FDA.reportPublic FDA data

Cell Fusion C Derma UV Mineral Sunscreen Broad Spectrum SPF 50

Manufacturer
CMS LAB Inc.
Effective date
2025-02-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:55:30

Label at a glance#

ProductCell Fusion C Derma UV Mineral Sunscreen Broad Spectrum SPF 50
Active ingredientZINC OXIDE
Label structure15 sections

Indications and uses

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

Dosage and administration

Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours. Use a water resistant sunscreen if swimming or sweating. Sun Protection Measures. 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: Limit time in the sun, especial...

Storage and handling

Protect this product in this container from excessive heat and direct sun. May stain some fabrics or surfaces.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 19.0%

PURPOSE

OTC - PURPOSE SECTION

Sunscreen

USES

INDICATIONS & USAGE SECTION

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

WARNINGS

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

  • Do not use​ on damaged or broken skin

OTC - WHEN USING SECTION

  • When using this product keep out of the eyes. Rinse with water to remove.

OTC - STOP USE SECTION

  • Stop use and ask a doctor if rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes before sun exposure.
  • Reapply at least every 2 hours.
  • Use a water resistant sunscreen if swimming or sweating.
  • Sun Protection Measures. 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:
  • Limit time in the sun, especially from 10 a.m.-2 p.m.
  • Wear long-sleeved shirts, pants, hats, and sunglasses
  • Children under 6 months of age: Ask a doctor.

OTHER INFORMATION

STORAGE AND HANDLING SECTION

  • Protect this product in this container from excessive heat and direct sun.
  • May stain some fabrics or surfaces.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Water, Cyclohexasiloxane, Isododecane, Butyloctyl Salicylate, 2,3-Butanediol, Propylheptyl Caprylate, Caprylyl Methicone, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Magnesium Sulfate, Centella Asiatica Extract, Citrus Aurantium Dulcis (Orange) Oil, Hippophae Rhamnoides Fruit Oil, Citrus Nobilis (Mandarin Orange) Peel Oil, Sodium Hyaluronate, Litsea Cubeba Fruit Oil, Lauryl Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Disteardimonium Hectorite, Methyl Methacrylate Crosspolymer, Polymethylsilsesquioxane, Triethoxycaprylylsilane, 1,2-Hexanediol, Alumina, Polyglyceryl-2 Dipolyhydroxystearate, Propylene Carbonate, Glyceryl Caprylate, Caprylyl Glycol, Ethylhexylglycerin, Tocopherol, Panthenol, Limonene, Citral, Linalool

QUESTIONS?

OTC - QUESTIONS SECTION

Call +1-949-418-8592
Outside U.S. +82-080-889-7760
cmslab_os@wonik.com

SPL UNCLASSIFIED SECTION

Distributed By
Hansung USA LLC
15375 Barranca Parkway
Suite B-109, Irvine, CA USA 92618
CMS LAB Inc.
www.cellfusionc.com
Made in Korea

PRINCIPAL DISPLAY PANEL: 50 ML / 1.69 FL.OZ. Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Cell Fusion C

DERMA
UV MINERAL
SUNSCREEN

BROAD SPECTRUM
SPF 50

SUITABLE FOR SENSITIVE SKIN
NATURAL FINISH

50 ML / 1.69 FL.OZ.

cell_fusion_c_derma_uv_mineral_sunscreen_spf50cell_fusion_c_derma_uv_mineral_sunscreen_spf50

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52554-9064-1Cell Fusion C Derma UV Mineral Sunscreen Broad Spectrum SPF 5050 mL in 1 TUBECREAM501
52554-9064-1Cell Fusion C Derma UV Mineral Sunscreen Broad Spectrum SPF 501 in 1 BOXCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52554-9064CELL FUSION C DERMA UV MINERAL SUNSCREEN BROAD SPECTRUM SPF 50 (HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE) CREAM [CMS LAB INC.]1Current NDC, 2 package rows20250221_2e5c2add-8ed0-a990-e063-6394a90a87ea.zip

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
52554-906452554-9064-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 31 matching rows.

Name, UNII, Kind table
NameUNIIKind
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
CITRALT7EU0O9VPPIACT
LINALOOLD81QY6I88EIACT
2,3-BUTANEDIOL45427ZB5IJIACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
CAPRYLYL GLYCOL00YIU5438UIACT
SODIUM HYALURONATEYSE9PPT4THIACT
.ALPHA.-TOCOPHEROL, DL-7QWA1RIO01IACT
CYCLOHEXASILOXANEXHK3U310BAIACT
ISODODECANEA8289P68Y2IACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
LAURYL POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S)H49Q67JS3BIACT
WATER059QF0KO0RIACT
CAPRYLYL METHICONEQ95M2P1KJLIACT
CENTELLA ASIATICA7M867G6T1UIACT
POLYMETHYLSILSESQUIOXANE59Z907ZB69IACT
1,2-HEXANEDIOLTR046Y3K1GIACT
ALUMINALMI26O6933IACT
LIMONENE, (+)-GFD7C86Q1WIACT
POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S)RLA2U05Z4QIACT
CITRUS AURANTIUM DULCIS (ORANGE) OILAKN3KSD11BIACT
PROPYLENE CARBONATE8D08K3S51EIACT
LITSEA CUBEBA FRUIT OIL2XIW34BN6OIACT
PANTHENOLWV9CM0O67ZIACT
PROPYLHEPTYL CAPRYLATE991Z19V2ODIACT
MAGNESIUM SULFATEDE08037SABIACT
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMEREG97988M5QIACT
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE9229XJ4V12IACT
GLYCERYL CAPRYLATETM2TZD4G4AIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
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
Cell Fusion C Derma UV Mineral Sunscreen Broad Spectrum SPF 50HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDECMS LAB Inc.2e5c2add-8ed0-a990-e063-6394a90a87ea2025-02-14WarningsExact identifier
ndc (package): 52554-9064-1
ndc (product): 52554-9064
ndc11 (package): 52554906401
spl id: 2e5c2af4-f033-aefe-e063-6394a90aa7b0
spl set id: 2e5c2add-8ed0-a990-e063-6394a90a87ea

Reported adverse events (FAERS/openFDA)#

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