FDA.reportPublic FDA data

Hyaluronic Hydra-Foundation SPF30 300W Warm Medium Fair

Manufacturer
Luxe Art Beaute SAS
Effective date
2020-03-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:38:07

Label at a glance#

ProductHyaluronic Hydra-Foundation SPF30 300W Warm Medium Fair
Active ingredientTITANIUM DIOXIDE, OCTINOXATE
Label structure7 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

Apply liberally and evenly 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, ...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanium dioxide 6.505%

Octinoxate 3.9972%

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 

OTC - STOP USE SECTION

if 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

  • Apply liberally and evenly 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

SPL UNCLASSIFIED SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

ISODODECANE, WATER, SILICA, CAPRYLIC/CAPRIC TRIGLYCERIDE, ISOHEXADECANE, PHENYL TRIMETHICONE, SYNTHETIC FLUORPHLOGOPITE, PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) OIL, TRIMETHYLSILOXYSILICATE, DIPROPYLENE GLYCOL, GLYCERIN, NIACINAMIDE, CETYL PEG/PPG-10/1 DIMETHICONE, C13-15 ALKANE, DIISOSTEARYL MALATE, SILICA DIMETHYL SILYLATE, MAGNESIUM SULFATE, TRIETHOXYCAPRYLYLSILANE, DISTEARDIMONIUM HECTORITE, POLYGLYCERYL-4 ISOSTEARATE, ALUMINUM HYDROXIDE, CAPRYLYL GLYCOL, GLYCERYL CAPRYLATE, FRAGRANCE, ETHYLHEXYLGLYCERIN, PALMITIC ACID, DIMETHICONE, ADENOSINE, SODIUM HYALURONATE, BHT, MYRISTIC ACID, STEARIC ACID, PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE, TOCOPHEROL
May contain: TITANIUM DIOXIDE, IRON OXIDES

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label9Label9Box9Box9

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69879-208-302023-09-02C16284748780-1f386c64a-41d5-0266-e053-dadaa90a7c1aHyaluronic Hydra-Foundation SPF30 300W Warm Medium Fair
69879-208-302023-01-30C16284748780-1f386c64a-41d5-0266-e053-dadaa90a7c1aHyaluronic Hydra-Foundation SPF30 300W Warm Medium Fair

Products#

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

DailyMed product names page 1 of 1 · 34 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69879-20869879-208-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 32 matching rows.

Name, UNII, Kind table
NameUNIIKind
ISODODECANEA8289P68Y2IACT
WATER059QF0KO0RIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
ISOHEXADECANE918X1OUF1EIACT
PHENYL TRIMETHICONEDR0K5NOJ4RIACT
ALMOND OIL66YXD4DKO9IACT
DIPROPYLENE GLYCOLE107L85C40IACT
GLYCERINPDC6A3C0OXIACT
NIACINAMIDE25X51I8RD4IACT
C13-15 ALKANE114P5I43UJIACT
DIISOSTEARYL MALATEQBS8A3XZGQIACT
SILICA DIMETHYL SILYLATEEU2PSP0G0WIACT
MAGNESIUM SULFATE, UNSPECIFIED FORMDE08037SABIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
POLYGLYCERYL-4 ISOSTEARATE820DPX33S7IACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
CAPRYLYL GLYCOL00YIU5438UIACT
GLYCERYL MONOCAPRYLATETM2TZD4G4AIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
PALMITIC ACID2V16EO95H1IACT
DIMETHICONE92RU3N3Y1OIACT
ADENOSINEK72T3FS567IACT
HYALURONATE SODIUMYSE9PPT4THIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
MYRISTIC ACID0I3V7S25AWIACT
STEARIC ACID4ELV7Z65APIACT
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE)255PIF62MSIACT
TOCOPHEROLR0ZB2556P8IACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
OCTINOXATE4Y5P7MUD51ACTIB

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
045f9610-ec9b-b53a-e063-6394a90afa2e9ff5086a-9f84-91ec-e053-2995a90a31b42023-09-02WarningsExact identifier
spl set id: 9ff5086a-9f84-91ec-e053-2995a90a31b4

Reported adverse events (FAERS/openFDA)#

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