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 01:26:55

Key Label Information#

Active Ingredients And Purpose

Active ingredients

Octinoxate 3.50 % Titanium Dioxide 3.76 %

Uses

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

Warnings

Warnings

For external use only.

Directions And Dosage

Directions

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 Label Information

Inactive ingredients

AQUA (WATER) • METHYL TRIMETHICONE • ISODODECANE • ALCOHOL • BUTYLENE GLYCOL • PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE • SYNTHETIC FLUORPHLOGOPITE • ACRYLATES/POLYTRIMETHYLSILOXYMETHACRYLATE COPOLYMER • SILICA • DIMETHICONE • ACRYLATES/DIMETHICONE COPOLYMER • DISTEARDIMONIUM HECTORITE • POLYGLYCERYL-10 DECAISOSTEARATE • CETYL DIMETHICONE • SODIUM MYRISTOYL GLUTAMATE • PARFUM (FRAGRANCE) • PROPYLENE CARBONATE • CHLORPHENESIN • ALUMINA • STEARIC ACID • ALUMINUM HYDROXIDE • TROMETHAMINE • HYDROLYZED VIOLA TRICOLOR EXTRACT • TOCOPHEROL • TROPAEOLUM MAJUS FLOWER/LEAF/STEM EXTRACT • ROSA MULTIFLORA FRUIT 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° 15866/Z

Package Labeling:30ml

Package Labeling:20ml

Package Labeling:2.7ml

Label Images#

30ml0
30ml0
30ml000
30ml000
20ml0
20ml0
2.7ml 001
2.7ml 001
2.7ml002
2.7ml002

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
61957-3027-0FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 2WO30 mL in 1 BOTTLEEMULSION304
61957-3027-1FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 2WO20 mL in 1 BOTTLEEMULSION204
61957-3027-2FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 2WO2.7 mL in 1 TUBEEMULSION2.74

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61957-302761957-3027-0, 61957-3027-1, 61957-3027-2

Ingredients#

Complete SPL Sections#

Drug Facts

SPL UNCLASSIFIED SECTION

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 3.50 % Titanium Dioxide 3.76 %

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.

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 • BUTYLENE GLYCOL • PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE • SYNTHETIC FLUORPHLOGOPITE • ACRYLATES/POLYTRIMETHYLSILOXYMETHACRYLATE COPOLYMER • SILICA • DIMETHICONE • ACRYLATES/DIMETHICONE COPOLYMER • DISTEARDIMONIUM HECTORITE • POLYGLYCERYL-10 DECAISOSTEARATE • CETYL DIMETHICONE • SODIUM MYRISTOYL GLUTAMATE • PARFUM (FRAGRANCE) • PROPYLENE CARBONATE • CHLORPHENESIN • ALUMINA • STEARIC ACID • ALUMINUM HYDROXIDE • TROMETHAMINE • HYDROLYZED VIOLA TRICOLOR EXTRACT • TOCOPHEROL • TROPAEOLUM MAJUS FLOWER/LEAF/STEM EXTRACT • ROSA MULTIFLORA FRUIT 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° 15866/Z

Package Labeling:30ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package Labeling:20ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package Labeling:2.7ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Source Document#

Source XML