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 218 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CLARINS Multi-Active Jour Niacinamide and Sea Holly Extract Sunscreen SPF 15AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENELaboratoires Clarinsa43d0d4f-94de-4c4b-a17a-63a819d5d2932025-04-07WarningsExact identifier
application number: M020
Gangnam Glow Sunscreen 50AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENELG HOUSEHOLD & HEALTH CARE LTD.30cc2e35-f752-8285-e063-6294a90afbf52025-04-07WarningsExact identifier
application number: M020
Carmex Daily Care Moisturizing Lip Balm SPF 15OCTINOXATE, OXYBENZONECarma Laboratories, Inc.26f8dc88-2096-4fa1-81ae-ea92fe1f353d2025-04-07WarningsExact identifier
application number: M020
Vacation Instant BrowningAVOBENZONE OCTISALATE OCTOCRYLENEVacation Inc.13028f61-3f62-22cc-e063-6394a90a6bf12025-04-04WarningsExact identifier
application number: M020
LBri Pure n Natural SPF 30ZINC OXIDEL'BRI HEALTH & BEAUTY8350791d-5cf2-4358-9f85-9384d35be9f42025-04-03WarningsExact identifier
application number: M020
SHEER MINERAL SUNSCREENZINC OXIDEPlant Devas Inc. dba evanhealyf620ef44-f30c-4cc9-bc82-28dc4a47a8da2025-04-02WarningsExact identifier
application number: M020
CLEAR GLOW BROAD SPECTRUM SUNCREEN SPF 50AVOBENZONE, HOMOSALATE OCTISALATE, OCTOCRYLENENAKED SUNDAYS PTY LTD0116cffa-3415-746b-e063-6394a90ab3b32025-04-01WarningsExact identifier
application number: M020
HYDRATING SUNSCREEN MOISTURIZER BROAD SPECTRUM SPF50 SPF 50AVOBENZONE, HOMOSALATE OCTISALATE,NAKED SUNDAYS PTY LTD04293280-e74a-f293-e063-6394a90a06f62025-04-01WarningsExact identifier
application number: M020
Glow Go Lip OilAVOBENZONE 30MG/G, HOMOSALATE 100MG/G, OCTOCRYLENE 100MG/G, OCTISALATE 50MG/G,NAKED SUNDAY PTY LTDe5aab267-b33b-a40d-e053-2a95a90a9d792025-04-01WarningsExact identifier
application number: M020
Glow Go Lip OilAVOBENZONE 30MG/G, HOMOSALATE 100MG/G, OCTOCRYLENE 100MG/G, OCTISALATE 50MG/G,NAKED SUNDAY PTY LTDe5beb9cd-aa3b-2b37-e053-2995a90a84092025-04-01WarningsExact identifier
application number: M020
Glow Go Lip OilAVOBENZONE 30MG/G, HOMOSALATE 100MG/G, OCTOCRYLENE 100MG/G, OCTISALATE 50MG/G,NAKED SUNDAY PTY LTDe5bdc0c8-af2c-1096-e053-2995a90a89172025-04-01WarningsExact identifier
application number: M020
Mesoestetic Mesoprotech Melan 130 Pigment ControlAVOBENZONE, HOMOSALATE, OCTOCRYLENEMESOESTETIC PHARMA GROUP SL3b50e874-9665-4df4-8b3a-fc932c29f3f62025-04-01WarningsExact identifier
application number: M020
AVON BEYOND GLOW SUN MOISTURIZERAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENELG HOUSEHOLD & HEALTH CARE LTD.30c83f4f-9de0-6fbf-e063-6394a90af1ae2025-04-01WarningsExact identifier
application number: M020
EltaMD UV DailyOCTINOXATE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc6dde7055-5f77-4a7f-a182-c03e1f30bfaa2025-03-31WarningsExact identifier
application number: M020
natural lip balm SPF15( chocolate sundae) 01AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.319e8e26-b29d-4627-e063-6294a90acfba2025-03-31WarningsExact identifier
application number: M020
Face Shield Cream SPF 30OCTINOXATE, HOMOSALATE, OCTISALATE, OXYBENZONE, AVOBENZONEVege Labs31aad575-a5d1-42b0-e063-6294a90a6c812025-03-31WarningsExact identifier
application number: M020
SOLMED SUNSCREEN FACE SHIELDAVOBENZONE, ETHYLHEXYL SALICYLATE, HOMOSALATE, OCTOCRYLENEFEELFREE LLC31b077cc-32b9-78e6-e063-6394a90a155a2025-03-31WarningsExact identifier
application number: M020
TATCHA THE SILK SUNSCREENZINC OXIDETATCHA INC.7799042a-d2de-480e-a8a3-827b3dc279072025-03-31WarningsExact identifier
application number: M020
Cotz Sensitive SPF 40 SunscreenZINC OXIDEFallien Cosmeceuticals, LTD.885a674b-3457-4dfe-a801-529094b004992025-03-31WarningsExact identifier
application number: M020
EltaMD UV Daily TintedOCTINOXATE, ZINC OXIDE SUNSCREENCP Skin Health Group, Incad8aafdf-f3bc-497f-9792-20c2911c12d02025-03-31WarningsExact 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