Untinted Sheer Defense

Product NDC
85516-202
11-digit product format
855160202
Labeler code
85516
Product ID
85516-202_46042d20-dc41-fe77-e063-6394a90a94aa
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide, Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
Kristina Lerner
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-05-05
Substance
ZINC OXIDE; TITANIUM DIOXIDE
Active strength
38; 80 mg/g; mg/g
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
Untinted Sheer Defense
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE38 mg/g
TITANIUM DIOXIDE80 mg/g

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
35be50b7-a9af-29ee-e063-6394a90a45baAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85516-202-50Untinted Sheer Defense53 g in 1 BOTTLE, PUMPCREAM532

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85516-202UNTINTED SHEER DEFENSE (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [KRISTINA LERNER]1Current NDC, 1 package rows20250524_35be50b7-a9af-29ee-e063-6394a90a45ba.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 210 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BALI BODY SPF15 BRONZE SHIMMERING TANNINGAVOBENZONE, OCTISALATE, OCTOCRYLENEBali Body Pty Ltd240d4d80-641c-ac57-e063-6394a90abe752025-06-16WarningsExact identifier
application number: M020
Environ Skin Care RAD Shield Mineral Sunscreen SPF 30SUNSCREENENVIRON SKIN CARE (PTY) LTD3778547e-11a8-3b30-e063-6394a90ab5b12025-06-13WarningsExact identifier
application number: M020
Voupre Age DefenseOCTINOXATE, HOMOSALATE, OCTISALATE, OXYBENZONE AND AVOBENZONEInnovation Brands Inc.8dfaa076-c62a-47ee-bc5d-75360416fa1a2025-06-13WarningsExact identifier
application number: M020
Instantly DryTITANIUM DIOXIDE, ZINC OXIDECLEAN BEAUTY BY ANAK LLC37624bf6-4949-1b10-e063-6294a90ac4882025-06-12Exact identifier
application number: M020
silk SPF facial sunscreen fluid hybrid broad spectrum SPF 30 UVA/UVBZINC OXIDE AND HOMOSALATEOneKind.25d739bc43-d76e-9258-e053-2a95a90a3d2c2025-06-12WarningsExact identifier
application number: M020
ULTRA SHEER DAILY DEFENSE FACIAL SPF 18HOMOSALATE, OCTISALATE, AND AVOBENZONEAndalou naturals0f7c6d3a-73ea-44d8-a8b9-6a6f1bb02c6f2025-06-11WarningsExact identifier
application number: M020
Hydrating Sheer Lip Balm Trio The Vivids Broad Spectrum SPF 30AVOBENZONE, OCTISALATE, AND HOMOSALATEMDSolarSciences374e770f-75b5-08d0-e063-6394a90adf922025-06-11WarningsExact identifier
application number: M020
Reflecting Mineral SunscreenZINC OXIDE, TITANIUM DIOXIDEHelande, LLC3750f04b-7f9f-8793-e063-6294a90a91432025-06-11WarningsExact identifier
application number: M020
Vitamin C BB Beauty Balm Sheer Tint SFP 30ZINC OXIDEAndalou naturalsf423b484-2119-4c95-a0da-77bcd07303eb2025-06-11WarningsExact identifier
application number: M020
Perfecting BB Beauty Balm Natural Tint SPF 30ZINC OXIDEAndalou naturals16ca3790-9973-4a04-a43c-e0f7b384f1472025-06-11WarningsExact identifier
application number: M020
SOME BY MI V10 HYAL LIP SUN PROTECTORAVOBENZONE, HOMOSALATE, OCTISALATEPERENNEBELL Co., Ltd.3690af2b-fe22-3a9a-e063-6294a90a709d2025-06-10WarningsExact identifier
application number: M020
Zinc OxidePACIFICA ULTRA CC CREAM RADIANT FOUNDATION SPF 30 COOL/DEEPPacifica Beauty, LLC373901f7-0e32-0f32-e063-6394a90abe252025-06-10WarningsExact identifier
application number: M020
Zinc OxidePACIFICA ULTRA CC CREAM RADIANT FOUNDATION SPF 30 WARM/TANPacifica Beauty, LLC37397b96-ef14-9098-e063-6294a90aafc92025-06-10WarningsExact identifier
application number: M020
Zinc OxidePACIFICA ULTRA CC CREAM RADIANT FOUNDATION SPF 30 WARM/LIGHTPacifica Beauty, LLC373aba7c-2ae1-8726-e063-6294a90ae3d82025-06-10WarningsExact identifier
application number: M020
Zinc OxidePACIFICA ULTRA CC CREAM RADIANT FOUNDATION SPF 30 NATURAL/MEDIUMPacifica Beauty, LLC373c29b9-2f75-9777-e063-6394a90a68a62025-06-10WarningsExact identifier
application number: M020
Hydrating Sheer Lip Balm Trio The Neutrals Broad Spectrum SPF 30AVOBENZONE, OCTISALATE, AND HOMOSALATEMDSolarSciences374395ea-ab91-de70-e063-6394a90aec562025-06-10WarningsExact identifier
application number: M020
ANDALOU NATURALS DEEP HYDRATION DAILY SHADE BLUE LIGHT DEFENSE FACIAL SPF 30ZINC OXIDEAndalou naturalsaa689e82-6512-46d8-aec9-269f9348d3f82025-06-09WarningsExact identifier
application number: M020
ALLIES OF SKIN The One SPF-50 Invisible SunscreenAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEALLIES GROUP PTE. LTD.36e1c61c-33ab-4a5d-853d-119c29632b082025-06-09WarningsExact identifier
application number: M020
SHISEIDO ULTIMATE SUN PROTECTION STITANIUM DIOXIDE AND ZINC OXIDEShiseido Americas Corporationb2fae1ba-67fe-48ef-b31f-62db343499612025-06-09WarningsExact identifier
application number: M020
Olay Super Cream with Sunscreen Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEThe Procter & Gamble Manufacturing Company372819f1-0813-2cd5-e063-6294a90ac5bf2025-06-09WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85516-202-508551602025053 g in 1 BOTTLE, PUMP (85516-202-50) 53 g2025-05-05NoNoCurrent