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 69 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ALOE KOTE SPF 25OCTINOXATE, OXYBENZONE, HOMOSALATEAloe Care International, LLC12e78c53-ba19-4c8e-bd2f-8c85fccbc1792026-01-26WarningsExact identifier
application number: M020
ALOE UP KIDS SPORT SUNSCREEN SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEAloe Care International, LLC62016e94-b5d2-4ba2-ab9c-b0b2c1ead6502026-01-26WarningsExact identifier
application number: M020
Homosalate 10 Avobenzone 3% Octocrylene 6%SPF 45 FACES&C Hampton Sun LLCe49808c9-5025-4965-8679-7fe824cf69072026-01-26WarningsExact identifier
application number: M020
ENVIRONMENTAL DEFENSEZINC OXIDEAvasol LLC1fbddab4-71f7-4167-ad21-30040b7c71bb2026-01-26WarningsExact identifier
application number: M020
Surfers BarrierZINC OXIDEAvasol LLCd6e2ac0a-3bf6-4d08-8647-6a23de2ac8572026-01-26WarningsExact identifier
application number: M020
SURFERS BARRIER SPF 50ZINC OXIDE, TITANIUM DIOXIDEAvasol LLCec55eef0-17e6-416d-bd5e-548f2f323cea2026-01-26WarningsExact identifier
application number: M020
Zenskin Watery Dew Nia-Cica SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE SUNSCREENZenskin Co. Ltd.49584899-d523-9677-e063-6394a90a14032026-01-26WarningsExact identifier
application number: M020
Caring mill sun serum with Vitamin C NiacinamideHOMOSALATE OCTOCRYLENE OCTISALATE AVOBENZONEFSA Store lnc.4931ee71-1088-1ac1-e063-6294a90ad82b2026-01-25WarningsExact identifier
application number: M020
Caring mill Mineral Eye CreamZINC OXIDEFSA STORE INC.4932ea19-28cc-b245-e063-6394a90ac7aa2026-01-25WarningsExact identifier
application number: M020
Ceile SPF 30 prime PROTECT Broad Spectrum SPF 30 SunscreenSUNSCREEN 30 MINERALLE COSMETICS INC2cee0413-d532-c192-e063-6294a90aa8232026-01-25WarningsExact identifier
application number: M020
BeginS by JUNGSAEMMOOL Blue Chamomile Hyaluronic Acid Aqua Sunscreen Broad Spectrum SPF 50 plusAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEJungsaemmool Beauty Co., Ltd.62e23503-7233-434a-91f0-092f10d2717d2026-01-24WarningsExact identifier
application number: M020
BeginS by JUNGSAEMMOOL Blue Chamomile Hyaluronic Acid Airy Sun Stick Broad Spectrum SPF 50 plusAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEJungsaemmool Beauty Co., Ltd.030a20fb-4846-4a5c-9808-a399aac2ff0b2026-01-24WarningsExact identifier
application number: M020
Mimosa Lane SPF45OCTINOXATE, OCTISALATE, ZINC OXIDE SUNSCREENR&G Divergency LLC40f3b8ea-bfa5-4c66-9c79-c4408bda857a2026-01-24WarningsExact identifier
application number: M020
111 SKIN SUNSCREEN SPF 50ZINC OXIDEBentley Laboratories, LLCb1265797-71dd-4302-ab26-dbff6ccec8562026-01-23WarningsExact identifier
application number: M020
Mania Holic Sunscreen PackOCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONEFirstmarket Co., ltd.b95a460c-1f7b-4193-b305-466e073af6402026-01-23WarningsExact identifier
application number: M020
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 320HOMOSALATE,OCTISALATE,ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.1cdbae71-441b-426d-99ee-c889d76af4522026-01-23WarningsExact identifier
application number: M020
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 250HOMOSALATE,OCTISALATE,ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.8f4b5e0a-4578-4af3-b7d9-a19d4eb732e72026-01-23WarningsExact identifier
application number: M020
ISA KNOX 365 BB SUNSCREEN Broad Spectrum SPF 40, PATITANIUM DIOXIDELG Household and Healthcare, Inc.65e70306-9e79-494d-9217-a43002f163072026-01-23WarningsExact identifier
application number: M020
O HUI Sun Science Ideal Cover Sunscreen Broad SpectrumTITANIUM DIOXIDELG Household and Healthcare, Inc.c15ffd23-271d-458d-9048-9bc50331d5d72026-01-23WarningsExact identifier
application number: M020
Aqua protection Sunscreen Broad Spectrum SPF50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEENGLEWOOD LAB, INC.627e6ea5-016b-4ab6-a50c-aa9c27e5cca12026-01-23WarningsExact 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