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 285 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HEB SPF 50 Pomegranate ContinuousAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.Bf5b48729-43d3-72b4-e053-2995a90a9d852024-10-15WarningsExact identifier
application number: M020
HEB SPF 50 For Men Continuous SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.Bf5b682aa-a194-09ff-e053-2a95a90ade732024-10-15WarningsExact identifier
application number: M020
HEB SPF 50 Birthday Cake Continuous SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.Bf5b755af-2bd3-33cf-e053-2a95a90a99612024-10-15WarningsExact identifier
application number: M020
HEB SPF 50 Watermelon Serbert Continuous SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.Bf5b77cc0-1ed5-c4ae-e053-2a95a90abc1a2024-10-15WarningsExact identifier
application number: M020
HEB SPF 50 Hydrate 50 Sunscreen with Hyaluronic Acid and Collagen Continuous SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.Bf6e0db20-594b-30a8-e053-6394a90a71642024-10-15WarningsExact identifier
application number: M020
HEB SPF 50 Refine 50 Sunscreen with Niacinamide and Collagen Continuous SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.Bf6dfe973-bd88-e0e4-e053-6394a90ac9272024-10-15WarningsExact identifier
application number: M020
HEB Face Primer 30 Sunscreen Face Primer SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH-E-Bf6e29c93-9fd9-36c6-e053-6394a90a17472024-10-15WarningsExact identifier
application number: M020
H.E.B. Mineral Sunscreen Broad Spectrum SPF 50TITANIUM DIOXIDE, ZINC OXIDEH.E.B.c5279caf-3af9-d163-e053-2995a90a943b2024-10-15WarningsExact identifier
application number: M020
HEB Face 50 Clear Zinc SunscreenOCTOCRYLENE, ZINC OXIDEH.E.B.f6e3c883-0087-dcd6-e053-6394a90a12722024-10-15WarningsExact identifier
application number: M020
HEB Mineral Sunscreen SPF 50ZINC OXIDEH.E.B.de99343b-c74c-3f43-e053-2995a90ac9dd2024-10-15WarningsExact identifier
application number: M020
HEB SPF 55 Babies and Kids SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.B.f5660a97-57c8-61c7-e053-2995a90a01642024-10-15WarningsExact identifier
application number: M020
H.E.BSPF 50 SUNSCREENH.E.B362f726b-d52b-4dae-ade6-a47de47697ef2024-10-15WarningsExact identifier
application number: M020
HEB Sensitive 50 Mineral Sensitive Skin Sunscreen For FaceZINC OXIDEH.E.B.dfb43fc5-4968-f999-e053-2a95a90a08192024-10-15WarningsExact identifier
application number: M020
H.E.B BABYSPF 50 SUNSCREENH.E.B61273611-ab7a-4216-aebe-2c8d896602812024-10-15WarningsExact identifier
application number: M020
H.E.B BANANASPF 50 SUNSCREENH.E.Bb9a9837a-094b-4a57-a50c-5c1437deda7b2024-10-15WarningsExact identifier
application number: M020
HEB Solutions SunscreenSPORT SPF 100 LOTIONH.E.B9e3ea66c-d6a0-49ca-a3c0-8175e06174532024-10-15WarningsExact identifier
application number: M020
H.E.B Solutions SunscreenULTRA SPF 50 LOTIONH.E.B12c76c72-4411-48d5-b79b-c58703bf1fdd2024-10-15WarningsExact identifier
application number: M020
H.E.B Solutions SunscreenSPORT SPF 50 CONTINUOUS SPRAYH.E.B86ad5d30-f700-42a2-b810-dd2e3ed0f2d82024-10-15WarningsExact identifier
application number: M020
H.E.BSPF 50 SUNSCREENH.E.B1f8d4f91-9eb9-41de-9066-a7a08c7ff84f2024-10-15WarningsExact identifier
application number: M020
H.E.B Solutions SunscreenULTRA SPF 100 CONTINUOUS SPRAYH.E.Bbe80244d-da6d-4d37-b228-4d3fac335caf2024-10-15WarningsExact 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