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 233 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TiZO Mineral Sun Defense SPF 50TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals Ltd.2cc8f7ef-eda3-fe71-e063-6394a90a6a9a2025-01-28WarningsExact identifier
application number: M020
Baby Diaper Rash CreamZINC OXIDEdoTERRA International, LLC641465a1-0daf-1bb9-e053-2a91aa0ab25d2025-01-28WarningsExact identifier
application number: M020
HydroPeptide S.P.F. Sun Protection FriendsTITANIUM DIOXIDE, ZINC OXIDEHydroPeptide LLCf3669a1e-8b75-4e94-a3f0-71dcbc3fa9142025-01-28WarningsExact identifier
application number: M020
doTERRA sun Face Daily MoisturizerZINC OXIDEdoTERRA International, LLCf3836517-e3ec-5e9e-e053-2a95a90a7af12025-01-28WarningsExact identifier
application number: M020
doTERRA sunZINC OXIDEdoTERRA International, LLCda5c48d6-1859-983d-e053-2a95a90a4c3e2025-01-28WarningsExact identifier
application number: M020
doTERRA sunZINC OXIDEdoTERRA International, LLCdd2fa6a2-2ba8-4333-e053-2a95a90a97902025-01-28WarningsExact identifier
application number: M020
Tri-water sheer mineral sunscreen cushion SPF30ZINC OXIDEEden Brands Inc.2cd22172-78cb-32f3-e063-6394a90a395d2025-01-28WarningsExact identifier
application number: M020
SOS Face Guard Broad Spectrum Sunscreen SPF 30ZINC OXIDETower 286687006a-bd79-4e1c-a546-0f0b51b299482025-01-28WarningsExact identifier
application number: M020
LBEL CONCENTRE GLOBAL ANTI AGING SERUM CONCEALER SPF 15 EYES FACE ALMENDRA 230OCTINOXATE, ZINC OXIDEBEL STAR S.A.2cb1a767-3228-71ea-e063-6294a90ac89e2025-01-27WarningsExact identifier
application number: M020
Meijer SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEMeijer26f7566e-5a89-21cf-e063-6294a90ac8862025-01-27WarningsExact identifier
application number: M020
TiZO Photoceutical AM Replenish Non-TintedZINC OXIDEFallien Cosmeceuticals, LTD2cb77125-ff77-2060-e063-6294a90ab69f2025-01-27WarningsExact identifier
application number: M020
GLOW RECIPE WATERMELON GLOW DEW SHIELD HYDRATING FLUID SPF 30AVOBENZONE, HOMOSALATE, OCTISALATEAramara Beauty LLC dba Glow Recipe2cb90666-6517-a02c-e063-6294a90ab0622025-01-27WarningsExact identifier
application number: M020
Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDEZ&Z Skin Essentials2cdc48f3-474f-9c06-e063-6294a90afea12025-01-27WarningsExact identifier
application number: M020
Cetaphil Sheer Mineral Sunscreen Stick SPF 50TITANIUM DIOXIDE, ZINC OXIDEGalderma Laboratories, L.P.54f6df65-e90c-4070-aa95-f47496dd11bd2025-01-27WarningsExact identifier
application number: M020
Cetaphil Healthy Renew Day Cream Broad Spectrum SPF 30HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEGalderma Laboratories, L.P.5b4e25ad-cd72-4960-9259-fc710bfd59da2025-01-27WarningsExact identifier
application number: M020
Well People Daygleamer Liquid Mineral Sunscreen SPF 34ZINC OXIDEe.l.f. Cosmetics, Inc.2c7621e9-0f1d-4712-e063-6294a90abd642025-01-24WarningsExact identifier
application number: M020
Equate Sunscreen SPF 30 SPORT Broad SpectrumAVOBENZONE, HOMOSALATE,OCTISALATE,OCTOCRYLENEWal-Mart Stores Inc1697628a-91d2-45bc-bd1b-91fb38f3f8df2025-01-24WarningsExact identifier
application number: M020
DR.JART EVERY SUN DAY SUN FLUIDHOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, AVOBENZONEHave & Be Co., Ltd.f06d8f90-f3df-6d76-e053-2a95a90af1f82025-01-24WarningsExact identifier
application number: M020
CoTZ Silky Foam - TintedTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTDd63088d7-a1d7-4b56-a7d8-ad217011a8a82025-01-24WarningsExact identifier
application number: M020
CoTZ Silky Foam Non-TintedTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD9c04b76e-ae65-4183-b475-3b8e8764db592025-01-24WarningsExact 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