HIGH IMPACT LIP COLOUR

Manufacturer
CLINIQUE LABORATORIES INC | ESTEE LAUDER COSMETICS, LTD | ESTEE LAUDER N.V. | Len-Ron Manufacturing Division of Aramis Inc. | Aramis Inc. | Northtec Bristol | Northtec Keystone | PADC 1 | Estee Lauder Pennsylvania Distribution Center 2 | Estee Lauder Cosmetics, Ltd. | Estee Lauder Cosmetics Distribution Center | Estee Lauder Kabushiki Kaisha | Whitman Laboratories Ltd. | Aveda Corporation
Effective date
2010-04-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:24:17

Label at a glance#

ProductHIGH IMPACT LIP COLOUR SPF 15
Active ingredientOCTINOXATE, ZINC OXIDE
Label structure3 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS: OCTINOXATE 7.50% [] ZINC OXIDE 2.10%

WARNINGS SECTION

WARNING: STOP USE IF IRRITATION OCCURS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL:


CLINIQUE

HIGH IMPACT LIP COLOUR SPF 15

NET WT.
0.13 OZ / 3.8 G


CLINIQUE LABORTORIES, DIST.
NEW YORK, NY 10022
FOLDING CARTON
FOLDING CARTON

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49527-727-012019-10-21C16284748780-1956f9ecf-d545-621f-e053-dbdaa90a74adae53c8be-f823-48b3-a95e-08899a448d2d

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49527-727-01HIGH IMPACT LIP COLOUR SPF 151 in 1 CARTONCREAM11
49527-727-02HIGH IMPACT LIP COLOUR SPF 153.8 g in 1 VIAL, PLASTICCREAM3.81

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49527-727HIGH IMPACT LIP COLOUR (OCTINOXATE, TITANIUM DIOXIDE) CREAM [CLINIQUE LABORATORIES INC]1Legacy NDC, 2 package rows20100421_ae53c8be-f823-48b3-a95e-08899a448d2d.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD511
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54Z1
OCTINOXATEACTIVE MOIETY4Y5P7MUD511
ZINC OXIDEACTIVE MOIETYSOI2LOH54Z1

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49527-72749527-727-02, 49527-727-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTINOXATE4Y5P7MUD51ACTIB
ZINC OXIDESOI2LOH54ZACTIB

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
147dcb1b-5838-4dd9-804a-b9f34a1db9fcae53c8be-f823-48b3-a95e-08899a448d2d2010-04-19WarningsExact identifier
spl id: 147dcb1b-5838-4dd9-804a-b9f34a1db9fc
spl set id: ae53c8be-f823-48b3-a95e-08899a448d2d

Reported adverse events (FAERS/openFDA)#

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