PHYSICAL TINTED MOISTURIZER SPF44

Manufacturer
Drmtlgy, LLC
Effective date
2025-11-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:16:43

Label at a glance#

ProductPHYSICAL TINTED MOISTURIZER SPF44
Active ingredientZINC OXIDE, TITANIUM DIOXIDE
Label structure10 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 after 80 minutes of swimming or sweating. Reapply immediately after towel drying at least every 2 hours.

Label contents#

Full prescribing information#

​Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 10%

Titanium Dioxide 5.5%

​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 after 80 minutes of swimming or sweating. Reapply immediately after towel drying 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, Caprylyl Methicone, C12-15 Alkyl Benzoate, Glycerin, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Octyldodecyl Neopentanoate, Dimethicone, Alumina, Sodium Chloride, Sodium Hyaluronate, Tocopherol, Ascorbyl Palmitate, Polyhydroxystearic Acid, Methicone, Disteardimonium Hectorite, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Dimethicone/PEG-10/15 Crosspolymer, Triethoxycaprylylsilane, Propylene Carbonate, 1,2 Hexanediol, Caprylyl Glycol, Ethylhexylglycerin, Phenoxyethanol, Iron Oxides (CI 77492), Iron Oxides (CI 77491), Iron Oxides (CI 77499)

Questions or comments?

OTC - QUESTIONS SECTION

1-888-DRMTLGY

SPL UNCLASSIFIED SECTION

PROTECT

Broad Spectrum
UVA/UVB Protection

Water Resistant for up to 80 minutes

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

Made in USA

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PHYSICAL TINTED MOISTURIZER SPF44PHYSICAL TINTED MOISTURIZER SPF44

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
83286-010-01PHYSICAL TINTED MOISTURIZER SPF4458 g in 1 BOTTLE, PUMPCREAM582

Products#

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

DailyMed product names page 1 of 1 · 33 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83286-01083286-010-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

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
PHYSICAL TINTED MOISTURIZER SPF44ZINC OXIDE, TITANIUM DIOXIDEDrmtlgy, LLC483d0d28-56f3-4b37-af03-0331e1653d732025-11-06WarningsExact identifier
ndc (package): 83286-010-01
ndc (product): 83286-010
ndc11 (package): 83286001001
spl id: 9b3c3980-473f-4cbb-92f0-cca9d5d29ed5
spl set id: 483d0d28-56f3-4b37-af03-0331e1653d73

Reported adverse events (FAERS/openFDA)#

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