FDA.reportPublic FDA data

TITANIUM DIOXIDE

Manufacturer
S.A. COMPTOIR NOUVEAU DE LA PARFUMERIE
Effective date
2026-02-18
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:46:25

Label at a glance#

ProductHermes Plein Air-Baume de Teint Perfecteur Naturel-Enhancing Complexion Balm 85 TAMARIN
Active ingredientTITANIUM DIOXIDE
Label structure9 sections

Indications and uses

Helps prevent sunburn If used as directed with other sun protection mesures (see  ), decreases the risk of skin cancer and early skin ageing caused by the sun. Directions

Dosage and administration

Apply liberally and evenly 15 minutes before sun exposure. Children under 6 months age: Ask a doctor. Use a water-resistant sunscreen if swimming or sweating. Reapply at least every 2 hours. Reapply immediately after towel drying. 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 oth...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 7,3%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn
  • If used as directed with other sun protection mesures (see  ), decreases the risk of skin cancer and early skin ageing caused by the sun. Directions

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin.

Stop use and ask a doctor

OTC - STOP USE SECTION

if rash occurs.

When using this product

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

keep out of eyes. Rinse with water to remove.

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.
  • Children under 6 months age: Ask a doctor.
  • Use a water-resistant sunscreen if swimming or sweating.
  • Reapply at least every 2 hours.
  • Reapply immediately after towel drying.
  • 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 : Sun Protection Measures.
  • Limit time in the sun, especially from 10 a.m-2 p.m.
  • Wear long-sleeved shirts, hats, and sunglasses.

Inactive ingredients

INACTIVE INGREDIENT SECTION

AQUA (WATER), METHYL TRIMETHICONE, NEOPENTYL GLYCOL DIETHYLHEXANOATE, DIMETHICONE, DIPROPYLENE GLYCOL, PEG-10 DIMETHICONE, CYCLOPENTASILOXANE, VINYL DIMETHICONE/ METHICONE SILSESQUIOXANE CROSSPOLYMER, PENTYLENE GLYCOL, BUTYLENE GLYCOL, GLYCERIN, PHENOXYETHANOL, POLYGLYCERYL-2 DIISOSTEARATE, SORBITOL, PARFUM (FRAGRANCE), DISTEARDIMONIUM HECTORITE, TRIMETHYLSILOXYSILICATE, SODIUM CITRATE, SODIUM CHLORIDE, STEARIC ACID, CAPRYLIC/CAPRIC TRIGLYCERIDE, ALUMINA, TOCOPHEROL, GLYCINE, DIMETHICONE/ VINYL DIMETHICONE CROSSPOLYMER, BENZYL SALICYLATE, SODIUM HYALURONATE, SCUTELLARIA BAICALENSIS ROOT EXTRACT, LIMONENE, OENOTHERA BIENNIS (EVENING PRIMROSE) SEED EXTRACT, MORUS ALBA BARK EXTRACT, GERANIOL,  CITRONELLOL, LINALOOL, HYDROXYCITRONELLAL [+/- (MAY CONTAIN) : MICA, CI 77891 (TITANIUM DIOXIDE), CI 77491/CI 77492/ CI 77499 (IRON OXIDES)].

Other information

SPL UNCLASSIFIED SECTION

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

Package Labeling:82494-010-01

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label 1mlLabel 1mlLabel 1ml 2Label 1ml 2

Package Labeling:82494-010-17

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label 17mlLabel 17mlLabel 17ml 2Label 17ml 2

Package Labeling:82494-010-40

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label0 40mlLabel0 40mlLabel 40ml 02Label 40ml 02

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82494-010-01Hermes Plein Air-Baume de Teint Perfecteur Naturel-Enhancing Complexion Balm 85 TAMARIN1 mL in 1 BAGCREAM14
82494-010-17Hermes Plein Air-Baume de Teint Perfecteur Naturel-Enhancing Complexion Balm 85 TAMARIN1 in 1 CARTONCREAM14
82494-010-17Hermes Plein Air-Baume de Teint Perfecteur Naturel-Enhancing Complexion Balm 85 TAMARIN17 mL in 1 TUBECREAM174
82494-010-40Hermes Plein Air-Baume de Teint Perfecteur Naturel-Enhancing Complexion Balm 85 TAMARIN40 mL in 1 TUBECREAM404
82494-010-40Hermes Plein Air-Baume de Teint Perfecteur Naturel-Enhancing Complexion Balm 85 TAMARIN1 in 1 CARTONCREAM14

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
82494-01082494-010-01, 82494-010-17, 82494-010-40

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
WATER059QF0KO0RIACT
METHYL TRIMETHICONES73ZQI0GXMIACT
NEOPENTYL GLYCOL DIETHYLHEXANOATEU68ZV6W62CIACT
DIMETHICONE92RU3N3Y1OIACT
DIPROPYLENE GLYCOLE107L85C40IACT
CYCLOMETHICONE 50THT5PCI0RIACT
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER9NH1UDD2RRIACT
PENTYLENE GLYCOL50C1307PZGIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
GLYCERINPDC6A3C0OXIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYGLYCERYL-2 DIISOSTEARATEDG195GP57PIACT
SORBITOL506T60A25RIACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
SODIUM CITRATE1Q73Q2JULRIACT
SODIUM CHLORIDE451W47IQ8XIACT
STEARIC ACID4ELV7Z65APIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
ALUMINUM OXIDELMI26O6933IACT
TOCOPHEROLR0ZB2556P8IACT
GLYCINETE7660XO1CIACT
BENZYL SALICYLATEWAO5MNK9TUIACT
HYALURONATE SODIUMYSE9PPT4THIACT
SCUTELLARIA BAICALENSIS ROOT7J95K7ID2SIACT
LIMONENE, (+)-GFD7C86Q1WIACT
EVENING PRIMROSE OIL3Q9L08K71NIACT
MORUS ALBA BARK7O71A48NDPIACT
GERANIOLL837108USYIACT
.BETA.-CITRONELLOL, (R)-P01OUT964KIACT
LINALOOL, (+/-)-D81QY6I88EIACT
HYDROXYCITRONELLAL8SQ0VA4YURIACT
TITANIUM DIOXIDE15FIX9V2JPACTIB

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
Hermes Plein Air-Baume de Teint Perfecteur Naturel-Enhancing Complexion Balm 85 TAMARINTITANIUM DIOXIDES.A. COMPTOIR NOUVEAU DE LA PARFUMERIEdacff3dc-49d7-6416-e053-2a95a90a85c62026-02-18WarningsExact identifier
ndc (package): 82494-010-17
ndc (package): 82494-010-40
ndc (package): 82494-010-01
ndc (product): 82494-010
ndc11 (package): 82494001040
ndc11 (package): 82494001001
ndc11 (package): 82494001017
spl id: 4b1e9811-918f-28d6-e063-6294a90ad7e8
spl set id: dacff3dc-49d7-6416-e053-2a95a90a85c6

Reported adverse events (FAERS/openFDA)#

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