FDA.reportPublic FDA data

PURE SHEER

Manufacturer
NARS COSMETICS | SHISEIDO AMERICA INC. | Davlyn Industries Inc.
Effective date
2010-03-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:53:17

Label at a glance#

ProductPURE SHEER Aurore
Active ingredientOctinoxate, Titanium dioxide
Label structure5 sections

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

OCTINOXATE 7.4%, TITANIUM DIOXIDE 3.2%,

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

HEPTYLUNDECYL HYDROXYSTEARATE, POLYGLYCERYL-2 TRIISOSTEARATE, POLYETHYLENE, CYCLOPENTASILOXANE, POLYBUTENE, BEESWAX, MICROCRYSTALLINE WAX, DIISOSTEARYL MALATE, DIMETHICONE CROSSPOLYMER, C10-30 CHOLESTEROL/LANOSTEROL ESTERS, ALUMINUM HYDROXIDE, OCTYLDODECANOL, STEARIC ACID, HYDROGENATED COCO-GLYCERIDES, IRVINGIA GABONENSIS KERNEL BUTTER, SODIUM MAGNESIUM SILICATE, TOCOPHEROL, GLYCERIN, METHICONE, EUTERPE OLERACEA FRUIT OIL, LINSEED OIL/PALM OIL AMINOPROPANEDIOL ESTERS, BHT, TETRADECENE, RIBES NIGRUM (BLACK CURRANT) SEED OIL, DIMETHICONE, RUBUS IDAEUS (RASPBERRY) SEED OIL, SILICA, WATER, POLYSILICONE-2, TIN OXIDE, RUBUS CHAMAEMORUS SEED OIL, SODIUM HYALURONATE, [+/- (MAY CONTAIN): MICA, TITANIUM DIOXIDE, IRON OXIDES, RED 6 LAKE, RED 7 LAKE, YELLOW 5 LAKE, YELLOW 6 LAKE, BLUE 1 LAKE],

WARNING

WARNINGS SECTION

IF RASH OR IRRITATION DEVELOPS AND PERSISTS, DISCONTINUE USE AND CONTACT A DOCTOR.

READ INSERTION

SPL UNCLASSIFIED SECTION

NARS™
NARS COSMETICS, NEW YORK, NY 10022 DIST. NEW YORK - SE PARIS - LONDON (UK) W2 5RH
MADE IN USA, MAKEUP YOUR MIND™ WWW.NARSCOSMETICS.COM, 1-888-788-NARS

PRINCIPAL DISPLAY PANEL - 0.06 Oz. Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NARS

PURE SHEER SPF LIP TREATMENT
SPF 15 SUNSCREEN

NET WT. 0.06 Oz. 1.7 g

PRINCIPAL DISPLAY PANEL - 0.06 Oz. Carton
PRINCIPAL DISPLAY PANEL - 0.06 Oz. Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
13734-022-402023-10-18C16284748780-1956f9ecf-d221-621f-e053-dbdaa90a74adNARS PURE SHEER SPF LIP TREATMENT SPF 15 SUNSCREEN
13734-023-402023-10-18C16284748780-1956f9ecf-d221-621f-e053-dbdaa90a74adNARS PURE SHEER SPF LIP TREATMENT SPF 15 SUNSCREEN
13734-024-402023-10-18C16284748780-1956f9ecf-d221-621f-e053-dbdaa90a74adNARS PURE SHEER SPF LIP TREATMENT SPF 15 SUNSCREEN
13734-025-402023-10-18C16284748780-1956f9ecf-d221-621f-e053-dbdaa90a74adNARS PURE SHEER SPF LIP TREATMENT SPF 15 SUNSCREEN
13734-026-402023-10-18C16284748780-1956f9ecf-d221-621f-e053-dbdaa90a74adNARS PURE SHEER SPF LIP TREATMENT SPF 15 SUNSCREEN
13734-027-402023-10-18C16284748780-1956f9ecf-d221-621f-e053-dbdaa90a74adNARS PURE SHEER SPF LIP TREATMENT SPF 15 SUNSCREEN
13734-022-402019-10-21C16284748780-1956f9ecf-d221-621f-e053-dbdaa90a74adNARS PURE SHEER SPF LIP TREATMENT SPF 15 SUNSCREEN
13734-023-402019-10-21C16284748780-1956f9ecf-d221-621f-e053-dbdaa90a74adNARS PURE SHEER SPF LIP TREATMENT SPF 15 SUNSCREEN
13734-024-402019-10-21C16284748780-1956f9ecf-d221-621f-e053-dbdaa90a74adNARS PURE SHEER SPF LIP TREATMENT SPF 15 SUNSCREEN
13734-025-402019-10-21C16284748780-1956f9ecf-d221-621f-e053-dbdaa90a74adNARS PURE SHEER SPF LIP TREATMENT SPF 15 SUNSCREEN
13734-026-402019-10-21C16284748780-1956f9ecf-d221-621f-e053-dbdaa90a74adNARS PURE SHEER SPF LIP TREATMENT SPF 15 SUNSCREEN
13734-027-402019-10-21C16284748780-1956f9ecf-d221-621f-e053-dbdaa90a74adNARS PURE SHEER SPF LIP TREATMENT SPF 15 SUNSCREEN

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
OctinoxateACTIVE INGREDIENT4Y5P7MUD511
Titanium dioxideACTIVE INGREDIENT15FIX9V2JP1
OctinoxateACTIVE MOIETY4Y5P7MUD511
Titanium dioxideACTIVE MOIETY15FIX9V2JP1

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
13734-02213734-022-40
13734-02313734-023-40
13734-02413734-024-40
13734-02513734-025-40
13734-02613734-026-40
13734-02713734-027-40

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
Octinoxate4Y5P7MUD51ACTIB
Titanium dioxide15FIX9V2JPACTIB
Octinoxate4Y5P7MUD51ACTIB
Titanium dioxide15FIX9V2JPACTIB
Octinoxate4Y5P7MUD51ACTIB
Titanium dioxide15FIX9V2JPACTIB
Octinoxate4Y5P7MUD51ACTIB
Titanium dioxide15FIX9V2JPACTIB
Octinoxate4Y5P7MUD51ACTIB
Titanium dioxide15FIX9V2JPACTIB
Octinoxate4Y5P7MUD51ACTIB
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
27119c99-ad7f-4d17-b4cb-d3c82c27e7586c952358-96d3-47d2-830e-a669070e46ff2023-10-18WarningsExact identifier
spl set id: 6c952358-96d3-47d2-830e-a669070e46ff

Reported adverse events (FAERS/openFDA)#

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