FDA.reportPublic FDA data

MATTIFYING EXTREME WEAR FOUNDATION

Manufacturer
ALTONA COSMETICS TECHNOLOGY (DBA NOTE COSMETICS)
Effective date
2016-04-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:27:37

Label at a glance#

ProductMATTIFYING EXTREME WEAR FOUNDATION SPF-15
Active ingredientOCTINOXATE, TITANIUM DIOXIDE
Label structure8 sections

Indications and uses

moderate protection against sunburn. higher SPF gives more sunburn protection.

Dosage and administration

• Apply generously 15 minutes before sun exposure and as needed. • Children under 6 months of age: ask a doctor Sun Protection Measures: 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 SPF value of 15 or higher and other sun protection measures including: • limit time in the sun, especially from 10 a.m.-2 p.m. ...

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

OCTINOXATE (0.9%)

TITANIUM DIOXIDE (12.2%)

PURPOSE

OTC - PURPOSE SECTION

SUNSCREEN

USES

INDICATIONS & USAGE SECTION

  • moderate protection against sunburn.
  • higher SPF gives more sunburn protection.

WARNINGS

WARNINGS SECTION

For external use only
When using this product keep out of eyes. Rinse with water to remove.
Stop use and ask a doctor • if skin rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

• Apply generously 15 minutes before sun exposure and as needed.
• Children under 6 months of age: ask a doctor
Sun Protection Measures: 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 SPF value of 15 or higher and other sun protection measures including:
• limit time in the sun, especially from 10 a.m.-2 p.m. [bullet] wear long-sleeved shirts, pants, hats, and sunglasses".

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

WATER/AQUA/EAU, CYCLOPENTASILOXANE, BUTYLENE GLYCOL, DIMETHICONE, HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, TRIMETHYLSILOXYSILICATE, DISTEARDIMONIUM HECTORITE, SILICA, SODIUM CHLORIDE, CETRUS ATLANTICA BARK OIL, SPIRAEA ULMARIA EXTRACT, FRAGRANCE/PARFUM, PHENOXYETHANOL, ETHYLHEXYLGLYCERIN, BHT, TRIETHOXYCAPRYLYSILANE
MAY CONTAIN: TITANIUM DIOXIDE(CI 77891), IRON OXIDES(CI 77492, CI 77491, CI 77499

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SPF-15 Matti Ext Wear Fndtn_DFSPF-15 Matti Ext Wear Fndtn_DF

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70474-102-512021-11-17C16284748780-1ba0f9c33-2bef-a910-e053-dadaa90a0b85e1e311a8-dfda-4443-9f6e-0206e5e1cb37
70474-102-512021-01-29C16284748780-1ba0f9c33-2bef-a910-e053-dadaa90a0b85e1e311a8-dfda-4443-9f6e-0206e5e1cb37

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70474-10270474-102-01, 70474-102-51

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTINOXATE4Y5P7MUD51ACTIB
TITANIUM DIOXIDE15FIX9V2JPACTIB
WATER059QF0KO0RIACT
CYCLOMETHICONE 50THT5PCI0RIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
DIMETHICONE92RU3N3Y1OIACT
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMERWB5K9Y35Y9IACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8)5041RX63GNIACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM CHLORIDE451W47IQ8XIACT
CEDRUS ATLANTICA BARK OILZX5QRE4U60IACT
FILIPENDULA ULMARIA WHOLE3LH0M209LNIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
FERRIC OXIDE RED1K09F3G675IACT
FERROSOFERRIC OXIDEXM0M87F357IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT

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
d0fe31d0-02f1-d4f1-e053-2995a90a9f76e1e311a8-dfda-4443-9f6e-0206e5e1cb372021-11-17WarningsExact identifier
spl set id: e1e311a8-dfda-4443-9f6e-0206e5e1cb37

Reported adverse events (FAERS/openFDA)#

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