FDA.reportPublic FDA data

MATTE UNIVERSAL TINTED MOISTURIZER SPF46

Manufacturer
Drmtlgy, LLC
Effective date
2025-08-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:14:52

Label at a glance#

ProductMATTE UNIVERSAL TINTED MOISTURIZER SPF46
Active ingredientZINC OXIDE, OCTINOXATE
Label structure9 sections

Indications and uses

Helps prevent sunburn • If used as directed with other sun protection measures, decreases the risk of skin cancer and early skin aging caused by the sun.

Dosage and administration

• Apply to face and neck, avoiding the eye area. Wait at least 30 minutes before sun exposure, or as directed by a physician. Reapply at least every 2 hours.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 12% 
Octinoxate 7.5%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

Helps prevent sunburn • If used as directed with other sun protection measures, decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

WARNINGS SECTION

For external use only.

When using this product • keep out of eyes. Rinse with water to remove. Stop use and ask physician if rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

• Apply to face and neck, avoiding the eye area. Wait at least 30 minutes before sun exposure, or as directed by a physician. Reapply at least every 2 hours.

Precautions

PRECAUTIONS SECTION

• Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum value of SPF 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m.-2 p.m. wear long-sleeved shirts, pants, hats, and sunglasses. Children under 6 months of age: Ask a physician.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water/Aqua/Eau, Cyclopentasiloxane, Niacinamide, Oleth-3 Phosphate, Diphenyl Dimethicone/Vinyl Diphenyl Dimethicone/Silsesquioxane Crosspolymer, Octyldodecyl Neopentanoate, Saccharomyces Ferment, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Glycerin, Knotweed (Polygonum Aviculare) Extract, Sodium Hyaluronate, Tocopheryl Acetate, Ethylhexylglycerin, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, PEG-7 Trimethylolpropane Coconut Ether, Lauroyl Lysine, Polyisobutene, Triethoxycaprylylsilane, Disodium EDTA, Iron Oxide (CI 77492), Iron Oxide (CI 77491), Iron Oxide (CI 77499), Phenoxyethanol

SPL UNCLASSIFIED SECTION

PROTECT

hydrate//mattify

Broad Spectrum
UVA/UVB Protection

Dist. by DRMTLGY, LLC
Chatsworth, CA 91311
www.DRMTLGY.com

Made in USA

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MATTE UNIVERSAL TINTED SPF46MATTE UNIVERSAL TINTED SPF46

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

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

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83286-01583286-015-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIM
OCTINOXATE4Y5P7MUD51ACTIB
WATER059QF0KO0RIACT
CYCLOMETHICONE 50THT5PCI0RIACT
NIACINAMIDE25X51I8RD4IACT
OLETH-3 PHOSPHATE8Q0Z18J1VLIACT
OCTYLDODECYL NEOPENTANOATEX8725R883TIACT
SACCHAROMYCES LYSATER85W246Z1CIACT
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%)86FQE96TZ4IACT
GLYCERINPDC6A3C0OXIACT
POLYGONUM AVICULARE TOPZCD6009IUFIACT
HYALURONATE SODIUMYSE9PPT4THIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONEX75PL53TZJIACT
POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S)RLA2U05Z4QIACT
PEG-7 TRIMETHYLOLPROPANE COCONUT ETHERMVJ3AD73GGIACT
LAUROYL LYSINE113171Q70BIACT
POLYISOBUTYLENE (2300 MW)DSQ2V1DD1KIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
EDETATE DISODIUM7FLD91C86KIACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
FERRIC OXIDE RED1K09F3G675IACT
FERROSOFERRIC OXIDEXM0M87F357IACT
PHENOXYETHANOLHIE492ZZ3TIACT

Source Document#

Source XML

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MATTE UNIVERSAL TINTED MOISTURIZER SPF46ZINC OXIDE, OCTINOXATEDrmtlgy, LLC8e284afd-b90f-41d5-b334-e5cf4440b4d32025-08-12WarningsExact identifier
ndc (package): 83286-015-01
ndc (product): 83286-015
ndc11 (package): 83286001501
spl id: f9dc4aca-ea4e-46c7-af3c-5fc5764d98bd
spl set id: 8e284afd-b90f-41d5-b334-e5cf4440b4d3

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.