Nubes SUN BLOCK

Manufacturer
UNIQUEMI | Kolmar Korea Co., Ltd
Effective date
2024-06-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:14:37

Label at a glance#

ProductNubes SUN BLOCK
Active ingredientHOMOSALATE, OCTINOXATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Homosalate 9.00% } ·········································Sunscreen

Octinoxate 6.80% } ···········································Sunscreen

Octisalate 4.50% } ············································Sunscreen

Octocrylene 4.00% } ·········································Sunscreen

Avobenzone 2.70% } ········································Sunscreen

INACTIVE INGREDIENT SECTION

Water, Propanediol, Butyloctyl Salicylate, Benzotriazolyl Dodecyl P-Cresol, Glycerin, Pentylene Glycol, 1,2-Hexanediol, Silica, Dimethicone/Vinyl Dimethicone Crosspolymer, Inulin Lauryl Carbamate, Vp/Eicosene Copolymer, Ammonium Acryloyldimethyltaurate/Vp Copolymer, Xanthan Gum, Ethylhexylglycerin,Iron Oxides(CI 77491), Iron Oxides(CI 77492), Bht, Tocophero

OTC - PURPOSE SECTION

helps prevent sunburn

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

keep out of reach of the children

INDICATIONS & USAGE SECTION

• Apply liberally and evenly 15 minutes before sun exposure.

• Reapply: At least 80 minutes after swimming or sweating,

immediately after towel drying, at least every 2 hours.

• For children under 6 months of age: Ask a doctor.

Sun Protection Measures. Spending time in the sun

increases your risk of skin cancer and early skin aging. To

decrease this risk, regulary use a sunscreen with a broad

spectrum SPF 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-sleeve shirts, pants, hats, and sunglasses.

WARNINGS SECTION

For extrernal use only.

Do not use on damaged or broken skin.

When using this product keep out of eyes. Rinse with water

to remove.

Stop use and ask a doctor if rash occurs.

Keep out of reach of children. If product is swallowed,

get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

topical use only

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
84514-0001-12025-07-29C16284748780-13b156c62-2e0a-fb37-e063-e6dba90a4e07Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84514-0001-1Nubes SUN BLOCK52 mL in 1 CONTAINERCREAM521

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84514-0001NUBES SUN BLOCK (HOMOSALATE, OCTINOXATE, OCTOCRYLENE,, AVOBENZONE) CREAM [UNIQUEMI]11 package rows20240704_1bb4a177-034c-e79d-e063-6294a90ab732.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84514-000184514-0001-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 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
1bb4a894-2c3b-5923-e063-6394a90aaa191bb4a177-034c-e79d-e063-6294a90ab7322024-06-25WarningsExact identifier
spl id: 1bb4a894-2c3b-5923-e063-6394a90aaa19
spl set id: 1bb4a177-034c-e79d-e063-6294a90ab732

Reported adverse events (FAERS/openFDA)#

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