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 152 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Banana Boat Sport Ultra Broad Spectrum SPF 50 Plus Sunscreen Lip BalmAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLCc7a3c03b-7fee-404c-e053-2a95a90a3a972025-12-04WarningsExact identifier
application number: M020
Poolside Bronze Service Instant bronzing lotion. SPF30HOMOSALATE,OCTOCRYLENE, OCTISALATE,OCTINOXATE, AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.4524129b-f8aa-171b-e063-6294a90aeebe2025-12-04WarningsExact identifier
application number: M020
Solbar Zinc SPF38SOLBAR ZINC SPF38Person and Coveyfac62a2f-92ee-4afd-9999-bc5011159e432025-12-04WarningsExact identifier
application number: M020
elf Sun Boss Gloss SPF 25 Sunscreen Pink Me GirlZINC OXIDEe.l.f. Cosmetics, Inc.6c316ce4-c2f6-4633-a789-e786d0f76abd2025-12-04WarningsExact identifier
application number: M020
Poolside Frostbite Sunscreen coconut SPF 15 Scented lip glossHOMOSALATE, OCTOCRYLENE, OCTISALATE , AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.452b5f2c-b61f-8915-e063-6294a90ac9112025-12-04WarningsExact identifier
application number: M020
Poolside Frostbite Sunscreen watermelon SPF 15 Scented lip glossHOMOSALATE , OCTOCRYLENE, OCTISALATE, AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.452b6e12-1bf9-8093-e063-6394a90a9e742025-12-04WarningsExact identifier
application number: M020
Poolside Frostbite Sunscreen Papaya SPF 15 Scented lip glossHOMOSALATE,OCTOCRYLENE,OCTISALATE,AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.452b6f22-5080-86ab-e063-6394a90a04162025-12-04WarningsExact identifier
application number: M020
Poolside Golden Hour SPF15 sunscreen lip oilHOMOSALATE,OCTOCRYLENE,OCTISALATE,AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.452b8393-1887-a660-e063-6394a90a4c2b2025-12-04WarningsExact identifier
application number: M020
Poolside Sun Daze Body Illuminator SPF 30 shimmer sunscreen gelHOMOSALATE,OCTOCRYLENE,OCTISALATE,AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.452b8dde-dd63-b585-e063-6394a90a35432025-12-04WarningsExact identifier
application number: M020
Binda Botanicals Baby and Kids Sunscreen SPF50ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED452b9b7d-4049-b483-e063-6394a90a53582025-12-04WarningsExact identifier
application number: M020
BINDA Face and Body Sunscreen SPF50ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED386f5013-430c-e07f-e063-6394a90a32a82025-12-04WarningsExact identifier
application number: M020
Poolside Not Your Babys Oil. SPF 30 sunscreen body oil.HOMOSALATE,OCTOCRYLENE,OCTISALATE,AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.452bcb25-848c-e8a7-e063-6394a90ace0f2025-12-04WarningsExact identifier
application number: M020
Sugargirl Glowy face screen sunbeam shimmer sunscreen for the face SPF 30HOMOSALATE, OCTOCRYLENE, OCTINOXATE, OCTISALATE, AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.452bd1d2-6a9f-f5e8-e063-6394a90ac9e32025-12-04WarningsExact identifier
application number: M020
Poolside Butter SCREEN SPF 30 sunscreen ButterHOMOSALATE , OCTOCRYLENE , OCTISALATE , AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.452bd24d-8654-e6c0-e063-6394a90a0aea2025-12-04WarningsExact identifier
application number: M020
Poolside Glow Butter Screen SPF 30 Shimmer sunscreen ButterHOMOSALATE , OCTOCRYLENE, OCTISALATE , AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.452bd69e-02c7-fcbd-e063-6394a90ae59b2025-12-04WarningsExact identifier
application number: M020
Softlips CherryDIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONEThe Mentholatum Companybececc42-1321-430a-80ef-438060fdcc862025-12-04WarningsExact identifier
application number: M020
ATTITUDE Sunly Lip Balm SPF 15 WatermelonZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE450d038b-3f99-add8-e063-6294a90aee9a2025-12-03WarningsExact identifier
application number: M020
Natrience Broad Spectrum SPF 30SKIN SHIELDSisel International, LLC1989370f-68a6-6f22-e063-6394a90aacaf2025-12-03Boxed warning, WarningsExact identifier
application number: M020
ATTITUDE Super leaves Lip Balm SPF 15 CoconutZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE450d8fd0-20ad-1920-e063-6394a90a72712025-12-03WarningsExact identifier
application number: M020
ATTITUDE Super leaves Lip Balm SPF 15 ExoticZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE450db2bb-1788-efc2-e063-6294a90a13c02025-12-03WarningsExact 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