SunStation USA SPF-30 SPORT SUNSCREEN

Product NDC
76348-407
11-digit product format
763480407
Labeler code
76348
Product ID
76348-407_2d043dd6-9aef-2b7e-e063-6294a90aec69
Type
HUMAN OTC DRUG
Nonproprietary name
ZINC OXIDE
Dosage form
LOTION
Route
TOPICAL
Labeler
RENU LABORATORIES, LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-02-20
Substance
OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE
Active strength
63; 9; 11.2; 11.2 g/896g; g/896g; g/896g; g/896g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
SunStation USA SPF-30 SPORT SUNSCREEN
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTINOXATE63 g/896g
OCTISALATE9 g/896g
TITANIUM DIOXIDE11.2 g/896g
ZINC OXIDE11.2 g/896g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4Y5P7MUD51Internal UNII lookup
4X49Y0596WInternal UNII lookup
15FIX9V2JPInternal UNII lookup
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
11d3c60e-238d-999e-e063-6394a90a624bAvailable on FDA.report

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

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 114 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Kind Restore Tinted Mineral SunscreenZINC OXIDEPOLISH BEAUTY3980d278-c0f4-2c59-e063-6394a90aac372025-12-16Exact identifier
application number: M020
Solar Eclipse Extreme SunscreenZINC OXIDEULTRAVIOLET SKINCARE LLC36bfa691-48c0-8033-e063-6294a90ad8992025-12-16Exact identifier
application number: M020
Kind Restore Moisturizing Lip BalmTITANIUM DIOXIDE, ZINC OXIDEPOLISH BEAUTY39814e27-4f3f-5ee6-e063-6394a90a941b2025-12-16Exact identifier
application number: M020
Yoali SPF 40ZINC OXIDEYOALI STUDIO LLC390b7f9c-bc04-80ec-e063-6294a90a40922025-12-16Exact identifier
application number: M020
Skin Defense Matte Tinted SunscreenZINC OXIDEGentlehomme LLC365eb727-3e7f-f1dd-e063-6394a90aa4692025-12-16Exact identifier
application number: M020
Dr B Clinical Skin Care Tinted SunscreenTITANIUM DIOXIDE, ZINC OXIDENAIRA BABAIAN, M.D., P.A.365da1f8-5250-7589-e063-6294a90a3e682025-12-16Exact identifier
application number: M020
Dr B Clinical Skin Care Non Tinted SunscreenTITANIUM DIOXIDE, ZINC OXIDENAIRA BABAIAN, M.D., P.A.365d7564-3025-257b-e063-6294a90ad1702025-12-16Exact identifier
application number: M020
Tinted Mineral SunscreenZINC OXIDEGentlehomme LLC365e7d8e-e3e0-4c08-e063-6294a90af4152025-12-16Exact identifier
application number: M020
Daily Replenish mineral sunscreenZINC OXIDEPURE VITALITY SKIN AND BODY, INC369896b1-f4b4-6201-e063-6394a90a5bca2025-12-16Exact identifier
application number: M020
Zinc 20 mineral sunscreen face Plus bodyZINC OXIDEPURE VITALITY SKIN AND BODY, INC36985373-22dd-2232-e063-6394a90a76fb2025-12-16Exact identifier
application number: M020
Matte Defense Mineral Sunscreen non tintedTITANIUM DIOXIDE, ZINC OXIDEPURE VITALITY SKIN AND BODY, INC3698090a-1639-00f9-e063-6394a90a7dd12025-12-16Exact identifier
application number: M020
Daily Replenish mineral sunscreenZINC OXIDEPURE VITALITY SKIN AND BODY, INC3698d309-b9bf-e197-e063-6294a90af5a12025-12-16Exact identifier
application number: M020
Zinc 20 mineral sunscreen face Plus bodyZINC OXIDEPURE VITALITY SKIN AND BODY, INC3698f29e-5d80-94af-e063-6394a90a04892025-12-16Exact identifier
application number: M020
Tinted Mineral Primer SPF 40TITANIUM DIOXIDE, ZINC OXIDEJOSEPHINA RAMIREZ365cf2be-8862-3622-e063-6394a90ac4e32025-12-16Exact identifier
application number: M020
SANCTUARY Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDECHAMPAGNE APOTHECARY LLC365ca99c-c878-1f4b-e063-6394a90a1f532025-12-16Exact identifier
application number: M020
Tinted Mineral Defense SPF 40ZINC OXIDEJOSEPHINA RAMIREZ365d299a-5886-5597-e063-6394a90a336c2025-12-16Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEMILL VALLEY DERMATOLOGY, INC.3b171a89-c757-47a1-e063-6294a90a7a642025-12-16WarningsExact identifier
application number: M020
Tinted BB CreamZINC OXIDEEco Esthetics LLC38f3e618-59e1-4504-e063-6394a90afa552025-12-16Exact identifier
application number: M020
Tinted Mineral SunscreenZINC OXIDEMADRE TIERRA, INC.3f697463-d3db-7b73-e063-6394a90ac2222025-12-16WarningsExact identifier
application number: M020
Non-Tinted Replenishing Daily ProtectionZINC OXIDEMADRE TIERRA, INC.3f69d6f3-454b-e60a-e063-6394a90a87812025-12-16WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76348-407-0176348040701896 g in 1 CONTAINER (76348-407-01) 896 g2024-02-20NoNoCurrent