Drug Facts

Manufacturer
L'Oreal USA Products Inc. | Cosmetique Active Production | Socoplan
Effective date
2024-01-01
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 00:06:18

Label at a glance#

ProductVichy Laboratoires Aqualia Thermal UV Defense Moisturizer Broad Spectrum SPF 30 Sunscreen
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 at least every 2 hours ● use a water resistant sunscreen if swimming or sweating ● 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...

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 5%

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

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.

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

Directions

DOSAGE & ADMINISTRATION SECTION

For sunscreen use:

● apply liberally 15 minutes before sun exposure

● reapply at least every 2 hours

● use a water resistant sunscreen if swimming or sweating

● 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, glycerin, silica, dimethicone, niacinamide, PEG-100 stearate, glyceryl stearate, mannose, stearic acid, ceramide NP, dimethicone/vinyl dimethicone crosspolymer, sodium hydroxide, sodium PCA, myristic acid, palmitic acid, ammonium polyacryloyldimethyl taurate, tocopherol, capryloyl glycine, caprylyl glycol, trisodium ethylenediamine disuccinate, xanthan gum, cetyl alcohol, fragrance

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-877-378-4249

Monday - Friday (9 a.m. - 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
49967-869-01Vichy Laboratoires Aqualia Thermal UV Defense Moisturizer Broad Spectrum SPF 30 Sunscreen1 in 1 CARTONLotion19
49967-869-01Vichy Laboratoires Aqualia Thermal UV Defense Moisturizer Broad Spectrum SPF 30 Sunscreen50 mL in 1 BOTTLELotion509
49967-869-02Vichy Laboratoires Aqualia Thermal UV Defense Moisturizer Broad Spectrum SPF 30 Sunscreen1.5 mL in 1 PACKETLotion1.59

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49967-869VICHY LABORATOIRES AQUALIA THERMAL UV DEFENSE MOISTURIZER BROAD SPECTRUM SPF 30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE) LOTION [L'OREAL USA PRODUCTS INC.]9Current NDC, Legacy NDC, 3 package rows20240102_08bcee1c-399a-4ec8-84cf-b5e83c4fa665.zip

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
49967-86949967-869-01, 49967-869-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 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
Vichy Laboratoires Aqualia Thermal UV Defense Moisturizer Broad Spectrum SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc.08bcee1c-399a-4ec8-84cf-b5e83c4fa6652024-01-01WarningsExact identifier
ndc (package): 49967-869-02
ndc (package): 49967-869-01
ndc (product): 49967-869
ndc11 (package): 49967086901
ndc11 (package): 49967086902
spl id: c44d3a93-b17d-4fc8-b972-87e75cd1d3e8
spl set id: 08bcee1c-399a-4ec8-84cf-b5e83c4fa665

Reported adverse events (FAERS/openFDA)#

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