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 201 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dolce and Gabbana Everlast Foundation SPF 20 12N Light MediumOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L26062cd7-3817-46c7-b65f-92cd57eca5dd2025-08-05WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 13C Light MediumOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L448a24a3-91ef-4530-828c-e77d8aae7f0b2025-08-05WarningsExact identifier
application number: M020
JORDAN FAT KIDS Tallow Sunscreen SPF 30MENTHOL, METHYL SALICYLATEJORDAN FAT KIDS LLC72ac88cf-9f20-44ea-b3a2-12c922eec2b32025-08-04WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 02C LightOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L09f9e59b-6f71-4d42-9b5d-275f756d985b2025-08-04WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 03W LightOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L3b1e4480-8409-425e-b98d-eb4dcf2471e82025-08-04WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 06W LightOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L3090422e-fc18-45b8-88f2-6a9b282a72052025-08-04WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 05N LightOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Lf93aa5d2-90ab-4e11-874e-2ede4b25c4b62025-08-04WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 04C LightOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Lf055cd51-7b1d-43df-8990-8f60ba1eb91c2025-08-04WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 07N LightOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Ld4c76bc5-205b-45fd-8a02-4f4b174585032025-08-04WarningsExact identifier
application number: M020
AHAVA Extreme Daily Firmness And Protection Broad Spectrum SPF30HOMOSALATE, OCTISALATE, AVOBENZONE, ENSULIZOLE, AND OCTOCRYLENEAHAVA Dead Sea Laboratories Ltdb22af9ef-4b69-4e70-a65d-f421e1d178af2025-08-01WarningsExact identifier
application number: M020
Neutrogena Collagen Bank SPF Moisturizer Broad Spectrum SPF 30 and Neutrogena Collagen Bank MoisturizerAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKenvue Brands LLC3b4dbc5a-0754-0e71-e063-6394a90aa63c2025-08-01WarningsExact identifier
application number: M020
Kids Tallow Sunscreen SPF50NON-NANO ZINC OXIDE 25%FOUNDATION COMMERCE INC3b4eca91-965f-66c6-e063-6394a90a78ca2025-08-01WarningsExact identifier
application number: M020
Vigority Tallow Sunscreen SPF30NON-NANO ZINC OXIDE 19%FOUNDATION COMMERCE INC3b4f5941-15ae-a760-e063-6394a90a2abe2025-08-01WarningsExact identifier
application number: M020
Pipette Mineral Sunscreen SPF 50ZINC OXIDEPipette LLC3a10657a-bc16-181d-e063-6294a90a485b2025-08-01WarningsExact identifier
application number: M020
No7 Restore and Renew Face and Neck Multi Action Day Cream Sunscreen Broad Spectrum SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENEBCM Cosmetique SAS3f0500cc-013b-7069-e063-6294a90a1a5f2025-08-01WarningsExact identifier
application number: M020
Daily Antioxidant Mineral SunscreenZINC OXIDEMONIKA G KIRIPOLSKY MD INC.3b3d7ff2-1463-8d8e-e063-6394a90a5ac82025-07-31WarningsExact identifier
application number: M020
Shaklee Shield Sheer Mineral Body Sunscreen SPF 30ZINC OXIDEShaklee Corpc9b8e04c-11ee-4c4f-8693-aa4dc6e66aca2025-07-31WarningsExact identifier
application number: M020
Equate SUNSCREEN spf 50 SPORT broadspectrumAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEWalmart4e5280b2-1437-4d97-bb4c-db1a1632fea72025-07-31WarningsExact identifier
application number: M020
Tallow Sunscreen SPF 30NON-NANO ZINC OXIDE 19%FOUNDATION COMMERCE INC3b410ed7-c629-e39c-e063-6294a90a12f62025-07-31WarningsExact identifier
application number: M020
Face Reality Brilliant Defense Sunscreen SPF 50OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONEFace Reality,LLC618f58b7-2f29-4dff-8c3a-4fdbe1eb8ce42025-07-29WarningsExact 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