FDA.reportPublic FDA data

OCTISALATE, TITANIUM DIOXIDE

Manufacturer
Parfums Christian Dior
Effective date
2024-08-06
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:16:44

Label at a glance#

ProductFOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Bro...
Active ingredientOCTISALATE, 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 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 ingredients

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 4.50 %

Titanium Dioxide 4.23 %

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 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

AQUA (WATER) • ALCOHOL • METHYL TRIMETHICONE • ISODODECANE • PHENYL TRIMETHICONE • GLYCERIN • PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE • TRIMETHTHYL PENTAPHENYL TRISILOXANE • ACRYLATES/DIMETHICONE COPOLYMER DIMETHICONE • BUTYLENE GLYCOL • CETYL DIMETHICONE • DISTEARDIMONIUM HECTORITE • CELLULOSE • CETYL PEG/PPG-10/1 DIMETHICONE • SODIUM MYRISTOYL GLUTAMATE • PARFUM (FRAGRANCE) • PROPYLENE CARBONATE • CHLORPHENESIN • VP/VA COPOLYMER • ALUMINA • STEARIC ACID • ALUMINUM HYDROXIDE • HIBISCUS SABDARIFFA FLOWER EXTRACT • TROMETHAMINE • TOCOPHEROL • TROPAEOLUM MAJUS FLOWER/LEAF/STEM EXTRACT • HEXADECENE • HYDROLYZED VIOLA TRICOLOR EXTRACT • 1,2-HEXANEDIOL • CAPRYLYL GLYCOL • IRIS FLORENTINA ROOT EXTRACT • SODIUM BENZOATE • POTASSIUM SORBATE • PENTAERYTHRITYL TETRA DI-BUTYL HYDROXYHYDROCINNAMATE.

[MAY CONTAIN : CI 77491, CI 77492, CI 77499 (IRON OXIDES), CI 77891 (TITANIUM DIOXIDE)].

N° 15857/Z

Package Labeling:30ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle16Bottle16Inner Bottle16Inner Bottle16

Package Labeling:20ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label 20ml 16Label 20ml 16

Package Labelling: 0.7ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label37.jpgLabel37.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61957-3116-0FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 4C30 mL in 1 BOTTLEEMULSION304
61957-3116-1FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 4C20 mL in 1 BOTTLEEMULSION204
61957-3116-7FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 4C0.7 mL in 1 PACKETEMULSION0.74

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61957-3116FOREVER SKIN GLOW 24H WEAR RADIANT FOUNDATION PERFECTION AND HYDRATION CONCENTRATED FLORAL SKINCARE WITH SUNCREEN BROAD SPECTRUM SPF 15 4C (OCTISALATE, TITANIUM DIOXIDE) EMULSION [PARFUMS CHRISTIAN DIOR]4Current NDC, Legacy NDC, 3 package rows20240807_e8f29488-10f8-4df6-b1f5-d9a670f60fca.zip

Products#

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

DailyMed product names page 1 of 1 · 33 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61957-311661957-3116-0, 61957-3116-1, 61957-3116-7

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 31 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
METHYL TRIMETHICONES73ZQI0GXMIACT
ISODODECANEA8289P68Y2IACT
PHENYL TRIMETHICONEDR0K5NOJ4RIACT
GLYCERINPDC6A3C0OXIACT
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONETYP81E471FIACT
TRIMETHYL PENTAPHENYL TRISILOXANEHE7ABK56N5IACT
BUTYLENE GLYCOL3XUS85K0RAIACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
POWDERED CELLULOSESMD1X3XO9MIACT
SODIUM MYRISTOYL GLUTAMATEAYU7QD893WIACT
PROPYLENE CARBONATE8D08K3S51EIACT
CHLORPHENESINI670DAL4SZIACT
COPOVIDONE K25-31D9C330MD8BIACT
ALUMINUM OXIDELMI26O6933IACT
STEARIC ACID4ELV7Z65APIACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
HIBISCUS SABDARIFFA FLOWER45TGG6IU6MIACT
TROMETHAMINE023C2WHX2VIACT
TOCOPHEROLR0ZB2556P8IACT
TROPAEOLUM MAJUS FLOWERING TOPRGT30824HYIACT
HEXADECENE (MIXED ISOMERS)38H8547VP0IACT
1,2-HEXANEDIOLTR046Y3K1GIACT
CAPRYLYL GLYCOL00YIU5438UIACT
IRIS X GERMANICA NOTHOVAR. FLORENTINA ROOTM30XO5X4XDIACT
SODIUM BENZOATEOJ245FE5EUIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE)255PIF62MSIACT
OCTISALATE4X49Y0596WACTIB
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
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 4COCTISALATE, TITANIUM DIOXIDEParfums Christian Diore8f29488-10f8-4df6-b1f5-d9a670f60fca2024-08-06WarningsExact identifier
ndc (package): 61957-3116-7
ndc (package): 61957-3116-1
ndc (package): 61957-3116-0
ndc (product): 61957-3116
ndc11 (package): 61957311600
ndc11 (package): 61957311601
ndc11 (package): 61957311607
spl id: 1f01cddd-6557-029f-e063-6294a90ac62a
spl set id: e8f29488-10f8-4df6-b1f5-d9a670f60fca

Reported adverse events (FAERS/openFDA)#

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