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 321 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gin Amber Beauty Mineral Sunscreen Broad Spectrum SPF 25 BB CreamZINC OXIDEGin Amber Beauty LLC32f48fe4-5788-449e-9ed8-9cd8b2ecc1c02023-11-14WarningsExact identifier
application number: M020
Private Label SPF 50 80 min Water ResistantHOMOSALATE, OCTISALATE, ZINC OXIDE SUNSCREENSwiss-American CDMO, LLC8849fa88-24c8-410d-b16e-60da38288f982023-11-14WarningsExact identifier
application number: M020
Cetaphil Sheer Mineral Face Liquid Sunscreen SPF 50ZINC OXIDEGalderma Laboratories, L.P.0d09b812-b3ca-4214-bed7-7e21ee3288b72023-11-14WarningsExact identifier
application number: M020
DAYWEAR ADVANCED MULTI-PROTECTION ANTI-OXIDANT 24H-MOISTURE CREME BROAD SPECTRUM SPF15AVOBENZONE, HOMOSALATE, OCTISALATEESTEE LAUDER INC0a0bfe4a-53b6-5b7c-e063-6394a90a23ec2023-11-13WarningsExact identifier
application number: M020
Bull Frog SPF 50 Mosquito Coast Sunscreen Plus Inspect RepellentAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENEBULLFROG BRANDS, LLC.f70b39c6-9f40-f5c1-e053-6394a90a1d432023-11-13WarningsExact identifier
application number: M020
Bull Frog SPF 50AVOBENZONE 3.00% HOMOSALATE 15.00% OCTISALATE 5.00% OCTOCRYLENE 10.00%Bullfrog Brands, LLCc90fc29e-d9fe-a6c9-e053-2995a90a69b32023-11-13WarningsExact identifier
application number: M020
Tropical Sands, SPF-50 Broad Spectrum SunscreenTITANIUM DIOXIDE, ZINC OXIDEElements Brands, Inc.493551d0-10a0-3d78-e054-00144ff8d46c2023-11-11WarningsExact identifier
application number: M020
Tropical Sands SPF-30 Broad Spectrum SunscreenTITANIUM DIOXIDE, ZINC OXIDEElements Brands, Inc.494a7886-d677-1648-e054-00144ff8d46c2023-11-11WarningsExact identifier
application number: M020
Tropical Sands SPF-30 Broad Spectrum SunscreenTITANIUM DIOXIDE, ZINC OXIDEElements Brands, Inc.ab691543-e37a-487a-912e-56d2e0e4d30a2023-11-11WarningsExact identifier
application number: M020
LBri Pure nNatural Oil Free MoisturizerOCTINOXATE, AVOBENZONE, OCTISALATEL'Bri Health & Beauty47f6ab9e-fa47-496a-e054-00144ff8d46c2023-11-11WarningsExact identifier
application number: M020
PURE HAVEN BODY SPF 30TITANIUM DIOXIDE, ZINC OXIDEPure haven, LLC6f298fcd-8a97-8f66-e053-2991aa0adb102023-11-11WarningsExact identifier
application number: M020
Sunstation All-Natural SPF 30 SunscreenTITANIUM DIOXIDE, ZINC OXIDESunstation USA, LLC499d366a-a7f1-6070-e054-00144ff88e882023-11-11WarningsExact identifier
application number: M020
PURE HAVEN Face Sunscreen SPF-30ZINC OXIDEPure Haven, LLC1fff88a0-4d23-4cd7-872e-1a0b8c6803422023-11-11WarningsExact identifier
application number: M020
Pure Haven EssentialsTITANIUM DIOXIDE, ZINC OXIDEPure Haven LLC4bccc017-266d-11ce-e054-00144ff8d46c2023-11-11WarningsExact identifier
application number: M020
No BS SPF20 MoisturizerOCTINOXATE, AVOBENZONE, OCTOCRYLENEProduct Management LLC690f68fa-d110-4a75-9a14-04aac1be45842023-11-11WarningsExact identifier
application number: M020
koa protect our ocean life OXYBENZONE FREE Broad Spectrum SPF 30 UVA UVB Protection SunscreenTITANIUM DIOXIDE, ZINC OXIDEKapa'ihi, Inc66e5eb1b-4ef0-459d-8428-b3e2f221bc852023-11-11WarningsExact identifier
application number: M020
Sea Star Sparkle SPF-50 PARTY CAKEOCTINOXATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDEMJ Products Association, LLC8cfaf1b6-0f25-4770-9760-2440b2c153b72023-11-11WarningsExact identifier
application number: M020
Sea Star Sparkle SPF-50 VERY BERRYOCTINOXATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDEMJ Products Association, LLC88c403ea-7c78-423e-b05e-1e17c21c5a532023-11-11WarningsExact identifier
application number: M020
FITGLOW Vita Shield Hyaluronic Primer SPF-30ZINC OXIDEFITGLOW BEAUTY LLCb9ba7783-74ca-4736-8a60-1692158590472023-11-11WarningsExact identifier
application number: M020
BLUE MONARCH Tinted SPF-50 (Rose Gold)ZINC OXIDEBlue Monarch, LLC9ba00a03-1015-4946-8c9b-5ef377a32e4b2023-11-11WarningsExact 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