FDA.reportPublic FDA data

FULL SPECTRUM MATTE AMBITION SKIN PRIMER SPF 20

Manufacturer
Noxell Corporation
Effective date
2024-11-19
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:38:05

Label at a glance#

ProductFULL SPECTRUM MATTE AMBITION SKIN PRIMER SPF 20
Active ingredientENSULIZOLE
Label structure14 sections

Indications and uses

helps prevent sunburn

Dosage and administration

apply liberally 15 minutes before sun exposure reapply at least every 2 hours use water resistant sunscreen if swimming or sweating children under 6 months: ask a doctor

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ensulizole 3%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

helps prevent sunburn

Warnings

WARNINGS AND PRECAUTIONS SECTION

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

OTC - WHEN USING SECTION

When using this product keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. 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 water resistant sunscreen if swimming or sweating
  • children under 6 months: ask a doctor

Other information

SPL UNCLASSIFIED SECTION

Protect this product from excessive heat and direct sun

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aqua/Water/Eau, Cyclopentasiloxane, Talc, Propylene Glycol, Dimethicone, Aluminum Starch Octenylsuccinate, PEG/PPG-18/18 Dimethicone, Sodium Chloride, PVP, Phenoxyethanol, Sodium Hydroxide, Acrylonitrile/Methyl Methacrylate/Vinylidene Chloride Copolymer, Synthetic Beeswax, Trihydroxystearin, Methicone, 1,2-Hexanediol, Caprylyl Glycol, Silica, Sodium Benzoate, Synthetic Wax, Polyglyceryl-4 Isostearate, Cetyl PEG/PPG-10/1 Dimethicone, Hexyl Laurate, Isopropyl Titanium Triisostearate, Ethylene Brassylate, Polyethylene.

Questions?

OTC - QUESTIONS SECTION

1-800-426-8374

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

full spectrum

COVERGIRL

MATTE AMBITION

MATTIFYING

SKIN PRIMER +

ENSULIZOLE

SUNSCREEN

SPF 20

30 mL (1.0 FL OZ)

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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
22700-201-30FULL SPECTRUM MATTE AMBITION SKIN PRIMER SPF 2030 mL in 1 TUBELIQUID305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
22700-201FULL SPECTRUM MATTE AMBITION SKIN PRIMER SPF 20 (ENSULIZOLE) LIQUID [NOXELL CORPORATION]5Current NDC, Legacy NDC, 1 package rows20241121_82f7bff9-718e-19ea-e053-2991aa0a3560.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
22700-20122700-201-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALUMINUM STARCH OCTENYLSUCCINATEI9PJ0O6294IACT
PEG/PPG-18/18 DIMETHICONE9H0AO7T794IACT
PHENOXYETHANOLHIE492ZZ3TIACT
SODIUM HYDROXIDE55X04QC32IIACT
HEXYL LAURATE4CG9F9W01QIACT
ETHYLENE BRASSYLATE9A87HC7RODIACT
DIMETHICONE92RU3N3Y1OIACT
SODIUM CHLORIDE451W47IQ8XIACT
POLYGLYCERYL-4 ISOSTEARATE820DPX33S7IACT
TALC7SEV7J4R1UIACT
WATER059QF0KO0RIACT
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)V2W71V8T0XIACT
ISOPROPYL TITANIUM TRIISOSTEARATE949E3KBJ1IIACT
ENSULIZOLE9YQ9DI1W42ACTIB

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
FULL SPECTRUM MATTE AMBITION SKIN PRIMER SPF 20ENSULIZOLENoxell Corporation82f7bff9-718e-19ea-e053-2991aa0a35602024-11-19WarningsExact identifier
ndc (package): 22700-201-30
ndc (product): 22700-201
ndc11 (package): 22700020130
spl id: 274a297b-8384-0832-e063-6294a90aaf98
spl set id: 82f7bff9-718e-19ea-e053-2991aa0a3560

Reported adverse events (FAERS/openFDA)#

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