FDA.reportPublic FDA data

MATTE UNIVERSAL TINTED MOISTURIZER SPF46

Product NDC
83286-015
11-digit product format
832860015
Labeler code
83286
Product ID
83286-015_f9dc4aca-ea4e-46c7-af3c-5fc5764d98bd
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide, Octinoxate
Dosage form
CREAM
Route
TOPICAL
Labeler
Drmtlgy, LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-01-01
Substance
ZINC OXIDE; OCTINOXATE
Active strength
12; 7.5 g/100mL; g/100mL
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
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
MATTE UNIVERSAL TINTED MOISTURIZER SPF46
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE12 g/100mL
OCTINOXATE7.5 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
4Y5P7MUD51Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8e284afd-b90f-41d5-b334-e5cf4440b4d3Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83286-015-01MATTE UNIVERSAL TINTED MOISTURIZER SPF4650 mL in 1 BOTTLECREAM501

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 254 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BABYGANICS SPF 50 Plus SUNSCREENZINC OXIDE, OCTISALATE, AND OCTOCRYLENEKAS Direct LLC dba Babyganics4075f9dc-c25f-434f-a3fc-a7f896295c3d2024-12-20WarningsExact identifier
application number: M020
SunscreenHOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONETotal Resources International7d4f820d-e154-428e-89c2-2e26e088ceef2024-12-20WarningsExact identifier
application number: M020
Babyganics Sheer Blend SPF50 Mineral SunscreenZINC OXIDEKAS Direct LLC dba BabyGanicsedced0dc-dd43-4ac9-b816-f4edb45fc87b2024-12-20WarningsExact identifier
application number: M020
NARS Radiance Primer Broad Spectrum SPF 35 SunscreenOCTISALATE, OCTOCRYLENE, AVOBENZONE, HOMOSALATECOSMAX USA, CORPORATION29ad7391-d932-3549-e063-6394a90ab2b22024-12-20WarningsExact identifier
application number: M020
Face Reality daily spf 30 plus Sunscreen SPF 30HOMOSALATE, OCTISALATE, AVOBENZONEFace Reality,LLC45a3ce12-15fe-4040-95da-ac8513a39fb92024-12-20WarningsExact identifier
application number: M020
Face Reality mineral matte spf 28 Sunscreen SPF 28ZINC OXIDE, TITANIUM DIOXIDEFace Reality, LLC29b70afe-cf9d-d0ba-e063-6394a90a1cc42024-12-20WarningsExact identifier
application number: M020
Sonage Roux Tinted Day Creme with SPF 30 Sheer Tinted MoisturizerZINC OXIDEASA Universal Inc. dba: Sonagefd14d70c-6cd0-5de6-e053-6294a90a7add2024-12-20WarningsExact identifier
application number: M020
Coola SPF 50 ClassicSUNSCREEN FACE MISTCOOLA LLCd18d0dac-5690-436e-e053-2995a90a02542024-12-20WarningsExact identifier
application number: M020
COOLA Mineral Body SPF 30 Tropical CoconutZINC OXIDECOOLA, LLCeeb5d4f1-8cba-9ef6-e053-2a95a90a823f2024-12-20WarningsExact identifier
application number: M020
Oars and Alps SPF 50 100% Mineral Antioxidant SunscreenTITANIUM DIOXIDE, ZINC OXIDEOars and Alps LLCf3971b85-a13e-4195-e053-2995a90a73cb2024-12-20WarningsExact identifier
application number: M020
Vacation SPF 30 MineralZINC OXIDEVacation Inc.f69513ae-f210-075f-e053-2a95a90a9b2e2024-12-20WarningsExact identifier
application number: M020
Vacation SPF 30 Chardonnay OilAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEVacation Inc.f694752d-4839-3768-e053-2995a90a5d3e2024-12-20WarningsExact identifier
application number: M020
Oars and Alps SPF 50 Hydrating Antioxidant SunscreenSprayAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEOars and Alps LLCec5b82f5-b36c-fbc5-e053-2995a90afa0c2024-12-20WarningsExact identifier
application number: M020
Oars and Alps SPF 70 Hydrating Antioxidant SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEOars and Alps LLCf39673a7-0b62-bdf7-e053-2995a90aa2b72024-12-20WarningsExact identifier
application number: M020
Carpe SPF 30 Face PrimerTITANIUM DIOXIDE, ZINC OXIDEClutch, Inc. DBA Carpefeac5ee2-faa5-fd17-e053-6394a90a7f992024-12-20WarningsExact identifier
application number: M020
Oars and Alps SPF 50 MineralZINC OXIDEOars and Alps LLCf395bc39-daa5-53b8-e053-2995a90a5f482024-12-20WarningsExact identifier
application number: M020
Babyganics Kids Sheer Blend SPF50 Mineral SunscreenZINC OXIDEKAS Direct LLC dba BabyGanics8a143645-3b52-4797-9b26-dc9dd63be38f2024-12-20WarningsExact identifier
application number: M020
Nuria Defend Matte Finish Daily Moisturizer Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDESmall World Brandsb1df4c81-333b-450d-963e-6670ab9bbda92024-12-20WarningsExact identifier
application number: M020
foundcealer multi-tasking foundation Broad Spectrum SPF 20 Sunscreen 8B porcelain beigeTITANIUM DIOXIDE AND ZINC OXIDETarte, Inc.062fa0d9-f384-48af-8269-42de3a788db12024-12-20WarningsExact identifier
application number: M020
Stokoderm Sunscreen PUREAVOBENZONE, OCTOCRYLENE, OCTISALATE, AND HOMOSALATESC Johnson Professional USA, Inc.3ddf81e6-de78-4f2f-814b-c75eadcddb392024-12-20WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83286-015-018328600150150 mL in 1 BOTTLE (83286-015-01) 50 ml2025-01-01NoNoCurrent