FDA.reportPublic FDA data

Note Sunglow Foundation

Manufacturer
ALTONA COSMETICS TECHNOLOGY SANAYI VE TICARET ANONIM SIRKETI
Effective date
2024-09-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:19:27

Label at a glance#

ProductNote Sunglow Foundation
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, Mica, Butylene Glycol, Dimethicone, Disteardimonium Hectorite, HDI/Trimethylol Hexyllactone Crosspolymer, Phenoxyethanol, Tocopheryl Acetate, Aluminum Starch Octenylsuccinate, Alcohol, Trimethylsiloxysilicate, Dimethicone/Vinyl Dimethicone Crosspolymer, Sodium Chloride, Fragrance (Parfum), Ethylhexylglycerin, BHT, Silica. May contain: Titanium Dioxide (CI 77891), Iron Oxides (CI 77491, CI 77492, CI 77499)

Package Labelling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sunglow.jpgSunglow.jpgSunglow2.jpgSunglow2.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70474-018-012025-11-26C16284748780-13b156c62-31e4-fb37-e063-e6dba90a4e07Note Sunglow Foundation Sunscreen SPF 15, 20
70474-018-012025-07-29C16284748780-13b156c62-31e4-fb37-e063-e6dba90a4e07Note Sunglow Foundation Sunscreen SPF 15, 20

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70474-018-01Note Sunglow Foundation1 in 1 CARTONCREAM11
70474-018-01Note Sunglow Foundation30 mL in 1 TUBECREAM301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70474-018NOTE SUNGLOW FOUNDATION (OCTINOXATE) CREAM [ALTONA COSMETICS TECHNOLOGY SANAYI VE TICARET ANONIM SIRKETI]1Current NDC, 2 package rows20240913_d790ae8a-901b-4962-9684-718b54b77dc8.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
70474-01870474-018-01

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
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
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
OCTINOXATE4Y5P7MUD51ACTIB
MICAV8A1AW0880IACT

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 Sunglow FoundationOCTINOXATEALTONA COSMETICS TECHNOLOGY SANAYI VE TICARET ANONIM SIRKETId790ae8a-901b-4962-9684-718b54b77dc82024-09-12WarningsExact identifier
ndc (package): 70474-018-01
ndc (product): 70474-018
ndc11 (package): 70474001801
spl id: 21f004f8-e4c9-ac9f-e063-6394a90af1bc
spl set id: d790ae8a-901b-4962-9684-718b54b77dc8

Reported adverse events (FAERS/openFDA)#

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