FDA.reportPublic FDA data

Note Mattifying Extreme Wear Foundation 110 Smoke

Manufacturer
ALTONA COSMETICS TECHNOLOGY SANAYI VE TICARET ANONIM SIRKETI
Effective date
2024-09-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:19:36

Label at a glance#

ProductNote Mattifying Extreme Wear Foundation 110 Smoke
Active ingredientOCTINOXATE
Label structure7 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 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 ...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 0.6%

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

When using this product

OTC - WHEN USING SECTION

  • keep out of eyes, Rinse with water to remove.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • rash occurs

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If 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 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.
  • wear long-sleeved shirts, pants, hats, and sunglases
  • children under 6 months of age: ask a doctor

Other information

SPL UNCLASSIFIED SECTION

  • Protect the product in this container from excessive heat and direct sun

Inactive ingredients

INACTIVE INGREDIENT SECTION

Cyclopentasiloxane, Water (Aqua), PEG-10 Dimethicone, Butylene Glycol, Dimethicone, HDI/Trimethylol Hexyllactone Crosspolymer, Disteardimonium Hectorite, Aluminum Starch Octenylsuccinate, Phenoxyethanol, Alcohol, Triethoxycaprylylsilane, Propylene Glycol, Trimethylsiloxysilicate, Sodium Chloride, Dimethicone/Vinyl Dimethicone Crosspolymer, Cedrus (Cedrus atlantica) Wood Oil, Fragrance (Parfum), Ethylhexylglycerin, Silica, BHT, Meadowsweet (Spiraea ulmaria) Extract, May contain: Titanium Dioxide (CI 77891), Iron Oxides (CI 77491, CI 77492, CI 77499)

Package Labelling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Smoke.jpgSmoke.jpgSmoke2.jpgSmoke2.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70474-008-012025-11-26C16284748780-13b156c62-2eef-fb37-e063-e6dba90a4e07Note Mattifying Extreme Wear Foundation SPF 15, 110 Smoke
70474-008-012025-07-29C16284748780-13b156c62-2eef-fb37-e063-e6dba90a4e07Note Mattifying Extreme Wear Foundation SPF 15, 110 Smoke

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70474-008-01Note Mattifying Extreme Wear Foundation 110 Smoke30 mL in 1 BOTTLECREAM301
70474-008-01Note Mattifying Extreme Wear Foundation 110 Smoke1 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70474-008NOTE MATTIFYING EXTREME WEAR FOUNDATION 110 SMOKE (OCTINOXATE) CREAM [ALTONA COSMETICS TECHNOLOGY SANAYI VE TICARET ANONIM SIRKETI]1Current NDC, 2 package rows20240918_0a9a30e7-4fcc-4518-bd83-a0126a459c9d.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70474-00870474-008-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
CYCLOMETHICONE 50THT5PCI0RIACT
WATER059QF0KO0RIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
DIMETHICONE, UNSPECIFIED92RU3N3Y1OIACT
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMERWB5K9Y35Y9IACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
ALUMINUM STARCH OCTENYLSUCCINATEI9PJ0O6294IACT
PHENOXYETHANOLHIE492ZZ3TIACT
ALCOHOL3K9958V90MIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SODIUM CHLORIDE451W47IQ8XIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
FILIPENDULA ULMARIA ROOT997724QNDSIACT
OCTINOXATE4Y5P7MUD51ACTIB
CEDRUS ATLANTICA WOOD OILJEX140NPX8IACT

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
Note Mattifying Extreme Wear Foundation 110 SmokeOCTINOXATEALTONA COSMETICS TECHNOLOGY SANAYI VE TICARET ANONIM SIRKETI0a9a30e7-4fcc-4518-bd83-a0126a459c9d2024-09-16WarningsExact identifier
ndc (package): 70474-008-01
ndc (product): 70474-008
ndc11 (package): 70474000801
spl id: 223e6756-8a7b-46c0-e063-6294a90af398
spl set id: 0a9a30e7-4fcc-4518-bd83-a0126a459c9d