FDA.reportPublic FDA data

Charlis Neutral Tinted Face Moisturizer Mineral Sunscreen SPF 25

Manufacturer
CHARLIS LLC
Effective date
2025-04-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:59:21

Label at a glance#

ProductCharlis Neutral Tinted Face Moisturizer Mineral Sunscreen SPF 25
Active ingredientZINC OXIDE
Label structure6 sections

Indications and uses

• helps prevent sunburn • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Dosage and administration

• Apply liberally 15 minutes before sun exposure. • Reapply at least every 2 hours. • Use a water-resistant sunscreen if swimming or sweating. • Sun Protection Measures. Spending time in the sun increases your riskof skin cancer and early skin aging. To decrease this risk, regularly usea sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: - Limit time in the sun, especi...

Label contents#

Full prescribing information#

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 22%

Purpose:

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

• helps prevent sunburn
• if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

WARNINGS SECTION

• For external use only.

Do not use

OTC - DO NOT USE SECTION

• on damaged or broken skin.

Stop use and ask a doctor

OTC - STOP USE SECTION

• if rash occurs.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

• If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

• Apply liberally 15 minutes before sun exposure.
• Reapply at least every 2 hours.
• Use a water-resistant sunscreen if swimming or sweating.
• Sun Protection Measures.Spending time in the sun increases your riskof skin cancer and early skin aging. To decrease this risk, regularly usea sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
- Limit time in the sun, especially from 10 a.m. – 2 p.m.
- Wear long-sleeve shirts, pants, hats, and sunglasses.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Acetyl Tetrapeptide-2, Allantoin, Artemisia Vulgaris Extract, Benzyl Alcohol, Caprylyl Glycol, Coco-Caprylate, Cetearyl Alcohol, Cetearyl Olivate, Ethylhexylglycerin, Iron Oxides, Laminaria Digitata Extract, Mixed Tocopherols, Panthenol, Polyhydroxystearic Acid, Saccharide Isomerate, Sorbitan Olivate, Stearyl/Octyldodecyl Citrate Crosspolymer, Tetrasodium Glutamate Diacetate, Tocopherol, Water (Aqua), Xanthan Gum, Zingiber Officinale Root Oil.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer PackageOuter PackageInner PackageInner Package

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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85566-322-01Charlis Neutral Tinted Face Moisturizer Mineral Sunscreen SPF 2530 mL in 1 JARCREAM301
85566-322-01Charlis Neutral Tinted Face Moisturizer Mineral Sunscreen SPF 251 in 1 BOXCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85566-322CHARLIS NEUTRAL TINTED FACE MOISTURIZER MINERAL SUNSCREEN SPF 25 (ZINC OXIDE) CREAM [CHARLIS LLC]1Current NDC, 2 package rows20250419_330f7470-0d53-7361-e063-6394a90a5d59.zip

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85566-32285566-322-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETYL TETRAPEPTIDE-2M24S4WZS8JIACT
ALLANTOIN344S277G0ZIACT
ARTEMISIA VULGARIS ROOT32MP823R8SIACT
BENZYL ALCOHOLLKG8494WBHIACT
CAPRYLYL GLYCOL00YIU5438UIACT
COCO-CAPRYLATE4828G836N6IACT
CETEARYL ALCOHOL2DMT128M1SIACT
CETEARYL OLIVATE58B69Q84JOIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
FERRIC OXIDE RED1K09F3G675IACT
LAMINARIA DIGITATA15E7C67EE8IACT
PANTHENOLWV9CM0O67ZIACT
SACCHARIDE ISOMERATEW8K377W98IIACT
SORBITAN OLIVATEMDL271E3GRIACT
STEARYL/OCTYLDODECYL CITRATE CROSSPOLYMERPN88NW0KPKIACT
TETRASODIUM GLUTAMATE DIACETATE5EHL50I4MYIACT
TOCOPHEROLR0ZB2556P8IACT
WATER059QF0KO0RIACT
XANTHAN GUMTTV12P4NEEIACT
ZINC OXIDESOI2LOH54ZACTIM

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
Charlis Neutral Tinted Face Moisturizer Mineral Sunscreen SPF 25ZINC OXIDECHARLIS LLC330f7470-0d53-7361-e063-6394a90a5d592025-04-18WarningsExact identifier
ndc (package): 85566-322-01
ndc (product): 85566-322
ndc11 (package): 85566032201
spl id: 330fb258-8908-3c28-e063-6294a90a3313
spl set id: 330f7470-0d53-7361-e063-6394a90a5d59

Reported adverse events (FAERS/openFDA)#

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