FDA.reportPublic FDA data

OCTINOXATE, TITANIUM DIOXIDE

Manufacturer
LVMH Fragrance Brands
Effective date
2023-11-06
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:21:46

Label at a glance#

ProductTEINT COUTURE EVERWEAR 24h Wear Satin Finish Full Coverage and Comfort Broad Spectrum SPF 20 P300
Active ingredientTITANIUM DIOXIDE, OCTINOXATE
Label structure8 sections

Indications and uses

helps prevent sunburn if used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by the sun. Directions

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. 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 of 15 or higher and other sun protection measures including: Sun Protection Measures. limit time in the sun, especially fro...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 3.00%

Titanium Dioxide 1.75%

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn if used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by the sun. Directions

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.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact 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.
  • 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 of 15 or higher and other sun protection measures including: Sun Protection Measures.
  • limit time in the sun, especially from 10 a.m. – 2 p.m.
  • wear long-sleeve shirts, pants, hats, and sunglasses
  • 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

water (aqua), methyl trimethicone, isododecane, alcohol, dimethicone, PEG-9 polydimethylsiloxyethyl dimethicone, acrylates/dimethicone copolymer, Glycerin, diphenyl dimethicone/vinyl diphenyl dimethicone/silsesquioxane crosspolymer, diisostearyl malate, disteardimonium hectorite, sodium myristoyl glutamate, aluminum hydroxide, glyceryl undecyl dimethicone, phenoxyethanol, propylene carbonate, vp/va copolymer, stearic acid, fragrance (parfum), tetrasodium EDTA, dipotassium glycyrrhizate, geraniol, BHT, citronellol, tocopherol.

May Contain: titanium dioxide, iron oxides.

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-855-424-8563 Monday-Friday 9am to 5pm EST consumerservices@lvmhfb.com

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer Package18Outer Package18Inner Package18Inner Package18BottleBottleP300P300

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
60905-081860905-0818-1, 60905-0818-0

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
METHYL TRIMETHICONES73ZQI0GXMIACT
ISODODECANEA8289P68Y2IACT
ALCOHOL3K9958V90MIACT
DIMETHICONE92RU3N3Y1OIACT
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONETYP81E471FIACT
GLYCERINPDC6A3C0OXIACT
DIISOSTEARYL MALATEQBS8A3XZGQIACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
SODIUM MYRISTOYL GLUTAMATEAYU7QD893WIACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
PHENOXYETHANOLHIE492ZZ3TIACT
PROPYLENE CARBONATE8D08K3S51EIACT
STEARIC ACID4ELV7Z65APIACT
EDETATE SODIUMMP1J8420LUIACT
GLYCYRRHIZINATE DIPOTASSIUMCA2Y0FE3FXIACT
GERANIOLL837108USYIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
.BETA.-CITRONELLOL, (R)-P01OUT964KIACT
TOCOPHEROLR0ZB2556P8IACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
OCTINOXATE4Y5P7MUD51ACTIB

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
253a44c3-a10c-cfe3-e063-6294a90aa39b5a304c59-e501-4f35-93ee-d1eab3eb95e52024-10-24WarningsExact identifier
spl set id: 5a304c59-e501-4f35-93ee-d1eab3eb95e5

Reported adverse events (FAERS/openFDA)#

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