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 229 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Quick Screen Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEThe Quick Flick PTY LTD3788666e-7efa-43da-95f5-6218b7fcb6ea2025-02-12WarningsExact identifier
application number: M020
Dolce AND Gabbana Get Your Healthy Glowy SkinZINC OXIDESocoplan91bf1cca-8d18-4c59-864d-4fd0619c67132025-02-12WarningsExact identifier
application number: M020
Cell Fusion C Aquatica UV Defense Sunscreen Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECMS LAB Inc.2dfd1f99-5896-1e0f-e063-6394a90aa71d2025-02-12WarningsExact identifier
application number: M020
Biore Aqua Rich UVOCTOCRYLENE, OCTISALATE, AVOBENZENE, HOMOSALATEKAO USAf9024581-dbab-b7cb-e053-6294a90a8b9a2025-02-12WarningsExact identifier
application number: M020
Dr Loretta Universal Glow Daily Defense SPF 40ZINC OXIDEDr. Loretta, LLCebdaf6c1-1572-4840-851b-6d780471fcb22025-02-11WarningsExact identifier
application number: M020
Sky and Sol Body Sunscreen SPF50SKY AND SOL BODY SUNSCREEN SPF50Guangzhou Fantesy Biotechnology Co.,Ltd2de9173b-fa02-8017-e063-6394a90ae0aa2025-02-11WarningsExact identifier
application number: M020
Beeswax SPF 15 Broad Spectrum Lip BalmBEESWAX SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inc2dcc2f9b-4a8c-b281-e063-6294a90ad9d62025-02-10WarningsExact identifier
application number: M020
Broad Spectrum SPF 30 Tropical SunscreenBROAD SPECTRUM SPF 30 TROPICAL SUNSCREENRaining Rose, Inc2dcca380-c0e4-4e04-e063-6394a90ac31e2025-02-10WarningsExact identifier
application number: M020
Artistry Ideal Radiance Illuminating CC SPF 50 Broad Spectrum Sunscreen DeepENSULIZOLE, OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDEAmway Corp88021a24-d3b5-48f8-8d26-affbfcfd098f2025-02-10WarningsExact identifier
application number: M020
Sun Defense Minerals (Sheer)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2dd20800-2cf9-02d4-e063-6294a90a0f002025-02-10WarningsExact identifier
application number: M020
Bondi Sands Fragrance Free Face SPF 50 Sunscreen MistHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEBONDI SANDS (USA) INC.2dd5ea23-eee6-5d14-e063-6294a90a0fd32025-02-10WarningsExact identifier
application number: M020
Centella Calming SUNSCREENCENTELLA CALMING SUNSCREENGUANGZHOU YUSONG FINE CHEMICLS Co., Ltd2dc0ee9b-d58b-fe40-e063-6394a90af4392025-02-09WarningsExact identifier
application number: M020
SOME BY MI V10 HYAL LIP SUN PROTECTOR ROSYAVOBENZONE, HOMOSALATE, OCTISALATEPERENNEBELL Co., Ltd2dc25afb-a171-f1f2-e063-6294a90ae3332025-02-09WarningsExact identifier
application number: M020
SOME BY MI V10 HYAL LIP SUN PROTECTOR BERRYAVOBENZONE, HOMOSALATE, OCTISALATEPERENNEBELL Co., Ltd2dc285ad-08cd-14e6-e063-6294a90a24fc2025-02-09WarningsExact identifier
application number: M020
PROBIOTIC RICE SunscreenPROBIOTIC RICE SUNSCREENGUANGZHOU YUSONG FINE CHEMICLS Co., Ltd2d9d6440-39b3-312a-e063-6394a90aa0722025-02-08WarningsExact identifier
application number: M020
NIA 24 SPF 30HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENENiadyne Ince5c9d56f-48b4-4f0e-add6-f73268755b162025-02-07WarningsExact identifier
application number: M020
Pacific Mango Sunscreen SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENESAN DIEGO NATURAL SOAP COMPANYd09e3096-0678-4433-a555-61f18a45873b2025-02-06WarningsExact identifier
application number: M020
DR.JART CICAPAIR TIGER GRASS COLOR CORRECTING TREATMENTZINC OXIDE, TITANIUM DIOXIDEHave & Be Co., Ltd.01cfe6a6-c2e4-8fb8-e063-6294a90adc782025-02-06WarningsExact identifier
application number: M020
Dr.Jart Premium Beauty Balm Medium-TanZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATEHave & Be Co., Ltd.02a8bab8-ca5d-6b65-e063-6294a90abb072025-02-06WarningsExact identifier
application number: M020
Dr.Jart Premium Beauty Balm Fair-LightZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATEHave & Be Co., Ltd.02a82029-bdb1-cbe0-e063-6294a90a08f32025-02-06WarningsExact 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