FDA.reportPublic FDA data

Drug Facts

Manufacturer
L’Oreal USA Products Inc | L’Oreal USA, Inc.
Effective date
2023-12-27
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:05:49

Label at a glance#

ProductVichy Laboratoires Capital Soleil 60 Daily AntiAging Face and Body Sunscreen Broad Spectrum SPF 60 Water Resistant 80...
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
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: ●  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 su...

Storage and handling

protect the product in this container from excessive heat and direct sun

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 7%

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:

●  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

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, styrene/acrylates copolymer, dimethicone, glycerin, polymethylsilsesquioxane, butyloctyl salicylate, alcohol denat., poly c10-30 alkyl acrylate, caprylyl methicone, trisiloxane, acrylates/c10-30 alkyl acrylate crosspolymer, acrylates/dimethicone copolymer, butylene glycol, caprylyl glycol, citric acid, disodium EDTA, fragrance, glyceryl stearate, inulin lauryl carbamate, p-anisic acid, PEG-100 stearate, PEG-8 laurate, phenoxyethanol, potassium cetyl phosphate, potassium sorbate, sodium benzoate, sodium dodecylbenzenesulfonate, tocopherol, triethanolamine, vitis vinifera (grape) fruit extract, xanthan gum

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49967-546-01Vichy Laboratoires Capital Soleil 60 Daily AntiAging Face and Body Sunscreen Broad Spectrum SPF 60 Water Resistant 80 Minutes150 mL in 1 TUBELOTION1503
49967-546-01Vichy Laboratoires Capital Soleil 60 Daily AntiAging Face and Body Sunscreen Broad Spectrum SPF 60 Water Resistant 80 Minutes1 in 1 CARTONLOTION13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49967-546VICHY LABORATOIRES CAPITAL SOLEIL 60 DAILY ANTIAGING FACE AND BODY SUNSCREEN BROAD SPECTRUM SPF 60 WATER RESISTANT 80 MINUTES (AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE) LOTION [L’OREAL USA PRODUCTS INC]3Current NDC, Legacy NDC, 2 package rows20231228_8404ef40-35fd-4460-a35f-d473b3c04c87.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
49967-54649967-546-01

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
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
WATER059QF0KO0RIACT
STYRENE/ACRYLAMIDE COPOLYMER (500000 MW)5Z4DPO246AIACT
DIMETHICONE92RU3N3Y1OIACT
GLYCERINPDC6A3C0OXIACT
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)59Z907ZB69IACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
ALCOHOL3K9958V90MIACT
CAPRYLYL TRISILOXANEQ95M2P1KJLIACT
TRISILOXANE9G1ZW13R0GIACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
CAPRYLYL GLYCOL00YIU5438UIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
EDETATE DISODIUM7FLD91C86KIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
P-ANISIC ACID4SB6Y7DMM3IACT
PEG-100 STEARATEYD01N1999RIACT
PEG-8 LAURATE762O8IWA10IACT
PHENOXYETHANOLHIE492ZZ3TIACT
POTASSIUM CETYL PHOSPHATE03KCY6P7UTIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM DODECYLBENZENESULFONATE554127163YIACT
TOCOPHEROLR0ZB2556P8IACT
TROLAMINE9O3K93S3TKIACT
WINE GRAPE3GOV20705GIACT
XANTHAN GUMTTV12P4NEEIACT

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 Daily AntiAging Face and Body Sunscreen Broad Spectrum SPF 60 Water Resistant 80 MinutesAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENELOreal USA Products Inc8404ef40-35fd-4460-a35f-d473b3c04c872023-12-27WarningsExact identifier
ndc (package): 49967-546-01
ndc (product): 49967-546
ndc11 (package): 49967054601
spl id: 6b13b60b-ad0d-462c-bff2-e9e50f150a40
spl set id: 8404ef40-35fd-4460-a35f-d473b3c04c87

Reported adverse events (FAERS/openFDA)#

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