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 234 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
natural lip balm SPF15(unflavored) 01AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.2c5a460a-dc93-14cc-e063-6294a90a0b612025-01-23WarningsExact identifier
application number: M020
360 by QUR Lemon Verbena lip balmOCTINOXATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEQur, Incbedb14c2-9181-5970-e053-2a95a90a41612025-01-23WarningsExact identifier
application number: M020
Soleo Organics SunscreenZINC OXIDESE Operations Pty Ltd59ea43e3-f6e6-4d10-9d8f-2f14eaf2f79b2025-01-22WarningsExact identifier
application number: M020
Neptune Ave. High Dive Barrier Repair Moisturizer Broad Spectrum SPF 50AVOBENZONE, OCTISALATE, OCTOCRYLENENeptune Ave. Inc.25034563-6420-daf6-e063-6394a90af9802025-01-22WarningsExact identifier
application number: M020
Jafra Sun body protector sunscreen broad spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEDistribuidora Comercial Jafra, S.A. de C.V.b8e49dd6-305c-f717-e053-2995a90a659c2025-01-22WarningsExact identifier
application number: M020
Jafra Royal Defy Sample KitAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEDistribuidora Comercial Jafra, S.A. de C.V.c3b265b1-ab84-4ea9-b283-c92f5a4cf4612025-01-22WarningsExact identifier
application number: M020
SUNSCREEN BROAD SPECTRUM SPF 50 FACE AND BODYAVOBENZONE/OCTISALATE/OCTOCRYLENEMary Kay Inc.2c4eaf2e-b034-8185-e063-6394a90a82752025-01-22WarningsExact identifier
application number: M020
Herbalife SKIN Protective Moisturizer Broad Spectrum SPF 30 Mineral SunscreenZINC OXIDEHerbalife International of America Inc.d30b7cf1-73bb-3568-e053-2995a90ad5792025-01-21WarningsExact identifier
application number: M020
Herbalife Herbal Aloe Face and Body Mineral Sunscreen Broad Spectrum SPF 30ZINC OXIDEHerbalife International of America, Inc.d30d9d02-bc31-db3c-e053-2a95a90a0dab2025-01-21WarningsExact identifier
application number: M020
Sugargirl Disco Stick SPF 30HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEI World LLC36f30834-62be-4076-9493-f385720a1e222025-01-20WarningsExact identifier
application number: M020
Sugargirl Glowy Face Screen Shimmer Sunscreen SPF 30HOMOSALATE, OCTOCRYLENE, OCTINOXATE, OCTISALATE, AVOBENZONEI World LLC757897b0-fc65-4147-8444-2a0efdc6f81c2025-01-20WarningsExact identifier
application number: M020
Sugargirl Hot Body Screen Shimmer Sunscreen SPF 30HOMOSALATE, OCTOCRYLENE, OCTINOXATE, AVOBENZONE, OCTISALATEI World LLCa9bf1342-1c4b-48ad-a955-715647df125a2025-01-20WarningsExact identifier
application number: M020
Sunceutical SPF 50 Mineral Glow SerumZINC OXIDEBaxter Laboratories Pty. Ltd.2c2c9b67-9588-efbe-e063-6294a90aa6a42025-01-20WarningsExact identifier
application number: M020
JAFRA SKIN Glow Face Cream Broad Spectrum SPF 15 SunscreenHOMOSALATE, OCTISALATE, AVOBENZONE,OCTOCRYLENEDistribuidora Comercial Jafra, S.A. de C.Vf627ab5b-85d4-4c92-9412-4bab72828f3d2025-01-17WarningsExact identifier
application number: M020
Proceuticals Private Label by TiZO Tinted Facial Mineral Sunscreen BackbarTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD2be9f92a-a041-0595-e063-6394a90af7a82025-01-17WarningsExact identifier
application number: M020
Prequel Sun Barrier Mineral Sunscreen Broad Spectrum SPF 50MINERAL SUNSCREENThe Center Brands, LLCcd35ae20-d5b7-479d-8a5e-0278eae9e83c2025-01-17WarningsExact identifier
application number: M020
HUTTON KLEIN HK DERMATOLOGISTS SPF 40 Mineral Based Facial Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDEHutton, Kathleen MD293a6a6c-adf3-452d-92f5-3baceb619e392025-01-16WarningsExact identifier
application number: M020
CAPTURE DREAMSKIN FRESH AND PERFECT CUSHION WITH SUNSCREEN BROAD SPECTRUM SPF 50 020OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEParfums Christian Dior594982d5-b4bf-4889-99b7-b3cd58fa80312025-01-16WarningsExact identifier
application number: M020
CAPTURE DREAMSKIN FRESH AND PERFECT CUSHION WITH SUNSCREEN BROAD SPECTRUM SPF 50 010OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEParfums Christian Dior26f1dcde-209e-4c6d-9577-1f3d3e21595f2025-01-16WarningsExact identifier
application number: M020
CAPTURE DREAMSKIN FRESH AND PERFECT CUSHION WITH SUNSCREEN BROAD SPECTRUM SPF 50 000OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEParfums Christian Dioradba288c-e94f-4b26-8f7d-336f3e5108bd2025-01-16WarningsExact 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