FDA.reportPublic FDA data

OCTINOXATE, TITANIUM DIOXIDE

Manufacturer
Parfums Christian Dior
Effective date
2023-11-04
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:22:19

Label at a glance#

ProductFOREVER 24h Wear High Perfection Skin-Caring Foundation With Sunscreen BROAD SPECTRUM SPF 35 Lasting Comfort and Care 7W
Active ingredientOCTINOXATE, TITANIUM DIOXIDE
Label structure9 sections

Indications and uses

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

Dosage and administration

Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours.  Use water-resistant sunscreen if swimming or sweating.  Spending time in the sun increases your risk of skin cancer and early skin aging. To decease this risk, regularly use 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 ...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 3.00% Titanium Dioxide 1.75%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn.
  • If used as directed with other sun protection measures ( ), decreases the risk of skin cancer and early skin aging caused by the sun. see 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 a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes before sun exposure.
  • Reapply at least every 2 hours. 
  • Use water-resistant sunscreen if swimming or sweating. 
  • Spending time in the sun increases your risk of skin cancer and early skin aging. To decease this risk, regularly use 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-sleeved 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, ISODODECANE, ALCOHOL, DIMETHICONE, PEG-9 POLYDIMETHYLILOXY ETHYL DIMETHICONE, SILICA, ACRYLATE/IMETHICONE CO POLYMER, DIPHENYL DIMETHICONE/SILSEQUIOXANE CROSSPOLYMER, METHYL METHACRYLATE, CROSSPOLYMER, DISTEARDIMONIUM HECTORITE, BUTYLENE GLYCOL, SODIUM MYRISTYL GLUTAMATE, PHENOXYETHANOL, GLYCERYL UNDECYL DIMETHICONE, ALUMINUM HYDROXIDE, PROPYLENE CARBONATE, VP/VA COPOLYMER, STEARIC ACID, PARFUM(FRAGRANCE), TETRASODIUM EDTA, VIOLA TRICOLOR EXTRACT, ROSA MULTIFLORE FRUIT EXTRACT, LINALOOL, LIMONENE, CITRONELLOL, ETHYLHEXYLGLYCERIN, TOCPHEROL. [MAY CONTAIN: CI 77163 (BISMUTH OXYCHLORIDE), CI 177493, CI 77492, CI 77499 (IRON OXIDE), CI 77891 (TITANIUM DIOXIDE)].N 13117/Z

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle4Bottle4Label4Label4Sticker4Sticker4

Package Labeling:61957-2989-1

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle16Bottle16

Package Labeling:61957-2989-2

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer LabelOuter LabelBottle05Bottle05

Products#

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

DailyMed product names page 1 of 1 · 32 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61957-298961957-2989-0, 61957-2989-1, 61957-2989-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

Name, UNII, Kind table
NameUNIIKind
VIOLA TRICOLOR WHOLE9Q24RAI43VIACT
ROSA MULTIFLORA FRUITEZ5DSL4T27IACT
LINALOOL, (+)-F4VNO44C09IACT
LIMONENE, (+)-GFD7C86Q1WIACT
.BETA.-CITRONELLOL, (R)-P01OUT964KIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
TOCOPHEROLR0ZB2556P8IACT
BISMUTH OXYCHLORIDE4ZR792I587IACT
FERRIC OXIDE RED1K09F3G675IACT
WATER059QF0KO0RIACT
METHYL TRIMETHICONES73ZQI0GXMIACT
ISODODECANEA8289P68Y2IACT
ALCOHOL3K9958V90MIACT
DIMETHICONE92RU3N3Y1OIACT
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONETYP81E471FIACT
SILICONZ4152N8IUIIACT
ACRYLIC ACIDJ94PBK7X8SIACT
DIPHENYL DIMETHICONE (100 CST)AG1ANB6B8OIACT
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMEREG97988M5QIACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
SODIUM MYRISTOYL GLUTAMATEAYU7QD893WIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
PROPYLENE CARBONATE8D08K3S51EIACT
COPOVIDONE K25-31D9C330MD8BIACT
STEARIC ACID4ELV7Z65APIACT
EDETATE SODIUMMP1J8420LUIACT
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
27d3e77e-0c25-a250-e063-6394a90ab4a09dd47141-e5b8-4f68-a45f-469ef8d00c1d2024-11-26WarningsExact identifier
spl set id: 9dd47141-e5b8-4f68-a45f-469ef8d00c1d

Reported adverse events (FAERS/openFDA)#

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