FDA.reportPublic FDA data

zinc oxide,octinoxate

Manufacturer
Bel Star S.A. (Colombia)
Effective date
2025-11-29
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
monthly-update
Hydrated at
2026-06-03 17:45:03

Label at a glance#

ProductMATTE PRO DEFENSE Base mate con multiproteccion de la piel FPS 20 Matte foundation with skin multiprotection SPF 20 M...
Active ingredientOCTINOXATE, ZINC OXIDE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients Purpose

OCTINOXATE 5.00% Sunscreen

ZINC OXIDE 4.20% Sunscreen

OTC - PURPOSE SECTION

Uses
Helps prevent sunburn.

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.

INDICATIONS & USAGE SECTION

Stop use and ask a doctor ifrash occurs.

WARNINGS SECTION

Warnings
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.
For external use only.
Do not useon damaged or broken skin.

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

DOSAGE & ADMINISTRATION SECTION

Directions

Apply liberally and evenly 15 minutes before sun exposure.

Reapply at least every 2 hours

Use a water resistant sunscreen if swimming or sweating.
Children under 6 months of age: Ask a doctor

OTHER SAFETY INFORMATION

Other information
Protect the product in this container from excessive heat and direct sun.

INACTIVE INGREDIENT SECTION

Inactive ingredients:WATER, DIMETHICONE, ISODODECANE, PEG-10 DIMETHICONE, TRIMETHYLSILOXYSILICATE, PROPYLENE GLYCOL, MICA, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, PEG/PPG-18/18 DIMETHICONE, POLYSILICONE-11, GLYCERIN, LECITHIN, SODIUM CHLORIDE, PHENOXYETHANOL, SILICA, SILICA DIMETHYL SILYLATE, BACKHOUSIA CITRIODORA LEAF EXTRACT, MALTODEXTRIN, CAPRYLYL GLYCOL, DISTEARDIMONIUM HECTORITE, HYDROXYETHYL UREA, PEG-8 CAPRYLIC/CAPRIC GLYCERIDES, CHLORPHENESIN, TOCOPHERYL ACETATE, LACTOBACILLUS FERMENT, OCTYLDODECETH-25, PERFLUOROOCTYL TRIETHOXYSILANE, SODIUM HYALURONATE, DECYLENE GLYCOL.

MAY CONTAIN :
TITANIUM DIOXIDE, IRON OXIDES, TRIETHOXYCAPRYLYLSILANE.

390-N

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

L'BEL

MATTE PRO DEFENSE
Base Mate con multiproteccion de la piel FPS 20
Matte foundation with skin multiprotection SPF 20
1.01 fl. oz. (30ml)
Tone MOKACCINO 390-N

Mokaccino 390-NMokaccino 390-N

Products#

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

DailyMed product names page 1 of 1 · 38 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
14141-22614141-226-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 36 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE)H895X08VNQIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
FERRIC OXIDE RED1K09F3G675IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
HYALURONATE SODIUMYSE9PPT4THIACT
ISODODECANEA8289P68Y2IACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
CAPRYLYL GLYCOL00YIU5438UIACT
LACTOBACILLUS FERMENTUM2C1F12C6APIACT
DECYLENE GLYCOLS57M60MI88IACT
HYDROXYETHYL UREAMBQ7DDQ7ARIACT
CHLORPHENESINI670DAL4SZIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
LECITHIN, SUNFLOWER834K0WOS5GIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM CHLORIDE451W47IQ8XIACT
SILICA DIMETHYL SILYLATEEU2PSP0G0WIACT
MALTODEXTRIN7CVR7L4A2DIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
MICAV8A1AW0880IACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
OCTYLDODECETH-25F8934HEL3MIACT
GLYCERINPDC6A3C0OXIACT
PEG-8 CAPRYLIC/CAPRIC GLYCERIDES00BT03FSO2IACT
DIMETHICONE92RU3N3Y1OIACT
PEG-10 DIMETHICONE (600 CST)8PR7V1SVM0IACT
BACKHOUSIA CITRIODORA LEAFFKN73KG747IACT
PERFLUOROOCTYL TRIETHOXYSILANE814P46684UIACT
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8)5041RX63GNIACT
PEG/PPG-18/18 DIMETHICONE9H0AO7T794IACT
WATER059QF0KO0RIACT
OCTINOXATE4Y5P7MUD51ACTIB
ZINC OXIDESOI2LOH54ZACTIB

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
44be2377-9bb4-b37f-e063-6294a90a7accc0852486-f83d-7fd1-e053-2995a90a321d2025-11-29WarningsExact identifier
spl id: 44be2377-9bb4-b37f-e063-6294a90a7acc
spl set id: c0852486-f83d-7fd1-e053-2995a90a321d

Reported adverse events (FAERS/openFDA)#

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