FDA.reportPublic FDA data

OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE

Manufacturer
Parfums Christian Dior
Effective date
2020-09-09
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 23:15:48

Label at a glance#

ProductCapture Totale Dreamskin Perfect Skin Cushion Youth Skincare Perfect Complexion Creator With Sunscreen Broad Spectrum...
Active ingredientOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE
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 of 15 or higher and other sun protection measures including:       • limit time in the sun, especi...

Label contents#

Full prescribing information#

Acitve ingredients

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 7.00%

Titanium Dioxide 4.15%

Zinc Oxide 9.80%

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 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-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), CYCLOPENTASILOXANE, CYCLOHEXASILOXANE, PEG-10 DIMETHICONE, DIMETHICONE, BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE, PROPANEDIOL, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, TRISILOXANE, PHENYL TRIMETHICONE, POLYMETHYL METHACRYLATE, SODIUM CHLORIDE, DISTEARDIMONIUM HECTORITE, ALUMINUM HYDROXIDE, PHENOXYETHANOL, DIMETHICONE/PEG-10/15 CROSSPOLYMER, STEARIC ACID, TRIETHOXYCAPRYLYLSILANE,PARFUM (FRAGRANCE), ETHYLHEXYLGLYCERIN, DISODIUM EDTA, SILICA, ZINC GLUCONATE, ADENOSINE, BUTYLPHENYL METHYLPROPIONAL, LIMONENE, SYNTHETIC FLUORPHLOGOPITE, ALPHA-ISOMETHYL IONONE, GERANIOL, BUTYLENE GLYCOL, ALCOHOL, HYDROGEN DIMETHICONE, BHT, SAPONINS, TOCOPHEROL, AFRAMOMUM ANGUSTIFOLIUM SEED EXTRACT.
[MAY CONTAIN: CI 77491, CI 77492, CI 77499 (IRON OXIDES), CI 77891 (TITANIUM DIOXIDE)]

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer PackageOuter PackageCaptureCaptureLabelLabel

Products#

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

DailyMed product names page 1 of 1 · 38 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61957-222261957-2222-1, 61957-2222-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 35 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
CYCLOMETHICONE 50THT5PCI0RIACT
CYCLOMETHICONE 6XHK3U310BAIACT
PEG-10 DIMETHICONE (600 CST)8PR7V1SVM0IACT
DIMETHICONE92RU3N3Y1OIACT
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE75D21FL1PIIACT
PROPANEDIOL5965N8W85TIACT
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE25G622K2RAIACT
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMERWB5K9Y35Y9IACT
TRISILOXANE9G1ZW13R0GIACT
PHENYL TRIMETHICONEDR0K5NOJ4RIACT
POLY(METHYL METHACRYLATE; 450000 MW)Z47NNT4J11IACT
SODIUM CHLORIDE451W47IQ8XIACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
PHENOXYETHANOLHIE492ZZ3TIACT
STEARIC ACID4ELV7Z65APIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
ZINC GLUCONATEU6WSN5SQ1ZIACT
ADENOSINEK72T3FS567IACT
BUTYLPHENYL METHYLPROPIONALT7540GJV69IACT
LIMONENE, (+)-GFD7C86Q1WIACT
ISOMETHYL-.ALPHA.-IONONE9XP4LC555BIACT
GERANIOLL837108USYIACT
1-BUTENELY001N554LIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
ALCOHOL3K9958V90MIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
TOCOPHEROLR0ZB2556P8IACT
AFRAMOMUM ANGUSTIFOLIUM SEEDOSF83Q896JIACT
OCTINOXATE4Y5P7MUD51ACTIB
TITANIUM DIOXIDE15FIX9V2JPACTIB
ZINC OXIDESOI2LOH54ZACTIM

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
aee1e9aa-0653-35d4-e053-2995a90abefa035be22a-904b-4115-8994-da09eb59b74e2020-09-09WarningsExact identifier
spl id: aee1e9aa-0653-35d4-e053-2995a90abefa
spl set id: 035be22a-904b-4115-8994-da09eb59b74e

Reported adverse events (FAERS/openFDA)#

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