FDA.reportPublic FDA data

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 153 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ATTITUDE Super leaves Lip Balm SPF 15 WatermelonZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE450dcc02-8bcb-6c07-e063-6394a90a5df42025-12-03WarningsExact identifier
application number: M020
ATTITUDE Sunly Mineral Sunscreen Face Stick SPF 50 UnscentedZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE44acf513-ffe6-888c-e063-6394a90a9c5c2025-12-03WarningsExact identifier
application number: M020
ATTITUDE Sunly Baby Mineral Sunscreen Face Stick SPF 50 UnscentedZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE450e52a9-5a6b-112f-e063-6394a90af7ca2025-12-03WarningsExact identifier
application number: M020
ATTITUDE Sunly Kids Mineral Sunscreen Face Stick SPF 50 UnscentedZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE450e6eb7-f49e-296e-e063-6294a90a05a42025-12-03WarningsExact identifier
application number: M020
Attitude - Leaves Bar - Lip Balm - SPF 15 - MangoZINC OXIDE9055-7588 Qubec Inc. DBA Attitude359a7ebf-46a6-4e99-b43c-f585e9bc08d92025-12-03WarningsExact identifier
application number: M020
ATTITUDE Sunly Lip balm Unscented SPF 15ZINC OXIDE9055-7588 Quebec Inc. DBA Attitude0d95a2b7-288d-7b29-e063-6294a90ae46b2025-12-03WarningsExact identifier
application number: M020
Attitude - Lip Balm - SPF 15 - CoconutZINC OXIDEAttitude DBA 9055-7588 Qubec Inc.068af2ec-a666-45bf-b0e0-89d1b93dedf12025-12-03WarningsExact identifier
application number: M020
Cancer Council Invisible Fluid SPF50 PlusAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEVitality US Co.1629b02b-e9f3-0593-e063-6294a90a9aa52025-12-03WarningsExact identifier
application number: M020
PRO-TECT SPORTS SUNSCREENMERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONEBio-Medical & Pharmaceutical Manufacturing Corporation16994959-cade-06de-e054-00144ff88e882025-12-03WarningsExact identifier
application number: M020
PRO-TECT SPORTS SUNSCREENMERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONEBio-Medical & Pharmaceutical Manufacturing Corporation66bb06fb-33d2-4b57-a65f-66bcd187c6272025-12-03WarningsExact identifier
application number: M020
PRO-TECT SUNSCREEN FOR PROFESSIONALSMERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONEBio-Medical & Pharmaceutical Manufacturing Corporation374e172b-90e8-4fca-8934-dee3ed7b599d2025-12-03WarningsExact identifier
application number: M020
LBEL SOLUTIONS PRO HIALURON BALM BALSAMO LABIAL HIDRATANTE 72H FPS 20 HYDRATING LIP BALM 72H SPF 20 BERRY UNIVERSELOCTINOXATE, ZINC OXIDEBEL STAR S A25b6cb46-6516-376a-e063-6394a90a44f62025-12-03WarningsExact identifier
application number: M020
LBEL LUMI AGE ANTI AGING NOURISHING FACIAL WITH SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENEBEL STAR SA4510cd0d-40b8-f452-e063-6394a90a44e52025-12-03WarningsExact identifier
application number: M020
BANANA BOATAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC45117885-c674-b58a-e063-6394a90af5f42025-12-03WarningsExact identifier
application number: M020
CANNON BALMOCTINOXATE, OCTISALATE, OCTOCRYLENE, AVOBENZONEDUKE CANNON SUPPLY CO.f70a0173-c8ba-da7c-e053-6294a90a67db2025-12-03WarningsExact identifier
application number: M020
Radically Rejuvenating SPF Day CreamZINC OXIDEBetter Planet Brands LLC1d8c8600-f2d1-6e12-e063-6294a90ab88a2025-12-03WarningsExact identifier
application number: M020
Seriously Soothing SPF Day CreamZINC OXIDEBetter Planet Brands LLC1d8d47f6-907d-ab31-e063-6394a90a05d82025-12-03WarningsExact identifier
application number: M020
Invisible Sunscreen Stick SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBetter Planet Brands LLC1d8df35e-0af6-36f6-e063-6394a90a0f032025-12-03WarningsExact identifier
application number: M020
Sun Serum DropsZINC OXIDEBetter Planet Brands LLC2cdb97bf-a4d7-1cb7-e063-6394a90ab2b82025-12-03WarningsExact identifier
application number: M020
Mineral Sunscreen SPF 50ZINC OXIDEBetter Planet Brands LLC1d8e727c-8b50-9cf2-e063-6394a90a2e152025-12-03WarningsExact 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