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Drug Facts

Manufacturer
L'Oreal USA Products Inc | Cosmetique Active Products | Socoplan
Effective date
2020-11-16
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 23:07:02

Label at a glance#

ProductVichy Laboratories Aqualia Thermal UV Defense SPF 30 Mineralizing Thermal Water Niacinamide Plant Sugar Vitamin E 48 ...
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 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 suncreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:    limit time in...

Storage and handling

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

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 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 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 suncreen 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 68-77ºF (20-25ºF)

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. to 5 p.m. EST)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of a cartonimage of a carton

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
49967-69849967-698-01, 49967-698-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
NameUNIIKind
AVOBENZONEG63QQF2NOXACTIB
homosalateV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
DIMETHICONE92RU3N3Y1OIACT
NIACINAMIDE25X51I8RD4IACT
PEG-100 STEARATEYD01N1999RIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
MANNOSE, D-PHA4727WTPIACT
STEARIC ACID4ELV7Z65APIACT
CERAMIDE NP4370DF050BIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
SODIUM HYDROXIDE55X04QC32IIACT
SODIUM PYRROLIDONE CARBOXYLATE469OTG57A2IACT
MYRISTIC ACID0I3V7S25AWIACT
PALMITIC ACID2V16EO95H1IACT
AMMONIUM POLYACRYLOYLDIMETHYL TAURATE (55000 MPA.S)F01RIY4371IACT
TOCOPHEROLR0ZB2556P8IACT
CAPRYLOYL GLYCINE8TY5YO42NJIACT
CAPRYLYL GLYCOL00YIU5438UIACT
TRISODIUM ETHYLENEDIAMINE DISUCCINATEYA22H34H9QIACT
XANTHAN GUMTTV12P4NEEIACT
CETYL ALCOHOL936JST6JCNIACT

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
917a4e63-4ba1-41d7-b88a-aa909bcf24d326a4a359-359c-4e30-98fc-99e4197d74262023-06-29WarningsExact identifier
spl set id: 26a4a359-359c-4e30-98fc-99e4197d7426

Reported adverse events (FAERS/openFDA)#

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