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 159 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aveeno Protect Plus Hydrate Sunscreen Broad Spectrum Body SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC0e905f47-a1d8-4c5a-8247-d7328d2cb4af2025-11-21WarningsExact identifier
application number: M020
SPF 50 Sport Sunscreen GoodSenseAVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Geiss, Destin, & Dunn, Inca22baebd-1f4d-6eae-e053-2a95a90afe512025-11-21WarningsExact identifier
application number: M020
Everyday Sun DefenseZINC OXIDEHommerejuvenate, Inc.05aa1a1a-9e4f-2781-e063-6394a90aef6b2025-11-21WarningsExact identifier
application number: M020
HYDRATING GLOW MIST SPF 50AVOBENZONE, OCTISALATE, OCTOCRYLENEWILD CHILD LABORATORIES PTY LTDdca2f4ce-1a3a-707e-e053-2995a90abad72025-11-21WarningsExact identifier
application number: M020
innisfree Daily UV Defense SunscreenAVOBENZONE, HOMOSALATE, AND OCTISALATE LOTIONInnisfree Corporation0e9b6697-28a3-f69f-e063-6394a90a9d112025-11-20WarningsExact identifier
application number: M020
SULWHASOO PERFECTING CUSHION NO. 15OCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDEAmorepacific Corporation8d420e4b-c778-3ed4-e053-2995a90a59a92025-11-20WarningsExact identifier
application number: M020
Anti-Aging Complex Eye Treatment Merle NormanOCTINOXATE, ZINC OXIDEMerle Norman Cosmetics, Inc13381b0d-52f6-4736-b2bf-faf34d5028a82025-11-20WarningsExact identifier
application number: M020
CC Cream Broad Spectrum SPF 30 Merle NormanHOMOSALATE, OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc93ebe819-6763-400c-8320-812276168b6c2025-11-20WarningsExact identifier
application number: M020
Protect Prevent Daily Mineral Sunscreen Broad Spectrum SPF30TITANIUM DIOXIDE, ZINC OXIDENorwex Usa, Inc.f527a8c5-b05e-5f3c-e053-2995a90aa1a32025-11-20WarningsExact identifier
application number: M020
Norwex Lip Glaze Broad Spectrum SPF 30 HazelnutZINC OXIDENorwex Usa, Inc.440bd831-ee0b-b527-e063-6294a90a93332025-11-20WarningsExact identifier
application number: M020
PRO-COLLAGEN SKIN PROTECTION FLUID SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEElemis Ltd.23f9222f-60ba-72fb-e063-6394a90a99652025-11-20WarningsExact identifier
application number: M020
AussieZinc Mineral Sunscreen Vegan and Organic Mozzie RepellantZINC OXIDE SUNSCREENVEGANIC SKN LIMITED36ca866e-adc3-5a4f-e063-6394a90a1d1d2025-11-20WarningsExact identifier
application number: M020
Sandra Plasencia Green Tea Daily SPF 50 MoisturizerTITANIUM DIOXIDESandra Plasencia Skincare43ef1f93-0e89-0a35-e063-6394a90afb512025-11-19WarningsExact identifier
application number: M020
Sunkissed by Heaven Unscented Sunscreen SPF 50ZINC OXIDESunkissed By Heaven, LLC09dbd05a-dd07-43c3-b3d0-68f8f4b3e86d2025-11-19WarningsExact identifier
application number: M020
KOVR Military grade sunscreen for womenZINC OXIDEACTIVE LIFE INC4d0691ad-ca1b-4ca7-b94a-7bbaaf6f6dae2025-11-19WarningsExact identifier
application number: M020
Dynamic Resurfacing SPF 30AVOBENZONE, OCTINOXATE, AND OCTOCRYLENEELEMIS Limitedfc64720c-060c-4f33-8c76-96456fac270d2025-11-19WarningsExact identifier
application number: M020
Daily Defence Shield SPF 30AVOBENZONE, OCTINOXATE, AND OCTOCRYLENEELEMIS Limitedb2b6de93-47c8-4b6e-9fb9-8bdc8909271a2025-11-19WarningsExact identifier
application number: M020
Duke Cannon Supply Co. Daily Defense Face Mineral Sunscreen Broad Spectrum SPF 32ZINC OXIDEDUKE CANNON SUPPLY CO.0c47278b-2ec2-81ab-e063-6294a90ac9372025-11-19WarningsExact identifier
application number: M020
Gold Dynamics Skin Boosting Moisturizer Broad Spectrum SPF 15 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE,OCTOCRYLENEDistribuidora Comercial Jafra, S.A. de C.V.03b0f2ee-526b-4513-b70a-2918ad322b5e2025-11-19WarningsExact identifier
application number: M020
Invisible Sunscreen SPF 40HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENEPARTICLE AESTHETIC SCIENCE LTD1b33b4fb-1deb-69f7-e063-6294a90a9cc02025-11-19WarningsExact 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