package): 85528059200
spl id: 33837cbb-2aab-a894-e063-6394a90acdda
spl set id: ba78aa73-a25b-4a8e-99b2-9262bb9a7d27

Reported adverse events (FAERS/openFDA)#

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