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Drug Facts

Manufacturer
L’Oreal USA Products Inc | Cosmetique Active Production
Effective date
2023-12-11
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:03:53

Label at a glance#

ProductVichy Laboratoires Capital Soleil 60 Mineral Sunscreen Broad Spectrum SPF 60 Water Resistant 80 Minutes Sheer Tint Ul...
Active ingredientTITANIUM DIOXIDE
Label structure13 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

For sunscreen use: shake well before use ●  apply liberally 15 minutes before sun exposure ●  reapply:     ●  after 80 minutes of swimming or 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 ...

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 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

For sunscreen use:

  • shake well before use

●  apply liberally 15 minutes before sun exposure

●  reapply:

    ●  after 80 minutes of swimming or 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, iron oxides, dipropylene glycol, disodium stearoyl glutamate, disteardimonium hectorite, helianthus annuus seed oil/sunflower seed oil, magnesium sulfate, PEG-8 laurate, phenoxyethanol, polyhydroxystearic acid, propylene carbonate, sodium citrate, sodium dodecylbenzenesulfonate, tocopherol

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-877-378-4249

Monday - Friday (9 a.m. to 5 p.m. EST)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of a cartonimage of a carton

image of a carton
image of a carton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49967-650-01Vichy Laboratoires Capital Soleil 60 Mineral Sunscreen Broad Spectrum SPF 60 Water Resistant 80 Minutes Sheer Tint Ultra Lightweight1 in 1 CARTONLOTION13
49967-650-01Vichy Laboratoires Capital Soleil 60 Mineral Sunscreen Broad Spectrum SPF 60 Water Resistant 80 Minutes Sheer Tint Ultra Lightweight45 mL in 1 BOTTLELOTION453

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49967-650VICHY LABORATOIRES CAPITAL SOLEIL 60 MINERAL SUNSCREEN BROAD SPECTRUM SPF 60 WATER RESISTANT 80 MINUTES SHEER TINT ULTRA LIGHTWEIGHT (TITANIUM DIOXIDE) LOTION [L’OREAL USA PRODUCTS INC]3Current NDC, Legacy NDC, 2 package rows20231212_4692b146-1abe-48e8-b097-ea9c556962b6.zip

Products#

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

DailyMed product names page 1 of 2 · 41 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49967-65049967-650-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 40 matching rows.

Name, UNII, Kind table
NameUNIIKind
TITANIUM DIOXIDE15FIX9V2JPACTIB
WATER059QF0KO0RIACT
ISODODECANEA8289P68Y2IACT
DIMETHICONE92RU3N3Y1OIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
UNDECANEJV0QT00NUEIACT
STYRENE/ACRYLAMIDE COPOLYMER (500000 MW)5Z4DPO246AIACT
CAPRYLYL TRISILOXANEQ95M2P1KJLIACT
NYLON-12446U8J075BIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
PHENETHYL BENZOATE0C143929GKIACT
DICAPRYLYL CARBONATE609A3V1SUAIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
TRIETHYLHEXANOIN7K3W1BIU6KIACT
ISOHEXADECANE918X1OUF1EIACT
TRIDECANEA3LZF0L939IACT
DICAPRYLYL ETHER77JZM5516ZIACT
TALC7SEV7J4R1UIACT
DIMETHICONE/PEG-10/15 CROSSPOLYMER21AS8B1BSSIACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
STEARIC ACID4ELV7Z65APIACT
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONETYP81E471FIACT
PENTYLENE GLYCOL50C1307PZGIACT
ALUMINUM OXIDELMI26O6933IACT
ALUMINUM STEARATEU6XF9NP8HMIACT
BENZOIC ACID8SKN0B0MIMIACT
BENZYL BENZOATEN863NB338GIACT
CAPRYLYL GLYCOL00YIU5438UIACT
FERRIC OXIDE RED1K09F3G675IACT
DIPROPYLENE GLYCOLE107L85C40IACT
DISODIUM STEAROYL GLUTAMATE45ASM2L11MIACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
MAGNESIUM SULFATE, UNSPECIFIED FORMDE08037SABIACT
PEG-8 LAURATE762O8IWA10IACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
PROPYLENE CARBONATE8D08K3S51EIACT
SODIUM CITRATE1Q73Q2JULRIACT
SODIUM DODECYLBENZENESULFONATE554127163YIACT
TOCOPHEROLR0ZB2556P8IACT

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
Vichy Laboratoires Capital Soleil 60 Mineral Sunscreen Broad Spectrum SPF 60 Water Resistant 80 Minutes Sheer Tint Ultra LightweightTITANIUM DIOXIDELOreal USA Products Inc4692b146-1abe-48e8-b097-ea9c556962b62023-12-11WarningsExact identifier
ndc (package): 49967-650-01
ndc (product): 49967-650
ndc11 (package): 49967065001
spl id: 469e72ca-e993-4577-a804-0d5496fc9d95
spl set id: 4692b146-1abe-48e8-b097-ea9c556962b6

Reported adverse events (FAERS/openFDA)#

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