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 190 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dolce and Gabbana Everlast Foundation SPF 20 38C DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L0358a87d-8002-4f3e-851a-3a582d356edf2025-09-03WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 39N DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L34dfc4c5-44f7-4531-97ba-8846ebe147242025-09-03WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 40C DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Lcf4b6f45-d4ae-4665-87b4-c5af4910befa2025-09-03WarningsExact identifier
application number: M020
DOLCE and GABBANA MEET YOUR FLAWLESS MATTE SKIN DUO - EVERLAST PRIMER EVERLAST FOUNDATIONOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDOLCE & GABBANA BEAUTY SRLeb63e9c6-bdb0-4bdf-8822-e4561a56adc92025-09-03WarningsExact identifier
application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 1N LightZINC OXIDEDolce & Gabbana Beauty S.R.L9507681c-236c-41c1-9dc9-ed4c0c0917412025-09-03WarningsExact identifier
application number: M020
Pure6 ManiShield Hand ScreenZINC OXIDE, TITANIUM DIOXIDEGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD3abcb6ba-1de8-55e7-e063-6294a90aecf12025-09-02WarningsExact identifier
application number: M020
Round Lab Dodo s Pick Bestseller SetAVOBENZONE, HOMOSALATE, OCTISALATESEORIN COMPANY Co., Ltd.3dd3db99-2e9f-16fc-e063-6294a90adda12025-09-02WarningsExact identifier
application number: M020
Sun Bum Premium Sunscreen Face Stick Broad Spectrum SPF 30 Sunscreen - PeggedAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3d86da52-6354-f53e-e063-6394a90aac552025-09-02WarningsExact identifier
application number: M020
Sheer Guard Natural Mineral Sunscreen Broad Spectrum SPF 50ZINC OXIDEBaxter Laboratories Pty3dd711c1-7758-31da-e063-6294a90a4f382025-09-02WarningsExact identifier
application number: M020
Sun Bum Road Tripper Mineral - Mineral Sunscreen Broad Spectrum SPF 30ZINC OXIDESun Bum, LLC3dd7b0af-dc37-1701-e063-6294a90a65c32025-09-02WarningsExact identifier
application number: M020
toty Ilumina CC Creamy Compact 6NTITANIUM DIOXIDEChipican LLC3da732e7-19b0-3195-e063-6394a90a9a0c2025-09-01WarningsExact identifier
application number: M020
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 4ENSULIZOLE ,HOMOSALATE,OCTINOXATE,TITANIUM DIOXIDEHangzhou Jingshen Trading Co., Ltd.3dba1360-f70f-e450-e063-6394a90a8c9f2025-09-01WarningsExact identifier
application number: M020
TOCOBO Cotton Airy Sun StickAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEPICTON CO., Ltd.2f7e7ef4-c3ac-4c26-e063-6394a90a9e422025-09-01WarningsExact identifier
application number: M020
TOCOBO Bio Watery Sun ScreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEPICTON CO., Ltd.3a7db6f4-66fd-4473-e063-6394a90a886e2025-09-01WarningsExact identifier
application number: M020
TOCOBO Bio Watery Sun ScreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEPICTON CO., Ltd.2f7eb413-ff49-711d-e063-6394a90ad6dc2025-09-01WarningsExact identifier
application number: M020
Ocean Potion Suncare Mineral 30 Essential Scent of Sunshine Zinc Oxide SunscreenZINC OXIDEGNL BRANDS INTERNATIONAL, LLC3db1cf3e-0640-6821-e063-6294a90a70362025-08-31WarningsExact identifier
application number: M020
Purpose Dual Treatment SPF 10OCTINOXATE 7.5%, OCTISALATE 5%, OXYBENZONE 3%Elysium Consumer Healthcare LLC3d7fe711-a671-df30-e063-6394a90afbbf2025-08-29WarningsExact identifier
application number: M020
Good Weather Skin The One Daily Sun Warm Glow SPF 30ZINC OXIDEGood Weather Inc.3d83aaa5-0e4e-928a-e063-6294a90a24da2025-08-29WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 33N DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Le249507c-d536-4c1d-a99d-857ca1e833d82025-08-29WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 32W Medium DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Lba99edea-bf68-4118-8bb7-ea40322db46a2025-08-29WarningsExact 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