Drug Facts

Manufacturer
L'Oreal USA Products Inc | Cosmetique Active Products
Effective date
2019-09-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:47:07

Label at a glance#

ProductVichy Laboratories Capital Soleil UVA UVB 60 Titanium Dioxide 100% Mineral 15 Mineral Rich Water Ultra lightweight
Active ingredientTITANIUM DIOXIDE
Label structure12 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 sun

Dosage and administration

For sunscreen use: Shake well before use apply liberally 15 minutes before sun exposure reapply:    after 80 minutes of swimming of sweating    immediately after towel drying    at least every 2 hours 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 value of 15 or higher and other ...

Storage and handling

protect the product in this container from excessive heat and direct sun store at 68-77°F (20-25°C)

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanium dioxide 14.8%

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 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

For sunscreen use:

  • Shake well before use
  • apply liberally 15 minutes before sun exposure
  • reapply:
  •    after 80 minutes of swimming of sweating
  •    immediately after towel drying
  •    at least every 2 hours
  • 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 value 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-sleeved shirts, pants, hats, and sunglasses
  • children under 6 months of age: Ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • protect the product in this container from excessive heat and direct sun
  • store at 68-77°F (20-25°C)

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, isododecane, dimethicone, c12-15 alkyl benzoate, undecane, styrene/acrylates copolymer, caprylyl methicone, nylon-12, butyloctyl salicylate, phenethyl benzoate, dicaprylyl carbonate, silica, triethylhexanoin, isohexadecane, tridecane, dicaprylyl ether, talc, dimethicone/PEG-10/15 crosspolymer, aluminum hydroxide, stearic acid, PEG-9 polydimethylsiloxyethyl dimethicone, pentylene glycol, alumina, aluminum stearate, benzoic acid, benzyl benzoate, caprylyl glycol, dipropylene glycol, disodium stearoyl glutamate, disteardimonium hectorite, helianthus annuus (sunflower) seed oil, iron oxides, magnesium sulfate, PEG-8 laurate, phenoxyethanol, polyhydroxystearic acid, propylene carbonate, sodium citrate, sodium dodecylbenzenesulfonate, tocopherol

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of cartonimage of carton

Products#

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

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49967-04049967-040-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 38 matching rows.

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
1c149b70-239e-4a70-a40f-c62d77bad5834563fdce-aeab-471d-9176-d958a1b451aa2024-01-02WarningsExact identifier
spl set id: 4563fdce-aeab-471d-9176-d958a1b451aa

Reported adverse events (FAERS/openFDA)#

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