FDA.reportPublic FDA data

SunStation USA SPF-30 SPORT SUNSCREEN

Manufacturer
RENU LABORATORIES, LLC
Effective date
2025-01-31
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:59:45

Label at a glance#

ProductSunStation USA SPF-30 SPORT SUNSCREEN
Active ingredientOCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE
Label structure12 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 cancer and early skin aging caused by the sun.

Dosage and administration

Apply liberally 15 minutes before sun exposure and as needed. Children under 6 months of age: ask a doctor. 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 ...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Octyl Methoxy Cinnamate 7.00% Sunscreen

Titanium Dioxide 1.25% Sunscreen

Zinc Oxide 1.25% Sunscreen

Octyl Salicylate 1.00% Sunscreen

Purpose

OTC - PURPOSE SECTION

Octyl Methoxy Cinnamate 7.00% Sunscreen

Titanium Dioxide 1.25% Sunscreen

Zinc Oxide 1.25% Sunscreen

Octyl Salicylate 1.00% 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 cancer and early skin aging caused by the sun.

WARNINGS

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 or irritation develops and lasts
  • Keep out of reach of children.
  • If swallowed, get medical help, or contact a Poison Control Center right away.
  • If pregnant or breast-feeding, ask a health professional before use.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes before sun exposure and as needed.
  • Children under 6 months of age: ask a doctor.
  • 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 between 10am and 2pm.
  • Wear long sleeve shirts, pants, hats and sunglasses.

OTHER INGREDIENTS

INACTIVE INGREDIENT SECTION

Aloe Barbadensis (Aloe Vera) Leaf Juice, Calendula Officinalis (Marigold) Flower Extract, Caprylyl Glycol, Ceteareth-20, Cetearyl Alcohol, Deionized Water, Dimethicone, Glycerin, Hexylene Glycol, Isocetyl Stearate, Malva Sylvestris (Mallow) Flower Extract, Panax Ginseng Root Extract, Phenoxyethanol, Polyester-7, Neopentyl Glycol, Diheptanoate, Sorbitol, Stearic Acid,

Symphytum Officinale (Comfrey) Leaf Extract, Triethanolamine, Tocopheryl Acetate (Vitamin E)

RECENT MAJOR CHANGES SECTION

  • added more descriptive text. No major change.
  • Changes to Directions are not major - just a reordering of phrases.

STATEMENT OF IDENTITY SECTION

SUNSTATION USA®

SPF-30 SPORT SUNSCREEN

OXYBENZONE & PARABEN FREE

UVA/UVB PROTECTION SUNSCREEN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.
If swallowed, get medical help, or contact a Poison Control Center right away.

OTHER SAFETY INFORMATION

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

OTC - QUESTIONS SECTION

QUESTIONS ?

816-686-1345

SUNSTATION PRODUCT LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SUNSTATION LABELSUNSTATION LABEL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76348-407-01SunStation USA SPF-30 SPORT SUNSCREEN896 g in 1 CONTAINERLOTION8962

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76348-407SUNSTATION USA SPF-30 SPORT SUNSCREEN (ZINC OXIDE) LOTION [RENU LABORATORIES, LLC]2Current NDC, 1 package rows20250427_11d3c60e-238d-999e-e063-6394a90a624b.zip

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76348-40776348-407-01

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
CETOSTEARYL ALCOHOL2DMT128M1SIACT
DIMETHICONE 3502Y53S6ATLUIACT
OCTINOXATE4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB
WATER059QF0KO0RIACT
ISOCETYL STEARATE3RJ7186O9WIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
TROLAMINE9O3K93S3TKIACT
ALOE VERA LEAFZY81Z83H0XIACT
POLYESTER-70841698D2FIACT
NEOPENTYL GLYCOL DIHEPTANOATE5LKW3C543XIACT
CAPRYLYL GLYCOL00YIU5438UIACT
PHENOXYETHANOLHIE492ZZ3TIACT
HEXYLENE GLYCOLKEH0A3F75JIACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
STEARIC ACID4ELV7Z65APIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
ASIAN GINSENGCUQ3A77YXIIACT
MALVA SYLVESTRIS FLOWER12X9JI52BSIACT
GLYCERINPDC6A3C0OXIACT
CETYL ALCOHOL936JST6JCNIACT
MATRICARIA RECUTITA FLOWERING TOP3VNC7T6Z02IACT
COMFREY LEAFDG4F8T839XIACT
ZINC OXIDESOI2LOH54ZACTIB
SORBITOL506T60A25RIACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT

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 USA SPF-30 SPORT SUNSCREENZINC OXIDERENU LABORATORIES, LLC11d3c60e-238d-999e-e063-6394a90a624b2025-01-31WarningsExact identifier
ndc (package): 76348-407-01
ndc (product): 76348-407
ndc11 (package): 76348040701
spl id: 2d043dd6-9aef-2b7e-e063-6294a90aec69
spl set id: 11d3c60e-238d-999e-e063-6394a90a624b

Reported adverse events (FAERS/openFDA)#

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