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 308 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Garnier green labs Pore Perfecting CannaB Serum Broad Spectrum SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENELOreal USA Products Inc21d9b6dc-6f99-4af4-a838-c762c3fb9e3a2024-01-01WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique Hydraphase UV Intense Moisturizer Broad Spectrum SPF 20 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Incad4f45b2-3391-4e32-9744-28838727260c2024-01-01WarningsExact identifier
application number: M020
La Roche Posay New 50 Body and Face SPF 50 Mineral Anthelios Gentle 100 percent mineral UV filters Soft finish with Cell Ox ShieldTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Incc0f7ae46-7161-4d48-9386-007bfafecfd52024-01-01WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios HA Mineral Broad Spectrum SPF 30 Daily Moisturizing SunscreenTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc7bca5947-88a3-4cb3-a6f2-9fa389d344ef2024-01-01WarningsExact identifier
application number: M020
LOreal Paris Revitalift Miracle Blur Broad Spectrum SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONEL'Oreal USA Products Inc45eb17f4-6fc0-4e6d-a905-78581175de952024-01-01WarningsExact identifier
application number: M020
LOreal Paris Skin Expert Revitalift Bright Reveal Brightening Day Moisturizer Broad Spectrum SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc454e4b9a-4ddf-44cf-8ee9-abab6f5744242024-01-01WarningsExact identifier
application number: M020
Kiehls Super Fluid Daily UV Defense SPF 50 plus Anti-Pollution Lightweight Formula for All Skin TypesAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONEL'Oreal USA Products Inc5bbd9e40-3b80-4ecb-b1d4-0110904135342024-01-01WarningsExact identifier
application number: M020
Garnier SkinActive Clearly Brighter AntiSun Damage Daily Moisturizer Broad Spectrum SPF 30 SunscreenAVOBENZONE, HOMOSLATE, OCTISALATE AND OCTOCRYLENELOreal USA Products Inc1d33dc1d-40d5-4a85-8dfe-708bfb9da5382024-01-01WarningsExact identifier
application number: M020
Vichy Laboratoires Aqualia Thermal UV Defense Moisturizer Broad Spectrum SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc.08bcee1c-399a-4ec8-84cf-b5e83c4fa6652024-01-01WarningsExact identifier
application number: M020
LOreal Paris Skin Paradise Water Infused Tinted Moisturizer Broad Spectrum SPF 19 SunscreenENSULIZOLEL'Oreal USA Products Inc913116de-1abf-4844-8611-1db1b093ad002024-01-01WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios Kids Gentle Broad Spectrum SPF 50 Sunscreen for Face and Body Water Resistant 80 MinutesAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc8a2fd46c-5767-4621-8e69-dd291f9fe5b12024-01-01WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios 50 Mineral Daily Tone Correcting Primer Broad Spectrum SPF 50 SunscreenTITANIUM DIOXIDEL'Oreal USA Products Inc89b59bd7-9a91-4b99-84e7-996a8b1d499e2024-01-01WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios Clear Skin Face Oil Free Dry Touch Broad Spectrum SPF 60 Sunscreen Water Resistant 80 MinutesAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Ince1310453-1880-43a5-982b-cf9b30cfdc472024-01-01WarningsExact identifier
application number: M020
Kiehls Since 1851 Super Multi Corrective Broad Spectrum SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENELOreal USA Products Inc733e7853-ab11-4887-83a2-b9d95c1634532024-01-01WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios 60 Melt In Sunscreen Milk Broad Spectrum SPF 60 Face and BodyAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONEL'Oreal USA Products Inc53ab6046-058b-4cdf-8e4e-7ce6f52887012023-12-31WarningsExact identifier
application number: M020
CeraVe Developed with Dermatologists Skin Renewing Broad Spectrum SPF 30 DayOCTINOXATE AND ZINC OXIDEL'Oreal USA Products Inc.50542a3b-2ef0-452f-b463-79b41e10d1e02023-12-31WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios 50 Tinted Mineral SunscreenTITANIUM DIOXIDEL'Oreal USA Products Inc6d3c5fc5-c818-46c4-8db3-cffcdcd56e062023-12-31WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique Sport Anthelios Activewear Broad Spectrum SPF 60 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc071bfb80-d980-4e62-9cd6-96149f1ba04a2023-12-31WarningsExact identifier
application number: M020
Garnier green labs Brightening Serum PineaC Broad Spectrum SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENELOreal USA Products Inc9302bccb-636d-45f1-8919-9b98c2e685672023-12-31WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios 50 Daily Antiaging Primer with SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONEL'Oreal USA Products Inc6b65d6d9-7ff3-4c84-986e-ef180161eadb2023-12-31WarningsExact 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