FDA.reportPublic FDA data

OCTISALATE, TITANIUM DIOXIDE

Manufacturer
Parfums Christian Dior
Effective date
2025-12-19
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:26:58

Label at a glance#

ProductFOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SP...
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 3.50 %

Titanium Dioxide 0.94 %

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) • METHYL TRIMETHICONE • ISODODECANE • ALCOHOL • SYNTHETIC FLUORPHLOGOPITE • BUTYLENE GLYCOL • PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE • ACRYLATES/POLYTRIMETHYLSILOXYMETHACRYLATE COPOLYMER • SILICA • DIMETHICONE • ACRYLATES/DIMETHICONE COPOLYMER • DISTEARDIMONIUM HECTORITE • CETYL DIMETHICONE • POLYGLYCERYL-10 DECAISOSTEARATE • SODIUM MYRISTOYL GLUTAMATE • PARFUM (FRAGRANCE) • PROPYLENE CARBONATE • CHLORPHENESIN • ALUMINUM HYDROXIDE • TROMETHAMINE • HYDROLYZED VIOLA TRICOLOR EXTRACT • TOCOPHEROL • ALUMINA • STEARIC ACID • TROPAEOLUM MAJUS FLOWER/LEAF/STEM EXTRACT • 1,2-HEXANEDIOL • CAPRYLYL GLYCOL • IRIS FLORENTINA ROOT EXTRACT • SODIUM BENZOATE • POTASSIUM SORBATE. [MAY CONTAIN : CI 77491, CI 77492, CI 77499 (IRON OXIDES), CI 77891 (TITANIUM DIOXIDE)].

N° 16029/Z

Package Labeling:30ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer Label4Outer Label4Inner Label4Inner Label4

Package Labeling:20ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label 20ml 4Label 20ml 4

Package Labeling:2.7ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label 2.7ml 4Label 2.7ml 4Label 2.7ml 04Label 2.7ml 04

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-133348901577762GTIN-13: 3348901577762
EAN-13: 3348901577762
GTIN storage (14 digits): 03348901577762		Outer Label4.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
61957-3004-0FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 7N30 mL in 1 BOTTLEEMULSION304
61957-3004-1FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 7N20 mL in 1 BOTTLEEMULSION204
61957-3004-2FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 7N2.7 mL in 1 TUBEEMULSION2.74

Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61957-300461957-3004-0, 61957-3004-1, 61957-3004-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
METHYL TRIMETHICONES73ZQI0GXMIACT
ISODODECANEA8289P68Y2IACT
ALCOHOL3K9958V90MIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONETYP81E471FIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
DIMETHICONE92RU3N3Y1OIACT
2-ETHYLHEXYL ACRYLATE, METHACRYLATE, METHYL METHACRYLATE, OR BUTYL METHACRYLATE/HYDROXYPROPYL DIMETHICONE COPOLYMER (30000-300000 MW)S7ZA3CCJ4MIACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
SODIUM MYRISTOYL GLUTAMATEAYU7QD893WIACT
PROPYLENE CARBONATE8D08K3S51EIACT
CHLORPHENESINI670DAL4SZIACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
TROMETHAMINE023C2WHX2VIACT
TOCOPHEROLR0ZB2556P8IACT
ALUMINUM OXIDELMI26O6933IACT
STEARIC ACID4ELV7Z65APIACT
TROPAEOLUM MAJUS FLOWERING TOPRGT30824HYIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
CAPRYLYL GLYCOL00YIU5438UIACT
IRIS X GERMANICA NOTHOVAR. FLORENTINA ROOTM30XO5X4XDIACT
SODIUM BENZOATEOJ245FE5EUIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
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 Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 7NOCTISALATE, TITANIUM DIOXIDEParfums Christian Diord3bd710b-7d1a-4f96-9fbc-a67c550d863b2025-12-19WarningsExact identifier
ndc (package): 61957-3004-0
ndc (package): 61957-3004-1
ndc (package): 61957-3004-2
ndc (product): 61957-3004
ndc11 (package): 61957300401
ndc11 (package): 61957300402
ndc11 (package): 61957300400
spl id: 464d9311-22e5-06d6-e063-6294a90ae18b
spl set id: d3bd710b-7d1a-4f96-9fbc-a67c550d863b

Reported adverse events (FAERS/openFDA)#

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