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 21:21:40

Label at a glance#

ProductTEINT COUTURE CITY BALM Radiant Perfecting Skin Tint 24h Wear Moisturizer Urban Shield SPECTRUM SPF 25 W480
Active ingredientOCTINOXATE, TITANIUM DIOXIDE
Label structure10 sections

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 from 1...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 3.00%

Titanium Dioxide 1.75%

OTC - PURPOSE SECTION

Sunscreen

Use

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.

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 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.-2p.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

aqua (water), methyl trimethicone, alcohol, isododecane, phenyl trimethicone, butylene glycol, PEG-9 polydimethylsiloxyethyl dimethicone, glycerin, acrylates/dimethicone copolymer, vinyl dimethicone/methicone silsesquioxane crosspolymer, disteardimonium hectorite, sodium myristoyl glutamate, glyceryl undecyl dimethicone, phenoxyethanol, aluminum hydroxide, xanthan gum, propylene carbonate, dimethicone, VP/VA copolymer, stearic acid, sodium hyaluronate, tetrasodium EDTA, parfum (fragrance), dipotassium glycyrrhizate, butyrospermum parkii (shea) seedcake extract, BHT, geraniol, 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: 60905-0843-0

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label9Label9BoxBox

Package Labeling: 60905-0843-1

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

30ml Label930ml Label9TesterTester

Package Labeling: 60905-0843-2

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

10ml Label910ml Label9

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
60905-084360905-0843-0, 60905-0843-1, 60905-0843-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
METHYL TRIMETHICONES73ZQI0GXMIACT
ALCOHOL3K9958V90MIACT
ISODODECANEA8289P68Y2IACT
PHENYL TRIMETHICONEDR0K5NOJ4RIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONETYP81E471FIACT
GLYCERINPDC6A3C0OXIACT
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER9NH1UDD2RRIACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
SODIUM MYRISTOYL GLUTAMATEAYU7QD893WIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
XANTHAN GUMTTV12P4NEEIACT
PROPYLENE CARBONATE8D08K3S51EIACT
DIMETHICONE92RU3N3Y1OIACT
COPOVIDONE K25-31D9C330MD8BIACT
STEARIC ACID4ELV7Z65APIACT
HYALURONATE SODIUMYSE9PPT4THIACT
EDETATE SODIUMMP1J8420LUIACT
GLYCYRRHIZINATE DIPOTASSIUMCA2Y0FE3FXIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
GERANIOLL837108USYIACT
OCTINOXATE4Y5P7MUD51ACTIB
TITANIUM DIOXIDE15FIX9V2JPACTIB

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
253ba50c-6c56-468c-e063-6394a90a661a02ea7f48-4bb6-4a62-9124-9e77dc2c6bd92024-10-24WarningsExact identifier
spl set id: 02ea7f48-4bb6-4a62-9124-9e77dc2c6bd9

Reported adverse events (FAERS/openFDA)#

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