Intensive Cover Blemish Balm

Manufacturer
CMS LAB Inc. | Kolmar Korea Co., Ltd.
Effective date
2017-11-11
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-05-31 22:52:57

Label at a glance#

ProductIntensive Cover Blemish Balm
Active ingredientOCTINOXATE, Titanium Dioxide, OCTISALATE, Zinc Oxide
Label structure8 sections

Indications and uses

Helps prevent sunburn

Dosage and administration

- Apply the adequate amount onto the entire face at the last stage of your skin care routine.  - Apply liberally 15 minutes before sun exposure. - Use a water-resistant sunscreen if swimming or sweating. - Children under 6 months of age: ask a doctor

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Ethylhexyl Methoxycinnamate (6%)

Titanium Dioxide (4.044%)

Ethylhexyl Salicylate (2%)

Zinc Oxide (1.92%)

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

Helps prevent sunburn

Warnings

WARNINGS SECTION

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

For external use only

Do not use when skin is red, inflamed, irritated, or painful

When using this product do not apply on other parts of the body do not use on damaged or broken skin avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water do not apply directly to wound or open cut

Stop use and ask a doctor if Rash or irritation on skin develops and lasts

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 (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

- Apply the adequate amount onto the entire face at the last stage of your skin care routine. 

- Apply liberally 15 minutes before sun exposure.

- Use a water-resistant sunscreen if swimming or sweating.

- Children under 6 months of age: ask a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

WATER, CYCLOPENTASILOXANE, METHYLPROPANEDIOL, TRIETHOXYCAPRYLYLSILANE, TRIMETHYLSILOXYSILICATE, DIMETHICONE, TRISILOXANE, PHENYL TRIMETHICONE, DIISOSTEARYL MALATE, TALC, METHICONE, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, TOCOPHEROL, DIMETHICONE/VINYLTRIMETHYLSILOXYSILICATE CROSSPOLYMER, ALUMINUM HYDROXIDE, ALUMINUM STEARATE, CETYL ETHYLHEXANOATE, DISTEARDIMONIUM HECTORITE, IRON OXIDES(CI 77492), TRIETHOXYCAPRYLYLSILANE, CAPRYLYL GLYCOL, PALMITIC ACID, TRIHYDROXYSTEARIN, GLYCERYL CAPRYLATE, IRON OXIDES(CI 77499), TRIETHOXYCAPRYLYLSILANE, ETHYLHEXYLGLYCERIN, LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL, ROSE FLOWER OIL, JUNIPERUS MEXICANA OIL, HYDROGENATED LECITHIN, CERAMIDE 3 (CERAMIDE NP), SUCROSE STEARATE, CHOLESTEROL, CHOLESTERYL MACADAMIATE, STEARIC ACID, HYDROLYZED LUPINE PROTEIN, SACCHARIDE ISOMERATE

Intensive Cover Blemish Balm

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

intensive cover bbintensive cover bb

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-138809086206885GTIN-13: 8809086206885
EAN-13: 8809086206885
GTIN storage (14 digits): 08809086206885
intensive cover bb.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52554-1113-22022-01-28C16284748780-1d6a99b39-82b1-a426-e053-dadaa90af4c2Intensive Cover Blemish Balm

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52554-1113-1Intensive Cover Blemish Balm30 mL in 1 TUBECREAM308
52554-1113-2Intensive Cover Blemish Balm1 in 1 PACKAGECREAM18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52554-1113INTENSIVE COVER BLEMISH BALM (ETHYLHEXYL METHOXYCINNAMATE, TITANIUM DIOXIDE, ETHYLHEXYL SALICYLATE, ZINC OXIDE) CREAM [CMS LAB INC.]8Legacy NDC, 2 package rows20171111_a9838ca8-31cd-430b-94d0-b0ee43222447.zip

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52554-111352554-1113-1, 52554-1113-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

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
a9796d5e-0551-4179-ac75-0b80088ab6b9a9838ca8-31cd-430b-94d0-b0ee432224472017-11-11WarningsExact identifier
spl id: a9796d5e-0551-4179-ac75-0b80088ab6b9
spl set id: a9838ca8-31cd-430b-94d0-b0ee43222447

Reported adverse events (FAERS/openFDA)#

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