FDA.reportPublic FDA data

PURE Tinted Mineral Sunscreen

Product NDC
85774-203
11-digit product format
857740203
Labeler code
85774
Product ID
85774-203_46042185-98ac-e8c7-e063-6394a90af605
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide, Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
LA JOLLA WELLNESS & AESTHETICS
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-05-09
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
80; 38 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
PURE Tinted Mineral Sunscreen
Listing expiration
2026-12-31

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
386bb911-9dbb-30fb-e063-6394a90a5e4dAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85774-203-15PURE Tinted Mineral Sunscreen1.5 g in 1 PACKETCREAM1.52
85774-203-50PURE Tinted Mineral Sunscreen53 g in 1 BOTTLE, PUMPCREAM532

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 264 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
I Conceal Flawless Foundation Broad Spectrum SPF 30 Sunscreen MahoganyZINC OXIDE AND TITANIUM DIOXIDEAllure Labsdcba05ff-7a68-c5c0-e053-2a95a90a61292024-12-09WarningsExact identifier
application number: M020
Prevention Daily Matte Moisturizer SPF 30ZINC OXIDE AND HOMOSALATEAllure Labsf0fb1b69-53f2-efff-e053-2995a90af9d42024-12-09WarningsExact identifier
application number: M020
MD Restoring daily Defense Moisturizer SPF 50ZINC OXIDE AND TITANIUM DIOXIDEAllure Labs Inceb8e7109-b5eb-5cc1-e053-2995a90a486f2024-12-09WarningsExact identifier
application number: M020
Prevention Sun Serum SPF 30 TintedZINC OXIDEAllure Labsf1761b09-9061-a052-e053-2a95a90a39c82024-12-09WarningsExact identifier
application number: M020
Prevention Sun Serum SPF30ZINC OXIDEAllure Labsf188669f-7b9f-6e01-e053-2995a90afa3c2024-12-09WarningsExact identifier
application number: M020
Prevention Clear Solar Gel SPF30AVOBENZON, OCTISALATE AND OCTOCRYLENEAllure LAbsf19f6d9b-5249-27a6-e053-2a95a90a8a392024-12-09WarningsExact identifier
application number: M020
OneSkin OS-01 SHIELD Broad Spectrum SPF 30 Mineral Sunscreen TintedZINC OXIDEAllure Labs02e7fb00-2039-c4f8-e063-6294a90a418f2024-12-09WarningsExact identifier
application number: M020
OneSkin OS-01 SHIELD Broad Spectrum SPF 30 Mineral Sunscreen UntintedZINC OXIDEAllure Labs02f9c859-8d7d-5146-e063-6394a90a57b52024-12-09WarningsExact identifier
application number: M020
Quench and Protect Hydrating SPF30ZINC DIOXIDE AND TITANIUM DIOXIDEAllure Labs.039e50c1-7b3d-d392-e063-6394a90a4b3c2024-12-09WarningsExact identifier
application number: M020
Tinted Face Cream SPF 15OCTOCRYLENE, OCTISALATEBentley Laboratories, LLC0d7300ee-adf4-41be-bb9f-257cd2986c0f2024-12-06WarningsExact identifier
application number: M020
Derm Institute Daily Defense Protection Sunscreen Broad Spectrum SPF50TITANIUM DIOXIDE, ZINC OXIDEBeautcella Inc.bad942d8-04da-31d2-e053-2a95a90a92752024-12-06WarningsExact identifier
application number: M020
TOM FORD ARCHITECTURE RADIANCE HYDRATING FOUNDATION BROAD SPECTRUM SPF 50ENSULIZOLE, OCTINOXATE, OCTISALATE, AND ZINC OXIDETOM FORD BEAUTY DIST289b824f-bb0b-313e-e063-6394a90ab7832024-12-06WarningsExact identifier
application number: M020
ATTITUDE Sunly Mineral Sunscreen Stick Orange Blossom SPF 30ZINC OXIDE9055-7588 Quebec Inc. DBA Attitude0d840001-a648-df1b-e063-6294a90ab2992024-12-06WarningsExact identifier
application number: M020
Performance Face Sunscreen Broad Spectrum SPF 30ZINC OXIDE, OCTOCRYLENE, OCTISALATEBentley Laboratories, LLC1629f061-b8fc-4fda-8378-c64e164d41bd2024-12-06WarningsExact identifier
application number: M020
Clear System Brightening Day Cream SPF 15OCTOCRYLENE, OCTISALATEBentley Laboratories, LLC8cbc8fa4-469f-4fa3-bd8e-27e815989c3f2024-12-06WarningsExact identifier
application number: M020
MISSHA M Perfect Cover BB Cream SPF42 (No. 25)ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATEAble C&C Co., Ltd.604e7a49-7986-11ee-e053-2a91aa0a1bee2024-12-05WarningsExact identifier
application number: M020
MISSHA M Perfect Cover BB No 27ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATEAble C&C Co., Ltd.c4e16cec-c7db-4e5e-9d05-5d7afdb790912024-12-05WarningsExact identifier
application number: M020
MISSHA M Perfect Cover BB SPF42 No29OCTINOXATE, ZINC OXIDE, TITANIUM DIOXIDEAble C&C Co., Ltd.3fc90114-4cdf-273e-e054-00144ff8d46c2024-12-05WarningsExact identifier
application number: M020
MISSHA M Perfect Cover BB No 31ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATEAble C&C Co., Ltd.95862d15-d977-7276-e053-2995a90ab6902024-12-05WarningsExact identifier
application number: M020
MISSHA M Perfect Cover BB Cream SPF42 No. 25ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATEAble C&C Co., Ltd.9c6f48b1-007b-434f-b756-242e3390e9b72024-12-05WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85774-203-15857740203151.5 g in 1 PACKET (85774-203-15) 1.5 g2022-05-09YesNoCurrent
85774-203-508577402035053 g in 1 BOTTLE, PUMP (85774-203-50) 53 g2022-05-09NoNoCurrent