FDA.reportPublic FDA data

non-tinted sheer matte mineral

Product NDC
85575-202
11-digit product format
855750202
Labeler code
85575
Product ID
85575-202_45b4adda-a258-da9e-e063-6294a90a98b1
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide, Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
NEXTEX CORPORATION
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-01-22
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
80; 38 mg/g; mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
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
non-tinted sheer matte mineral
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
35ba6cc9-0d49-6d0c-e063-6394a90ac7c3Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85575-202-50non-tinted sheer matte mineral53 g in 1 BOTTLE, PUMPCREAM532

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85575-202NON-TINTED SHEER MATTE MINERAL (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [NEXTEX CORPORATION]1Current NDC, 1 package rows20250523_35ba6cc9-0d49-6d0c-e063-6394a90ac7c3.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 307 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EA EIGHT HR LIP SHEER TINTSOXYBENZONE, PADIMATE O, PETROLATUMREVLONb671d630-2b71-66d2-e053-2a95a90a84612024-01-12WarningsExact identifier
application number: M020
Revlon Colorstay Light Cover FoundationHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE,ZINC OXIDERevlonb0006b5f-0d56-0efb-e053-2a95a90a59792024-01-12WarningsExact identifier
application number: M020
PREVAGE CITY SMARTTITANIUM DIOXIDE, ZINC OXIDEREVLONb60c9b41-cf32-ee94-e053-2a95a90abab02024-01-12WarningsExact identifier
application number: M020
CERAMIDE MAKEUP SPF 15OCTINOXATE, TITANIUM DIOXIDEREVLONb3ad9686-47ed-4b60-e053-2995a90abcdd2024-01-12WarningsExact identifier
application number: M020
Aruba Aloe broad spectrum SPF 15 Lip sunscreen and MoisturizerAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEAruba Aloe Balm NV9e3ed6dc-14ba-4bb2-a633-1a1fe92099ce2024-01-11WarningsExact identifier
application number: M020
Principal Secret Reclaim Botanical (with SP) Radiant Recovery Day Broad Spectrum SPF 15OCTINOXATE, OCTISALATE, AND ZINC OXIDEGuthy-Renker LLC6437fbf6-c84b-497e-bf69-b20153d4c7062024-01-11WarningsExact identifier
application number: M020
I Conceal Flawless Foundation BS SPF 30 Sunscreen SUEDEZINC OXIDE AND TITANIUM DIOXIDEAllure Labs0e9d006c-2ea0-8228-e063-6394a90a65d62024-01-10WarningsExact identifier
application number: M020
Principal Secret Reclaim Sunscreen For Face and Body SPF 30MERADIMATE, OCTINOXATE, OXYBENZONE, AND ZINC OXIDEGuthy-Renker LLC4a183aa2-deda-4b26-a126-6f98cfbdb0f32024-01-10WarningsExact identifier
application number: M020
EVEN BETTER MAKEUP BROAD SPECTRUM SPF 15OCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDECLINIQUE LABORATORIES LLCd4de3c7b-3993-40e5-88a4-f6005ab975312024-01-09WarningsExact identifier
application number: M020
Principal Secret Reclaim Oil Control hydrator SPF-8TITANIUM DIOXIDEGuthy-Renker LLC97b7cd4e-78aa-418b-a112-263971fa98272024-01-08WarningsExact identifier
application number: M020
Principal Secret Advanced with Hydrospheres Continuous Moisture SPF8OCTINOXATE AND OCTISALATEGuthy-Renker LLCf4310455-8b3f-40a9-8674-fe7fc3abaced2024-01-08WarningsExact identifier
application number: M020
Aruba Sun SPF 30 SunscreenAVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 6%Derma Care Research Labs,LLCd8b4f8c4-811b-4139-e053-2995a90a04c22024-01-05WarningsExact identifier
application number: M020
MIAMI BEACH BUM Save Face Sheer Mineral Sunscreen SPF 50ZINC OXIDEMIAMI BEACH BUM95675bd2-a0ae-44db-a75a-5c432e9614952024-01-04WarningsExact identifier
application number: M020
GINZING SPF 30 DAILY MOISTURIZERAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEORIGINS NATURAL RESOURCES INC.0e106c03-4c25-5bfb-e063-6294a90ab3e12024-01-03WarningsExact identifier
application number: M020
Avon Anew Platinum Day-Cream SPF 25 SunscreenAVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEThe Avon Company148203ef-7d73-369c-e063-6394a90a0e582024-01-03WarningsExact identifier
application number: M020
Avon Anew Ultimate Day Multi-Performance-Cream SPF 25 SunscreenAVOBENZONE, HOMOSALATE, OCTINOXATE, OXYBENZONEThe Avon Company14833e71-704d-9a88-e063-6394a90a31b22024-01-03WarningsExact identifier
application number: M020
Prime Time Daily Protecting Primer SPF 30SPF 30 PRIME TIME PRIMERAutumn Harp Inc.f2619092-3e7f-5105-e053-2a95a90a3f5a2024-01-03WarningsExact identifier
application number: M020
ARTISTRY IDEAL RADIANCE UV Protect SPF 50 PLUS Broad Spectrum SunscreenOCTINOXATE, OCTISALATE, ZINC OXIDE, TITANIUM DIOXIDEAmway Corpa1a700b5-d039-4bd2-8420-5c20530957062024-01-02WarningsExact identifier
application number: M020
Garnier green labs Replumping HyaluMelon Broad Spectrum SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENELOreal USA Products Inc5bece3c9-c310-4fb2-b644-507407fcfb082024-01-02WarningsExact identifier
application number: M020
Josie Maran Argan Daily Moisturizer SPF47 Protect and PerfectZINC OXIDE, TITANIUM DIOXIDEAutumn Harp, Inc.cb91c130-45d4-46a0-9628-50e701a6960c2024-01-02Boxed warning, WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85575-202-508557502025053 g in 1 BOTTLE, PUMP (85575-202-50) 53 g2020-01-22NoNoCurrent