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 219 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EltaMD UV Clear Tinted SPF46ZINC OXIDE AND OCTINOXATE SUNSCREENCP Skin Health Group, Inc.1ac59ef1-113e-4ad1-90c3-38353bc7e1ec2025-03-31WarningsExact identifier
application number: M020
lip balm SPF15( CB222) 01AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.316416d0-52b5-6f2f-e063-6294a90a9bc12025-03-28WarningsExact identifier
application number: M020
lip balm SPF15( CB400) 01OCTOCRYLENE,OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.316463e0-dc1f-e2ae-e063-6394a90a0c3c2025-03-28WarningsExact identifier
application number: M020
Sunscreen Stick SPF30( CB400) 01AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.316498d9-32fe-f884-e063-6394a90a43072025-03-28WarningsExact identifier
application number: M020
ALEX MD PHD Sheer Mineral SunscreenZINC OXIDE, TITANIUM DIOXIDEPHYSICIAN LABORATORIES INC8f64c4fa-92ee-4af0-ab1b-6c3673f9a6222025-03-28WarningsExact identifier
application number: M020
ALEX MD PHD Tinted Mineral SunscreenZINC OXIDE, TITANIUM DIOXIDEPHYSICIAN LABORATORIES INC93873c34-5c72-43c8-b6c2-c65b596191d72025-03-28WarningsExact identifier
application number: M020
TRADER JOES SHIMMER GLOW SUNSCREEN SPF 40AVOBENZONE, OCTISALATE, OCTOCRYLENETrader Joe's Company316c7793-5937-9ce4-e063-6294a90ae0a12025-03-28WarningsExact identifier
application number: M020
CeraVe AM Facial Moisturizing Broad Spectrum SPF 50 SunscreenHOMOSALATE, OCTISALATE, OCTOCRYLENE AND ZINC OXIDEL'Oreal USA Products Incdc85cff3-df18-4bb7-8d71-bb0878959fe22025-03-28WarningsExact identifier
application number: M020
City Skin Age Defense Broad Spectrum SPF 50TITANIUM DIOXIDE AND ZINC OXIDEMurad, LLCf8c572a2-b4bc-49e9-95df-359f05bd69b72025-03-28WarningsExact identifier
application number: M020
HEB SPF 50 Rejuvenate Sunscreen with Moisturizing Oils and Vitamins Continuous SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.B314c54ed-32f8-5c20-e063-6394a90a0af52025-03-27WarningsExact identifier
application number: M020
natural lip balm SPF15( blueberry) 01AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.314f8990-4b33-e2b1-e063-6394a90a4d792025-03-27WarningsExact identifier
application number: M020
natural lip balm SPF15( bubble gum) 01AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.31507a62-09a7-6bcc-e063-6394a90aa5752025-03-27WarningsExact identifier
application number: M020
natural lip balm SPF15( Birthday cake) 01AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.3152bd5d-474f-e392-e063-6294a90aa9302025-03-27WarningsExact identifier
application number: M020
Lip Balm SPF15 Bubble Gum FlavoredLIP BALM SPF15 BUBBLE GUM FLAVOREDLS Promotions Inc3152bd5d-4750-e392-e063-6294a90aa9302025-03-27WarningsExact identifier
application number: M020
natural lip balm SPF15( Cocount Pina Colada) 01AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.31538f32-9f71-bd40-e063-6394a90a1cd82025-03-27WarningsExact identifier
application number: M020
Lip Balm SPF15 Birthday Cake flavoredLIP BALM SPF15 BIRTHDAY CAKE FLAVOREDLS Promotions Inc3153bc6a-8f60-ea37-e063-6294a90acd972025-03-27WarningsExact identifier
application number: M020
natural lip balm SPF15( Apple pie) 01AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.3153e1fe-1c43-def0-e063-6294a90a6b3a2025-03-27WarningsExact identifier
application number: M020
Lip Balm SPF15 Strawberry Shortcake flavoredLIP BALM SPF15 STRAWBERRY SHORTCAKE FLAVOREDLS Promotions Inc315402e4-c1ec-150f-e063-6294a90ae29e2025-03-27WarningsExact identifier
application number: M020
natural lip balm SPF15( Vanilla) 01AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.3154206c-00b3-e5e3-e063-6394a90afee82025-03-27WarningsExact identifier
application number: M020
natural lip balm SPF15( Passion Fruit) 01AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.31544568-c556-72b2-e063-6294a90ace912025-03-27WarningsExact 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