FDA.reportPublic FDA data

SPF 30 Sunscreen

Product NDC
83294-101
11-digit product format
832940101
Labeler code
83294
Product ID
83294-101_471ab663-50b0-9e95-e063-6294a90a6115
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide, Titanium Dioxide
Dosage form
LOTION
Route
TOPICAL
Labeler
CLEURE
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-08-22
Substance
ZINC OXIDE; TITANIUM DIOXIDE
Active strength
9; 4.51 g/100mL; g/100mL
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
SPF 30 Sunscreen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE9 g/100mL
TITANIUM DIOXIDE4.51 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup
15FIX9V2JPInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f5512f34-08ee-b0f6-e053-2a95a90ab5bdAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83294-101-18SPF 30 Sunscreen118 mL in 1 TUBELOTION1184

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83294-101SPF 30 SUNSCREEN (ZINC OXIDE, TITANIUM DIOXIDE) LOTION [CLEURE]3Current NDC, 1 package rows20250101_f5512f34-08ee-b0f6-e053-2a95a90ab5bd.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 36 of 361 · 7,213 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
THANKYOU FARMER Sun Project Moisture SunHOMOSALATE, OCTOCRYLENE, OCTISALATE, OCTINOXATE, AVOBENZONETHANK YOU FARMER CO., LTD300d8526-0daf-2255-e063-6394a90a21b12026-05-05WarningsExact identifier
application number: M020
LUMINOUS EYE CORRECTOR SPF 41 - FAIRTITANIUM DIOXIDE, ZINC OXIDEDrmtlgy, LLC8cfb1f8c-1bd7-4983-ab82-1c9bd8925afa2026-05-04WarningsExact identifier
application number: M020
LUMINOUS EYE CORRECTOR SPF 41 - DEEPTITANIUM DIOXIDE, ZINC OXIDEDrmtlgy, LLC930bd1de-5a0e-4607-8d3c-b1ca918f890b2026-05-04WarningsExact identifier
application number: M020
THANKYOU FARMER Sun Project Rice Tinted Mineral SunscreenZINC OXIDETHANK YOU FARMER CO., LTD30086b1e-d876-2528-e063-6294a90a4e9f2026-05-04WarningsExact identifier
application number: M020
Blue Berry SPF 15 Broad Spectrum Lip BalmBLUE BERRY SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inc50ff6ecb-c8b3-02fc-e063-6394a90a68de2026-05-04WarningsExact identifier
application number: M020
White Mint SPF 15 Broad Spectrum Lip BalmWHITE MINT SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inc50ff8c38-94f1-f589-e063-6294a90a5ba82026-05-04WarningsExact identifier
application number: M020
Surface Sun SPF 50 MineralZINC OXIDESurface Products Corpcabaf7e1-b940-4d6e-b21b-d99c3a4047a72026-05-04WarningsExact identifier
application number: M020
SPF 50 Dry Touch Continuous No fragranceHOMOSALATE 10.00% OCTISALATE 5.00% AVOBENZONE 3.00%Surface Products Corp503d6b48-3516-4264-9fe8-71a9939669fe2026-05-04WarningsExact identifier
application number: M020
Surface SPF 50 3oz Tinted mineral sunscreen with Water ResistanceZINC OXIDESurface Products Corp02b770cf-7351-444b-b2c8-ad112e9bea3e2026-05-04WarningsExact identifier
application number: M020
SPF 30 Dry Touch Continuous No fragranceHOMOSALATE 10.00% OCTISALATE 5.00% AVOBENZONE 3.00%Surface Products Corpd13c9e6e-a5da-4691-8792-9d6025e166d72026-05-04WarningsExact identifier
application number: M020
LUMINOUS EYE CORRECTOR SPF 41 - MEDIUMTITANIUM DIOXIDE, ZINC OXIDEDrmtlgy, LLC0206c676-c24d-470e-adb2-7cb3173f37272026-05-04WarningsExact identifier
application number: M020
LUMINOUS EYE CORRECTOR SPF 41 - TANTITANIUM DIOXIDE, ZINC OXIDEDrmtlgy, LLC5c5aad09-9f93-4634-8db1-c67570b38b2b2026-05-04WarningsExact identifier
application number: M020
OBGE PORE-ZERO Oil CONTROL SUN StickHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEAdapt Inc.67209e46-1b7a-42df-b31f-fcb3cefbd7e12026-05-03WarningsExact identifier
application number: M020
EquateOCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONEWALMART INC2617e5bc-27a2-f187-e063-6394a90a69802026-05-03WarningsExact identifier
application number: M020
THANK YOU FARMER Sun Project Rice Tinted Mineral Sun CreamZINC OXIDETHANK YOU FARMER CO., LTD20a44597-3d44-f0ea-e063-6294a90a903d2026-05-03WarningsExact identifier
application number: M020
Ultra Violette Sheen Screen Hydrating Lip Balm Last Bite Broad Spectrum SPF 50AVOBENZONE, OCTISALATE, OCTOCRYLENEGrace and Fire USA Inc.4df3e90e-98a0-edbf-e063-6394a90ae3c92026-05-01WarningsExact identifier
application number: M020
Ultra Violette Sheen Screen Hydrating Lip Balm Silk Pillow Broad Spectrum SPF 50AVOBENZONE, OCTINOXATE, OCTOCRYLENEGrace and Fire USA Inc.4df6d28b-64ce-59b3-e063-6394a90a63602026-05-01WarningsExact identifier
application number: M020
EXTREME PROTECT SPF 30OCTINOXATE, ZINC OXIDESCIENCE OF SKINCARE LLCecc4d304-e7e2-45b6-b9b2-2c64d36308602026-05-01WarningsExact identifier
application number: M020
Blue Lizard Sport SPF 50 SunscreenOCTISALATE AND TITANIUM DIOXIDE AND ZINC OXIDECrown Laboratories4955fa1c-789d-4f42-af75-70223310644a2026-05-01WarningsExact identifier
application number: M020
Blue Lizard Kids SPF 50 SunscreenOCTISALATE AND TITANIUM DIOXIDE AND ZINC OXIDECrown Laboratoriesba4ae906-48c0-8384-e053-2995a90afb912026-05-01WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83294-101-1883294010118118 mL in 1 TUBE (83294-101-18) 118 ml2022-08-22NoNoCurrent